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Offer No.

8662

Date March 6, 2015

Customer Marcyrl - Egypt

PRICED OFFER

This proposal is in accordance with the URS


with no exceptions thereto other than those listed in the attached
"Compliance Matrix/List of remarks to the URS".

ITEM A
MICRO MAIN LAB AUTOCLAVE

DESCRIPTION PRICE

EURO

AUTOCLAVE + ACCESSORIES

A.1) No.1 saturated steam sterilizer DLOV 10-10 1S type - in AISI 316L stainless steel 50.850,00
execution - nominal internal dimensions mm.450(h)x450(w)x1000(d) - nominal
volume 203 lts. - one automatic vertically sliding closing door

A.1.1) EXTRA for sterilizer execution with tight sealing system (bioseal) to isolate 6.740,00
loading side from technical area

* in alternative to Item A.1) *

A.2) No.1 saturated steam sterilizer DLOV 10-10 2S type - in AISI 316L stainless steel 57.000,00
execution - with double ended chamber for installation pass-through wall towards
a controlled contamination area (sterile zone) with tight sealing system (bioseal)
for no cross contamination nominal internal dimensions mm.450(h)x450(w)x
1000(d) - nominal volume 203 lts. - two automatic vertically sliding closing doors
fitted with relevant interlock device

A.2.1) EXTRA for sterilizer execution with double tight sealing system (double 6.740,00
bioseal) to isolate loading & unloading side from the technical area

A.3) EXTRA for body (chamber & door/s) active surfaces passivation according to De 3.770,00
Lamas procedure No.IO75-01 and ASTM No.A967 Standard Specification for
Chemical Passivation Treatments for stainless steel parts (where applicable)

A.4) EXTRA for one additional validation port for the chamber, with clamp connection, for 890,00
validation thermocouples (number of installed ports will become, in total, No.2)

A.5) EXTRA for piping active surfaces passivation according to De Lamas procedure 2.050,00
No.IO75-01 and ASTM No.A967 Standard Specification for Chemical Passivation
Treatments for stainless steel parts (where applicable)

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.1 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

DESCRIPTION PRICE

EURO

A.6) EXTRA for pressure reducing unit, made of AISI 316L stainless steel, fitted with 6.440,00
relevant valves, safety valve and accessories, for incoming process steam from factory
utility line to the chamber

A.7) EXTRA for equipment execution in order to perform chamber incoming steam quality 5.250,00
test according to EN 285 including suitable connections on the steam incoming pipe,
sample valve on the steam line, check valve, steam trap and cooler

A.8) EXTRA for system for recovery of water circulating into the jacket & the vacuum 3.500,00
pump fitted with storage tank, exchangers, pump, valves and accessories for a correct
operation

A.9) EXTRA for air filtering unit upstream vacuum pump composed of filter, valves, 7.330,00
temperature sensor, ancillary devices for a correct operation and S/W to perform
automatic PROGRAM A_LP useful for decontamination of solids at low pathogenic
risk Biological agent group 1 or 2 of the European Directive 2000/54/EC
NOTE : Such configuration is not suitable for treatment of high pathogenic risk
materials (Biological agent group 3 or 4 of the European Directive
2000/54/EC) and, therefore, De Lama is not liable for such unappropriate
use of the autoclave

A.10) EXTRA for two additional temperature sensors Pt 100 Ohm (management S/W 1.440,00
included) for temperature control inside the chamber or in the load (total number of No.2 sensors
installed temperature sensors will become : No.1 into the drain + No.3 into the
chamber or in the load + No.1 into the jacket)

A.11) EXTRA for air detector system to comply with HTM 2010, fitted with all ancillary 6.440,00
devices/accessories for a correct operation and needle valve for air detector calibration,
with S/W to perform automatic PROGRAM A_NCGT useful for sterilization of
solids and porous materials with measurement of level of non-condensable gases
contained in the steam before sterilization

A.12) Control and management system OLIMPYA/WP-TS type, fitted with relevant INCLUDED
thermic process printer and integrated touch screen, provided with standard S/W
package to perform following automatic standard programs:
PROGRAM I : automatic control/utility program chamber vacuum leakage
test according to European Standard EN 285
PROGRAM A : automatic sterilization program for solids (e.g. empty glassware,
rubber stoppers, aluminium caps, instruments, machine parts,
empty containers, filters, rubber materials, etc.) and porous
materials (e.g. textiles, etc.) with final drying
System, composed of PC + microprocessor based electronics (De Lama PLC), is
CFR-21 Part 11 compliant. Thanks to system H/W configuration and S/W modularity,
Customer can store as many cycles as he wants with virtually no limits, within
installed programs. It is possible, therefore, to create a Customized library of cycles,
stored with identification file names, with different parameters which can be selected
by the Operator according to type of load.
NOTE : System in standard configuration features a Ethernet I/F whose default
protocol DHCP (Dynamic Host Configuration Protocol) allows the
connection to existing remote PCs (or servers).

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.2 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

DESCRIPTION PRICE

EURO

No additional S/W is required since the process controller runs under


Windows operating system. Network configuration has to be performed by
the Customers on their own remote PC (or server).

A.13) EXTRA for additional programs useful for Customers applications:


PROGRAM BD : automatic control/utility program Bowie-Dick test FREE
according to European Standard EN 285 OF CHARGE
PROGRAM J : control/utility program for automatic Sterilize-In-Place of 2.580,00
the process air filter (instead of basic semi-automatic
sterilization)
NOTE : Temperature control inside filter housing is
performed by a dedicated temperature sensor
PROGRAM P : automatic control/utility program chamber pressure leakage 1.340,00
test according to HTM 2010
PROGRAM WIT_P : control/utility program for valves control step-by-step, via 5.200,00
HMI, to perform Water Intrusion Test of the process air inlet
filter through Sartocheck, Palltronic or other external
test system (not included in De Lamas scope of supply)
connected to the sterilizer with cycle tracking on the cycle
report (external test system does not exchange signals with
sterilizer and, therefore, is used in separate mode)
PROGRAM F_N : automatic sterilization program for liquid solutions 3.280,00
and/or culture media in sealed/unsealed glass or non
deformable containers with final natural cooling by inlet of
sterile compressed air for counterpressure inside the
chamber
S/W implementation on control system, suitable H/W and equipment configuration
necessary to perform programs are included.

A.14) Rails, made of AISI 316L stainless steel, placed inside the chamber, for trolleys/shelf INCLUDED
racks rolling

A.15) One set of loading/unloading accessories composed of:


A.15.1) No.1 in-chamber trolley, made of AISI 316L stainless steel, CCA2 type - 1.220,00
approx. dimensions mm.410(h)x410(w)x950(d) suitably designed to support
trays on adjustable levels and fitted with a number of brackets sufficient to
house the purchased number of trays only
A.15.2) No.3 multipurpose perforated trays, made of AISI 316L stainless steel, MIC 380,00
type - approx. dimensions mm.360(w)x950(d)x50(h) each tray
A.15.3) No.1 transfer trolley, made of AISI 304 stainless steel, ETASS/A type 2.000,00
approx. dimensions mm.900(h)x350(w)x1350(d) each trolley

NOTES :

a) Number of transfer trolleys can be doubled (two instead of one) if Customer


requires a double-door sterilizer (one trolley for loading side and one trolley for
unloading side)
b) Trolleys/trays load has been calculated on information available at present.

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.3 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

DESCRIPTION PRICE

EURO

Before issuing final offer (prior to Purchase Order), the load (quantity, dimensions
and weight) needs to be confirmed by the Customer in order to enable De Lama to
perform the final verification of trolleys/trays actual loading capacity.

A.16) EXTRA for autoclave configuration for working both by process steam coming from 4.050,00
factory utility line (at a pressure of 4 bar abs.) and by process steam from built-in clean
steam generator quoted at ITEM A.17)
Switching for required type of heating is performed through the HMI

A.17) EXTRA for built-in clean steam generator, electrically heated, DLSG/O/E/C-20 type - 10.250,00
suitable to feed the autoclave - body dimensions mm.300x500(d) - power : 20 kW -
steam production : approx. 27 kg/h at a max. pressure of 5 bar abs. Since the steam
generator is devoted to the autoclave it is managed by the main control system of the
autoclave itself.
NOTE : Steam generator production has been calculated on information available at
present. Before issuing final offer (prior to Purchase Order), the load
(quantity, dimensions and weight) needs to be confirmed by the Customer in
order to enable De Lama to perform the final verification of steam generator
production

DOCUMENTATION

A.18) De Lamas standard FAT protocol Factory Acceptance Test Doc. ID : FREE
FAT-00-G_xxxx, in English language, to be filled out during FAT. OF CHARGE
FAT execution is separately indicated at ITEM C).

A.19) De Lamas standard SAT protocol Site Acceptance Test Doc. ID : FREE
SAT-00-G_xxxx, in English language, to be filled out during SAT. OF CHARGE
SAT execution is separately quoted at ITEM C).

A.20) EXTRA for following additional De Lamas documentation, in English language,


useful to comply with Customers URS:
A.20.1) Pressure vessel drawing (including welding map) 2.090,00
A.20.2) Manufacturer Data Report for pressure vessels complete of mill certificates 5.740,00
A.20.3) 3D Design Drawings for Equipment and Piping complete of Piping Materials 12.390,00
& Welding Traceability including Welding Summary and Orbital welding
report
A.20.4) Manufacturer declaration for surface roughness and/or passivation for vessel 270,00
A.20.5) Boroscopic Inspection Report of the Internal Piping Welds (10% Automatic 2.040,00
100% Manual NDT Visual Inspection)
A.20.6) WPS and Welders certificate for pressure vessels 270,00
A.20.7) WPS and Welders certificate for piping 270,00
A.20.8) Welding filler materials and gas certificate for piping 750,00

NOTE : Should Customer require additional documents De Lama is available to


evaluate them and supply an eventual additional quotation

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.4 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

DESCRIPTION PRICE

EURO

A.21) De Lamas standard GAMP documentation in English language (see Paragraph 2.2 of 4.400,00
attached document - DOC ID : DOC-00-G_0000 Rev.14)

A.22) De Lamas standard IQ/OQ validation protocols, procedures and blank set of forms 3.300,00
Installation Qualification Doc. ID : IQ-00-G_xxxx and Operational Qualification
Doc. ID : OQ-00-G_xxxx in English language to be filled out during IQ/OQ.
IQ/OQ activities execution is not included in quoted price.

SPARE PARTS / PACKING

A.23) One set of recommended spare parts for two years of operation (electric & electronic Quoted
components excluded) on request

A.24) Seaworthy packing charges (autoclave + all relevant quoted accessories) 2.100,00

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.5 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

ITEM B
MICRO MAIN DISCARDING AUTOCLAVE

DESCRIPTION PRICE

EURO

AUTOCLAVE + ACCESSORIES

B.1) No.1 monobloc vertical saturated steam sterilizer DLV CAB-TS 50.80 type - in AISI 21.950,00
316L stainless steel execution internal dimensions mm.500x800(h) chamber
volume 170 lts. useful capacity 157 lts. No.1 horizontally swivelling lid - fed by
process steam from built-in clean steam generator.

COTS device (Commercial Of The Shelf). For the available documentation and
validation strategy, please refer to attached documents:
De Lama documentation list - Doc. ID : DOC-00-G_0000
Validation Strategy Standards - Doc. ID : VSS-00-G_0000

B.2) Vacuum pump group composed of liquid ring vacuum pump with relevant accessories INCLUDED

B.3) Built-in clean steam generator, electrically heated, DLSG/O/E/C-9 type - body dimen- INCLUDED
sions mm.220x500(d) - power 9 kW - steam production : approx. 12 kg/h at a max.
pressure of 5 abs. bar

B.4) EXTRA for autoclave arrangement for combinated heating : electrical (from built-in 1.000,00
steam generator) or by process steam from factory utility line. Switching for required
type of heating is performed through a 3-way manual valve fitted with limit switch in
order to monitor relevant position

B.5) EXTRA for air filtering unit upstream vacuum pump composed of filter, valves, 3.900,00
temperature sensor, ancillary devices for a correct operation and S/W to perform
automatic PROGRAM A_LP useful for decontamination of solids at low pathogenic
risk Biological agent group 1 or 2 of the European Directive 2000/54/EC
NOTE : Such configuration is not suitable for treatment of high pathogenic risk
materials (Biological agent group 3 or 4 of the European Directive
2000/54/EC) and, therefore, De Lama is not liable for such unappropriate
use of the autoclave

B.6) EXTRA for two additional temperature sensors Pt 100 Ohm (management S/W 1.440,00
included) for temperature control inside the chamber or into the load (total number of No.2 sensors
installed temperature sensors will become : No.1 into the drain + No.1 for the jacket +
No.1 for the steam generator + No.2 for the chamber or for the load)

B.7) Control and management system OLIMPYA/WP-TS type, fitted with integrated touch INCLUDED
screen, provided with standard S/W package to perform following automatic standard
programs:
PROGRAM I : automatic control/utility program chamber vacuum leakage
test according to European Standard EN 285
PROGRAM A : automatic sterilization program for solids (e.g. empty glassware,
instruments, machine parts, filters, rubber materials, etc.) and

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.6 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

DESCRIPTION PRICE

EURO

porous materials (e.g. textiles, etc.) with pulsated initial vacuum


and pulsated final drying
System, composed of PC + microprocessor based electronics (De Lama PLC), is
CFR-21 Part 11 compliant. Thanks to system H/W configuration and S/W modularity,
Customer can store as many cycles as he wants with virtually no limits, within
installed programs. It is possible, therefore, to create a Customized library of cycles,
stored with identification file names, with different parameters which can be selected by
the Operator according to type of load.
NOTE : System in standard configuration features a Ethernet I/F whose default
protocol DHCP (Dynamic Host Configuration Protocol) allows the
connection to existing remote PCs (or servers). No additional S/W is
required since the process controller runs under Windows operating
system. Network configuration has to be performed by the Customers on
their own remote PC (or servers).

B.8) EXTRA for additional programs useful for Customers applications:


PROGRAM J : control/utility program for Sterilize-In-Place of the air filter 2.200,00
PROGRAM F : automatic sterilization program for liquid solutions and/or culture 2.350,00
media in sealed/unsealed glass or non-deformable containers
with final cooling by inlet of sterile compressed air for counter-
pressure inside the chamber and water circulation inside the
jacket
S/W implementation on control system, suitable H/W and equipment configuration
necessary to perform programs are included

B.9) EXTRA thermic data printer 850,00

B.10) One set of loading/unloading accessories composed of:


B.10.1) No.2 open top wire baskets, made of AISI 316 stainless steel, MW type ( mm. 350,00
475x390h), with central lifting handle each basket

NOTE : Baskets load has been calculated on information available at present. Before
issuing final offer (prior to Purchase Order), the load (quantity, dimensions
and weight) needs to be confirmed by the Customer in order to enable De
Lama to perform the final verification of baskets actual loading capacity

DOCUMENTATION

B.11) De Lamas standard FAT protocol Factory Acceptance Test Doc. ID : FREE
FAT-00-G_xxxx, in English language, to be filled out during FAT. OF CHARGE
FAT execution is separately indicated at ITEM C).

B.12) De Lamas standard SAT protocol Site Acceptance Test Doc. ID : FREE
SAT-00-G_xxxx, in English language, to be filled out during SAT. OF CHARGE
SAT execution is separately quoted at ITEM C).

B.13) De Lamas standard GAMP documentation in English language (see Paragraph 2.2 of 3.200,00
attached document - DOC ID : DOC-00-G_0000 Rev.14)

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.7 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

DESCRIPTION PRICE

EURO

B.14) De Lamas standard IQ/OQ validation protocols, procedures and blank set of forms 2.400,00
Installation Qualification Doc. ID : IQ-00-G_xxxx and Operational Qualification
Doc. ID : OQ-00-G_xxxx in English language to be filled out during IQ/OQ.
IQ/OQ activities execution is not included in quoted price.

SPARE PARTS / PACKING

B.15) One set of recommended spare parts for two years of operation (electric & electronic Quoted
components excluded) on request

B.16) Seaworthy packing charges (autoclave + all relevant quoted accessories) 1.600,00

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.8 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

ITEM C
TRANSPORT + ACTIVITIES BY DE LAMAs PREMISES & ON SITE FOR No.2 UNITS

GENERAL NOTE
To quote transport and activities we took into consideration the following points:
that the No.2 units are ordered together (one single order)
that FAT is performed on the No.2 units at the same time
that the No.2 units are forwarded/shipped together
to optimize schedule of activities on site, reduce travel days with relevant costs, reduce costs for living and site
accommodation for De Lamas staff on site and avoid eventual non-working days at weekend we based our
quotation considering that the several activities are performed in succession on the No.2 units (one after the
other without stops) during one or multiple visits of De Lamas engineer.
In any case if Customer prefer/require to subdivide execution of activities in a different period or decide to purchase
only one of the quoted units De Lama is available to revise the offer accordingly.

DESCRIPTION TOTAL PRICE


FOR 2 UNITS

EURO

FAT

C.1) Factory acceptance test (FAT) by De Lamas premises in San Martino Siccomario
(Pavia), prior to delivery of the units, witnessed by max. No.23 inspectors (Customer
+ agent):
FAT execution with empty chamber and without load according to De Lamas FREE
standard document Factory Acceptance Test Doc. ID : FAT-00-G_ xxxx on No.2 OF CHARGE
units at the same time : No.2 days max. (No.8 working hours/day max.)
De Lamas internal costs to perform FAT (including use of necessary accessories, at De Lamas charge
instrumentation and utilities arrangement)
Travel charges and hotel accommodation (board and lodging expenses) for at Customers/
Customers/agents inspectors agents charge
Lunch expenses at De Lamas charge

NOTES :

a) In case staff in charge of FAT attendance is composed of more than No.23


inspectors, De Lama reserve the right to decide to charge additional costs for
management of such activities
b) De Lamas staff involved in FAT activity will carry out a short training to
Customers inspectors on equipment working and maintenance

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.9 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

DESCRIPTION TOTAL PRICE


FOR 2 UNITS

EURO

TRANSPORT / ACTIVITIES ON SITE

C.2) Charges for delivery FOB (Incoterms 2010) in Northern Italy Seaport for No.2 units 1.600,00
with relevant quoted accessories, shipped together
NOTE : Price does not include expenses for the legalization of documents
(original invoice + certificate of origin) that, if requested, will be quoted.

C.3) Equipment transport to Customers factory (with relevant insurance), off-load and at Customers charge/
handling activities inside Customers premises, eventual storage, unpacking, eventual out of De Lamas
lifting operations to bring equipment to final installation area, disposal of packaging scope of work
materials, final positioning at site, installation and connection of utilities to delivery
points (according to De Lamas instructions, indications and dwgs.)

C.4) Intervention of one De Lamas skilled engineer by Customers factory to carry out 10.900,00
following activities on the No.2 units: lump sum
check of correct installation and connection of utilities to delivery points (already
performed by Customers technical team or by Others on De Lamas instructions and
indications)
commissioning, start-up & training according to De Lamas document
Commissioning & Start-up Doc. ID : COMM-ML-G_xxxx
SAT according to De Lamas standard protocol Site Acceptance Test Doc. ID .
SAT-00-G_xxxx

Activities will be performed in succession on No.2 units (one after the other without
stops during one visit only).

Intervention total length : max. No.9 days (including work, travel days and max. one
non-working day at weekend) considering ten hours/day max. and one day off per
week (the last 12 days will be dedicated to the training of Customers staff).

The price is inclusive of return air ticket for De Lamas engineer.


The quoted lump sum does not include following items that will be fully at
Customers charge:
living and site accommodation (full board and lodging expenses) for De Lamas
engineer
all local transports on site for De Lamas engineer

NOTES :

a) Listed activities have to be performed within and not beyond 1 month from the
shipping/forwarding date. After such period, De Lama has the right to update the
applied service tariffs
b) Before the visit of De Lamas engineer the equipment should be already installed
and connected to utilities (utilities have to be available and in compliance with
required features : type, quality and quantity)
c) One Customers engineer will have to be available to support De Lamas engineer
during all intervention. Any activity will be witnessed by the Customers staff
d) Number of days to perform activities was estimated according to De Lamas
experience. Should additional days be necessary or should Customer require

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.10 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

DESCRIPTION TOTAL PRICE


FOR 2 UNITS

EURO

additional activities which are not expressly indicated in this quotation, exceeding
days will be invoiced, according to daily working reports duly signed by the
Customer for acceptance, at the following rates and conditions:
daily rate for each eventual additional weekday EURO 980,00=/day
of work or travel (ten hours per day max.)
daily rate for each eventual additional non- EURO 640,00=/day
working day at week-ends or holidays
eventual additional expenses for living and at Customers charge
site accommodation (full board and lodging
expenses)
eventual additional air ticket/s at Customers charge
eventual additional local transport on site at Customers charge

C.5) IQ/OQ activities execution at Customers charge


alternatively
quoted on request

C.6) PQ activities & Biological Qualification activities execution at Customers charge/


out of De Lamas
scope of work

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.11 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

DE LAMAs COMPLIANCE MATRIX/LIST OF REMARKS TO THE URS

Considering that the offered De Lamas sterilizers satisfy documents sent to De Lama, the present
compliance matrix refers only to:
items/documents for which some remarks are necessary
items to which De Lamas does not comply
items not applicable to De Lamas scope of supply

1) Doc. Ref. : Micro main lab autoclave URS

Items Requirement DE LAMAs remarks


and/or deviations

Construction A quarter inch BSP port should be present at lower Such requirement is not clear and needs to be
& utilities portion of chamber to attach air flow meter expanded by the Customer.

Construction Automatic chamber & jacket pressure safety valves with Operator can vent via HMI using the appropriate
& utilities manual pressure relief valves. cycle.

Installation of manual valves is very dangerous


especially in case of liquid loads since it overrides
all safety devices linked to the temperature and
the pressure reading. Customer requirement is not
recommended by the safety regulations and,
therefore, is not applicable to De Lamas scope of
supply.

Monitoring Chamber & jacket differential pressure gauges. Chamber and jacket pressure is monitored by
Bourdon pressure/vacuum gauges not by
differential pressure gauges.

Software Allowing develop of new cycles with different phases Such functionality is not allowed.
option Thanks to system H/W configuration and S/W
modularity, Customer can store as many cycles as
he wants with virtually no limits, within installed
programs. It is possible, therefore, to create a
Customized library of cycles, stored with
identification file names, with different parameters
which can be selected by the Operator according
to type of load

2) Doc. Ref. : Micro lab discarding autoclave URS

Items Requirement DE LAMAs remarks


and/or deviations

2.3 Software can allow developing of different cycles. (Not Such functionality is not allowed.
already existed in software). Thanks to system H/W configuration and S/W
modularity, Customer can store as many cycles as
he wants with virtually no limits, within installed
programs. It is possible, therefore, to create a
Customized library of cycles, stored with
identification file names, with different parameters
which can be selected by the Operator according
to type of load

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.12 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

EXCLUSIONS
Following additional items are out of De Lamas scope of supply:
general construction works including civil, structural and architectural
utilities inlet piping
safety valve external conveying system
silicone sealing of air tight system/s (bioseal/s) to walls and floor of the Customers building
discharge/drain piping and vents
optional equipment, accessories and activities not specifically indicated in the offer

ADDITIONAL REMARKS
All documentation will be issued in English language on De Lamas forms and according to De Lamas
templates.
Should Customer require customized documentation involving overhauls of De Lamas standard documents or
compliance with specific needs, De Lama is available to supply relevant additional quotation.
Unless differently specified in the URS, documents that will be submitted to Customer for their approval are the
lay-out and the fluids data sheets
De Lama will provide to inform Customer, suitably in advance, about plant ready for FAT. In case such activity
cannot be performed within 30 days from De Lama notification, owing to Customer impossibility to be present,
FAT will be carried out by De Lama engineers. In this case, such activities, not witnessed by the Customer, will
have full contractual value.
Activities on site (commissioning, start-up, etc.) performed by Bioflow will be carried out according to De
Lamas standard protocols.
Should Customer require activities execution according to customized procedures involving overhauls of De
Lamas standard protocols, De Lama is available to supply relevant additional quotation
Any kind of activity included in the present offer, both free of charge or for a valuable consideration, has to be
deemed tacitly no more feasible, at terms indicated in the offer itself, if it is not required and performed, for
reasons not imputable to De Lama, within 24 months from shipping/forwarding date. This is valid unless clauses
otherwise agreed with Customer.
In case of performances already paid, payment has to be considered no more refundable.

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.13 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

SPECIAL TERMS OF SALE


DELIVERY TERM FOB (Incoterms 2010) in Northern Italy Seaport

PACKING as indicated in the priced offer

DELIVERY TIME equipment ready for FAT execution after 5 6 months from receipt of order (complete of all
(AUGUST AND technical details to start production ) + 30% downpayment.
DECEMBER NOTE : Shipment/forwarding date can be increased of approx. 1 week in case passivation is
EXCLUDED) purchased
Order will be deemed executive only after receipt of downpayment.
Delivery schedule can, however, be agreed according to Customer requirements

PAYMENT 30% on order by bank transfer


70% covered by irrevocable documentary credit confirmed by De Lamas bank
that will be communicated in phase of order.
L/C involving issue of drafts will not be accepted.
Documentary credit, whose text will have to be approved by De Lama, will be payable at
sight against shipping documents presentation.
Documentary credit expenses will be in full at opener account (including even charges
for confirmation). Place of payment has to be Pavia.
Goods belong to De Lama till the complete payment of the price from the Buyer.
It is expressly foreseen the possibility for De Lama to transfer the credit of the purchase
contract to a primary Factoring Company. Moreover, Customer will have to be fully available
to receive and to accept any notification that Factoring Company will sent to them, via the
most suitable mean of communication, at the beginning of the relationship and at any time

WARRANTY 12 months from the shipping/forwarding date.


NOTE : Should plant putting into service be delayed, Customer will have to take
care of equipment proper/suitable storage in order to avoid any damage
arising from temperature/humidity/particulate (in particular to mechanical
parts - e.g. vacuum pump - electronic components and filters).
Terms of warranty are detailed indicated in our attached General Terms of Sales (CGV Rev.6)
which are an integral part of this offer unless differently specified in these Special Terms of
Sale. In particular, De Lama highlights that warranty will include only charges for components
to be substituted and labour by DE LAMAs factory. Therefore, transport costs for the
components and travel charges, full board and lodging expenses, travelling allowance and
engineers travelling hours are excluded.
If plant malfunctioning during warranty period can be traced to bad use from Customer or to
facts not imputable to De Lama, all burdens will be invoiced to Customer according to terms
and rates in force. Electronic parts and parts in glass, rubber, plastic and all parts subject to
normal wear are excluded from warranty.
Owing to their particular structural fragility and typical working conditions, absolute filters and
prefilters are excluded from the warranty once they are delivered and accepted by the
Customer in normal integrity conditions (even if installed on a plant)

OFFER VALIDITY May 15, 2015

OTHER CONDITIONS For everything else not specifically indicated in this offer, annexed De Lamas general terms of
sale (CGV Rev.6) have to be considered valid. In case of conflict between De Lamas Special
Terms of Sale and De Lamas General Terms of Sale priority will be given to Special Terms.

Enclosures : Typical technical specifications of quoted units complete of relevant attachments and preliminary lay-out dwgs.
No.504046 Rev.0 and No. LAY-00-G_DLVCAB Rev.0 with preliminary fluids data sheets No.DLOV 10-10 FDS
Rev.1 and No.DLV CAB 50.80 FDS Rev.1

Priced Offer / Compliance matrix to the URS / Special Terms of Sale Page No.14 of No.51
Document ID PEFS-00-G_DLOV

Document title Typical preliminary specification of saturated steam sterilizers


DLOV series

Document preparation and approval

Issue
Issue Date Written by Reviewed by Approved by
Description
First issue A. Monegato A. Muggiasca G. Botteri
0 March 27, 2007
for offer Technical Dept. Technical Manager Quality Assurer

Revised A. Monegato A. Muggiasca G. Botteri


1 July 25, 2007
to add options Technical Dept. Technical Manager Quality Assurer

Revised to update A. Monegato A. Muggiasca G. Botteri


2 Oct.5, 2007
documentation Technical Dept. Technical Manager Quality Assurer

Revised to update A. Monegato A. Muggiasca G. Botteri


3 Nov.30,2007
process data Technical Dept. Technical Manager Quality Assurer

A. Monegato A. Muggiasca G. Botteri


4 Jan.30, 2008 General update
Technical Dept. Technical Manager Quality Assurer

Revised D. Bianchi A. Muggiasca G. Botteri


5 Apr.3, 2008
to update finish Technical Dept. Technical Manager Quality Assurer
Revised S. Noviello
A. Muggiasca G. Botteri
6 Apr.23, 2008 to update safety Electrical Design
Technical Manager Quality Assurer
devices Dept.
Revised
M. Bianchi A. Muggiasca G. Botteri
7 June 25, 2008 to update applicable
Technical Dept. Technical Manager Quality Assurer
documents
A. Monegato A. Muggiasca G. Botteri
8 Dec.15, 2008 General update
Technical Dept. Technical Manager Quality Assurer

A. Monegato A. Muggiasca G. Botteri


9 Feb.25, 2010 General update
Technical Dept. Technical Manager Quality Assurer

A. Monegato A. Muggiasca G. Botteri


10 Oct.10, 2011 General update
Technical Dept. Technical Manager Quality Assurer

A. Monegato A. Muggiasca G. Botteri


11 May 28, 2013 General update
Technical Dept. Technical Manager Quality Assurer

A. Monegato A. Muggiasca G. Botteri


12 Oct.20, 2014 General update
Technical Dept. Technical Manager Quality Assurer

This document, sole property of De Lama S.p.A., contains Company information and shall not
be released to, nor discussed with third parties, nor duplicated totally or partially by any
method without the express permission of De Lama S.p.A. who will safeguard their rights
according to the provision of the law.
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

TABLE OF CONTENTS

1. OVERVIEW ..................................................................................................................................................... 18
2. STANDARDS AND GUIDELINES ................................................................................................................ 18
3. DESIGN AND OPERATING CONDITIONS ................................................................................................. 18
3.1 Optionals .................................................................................................................................................. 18
4. DIMENSIONAL DATA ................................................................................................................................... 18
4.1 CAPACITIES .......................................................................................................................................... 18
4.2 CHAMBER NOMINAL INTERNAL DIMENSIONS ............................................................................ 19
4.3 EQUIPMENT OVERALL DIMENSIONS ............................................................................................. 19
5. CONSTRUCTION FEATURES....................................................................................................................... 19
5.1 PRESSURE VESSEL .............................................................................................................................. 19
5.1.1 Optionals....................................................................................................................................... 19
5.2 DOOR/S ................................................................................................................................................... 20
5.2.1 Available type of door/s:............................................................................................................... 20
5.2.2 Optionals....................................................................................................................................... 20
5.3 INSULATION/LAGGING ...................................................................................................................... 21
5.3.1 Optionals....................................................................................................................................... 21
5.4 PANELING ............................................................................................................................................. 21
5.4.1 Optionals....................................................................................................................................... 21
5.5 PIPING SYSTEM .................................................................................................................................... 21
5.5.1 Optionals....................................................................................................................................... 22
5.6 FLUIDS FILTRATION ........................................................................................................................... 23
5.6.1 AIR FILTER ................................................................................................................................. 23
5.6.2 OPTIONAL STEAM FILTER ..................................................................................................... 24
6. SAFETY DEVICES.......................................................................................................................................... 24
7. INSTRUMENTATION .................................................................................................................................... 24
7.1 PRESSURE INDICATORS ..................................................................................................................... 24
7.1.1 Optionals....................................................................................................................................... 24
7.2 PRESSURE INSTRUMENTS ................................................................................................................. 25
7.2.1 Optionals....................................................................................................................................... 25
7.3 TEMPERATURE SENSORS .................................................................................................................. 25
7.3.1 Optionals....................................................................................................................................... 25
7.4 TEMPERATURE INSTRUMENTS ........................................................................................................ 25
7.4.1 Optionals....................................................................................................................................... 25
7.5 ADDITIONAL OPTIONAL INSTRUMENTS ....................................................................................... 25
7.5.1 Level instrument ........................................................................................................................... 25
7.5.2 Air detector system ....................................................................................................................... 25
8. OPTIONAL AUTOCLAVE CONFIGURATIONS (quoted on request).......................................................... 26
8.1 VERSION TO PERFORM STERILIZATION BY STEAM+FORMALDEHYDE ................................ 26
8.2 VERSION TO PERFORM WASHDOWN TREATMENTS .................................................................. 26
8.3 AIR/STEAM MIXTURE VERSION ...................................................................................................... 26
8.4 HIGH PATHOGEN VERSION ............................................................................................................... 26
8.5 VERSION TO PERFORM EVEN STERILIZATION BY SUPERHEATED WATER ......................... 27
9. ELECTRICAL SYSTEM ................................................................................................................................. 28
10.CONTROL AND MANAGEMENT SYSTEM ................................................................................................ 28
11.WORKING PROGRAMS ................................................................................................................................ 28
11.1 DESCRIPTION OF STANDARD STORED PROGRAMS .................................................................... 30
11.1.1 DESCRIPTION OF CONTROL/UTILITY PROGRAM ............................................................. 30
11.1.2 DESCRIPTION OF STERILIZATION PROGRAM ................................................................... 30
12.TECHNICAL PERFORMANCES ................................................................................................................... 30
12.1 TEMPERATURE UNIFORMITY INSIDE THE EMPTY CHAMBER ................................................. 30
12.2 TEMPERATURE UNIFORMITY INSIDE THE LOAD TO BE STERILIZED .................................... 30
13.TEST PRESSURE ............................................................................................................................................ 31
14.TECHNICAL DATA, UTILITIES AND FLUIDS........................................................................................... 31
15.IDENTIFICATION DATA............................................................................................................................... 31
16.DOCUMENTATION ....................................................................................................................................... 31
17.NOTES.............................................................................................................................................................. 31

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.16 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

18.LOADING/UNLOADING ACCESSORIES .................................................................................................... 31


18.1 IN-CHAMBER TROLLEY CCA2 type............................................................................................... 31
18.1.1 FEATURES .................................................................................................................................. 32
18.1.2 OPTIONALS ................................................................................................................................ 32
18.1.3 APPROX. DIMENSIONS ............................................................................................................ 32
18.2 MULTIPURPOSE PERFORATED TRAY MIC type ......................................................................... 32
18.2.1 FEATURES .................................................................................................................................. 32
18.2.2 OPTIONALS ................................................................................................................................ 32
18.2.3 APPROX. DIMENSIONS ............................................................................................................ 32
18.3 TRANSFER TROLLEY ETASS/A type (for autoclaves).................................................................... 32
18.3.1 FEATURES .................................................................................................................................. 33
18.3.2 OPTIONALS ................................................................................................................................ 33
18.3.3 APPROX. DIMENSIONS ............................................................................................................ 33

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.17 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

1. OVERVIEW
The saturated steam sterilizers DLOV type are the most versatile autoclaves, designed to meet the widest
requirements of the Pharmaceutical Industry. Sterilizers incorporate a high degree of operational flexibility
that enable them to be used even for a wide range of industrial and laboratory applications.
Fields of application:
Sterilization of solids (e.g. empty glassware, stainless steel items, parts of equipment, tools, etc.)
Sterilization of porous materials (e.g. textiles)
Sterilization of stoppers and rubber materials
Sterilization of filters and respective accessories
Sterilization of filled glass or non-deformable containers (e.g. ampoules, bottles, etc.)
Sterilization of products used at animal facilities (e.g. cages, beddings, feedstuffs, etc.)
Decontamination of solids at low pathogenic risk (biological agents group 1 or 2 of the European Directive
2000/54/EC)
Tyndallization of products sensitive to high temperatures
Pasteurization for treatment of packed food products
Washdown treatments for removal of powder residuals, particulates, contaminants
Autoclave in basic configuration is suitable to perform sterilization of solids and porous materials and is
fitted with control/utility programs.
Some of the above-mentioned applications can be carried out only if suitable equipment options are
purchased and installed.

2. STANDARDS AND GUIDELINES


Equipment is designed, manufactured and tested in compliance with UNI EN ISO 9001 and UNI EN ISO
13485 Quality Management Systems procedures, following cGMP requirements, FDA and cGAMP
Guidelines.
De Lamas document Applicable Standards, Directives and Guidelines Doc. ID : DLSTD-00-G_0000 is
applicable to De Lamas scope of supply.

3. DESIGN AND OPERATING CONDITIONS


Sterilizer DLOV type is designed, manufactured and tested according to European Pressure Equipment
Directive (P.E.D.) No.97/23/EC.
Structural calculations and relevant realization consider following parameters:
design pressure : 3,5 bar abs.
design temperature : 138,2C
max. operating pressure : 3,5 bar abs.
max. operating temperature : 138,2C
Autoclave is tested according to parameters and criteria fixed by the applicable pressure vessels code.

3.1 Optionals

Following items are out of the scope of supply and can be quoted on request:
autoclave design for operation at higher pressure/temperature
autoclave design, manufacture and test in compliance with other pressure vessels codes

4. DIMENSIONAL DATA

4.1 CAPACITIES

NOMINAL VOLUME : lts. 203

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.18 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

4.2 CHAMBER NOMINAL INTERNAL DIMENSIONS

HEIGHT : mm. 450


WIDTH : mm. 450
DEPTH : mm.1000

4.3 EQUIPMENT OVERALL DIMENSIONS

See preliminary lay-out dwg.

5. CONSTRUCTION FEATURES

5.1 PRESSURE VESSEL

The horizontal body, parallelepiped double-wall type, has following main features:
Internal vessel (chamber + door/s) made of highly satin finish (Ra < 0,375 m) high thickness AISI
316L stainless steel sheet with rounded edges to avoid undesired accumulation of solid particles in the
corners or in the plate bends and to allow easy cleaning.
Chamber bottom, converging towards the drain, assures the liquids and condensates full drainage.
All internal components have been carefully designed to avoid pockets or sharp edges.
Dimple shell, made of AISI 304 stainless steel, with U-shaped stiffeners. Such shell, covering the
whole external chamber, forms a jacket used for heating, load drying and eventual cooling (by water
circulation)
Set of outlet/inlet connections for supply of the utilities made of AISI 316L stainless steel
One special port, with clamp connection, for access of thermocouples or flexible temperature sensors
Pt 100 Ohm to be used for validation activities

5.1.1 Optionals

Following items are out of the scope of supply and can be quoted on request:
autoclave design to perform loading/unloading operations at floor level. If such execution is
requested, equipment will have to be installed in a pit (suitably arranged by the Customer) and
will be fitted with foldaway bridge/s useful for joining the sterilizer to the floor in order to
enable shelf-racks/trolleys pushing/extraction (bridge/s, hinged to the chamber bottom, is/are
housed into the chamber itself when the door/s is/are closed and act as a device useful to block
shelf-racks/trolleys after loading)
chamber contact parts in AISI 316Ti stainless steel
mirror polished internal finishing Ra < 0,375 m
body active surfaces passivation according to De Lamas procedure No.IO75-01 and ASTM
No.A967 Standard Specification for Chemical Passivation Treatments for stainless steel
parts (where applicable)
jacket execution in AISI 316L stainless steel
system for recovery of water circulating into the jacket fitted with storage tank, pump,
exchanger, valves and accessories for a correct operation
tub, made of AISI 304 stainless steel, located on the equipment support frame, with drainage
hole, for the collection of eventual drippings
additional ports
temperature sensors coupling device (probe holder) in AISI stainless steel, fitted with tri-clamp
connection, for passage of up to No.32 thermocouples
device useful for heating of chamber incoming air and improve drying performances, mainly
composed of a steam powered exchanger with relevant ancillary devices and accessories for a
correct operation
ventilator system useful to grant the best heat distribution, speed up load cooling operations in
counterpressure and improve drying performances in the respective cycles
exchanging plates, made of AISI 316L stainless steel, located on the chamber lateral walls, to
improve thermal exchange during the cycles involving cooling phases

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.19 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

5.2 DOOR/S

Autoclave is available in the following versions:

Single door version : sterilizer is fitted with one door. Loading/unloading operations are
performed on the same side

Double door version : sterilizer is pass-through type fitted with a single door on each side (one
for loading and one for unloading).
Double ended chamber is standard designed for installation pass-
through wall towards a controlled contamination area (sterile area). Seal
system consists of a compensation structure, in fine satin finish stainless
steel, welded to the chamber on unloading side, which provides for a
full air-tight barrier (bioseal) avoiding any cross-contamination
Such structure, together with doors interlock device and doors gaskets,
assures the best insulation between the different working areas.
The structure sealing to walls and floor of the Customer building will
have to be made on site and is not included in De Lamas scope of
supply.

5.2.1 Available type of door/s:

5.2.1.1 Automatic sliding type

Automatic sliding door/s (vertically or horizontally sliding according to door/s size - see
preliminary lay-out). Door/s translation is performed through gearmotor and
chain/toothed belt (respectively if vertically or horizontally sliding).
Opening/closing system, of De Lamas exclusive design, guarantees best sealing and
smooth and safe operation.
Door/s peripheral sealing gasket, with special profile, is in silicone rubber withstanding
high operating temperatures. Gasket is housed in a milled gasket seat which prevents
any leakage.
Gasket pushing towards the door/s is made by compressed air thrust behind the gasket
itself.

5.2.1.2 Semi-automatic hinged type

Door/s swinging is made manually while the locking/unlocking operations are


automatically performed by two operating pushbuttons (open/closed) and controlled by
limit-switches.
Opening/closing system, of De Lamas exclusive design, guarantees best sealing and
smooth and safe operation with no physical effort.
Door/s peripheral sealing gasket, with special profile, is in silicone rubber withstanding
high operating temperatures. Gasket is housed in a milled gasket seat which prevents
any leakage.
Gasket pushing towards the door/s is made by compressed air thrust behind the gasket
itself

5.2.2 Optionals

Following items are out of the scope of supply and can be quoted on request:

5.2.2.1 Single door version

tight sealing system (bioseal) to isolate loading side from the technical area (to keep
the pressure of each area in case of different sterility classes) with eventual air tight
execution of the technical area service door
viewing port for inspection on the door (eventually fitted with built-in light)

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.20 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

5.2.2.2 Double door version

autoclave without tight sealing system (bioseal)


double tight sealing system (double bioseal) to isolate loading & unloading sides from
the technical area with eventual air tight execution of the technical area service door
viewing ports for inspection on the doors (eventually fitted with built-in light)

5.3 INSULATION/LAGGING

The whole autoclave body is insulated by suitable high thickness asbestos free and chlorine free
material useful for personnel protection and for heat loss prevention.
Chamber insulation is standard covered by aluminium sheet panelling. Door/s insulation is standard
covered by a dual layer aluminium/AISI 304 stainless steel sheet.
Insulation assures a temperature on external surfaces lower than 40C with ambient temperature of
22C.

5.3.1 Optionals

Following items are out of the scope of supply and can be quoted on request:
chamber insulation covering by AISI 304 stainless steel sheet
door/s insulation covering by dual layer aluminium/AISI 316L stainless steel sheet

5.4 PANELING

Autoclave is fitted with external panels made of AISI 304 stainless steel (three sides).

5.4.1 Optionals

Following items are out of the scope of supply and can be quoted on request:
External panels made of AISI 316L stainless steel
Extension of panels to the suspended ceiling (suspended ceiling height to be communicated by
the Customer)
Support base made of AISI 304 stainless steel (height mm.100) eventually shaped to allow
water drainage and/or sealing to the floor

5.5 PIPING SYSTEM

The hydraulic piping is wholly made of AISI 316L stainless steel with internal surface having
roughness Ra 0,8m.
Pipes connections are made by tri-clamp couplings with suitable seals except for some special
requirements due to operating temperatures/pressures.
Hot pipes are insulated by special material to reduce heat loss (cellular silicone).
Components in direct contact with noble fluids (process steam, process air and process water) are made
of AISI 316L stainless steel.
Gaskets are made of teflon/silicone.
Specific construction criteria relevant to valves connection systems and piping slope towards drainage
will be in full compliance with cGMP and FDA Guidelines.
Main components:
One automatic steam trap, for the jacket, to discharge condensate and cold air
One set of manual valves and fittings to allow eventual emergency/maintenance operations
One on/off valve upstream the modulating valve
One pneumatic proportional valve (modulating valve) for steam pressure regulation inside the
chamber
One set of pneumatic on/off valves complete of position visual indicator and manual control of the
relevant solenoid valve
One strainer filter located on the chamber drain
One strainer filter located on the jacket drain

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.21 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - E
Egypt

One vacuum m pump grouup composed of liquid ring vacuum puump (with body made of cast c iron),
relevant acccessories and pressure
p switcch to check sooftened water supply
s from thhe battery lim
mit and rise
an alarm in case of waterr lack/insufficiient pressure
Two m
marked safety valves, testedd and approveed according to applicable pressure vesssels code,
protecting thhe chamber annd the jacket, with external parts made of brass

5
5.5.1 Option
nals

wing items are out of the scoope of supply and can be quuoted on requeest:
Follow
pipinng system in contact
c with thhe sterilizationn chamber acccording to ISO O 1127 and AS SME BPE
20122 with dead legg <2D where possible (wheere not, dead leg l <6D)
pipinng system in contact withh the sterilizaation chamberr (valves exccluded) in fulll sanitary
desiggn, accordingg to ISO 11277 and ASME E BPE 2012, with piping iinternal surfaace having
rougghness Ra 0,51 m and saanitary tri-clam mps couplingss
pipinng active surffaces passivatiion or passivaation & electrropolishing acccording to De D Lamas
procedure No.IO775-01 and AST TM No.A967 Standard Sppecification foor Chemical Passivation
P
Treaatments for staainless steel paarts (where applicable)
a
hot pipes
p insulatioon by rock wool cladded by y aluminium orr AISI 304 staainless steel
cold pipes insulatiion by Armafllex cladded by b aluminium or AISI 304 sstainless steel
diaphhragm sanitarry valves, madde of AISI 316 6L stainless stteel, on processs fluids lines
devicce, fitted witth air break, suitable to cool c drain. Device
D is avaiilable in the following
versiions:
tannk fed by servvice water, made of AISI 304 3 stainless steel,
s with rellevant ancillarry devices
(coooling water spray
s nozzles, on/off valve, thermostat foor temperaturee regulation, etc.)
exchanger, fed by b chilled watter, with relev vant ancillary devices
d
presssure reducing unit, fitted with
w relevant valves,
v safety valve and accessories, for incoming
comppressed air to the chamber
buffeer device, fitteed with relevaant accessoriess, to ensure suupply of comppressed air for sealing to
doorr/s in case of utility
u loss
presssure reducing unit, fitted with
w relevant valves,
v safety valve and accessories, for incoming
process steam to thhe chamber
presssure reducing unit, fitted with
w relevant valves,
v safety valve and accessories, for incoming
industrial steam too the jacket
equippment executiion in order too perform chamber incominng steam qualiity test accord ding to EN
285 with
w a samplee point on the steam line eveentually fittedd with cooler
vacuuum pump entirely made off AISI 316L sttainless steel
cham mber safety vaalve entirely made
m of AISI 316L
3 stainlesss steel
ruptuure disk/s for chamber
c & jaacket (instead of safety valvves)
ruptuure disk/s betw ween chamberr/jacket & safe fety valves
set of
o monitoring devices, direcctly connected d to control syystem, to checck utilities suupply from
the battery
b limit and
a rise an alaarm in case off fluids lack/innsufficient preessure (pressu ure-gauges
fittedd with electricc contact for alarm
a or pressu ure switches)
thermmostat to conntrol the tem mperature of the water to the vacuum m pump/jackett, directly
connnected to the control
c systemm, to rise an ev ventual overtem mperature alaarm
thermmometer for loocal indicationn of water tem mperature (servvice water andd/or process water)
w
doubble water inlett : one for RO O water and on ne for WFI (thhe two inlet coonnections willl be fitted
with automatic onn/off valves - valve for WF FI will be saniitary type. Vaalves are equipped with
limitt switch in orrder to have safety
s feedbacck of the watter fed to the autoclave. Th he control
systeem will enablee the Operatoor to select thee proper sterillization prograam with differrent water
feediing according to product to be sterilized))
steamm traps for draainage of the condensate co oming from thhe process steeam and the pllant steam
distribution lines
dryinng manifold forfo process steeam to the chaamber mainly composed off a steam sepaarator with
steamm trap, check valve and all ancillary deviices and accesssories for a coorrect operatio on
headder, made of galvanized steel, s fitted with
w flange too connect saffety valves to ogether to
Custtomer exhaustt system (ducct from headeer to exhaust system out oof De Lamass scope of
suppply)
singlle or double liimit switches on pneumatic valves in ordder to monitor their position n

Docu
ument ID : PE
EFS-00-G_DLO
OV Rev.12 Date : Oct.20, 2014 Page No.2
22 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

system for recovery of water circulating into the vacuum pump fitted with storage tank,
exchanger, valves and accessories for a correct operation
heat exchanger to cool down condensates prior to entry into the vacuum pump
sample valves on process fluids incoming lines
strainer filter/s to be located upstream the utilities incoming lines in order to avoid eventual
entrainment of impurities
shut-off valve/s to be located upstream the incoming utilities connections
non-return valve/s for backflow prevention on utilities incoming lines
non-return valve for backflow prevention on the chamber drain (air break to be provided at
Customer charge)

5.6 FLUIDS FILTRATION

5.6.1 AIR FILTER

Autoclave is standard fitted with an air inlet filter, sterilize-in-place type, with 0,22 micron
cartridge and housing made of AISI 316L stainless steel, for process air, atmospheric air (for
pressure balance) and vacuum break.
Sterilize-In-Place of the air filter is performed:
by semi-automatic mode (basic configuration)
by fully automatic mode (optional quotation)
The absolute filter is assembled and equipped with fittings/manual valves for connection to
Sartocheck, Palltronic or other similar test system (out of De Lamas scope of supply) in
order to perform WIT.

5.6.1.1 Optionals

Following items are out of the scope of supply and can be quoted on request:
additional air filter 0,22 m in series to the standard already installed air filter
air inlet filter location in an alcove, on the loading side, in order to assure relevant
inspection, removal, change, testing, WIT and sterilization in place with no need of
access to the technical area
fittings for air inlet filter connection to Sartocheck, Palltronic or other external
test system (not included in De Lamas scope of supply) located in an alcove, on the
loading side, in order to perform WIT with no need of access to the technical area
autoclave execution with automatic valves to perform Water Intrusion Test of the
process air filter through Sartocheck, Palltronic or other external test system (not
included in De Lamas scope of supply). Two S/W configurations are available:
valves control via HMI without cycle tracking on the cycle report
valves control step-by-step via HMI through a suitable control/utility program
(PROGRAM WIT_P) with cycle tracking on the cycle report
built-in device useful to perform integrated air filter Water Intrusion Test (WIT)
without the use of Sartocheck, Palltronic or other external test system. All
operations are performed thanks to the additional configuration integrated in the
autoclave itself (piping, hydraulic components, accessories and relevant S/W) and
managed by the autoclave main control system. The Water Intrusion Test is,
therefore, configured as a simple service program which is always available, with no
need to connect additional equipment to the sterilizer, and which can be performed in
every moment thus reducing quarantine times of sterilized load. H/W configuration
and S/W were developed and validated in cooperation with Sartorious (on request, the
built-in device is also available for Pall filters)
NOTE : In order to perform WIT through the built-in device, WFI at a max.
temperature of 25C has to be available. If not, Customer has to foresee
purchase of a system to condensate process steam into WFI whose
quotation is supplied on request
additional absolute filter/s, with 0,22 m cartridge and housing made of AISI 316L
stainless steel, for compressed air feeding to the door/s gasket system

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.23 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

air filtration system upstream vacuum pump composed of filtering unit, valves,
temperature sensor, ancillary devices for a correct operation and relevant S/W to
perform automatic PROGRAM A_LP, to perform decontamination of materials at
low pathogenic risk Biological agents group 1 or 2 of the European Directive
2000/54/EC
NOTE : Such configuration is not suitable for treatment of high pathogenic risk
materials (Biological agents group 3 or 4 of the European Directive
2000/54/EC) and, therefore, De Lama is not liable for such un-
appropriate use of the autoclave

5.6.2 OPTIONAL STEAM FILTER

To avoid eventual entrainment of impurities from piping, a filter for feeding steam coming from
factory utility line can be installed optional quotation, on request.
The filter is made of sintered AISI 316L stainless steel and has an absolute removal rating lower
than 10 m.
The steam filter is assembled to be easy inspected and constantly drained from condensate.

6. SAFETY DEVICES
Following devices are installed:
device preventing door/s opening with pressure in the chamber
device preventing steam inlet into the chamber if the door/s is/are not perfectly closed or the door/s gasket
is not in perfect seal condition
interlock device preventing doors simultaneous opening (installed in case of double-door plant only). Such
device blocks one door when the opposite one is open or not well closed and allows opening of the door on
sterile area only after a valid sterilization cycle has been performed
device allowing opening of door on loading side after a valid cycle only if Operator on unloading side has
already opened/closed the door (installed in case of double-door plant only)
device which locks the door/s when the sterilization cycle is in progress
device preventing door/s closing when there is an obstacle in the sliding space (installed in case of plant in
sliding door/s execution only)
device preventing door/s opening in case of chamber internal temperature higher than 70C

7. INSTRUMENTATION
Sterilizer is equipped with following instrumentation:

7.1 PRESSURE INDICATORS

One bourdon pressure/vacuum gauge, range -1 +5 barg, for pressure indication inside the
sterilization chamber, located on loading side
One bourdon pressure/vacuum gauge, range -1 +5 barg, for pressure indication inside the jacket,
located on loading side
One bourdon pressure/vacuum gauge, range -1 +5 barg, for pressure indication inside the
sterilization chamber, located on unloading side (installed in case of double-door plant only)

7.1.1 Optionals

Following items are out of the scope of supply and can be quoted on request:
gauges for pressure indication inside the chamber fitted with diaphragm seal
one bourdon pressure/vacuum gauge, range -1 +5 barg, to verify zero pressure in the
housing of the filter on air inlet before any maintenance operation/cartridge replacement

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.24 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

7.2 PRESSURE INSTRUMENTS

One pressure transmitter, to control and regulate the pressure inside the chamber, with a standard
normalized 4-20 mA output and an end-scale 5 abs. bar. Sensor is mounted directly on the sterilizer
chamber. The pressure sensor is thermal compensated around the operating temperature (100130C).
One I/P converter to control modulating valves (input 4/20 mA / output 315 psi)

7.2.1 Optionals

Following items are out of the scope of supply and can be quoted on request:
additional pressure transmitters to control pressure inside the chamber
pressure transmitter/s to monitor pressure inside the jacket
pressure transmitter/s fitted with diaphragm separator

7.3 TEMPERATURE SENSORS

Two 4-wire temperature sensors Pt 100 Ohm complying with European Standards CEI EN
60751:1998 (precision: better than Class A) - one of which is located in the chamber drain - to control
temperature inside the chamber.
One 4-wire temperature sensor Pt 100 Ohm, complying with European Standards CEI EN
60751:1998 (precision: better than Class A) to control and regulate temperature inside the jacket

7.3.1 Optionals

Following items are out of scope of supply and can be quoted on request:
additional temperature sensors Pt 100 Ohm for temperature control inside the chamber
(number of sensors can be increased according to type of control system and number of
installed field sensors)

7.4 TEMPERATURE INSTRUMENTS

One digital indicator (accuracy class 0.5% full-scale) preventing doors opening in case of chamber
internal temperature higher than 70C. Such instrument, equipped with No.1 temperature sensor Pt
100 Ohm, performs even monitoring of temperature inside the chamber independently from the probe
connected to control system as per Paragraph 7.3

7.4.1 Optionals

Following items are out of scope of supply and can be quoted on request:
additional digital indicator for chamber temperature visualization only, located on unloading
side (available in case of double-door plant only)

7.5 ADDITIONAL OPTIONAL INSTRUMENTS

Following items are out of the scope of supply and can be quoted on request:

7.5.1 Level instrument

Device for monitoring of water and/or condensate level inside the chamber to avoid their
coming in contact with the lowest load to be sterilized. Device is composed of:
sight level assembly, made of AISI 316 stainless steel and borosilicate glass, with relevant
gaskets
capacitive level sensor, connected to the control system, to activate an alarm during the
sterilization phase

7.5.2 Air detector system

System, to comply with HTM 2010, useful to determine whether the non-condensable gases
contained in the steam delivered to the sterilizer and the air remaining after the air removal

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.25 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

stage of the sterilization cycle are in such a quantity as to cause the sterilizing process to be of
uncertain efficacy.
The steam for the air detector (NCGT non-condensable gas test) is sampled on the autoclave
discharge line close to the drainage.
NCGT pack is mainly composed of a jacketed container equipped with a temperature sensor Pt
100 Ohm, a pressure sensor, both connected to the control system, one set of pneumatic on/off
valves a needle valve for air detector calibration and S/W to perform automatic PROGRAM
A_NCGT useful for sterilization of solids and porous materials with measurement of level of
non-condensable gases contained in the steam before sterilization.
Controller, on the basis of detected pressure and temperature values, provides, in fact, for
calculation of pressure according to Dalton law in order to check presence of non-condensable
gases

8. OPTIONAL AUTOCLAVE CONFIGURATIONS (quoted on request)


To perform treatment of some specific types of loads, sterilizer can be fitted with following additional
configurations:

8.1 VERSION TO PERFORM STERILIZATION BY STEAM+FORMALDEHYDE

Autoclave can be designed to enable Customer to perform sterilization by steam+formaldehyde of


products sensitive to high temperatures. Autoclave in such configuration features:
hydraulic system supplemented by an additional loop mainly including an evaporation tank, a set of
pipes, valves and all ancillary devices and accessories for a correct operation
S/W to perform automatic PROGRAM AF

8.2 VERSION TO PERFORM WASHDOWN TREATMENTS

Autoclave can be designed to enable Customer to use the same equipment to perform washing (by water
with/without detergent or soda) of frames, plates, trays, parts of equipment, etc. as a solo cycle or as a
combined cycle before sterilization. Autoclave in such configuration (model DLOV/W) features:
hydraulic system supplemented by an additional loop including distribution header/s, suitably located
in the chamber, made of AISI 316L stainless steel, fitted with spraying nozzles to assure washing
fluid uniform distribution on the load, a set of pipes, valves, dosing pump, and all ancillary devices
and accessories for a correct operation
S/W to perform automatic washing only or washing + sterilization

8.3 AIR/STEAM MIXTURE VERSION

Autoclave can be designed to enable Customer to use the same equipment to run two different types of
process cycles : the conventional steam sterilization combined with the air/steam mixture suitable for
treatment of pressure/temperature sensitive products such as plastic containers, products in blister
packs, pre-filled syringes, etc. Autoclave in such configuration (model DLOV-AV) features:
chamber structure suitable to withstand sterilization in overpressure condition (4,5 bar abs.)
ventilator group which provides for air/steam mixture forced circulation and homogenization
throughout the chamber, heat transfer during the heating phase, internal temperature uniform
distribution during the cycle phases, speed up load cooling operations in counterpressure and improve
drying performances in the respective cycles.
Ventilator is composed of one or more high efficiency fan/s, made of AISI 316L stainless steel,
equipped with relevant accessories and ancillary devices for a correct operation. Each fan is fitted
with a cowling, made of AISI 316L stainless steel punched and bent sheet, located on the chamber
internal walls, for air/steam throw and suction to assure homogeneous distribution of air/steam fluid
on product
S/W to perform automatic PROGRAM M_F

8.4 HIGH PATHOGEN VERSION

The materials at high pathogenic risk - Biological agents group 3 or 4 of the European Directive
2000/54/EC have to be submitted to a specific treatment before being re-used, disposed or re-cycled in

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.26 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

order to avoid any risk of pollution/contamination for the Operators, the working area and the
environment.
After such treatment load is safe and ready to be re-used or disposed.
Typical applications:
materials coming from the pharmaceutical field (e.g. from laboratories for production of vaccines,
serums, etc.)
products coming from research and/or microbiology laboratories (e.g. diagnostic or biotechnological
products or manufacturing wastes)
products coming from the hospitals (e.g. materials outcoming from infectious diseases areas)
highly resistant pathogenic organisms (e.g. from Creutzfeldt-Jakob disease bovine spongiform
encephalopathy well-known as mad cow disease and from correlated syndromes)
Should Customer require to perform treatment of high pathogenic risk loads, autoclave can be designed
to combine the conventional steam sterilization with the air/steam mixture sterilization (Customer is
enabled to use the same equipment to run two different types of process cycles).
Autoclave in configuration for treatment of high pathogenic risk materials (model DLOV-HP) features:
chamber structure suitable to withstand sterilization in overpressure condition (5 bar abs.)
no evacuation of fluids before being sterilized
no venting of contaminated air till the end of the sterilization process
homogenization of the air/steam mixture throughout the chamber by the application of a ventilator
group which is useful to assure the internal temperature uniform distribution during the cycle different
phases, speed up load cooling operations in counterpressure and improve drying performances in the
respective cycles.
Ventilator group is composed of one or more high efficiency fan/s, made of AISI 316L stainless steel,
equipped with relevant accessories and ancillary devices for a correct operation. Each fan is fitted
with a cowling, made of AISI 316L stainless steel punched and bent sheet, located on the chamber
internal walls, for air/steam throw and suction to assure homogeneous distribution of air/steam fluid
on product
application of pressure gauge/s with diaphragm seal and pressure transmitter/s with diaphragm
separator
S/W to perform following automatic programs:
PROGRAM A_HP : air/steam mixture sterilization/decontamination of solids at high pathogenic
(standard) risk maximum temperature : 138C
PROGRAM F_HP : air/steam mixture sterilization/decontamination of liquid products/materials
(optional) at high pathogenic risk - maximum temperature: 138C

8.5 VERSION TO PERFORM EVEN STERILIZATION BY SUPERHEATED WATER

Autoclave can be designed to enable Customer to use the same equipment to run two different types of
process cycles : the saturated steam sterilization or the superheated water sterilization suitable for
treatment of liquid solutions in non-deformable containers or in deformable containers proven to
withstand sterilization conditions by hot water spray.
Autoclave in such configuration (model DLOV-S) features:
cylindrical shaped chamber whose lower circular sector is used as a sump for process water collection
hydraulic system supplemented by an additional loop mainly including :
distribution headers, suitably located in the chamber (two placed on the lateral walls and one on
the chamber upper sector), made of AISI 316L stainless steel, fitted with spraying nozzles to
assure fluid uniform distribution on the load
set of pipes made of AISI 316L stainless steel
valves made of AISI 316L stainless steel
high efficiency, sanitary plate-type heat exchanger, in AISI 316L stainless steel, for circulating
water heating (by steam) and cooling (by water)
pump in AISI 316L stainless steel, special seal on shaft, suitable for circulation of superheated
water at 128C in closed loop
all ancillary devices and accessories for a correct operation
S/W to perform following automatic programs:
PROGRAM ASW : Sterilization program for bags and/or bottles with counterpressure at a value
settable by the Operator

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.27 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

PROGRAM CSW : Sterilization program for bags and/or bottles with counterpressure,
according to the Mollier diagram, settable by the Operator
PROGRAM BSW : Demineralised water drainage

9. ELECTRICAL SYSTEM
For electricals, De Lama document Electrical specification - horizontal process equipment and steam
generators Doc. ID : ELS-00-G_0000 is applicable to De Lamas scope of supply.

10. CONTROL AND MANAGEMENT SYSTEM


For automation, De Lama document Process control system specification OLIMPYA/WP-TS Doc. ID :
PCSS-00-G_WPTS is applicable to De Lamas scope of supply.

11. WORKING PROGRAMS


High flexibility of the control and management systems allows the execution of automatic programs.
Particular H/W configuration and S/W modularity of De Lamas controllers enable memorization, with
virtually no limits, of all cycles Customer is interested in within all installed programs. User with proper
permission level can, therefore, create a Customized cycles library, according to type of loads to be treated,
with operating sequences, phases and parameters (e.g.: time, temperature, etc.) which can be selected and
stored by the Operator with identification file names.
In alternative to programs management with storage of time and temperature parameters, sterilization phase
can be managed and regulated by means of the F0 exponential function to a programmed value.
Process regulation by the F0 function is described, in detail, in De Lama document F0 function Doc. ID :
F0-00-G_0000.
Programs indicated as optional require, in addition to the implementation of relevant S/W useful to perform
them, even a suitable H/W and equipment configuration.
Optional programs which might be useful for Customers applications are separately quoted in the priced
offer.

LIBRARY OF STANDARD STORED PROGRAMS:

CONTROL/UTILITY PROGRAM:

PROGRAM I : Chamber vacuum leakage test according to European Standard EN 285

STERILIZATION PROGRAM:

PROGRAM A : Sterilization of solids and porous materials with initial vacuum and final
drying under vacuum

LIBRARY OF OPTIONAL STORABLE PROGRAMS:

CONTROL/UTILITY PROGRAMS:

PROGRAM BD : Bowie-Dick test according to European Standard EN 285


PROGRAM B_CT : Cold crash test for ampoules with initial vacuum, vacuum seal test phase
inlet of sterile compressed air for counterpressure inside the chamber,
rinsing by sterile demineralised water spray on load and subsequent drying
PROGRAM J : Automatic Sterilize-In-Place of the air filter
PROGRAM L : Hot chamber vacuum leakage test
PROGRAM P : Chamber pressure leakage test according to HTM 2010
PROGRAM WIT_P : Valves control step-by-step, via HMI, to perform Water Intrusion Test of
the process air filter, through Sartocheck, Palltronic or other external
test system (not included in De Lamas scope of supply) connected to the
sterilizer, with cycle tracking on the cycle report.
NOTE : External test system does not exchange signals with sterilizer
(and, therefore, is used in a separate mode)

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.28 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

PROGRAM WIT : Air filter integrated Water Intrusion Test carried out with a suitable built-in
De Lamas device

STERILIZATION PROGRAMS:

PROGRAM A_T : Sterilization of rubber stoppers used for lyophilized products or rubber
stoppers for which a low content of residual humidity is required with final
drying by sterile hot air (air heating carried out through a suitable device
mainly composed of a steam powered exchanger)
PROGRAM A/S : Sterilization of solids and porous materials with initial vacuum, final drying
under vacuum and subsequent product rapid cooling SUPERCOOLING (*)
PROGRAM B : Sterilization of ampoules with initial vacuum, vacuum seal test phase and
final cooling by inlet of sterile compressed air for counterpressure inside the
chamber and sterile demineralised water spray on load
PROGRAM BA : Sterilization of ampoules with initial vacuum, vacuum seal test phase,
cooling by inlet of sterile compressed air for counterpressure inside the
chamber + sterile demineralised water spray on load, subsequent drying
and final cooling by water circulation inside the jacket
PROGRAM BA_T : Sterilization of ampoules with initial vacuum, vacuum seal test phase,
cooling by inlet of sterile compressed air for counterpressure inside the
chamber + sterile demineralised water spray on load, subsequent drying by
sterile hot air (air heating carried out through a suitable device mainly
composed of a steam powered exchanger) and final cooling by water
circulation inside the jacket
PROGRAM C : Sterilization of liquid solutions in sealed/unsealed glass or non-deformable
containers with initial vacuum and final cooling by inlet of sterile
compressed air for counterpressure inside the chamber and sterile
demineralised water spray on load
PROGRAM E : Sterilization of membrane filters with initial slow vacuum, steam injection,
slow steam exhaust with final drying under vacuum
PROGRAM E/S : Sterilization of membrane filters with initial slow vacuum, steam injection,
slow steam exhaust with final drying under vacuum and subsequent product
rapid cooling SUPERCOOLING (*)
PROGRAM E_ATF : Sterilization of ATF filters with initial vacuum pulses at different set point,
steam injection at controlled slope, steam exhaust at controlled slope and
final drying under vacuum
PROGRAM F : Sterilization of liquid solutions and/or culture media in sealed/unsealed
glass or non-deformable containers, with initial vacuum and final cooling
by inlet of sterile compressed air for counterpressure inside the chamber
and water circulation inside the jacket
PROGRAM GM : Ampoules seal test by methylene blue
PROGRAM GW : Sterilization of ampoules with ampoules seal test by water flooding with
eventual load final drying
PROGRAM T_A : Tyndallisation for solids
PROGRAM T_F : Tyndallisation for liquid materials/products

(*) SUPERCOOLING is a cooling system of DE LAMAs original design (H/W and S/W) which enables
extraction of sterilized products at a temperature (approx. 40 C) which is compatible with Operators
handling.

DECONTAMINATION PROGRAMS

To prevent any risk of pollution/contamination for the Operators/environment, the air extracted from the
chamber can be filtered by a air filtration system, located upstream vacuum pump, composed of filtering
unit, valves, temperature sensor and ancillary devices for a correct operation.
Such additional device, useful to perform decontamination of materials at low pathogenic risk
Biological agents group 1 or 2 of the European Directive 2000/54/EC - can be integrated in the autoclave
and used in conjunction with all programs which include a air removal phase.

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.29 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

11.1 DESCRIPTION OF STANDARD STORED PROGRAMS

11.1.1 DESCRIPTION OF CONTROL/UTILITY PROGRAM

I : Chamber vacuum leakage test according to European Standard EN 285

Sequence:

plant arrangement to operating conditions with empty chamber and closed door/s
vacuum pump start and operation up to programmed residual value of 70 mbar
N.B. : vacuum of 70 mbar can be achieved with feeding water to vacuum
pump having temperature 20C
vacuum pump stop
vacuum holding for stabilization, at the reached value, for a programmed time of
5 minutes. If the pressure rises over a programmed value, an alarm signal is
activated
chamber vacuum leakage test phase, with vacuum holding at the value reached
after stabilization, for a programmed time of 10 minutes
verification that, during such period, pressure does not rise over programmed
residual value of 13 mbar. On the contrary, an alarm signal is activated
air inlet through sterile filter for pressure balance
end of cycle

11.1.2 DESCRIPTION OF STERILIZATION PROGRAM

A : Sterilization of solids (e.g. empty glassware, rubber stoppers, aluminium caps,


instruments, machine parts, cages, empty containers, filters, rubber materials) and
porous materials (e.g. textiles, etc.)

Sequence:

jacket heating
initial vacuum phase inside the chamber, simple of pulsated type, up to
programmed residual pressure value
steam inlet inside the chamber
air and condensate elimination by vacuum pump
achievement of programmed temperature value (in the coldest point)
start of sterilization phase with calculation of programmed phase time
end of sterilization phase
stop of steam inlet inside the chamber
load drying phase
vacuum at programmed value, for set time, with jacket heating holding.
Eventual successions of sterile air inlets (drying by pulsated vacuum)
air inlet through sterile filter for pressure balance
end of cycle

12. TECHNICAL PERFORMANCES

12.1 TEMPERATURE UNIFORMITY INSIDE THE EMPTY CHAMBER

Inside the empty sterilization chamber of a saturated steam sterilizer DLOV type in standard execution,
the temperature difference between the hottest point and the coldest one will not be higher than 0,5C
compared with the reference temperature.

12.2 TEMPERATURE UNIFORMITY INSIDE THE LOAD TO BE STERILIZED

For saturated steam sterilizer DLOV type in standard execution, the temperature difference between the
hottest point and the coldest one of one load of homogeneous material will not be higher than 0,5C
compared with the reference temperature.

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.30 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - E
Egypt

13. TEST
T PRESSUR
RE
Autocclave (meant asa chamber annd relevant fitttings), designned according to pressure veessels code in
ndicated in
Paraggraph 3, is tested for the folllowing operatiing pressures::
chamber max. opperating pressuure : 3,5 bar abs.
jackket max. operaating pressuree : 3,5 bar abs.
Main weldings willl be X-ray innspected and piping
p b submitted tto dye penetrant test in
fittingss welds will be
accorddance with thee applicable sections of releevant applicabble pressure veessels code.

14. TECHNICAL DATA,


D UTIL
LITIES AND
D FLUIDS
Utilitiies necessary for sterilizer correct
c operattion are those indicated in respective fluids data sheetss and must
be avaailable and in compliance with
w stated feaatures (type, qu uality, quantitty and pressurre).

15. IDEN
NTIFICATIION DATA
The stterilizer is perrmanently proovided with following readaable data:
idenntification num
mber
nam
me of the manuufacturer
maiin design dataa
marking withh identificationn of Control Body
B

16. DOC
CUMENTAT
TION
For documentation
d n, De Lama document
d Dee Lama docu
umentation lisst Doc. ID : DOC-00-G
G_0000 is
appliccable to De Laamas scope of
o supply.

17. NOT
TES
a) Affter the orderr, in phase of o executive design, De Lama
L will prrovide to determine equip
pment and
wgs. will be submitted to Customer forr approval
acccessories finaal constructionn dimensionss. Relevant dw
beefore construction
b) Ow wing to the hiigh flexibility of programm ming systems, De Lamas enngineering deppartment is av
vailable to
stuudy eventual further
f sterilizzation program
ms to meet parrticular requirrements.
c) Inn case of orderr, Customer is kindly requessted to commu unicate to De Lama:
installation rooom height annd dimensions (in case of double-door sterilizer bothh sterile and non-sterile
n
area)
pressure of pllant installatioon room (in caase of double-door sterilizerr both sterile aand non-sterilee area)
wall thickness between sterrile and non-ssterile area (onnly in case of double-door
d ssterilizer)
d) Dee Lama drawss Customer atttention on thee fact that, aftter equipmentt installation, Customer hass to bound
alll relevant safe
fety areas provviding, eventuually, suitablee barriers or devices
d and afffixing all saffety signs,
inside the depaartment. Furthhermore, Custtomer has to perform a traaining activityy to the operaators with
sppecific reference to safety prroblems relevvant to the new
w equipment

18. LOA
ADING/UNL
LOADING ACCESSOR
A RIES
Loadiing/unloading accessories are
a characterizzed by a careeful constructiion, fully executed in stain nless steel,
whichh conforms to ergonomic crriteria and quaality standardss required for pharmaceutic
p al application
ns.

18.1 IN-CHAMBE
I ER TROLLE
EY CCA2 type
t

The in-chambber trolleys, CC


T CA2 type, aree quick, efficieent, functionaal and safe meaans to load prroduct into
t process chhamber.
the

Docu
ument ID : PE
EFS-00-G_DLO
OV Rev.12 Date : Oct.20, 2014 Page No.3
31 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

18.1.1 FEATURES

Materials
highly satin finish AISI 304 / AISI 316L stainless
steel
Construction
Single frontal bay to house product loading trays
Solid frame made of welded square section pipe bars,
channels and flat bars
Bracketing to support trays at adjustable distance
No.4 wheels for trolleys sliding either on rails placed
inside the process chamber or on transfer trolleys

18.1.2 OPTIONALS

Following items can be quoted on request:


Side-loaded execution

18.1.3 APPROX. DIMENSIONS

See dimensions in the priced offer

18.2 MULTIPURPOSE PERFORATED TRAY MIC type

18.2.1 FEATURES

Materials
electropolished AISI 304 / AISI 316L stainless
steel
Construction
tray closed on No.4 sides with perforated bottom
(with holes according to type of product to be
loaded)

18.2.2 OPTIONALS

Following items can be quoted on request:


Perforated cover with or without handle

18.2.3 APPROX. DIMENSIONS

See dimensions in the priced offer

18.3 TRANSFER TROLLEY ETASS/A type (for autoclaves)

Trolleys are useful to transport in-chamber shelf racks/trolleys to and from the process chamber. The in-
chamber shelf rack/trolley is kept off the floor reducing the quantity of dirt or contaminants entering the
chamber itself.
Transfer trolleys feature a solid structure, absolute safety in use, compact dimensions and easy handling.

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.32 of No.51


Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

18.3.1 FEATURES

Materials
highly satin finish AISI 304 stainless steel
Construction
Solid frame made of welded square section pipe
bars and flat bars
Ergonomic handle for moving
U-section rails for in-chamber shelf rack/ trolley
moving
Mechanical safety device keeping the in-chamber
shelf rack/ trolley secure during transportation
Mechanical safety device to lock together the
transfer trolley and the process chamber during the
in-chamber shelf rack/trolley positioning phase
No.4 height-adjustable wheels (two of which
swivel type with brake)

18.3.2 OPTIONALS

Following items can be quoted on request:


Execution with No.4 swivel wheels
Execution by round section pipes to allow an optimal cleaning specially in a sanitary
environment

18.3.3 APPROX. DIMENSIONS

See dimensions in the priced offer

Document ID : PEFS-00-G_DLOV Rev.12 Date : Oct.20, 2014 Page No.33 of No.51


Document ID PEFS-00-G_DLSG-OEC

Document title Typical preliminary specification of clean steam generators


DLSG/O/E/C series

Document preparation and approval

Issue
Issue Date Written by Reviewed by Approved by
Description
First issue A. Monegato A. Muggiasca G. Botteri
0 June 5, 2007
for offer Technical Dept. Technical Manager Quality Assurer

A. Monegato A. Muggiasca G. Botteri


1 Jan.30, 2009 General review
Technical Dept. Technical Manager Quality Assurer

A. Monegato A. Muggiasca G. Botteri


2 April 20, 2011 General update
Technical Dept. Technical Manager Quality Assurer

Revised to update
A. Monegato A. Muggiasca G. Botteri
3 July 15, 2013 passivation
Technical Dept. Technical Manager Quality Assurer
procedures

This document, sole property of De Lama S.p.A., contains Company information and shall not
be released to, nor discussed with third parties, nor duplicated totally or partially by any
method without the express permission of De Lama S.p.A. who will safeguard their rights
according to the provision of the law.
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

TABLE OF CONTENTS

1. OVERVIEW ..................................................................................................................................................... 36
2. STANDARDS AND GUIDELINES ................................................................................................................ 36
3. DESIGN AND OPERATING CONDITIONS ................................................................................................. 36
4. TECHNICAL DATA ........................................................................................................................................ 36
5. DIMENSIONAL DATA ................................................................................................................................... 36
5.1 BODY DIMENSIONS............................................................................................................................. 36
6. CONSTRUCTION FEATURES....................................................................................................................... 37
6.1 PRESSURE VESSEL .............................................................................................................................. 37
6.1.1 Optionals....................................................................................................................................... 37
6.2 SUPPORT FRAME (for external generators with independent controller only) ..................................... 37
6.2.1 Optionals....................................................................................................................................... 37
6.3 INSULATION/LAGGING ...................................................................................................................... 37
6.3.1 Optionals....................................................................................................................................... 37
6.4 PIPING SYSTEM .................................................................................................................................... 37
6.4.1 Optionals....................................................................................................................................... 38
7. INSTRUMENTATION / SAFETY DEVICES............................................................................................... 38
7.1 PRESSURE INDICATORS ..................................................................................................................... 38
7.2 PRESSURE INSTRUMENTS ................................................................................................................. 38
7.3 TEMPERATURE SENSORS .................................................................................................................. 38
7.4 WATER LEVEL INSTRUMENT ........................................................................................................... 38
8. ELECTRICAL SYSTEM ................................................................................................................................. 38
9. CONTROL AND MANAGEMENT SYSTEM ................................................................................................ 38
10.TECHNICAL DATA, UTILITIES AND FLUIDS........................................................................................... 38
11.IDENTIFICATION DATA............................................................................................................................... 39
12.DOCUMENTATION ....................................................................................................................................... 39
13.OPTIONAL ACCESSORIES ........................................................................................................................... 39
14.NOTES.............................................................................................................................................................. 39

Document ID : PEFS-00-G_DLSG-OEC Rev.3 Date : July 15, 2013 Page No.35 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

1. OVERVIEW
DE LAMA clean steam generator DLSG/O/E/C type uses electrical energy as heating medium.
Designed to satisfy more strict and rigorous quality requirements of Pharmaceutical and Biotechnology
Industries, unit is suitable for production of high quality steam, free of impurities and oxides, mainly used for
injection into sterilizers.
Generator, directly heated by armoured electrical resistances, has horizontal cylindrical accumulation/
evaporator body.
According to generator location and use following configurations are available:
generator controlled by a sterilizer : generator is devoted to a steam sterilizer and is located either
inside the autoclave containing cabinet (built-in type) or near the
autoclave itself in order to be managed by the sterilizer main
control system
generator with independent controller : generator is a stand-alone unit for multiple use, easy to be
installed and ready to work

2. STANDARDS AND GUIDELINES


Equipment is designed, manufactured and tested in compliance with UNI EN ISO 9001 and UNI EN ISO
13485 Quality Management Systems procedures, according to requirements of the more advanced
International Pharmacopoeia, following cGMP requirements and cGAMP Guidelines.
De Lamas document Applicable Standards, Directives and Guidelines Doc. ID : DLSTD-00-G_0000 is
applicable to De Lamas scope of supply.

3. DESIGN AND OPERATING CONDITIONS


Clean steam generator DLSG/O/E/C type is designed, manufactured and tested according to European
Pressure Equipment Directive (P.E.D.) No.97/23/EC.
Structural calculations and relevant realization consider following parameters:
accumulation/evaporator body design pressure : 5 bar abs.
accumulation/evaporator body design temperature : 152C
accumulation/evaporator body max. operating pressure : 5 bar abs.
accumulation/evaporator body max. operating temperature : 152C
Generator is tested according to parameters and criteria fixed by the applicable pressure vessels Code.

4. TECHNICAL DATA
Installed power : 20 kW
Clean steam production : approx. 27 kg/h at a pressure of 5 abs. bar

5. DIMENSIONAL DATA

5.1 BODY DIMENSIONS

DIAMETER : mm.300
DEPTH : mm.500

Document ID : PEFS-00-G_DLSG-OEC Rev.3 Date : July 15, 2013 Page No.36 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - E
Egypt

6. CON
NSTRUCTIO
ON FEATURES

6.1 PRESSURE VESSEL

The steam gennerator, horizontal type, is mainly compo


osed of:
horizontal accumulation/
a /evaporator boody, made of pickled
p AISI 316L
3 stainlesss steel
heating grooup consistingg of one or more
m armoured
d electrical ressistances, in IIncoloy 800, easy
e to be
removed, directly
d immerrsed in feedwater. In order to avoid distuurbs to power supply line, tootal power
is subdivideed into steps controlled
c andd managed by timer and safe
fety pressure switch.

6.1.1 Optionals

Folloowing items arre out of the scope of supplly and can be quoted
q on reqquest:
boddy active surffaces passivattion & highly y satin finishinng Ra < 0,3775 m accord ding to De
Lammas proceduure No. No.IO75-01 e ASTM M No.A967 Standard
Speecification for Chemical
Passsivation Treaatments for staainless steel parts (where applicable)
a
boddy active surffaces passivattion or passivation & electrropolishing acccording to DeD Lamas
proocedure No. No.IO75-01 e ASTM No.A967 N Staandard Speciification for Chemical
Passsivation Treaatments for staainless steel parts (where applicable)
a

6.2 SUPPORT FRAME


F (for external geneerators with independent
i nly)
controller on

The whole unnit and its coomponents aree easily demo


ountable and accessible.
a Thhey are suppo
orted by a
heavy-duty frrame in AISI 304
3 stainless steel.
s

6.2.1 Optionals

Folloowing items arre out of the scope of supplly and can be quoted
q on reqquest:
fraame fitted withh wheels for roolling (movab
ble version to allow a more versatile use)

6.3 INSULATIO
ON/LAGGING
G

The whole geenerator bodyy is insulated by b suitable assbestos free annd chlorine frree material to
o obtain a
very high therrmal efficienccy. Insulation has an externaal protection covering
c madee of aluminium m sheet.

6.3.1 Optionals

Folloowing items arre out of the scope of supplly and can be quoted
q on reqquest:
inssulation coveriing by AISI 304 stainless stteel sheet

6.4 PIPING SYS


STEM

The hydraulicc piping in conntact with gennerated steam


T m is wholly maade of AISI 316L stainless steel with
i
internal surfacce having rouughness Ra 0,8m
(meannt as arithmetical mean diffference of reeal surface
p
profile compaared to mediumm line).
Main componnents:
One systemm for pre-treateed water autom matic filling complete
c of:
one electrrical pump in AISI 316 staiinless steel
one pneumatic valve inn AISI 316L stainless
s steel
one checkk valve in AIS SI 316L stainlless steel
One manuaal valve, in AISI 316L stainnless steel, for steam outlet
One manuaal drainage vallve, in AISI 316L stainless steel
One m
marked safety valve, tested and approved according to t applicable pressure vesssels Code,
with internaal parts in AIS SI 316L stainlless steel
One air inleet filter with 0,22
0 micron caartridge for atm mospheric air useful for gennerator vent
One set of sanitary
s tri-claamp connectioons on the clean steam line

Document ID : PEFS
S-00-G_DLSG--OEC Rev.3 Date : July
y 15, 2013 Page No.3
37 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

6.4.1 Optionals

Following items are out of the scope of supply and can be quoted on request:
piping active surfaces passivation or passivation & electropolishing according to De Lamas
procedure No. No.IO75-01 e ASTM No.A967 Standard Specification for Chemical
Passivation Treatments for stainless steel parts (where applicable)
device suitable to cool drain if the temperature becomes too high
valve for steam outlet pneumatic type

7. INSTRUMENTATION / SAFETY DEVICES


Generator is equipped with following instrumentation/safety devices:

7.1 PRESSURE INDICATORS

one bourdon pressure gauge for pressure indication inside the generator

7.2 PRESSURE INSTRUMENTS

one pressure switch preventing heating in case of overpressure


one pressure transmitter for steam generator evaporation body pressure control loop, with a standard
normalized 4-20 mA output and an end-scale 5 bar abs. (for generators with independent controller
only)

7.3 TEMPERATURE SENSORS

one temperature sensor Pt 100 Ohm for steam generator evaporation body pressure control loop (for
generators controlled by a sterilizer only).

7.4 WATER LEVEL INSTRUMENT

device for monitoring of water level inside the generator composed of:
sight level assembly, made of AISI 316 stainless steel and borosilicate glass, with relevant gaskets
one capacitive level sensor for automatic control of water inside the evaporator body
one capacitive level sensor to shut-off heating group/s in case of water lack

8. ELECTRICAL SYSTEM
For electricals, De Lama document Electrical specification - horizontal process equipment and steam
generators Doc. ID : ELS-00-G_0000 is applicable to De Lamas scope of supply.

9. CONTROL AND MANAGEMENT SYSTEM


Generator controlled by a sterilizer : since the steam generator is devoted to a steam sterilizer it is
managed by the main control system of the autoclave itself
Generator with independent controller : for automation, De Lama document relevant to the chosen
control system is applicable to De Lamas scope of supply

10. TECHNICAL DATA, UTILITIES AND FLUIDS


Utilities necessary for generator correct operation are those indicated in respective fluids data sheets and
must be available and in compliance with stated features (type, quality, quantity and pressure).

Document ID : PEFS-00-G_DLSG-OEC Rev.3 Date : July 15, 2013 Page No.38 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - E
Egypt

11. IDEN
NTIFICATIION DATA
The generator
g is peermanently proovided with foollowing readaable data:
idenntification num
mber
nam
me of the manuufacturer
maiin design dataa
marking withh identificationn of Control Body
B

12. DOC
CUMENTAT
TION
For documentation
d n, De Lama document
d Dee Lama docu
umentation lisst Doc. ID : DOC-00-G
G_0000 is
appliccable to De Laamas scope of
o supply.

13. OPTIONAL AC
CCESSORIE
ES
Follow
wing items aree out of scopee of supply andd can be quoteed on request::
3-w
way ball valve with the funcction to switchh the steam sup
pply for generrator multiple use
feeddwater storagee tank made of
o pickled AIS SI 316L stainleess steel

14. NOT
TES
a) Affter the orderr, in phase of
o executive design,
d De Lama
L will proovide to deteermine equipmment final
coonstruction dim
mensions. Rellevant dwgs. will mer for approvval before construction
w be submittted to Custom

b) Dee Lama drawss Customers attention


a on thhe fact that, affter equipmennt installation, Customer hass to bound
alll relevant safe
fety areas provviding, eventuually, suitablee barriers or devices
d and afffixing all saffety signs,
inside the depaartment. Furthhermore, Custtomer has to perform a traaining activityy to the operaators with
sppecific reference to safety prroblems relevvant to the neww equipment

c) Usse of feedwatter of approprriate chemicall and microbiiological quallity, suitably ppre-treated, iss required.
Innterfacing betw
ween generatoor and Custommer utility lin
ne needs to be agreed betw ween Customeer and De
Laama and evenntually quoteed before ordder issue in order
o to avoiid additional implementattions after
coonstruction.

d) Prrior to Purchasse Order, if geenerator is devvoted to a sterilizer, the loaad (quantity, ddimensions an
nd weight)
neeeds to be connfirmed by the Customer inn order to enaable De Lamaa to perform tthe final veriffication of
steeam generatorr production

Document ID : PEFS
S-00-G_DLSG--OEC Rev.3 Date : July
y 15, 2013 Page No.3
39 of No.51
Document ID PEFS-00-G_DLV CAB

Document title Typical preliminary specification of monobloc vertical saturated


steam sterilizers DLV CAB series

Document preparation and approval

Issue
Issue Date Written by Reviewed by Approved by
Description
First issue A. Monegato A. Muggiasca G. Botteri
0 May 5, 2008
for offer Technical Dept. Technical Manager Quality Assurer

A. Monegato A. Muggiasca G. Botteri


1 July 3, 2008 General update
Technical Dept. Technical Manager Quality Assurer

Revised to update A. Monegato A. Muggiasca G. Botteri


2 Dec.15, 2008
PROGRAM I Technical Dept. Technical Manager Quality Assurer

A. Monegato A. Muggiasca G. Botteri


3 Jan.25, 2010 General update
Technical Dept. Technical Manager Quality Assurer

Revised to update
optional A. Monegato A. Muggiasca G. Botteri
4 Oct.10, 2011
configurations and Technical Dept. Technical Manager Quality Assurer
optional programs

A. Monegato A. Muggiasca G. Botteri


5 May 24, 2013 General update
Technical Dept. Technical Manager Quality Assurer

This document, sole property of De Lama S.p.A., contains Company information and shall not
be released to, nor discussed with third parties, nor duplicated totally or partially by any
method without the express permission of De Lama S.p.A. who will safeguard their rights
according to the provision of the law.
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

TABLE OF CONTENTS

1. OVERVIEW ..................................................................................................................................................... 42
2. STANDARDS AND GUIDELINES ................................................................................................................ 42
3. DESIGN AND OPERATING CONDITIONS ................................................................................................. 42
3.1 Optionals .................................................................................................................................................. 43
4. DIMENSIONAL DATA ................................................................................................................................... 43
4.1 CAPACITIES .......................................................................................................................................... 43
4.2 CHAMBER INTERNAL DIMENSIONS ............................................................................................... 43
4.3 EQUIPMENT OVERALL DIMENSIONS ............................................................................................. 43
5. CONSTRUCTION FEATURES....................................................................................................................... 43
5.1 AUTOCLAVE BODY ............................................................................................................................. 43
5.1.1 Optionals....................................................................................................................................... 43
5.2 LID ........................................................................................................................................................... 44
5.3 STEAM GENERATOR ........................................................................................................................... 44
5.3.1 Optionals....................................................................................................................................... 44
5.4 INSULATION/LAGGING ...................................................................................................................... 44
5.5 PANELING ............................................................................................................................................. 44
5.6 PIPING SYSTEM .................................................................................................................................... 44
5.6.1 Optionals....................................................................................................................................... 45
5.7 FLUIDS FILTRATION ........................................................................................................................... 45
5.7.1 AIR FILTER ................................................................................................................................. 45
6. SAFETY DEVICES.......................................................................................................................................... 45
7. INSTRUMENTATION .................................................................................................................................... 46
7.1 PRESSURE INDICATORS ..................................................................................................................... 46
7.2 PRESSURE INSTRUMENTS ................................................................................................................. 46
7.3 TEMPERATURE SENSORS .................................................................................................................. 46
7.3.1 Optionals....................................................................................................................................... 46
7.4 LEVEL INSTRUMENTS ........................................................................................................................ 46
8. OPTIONAL AUTOCLAVE CONFIGURATIONS (quoted on request).......................................................... 46
8.1 AIR/STEAM MIXTURE VERSION ...................................................................................................... 46
8.2 HIGH PATHOGEN VERSION ............................................................................................................... 47
9. ELECTRICAL SYSTEM ................................................................................................................................. 48
10.CONTROL AND MANAGEMENT SYSTEM ................................................................................................ 48
11.WORKING PROGRAMS ................................................................................................................................ 48
11.1 DESCRIPTION OF STANDARD STORED PROGRAMS .................................................................... 49
11.1.1 DESCRIPTION OF CONTROL/UTILITY PROGRAM ............................................................. 49
11.1.2 DESCRIPTION OF STERILIZATION PROGRAM ................................................................... 50
12.TECHNICAL PERFORMANCES ................................................................................................................... 50
12.1 TEMPERATURE UNIFORMITY INSIDE THE EMPTY CHAMBER ................................................. 50
13.TEST PRESSURE ............................................................................................................................................ 50
13.1 Optionals .................................................................................................................................................. 50
14.TECHNICAL DATA, UTILITIES AND FLUIDS........................................................................................... 50
15.IDENTIFICATION DATA............................................................................................................................... 50
16.DOCUMENTATION ....................................................................................................................................... 51
17.NOTES.............................................................................................................................................................. 51
18.LOADING/UNLOADING ACCESSORIES .................................................................................................... 51
18.1 ROUND-SHAPED WIRE BASKET MW type ................................................................................... 51
18.1.1 FEATURES .................................................................................................................................. 51
18.1.2 APPROX. DIMENSIONS ............................................................................................................ 51
19.OPTIONAL ACCESSORIES ........................................................................................................................... 51

Document ID : PEFS-00-G_DLV CAB Rev.5 Date : May 24, 2013 Page No.41 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

1. OVERVIEW
The saturated steam sterilizers DLV CAB type are the most versatile vertical autoclaves, designed to meet
the widest requirements of the Pharmaceutical Industry. Sterilizers incorporate a high degree of operational
flexibility that enable them to be used even for a wide range of industrial and laboratory applications.
Fields of application:
Sterilization of solids (e.g. empty glassware, stainless steel items, parts of equipment, test tubes, stoppers,
surgical instruments, etc.)
Sterilization of porous materials (e.g. textiles, garments, gauzes, etc)
Sterilization of stoppers and rubber materials
Sterilization of filled glass or non-deformable containers (e.g. ampoules, bottles, etc.)
Sterilization of products used at animal facilities (e.g. cages, beddings, feedstuffs, etc.)
Decontamination of solids at low pathogenic risk (biological agents group 1 or 2 of the European Directive
2000/54/EC)
Tyndallization of products sensitive to high temperatures
Pasteurization/sterilization for treatment of packed food products
Autoclave in basic configuration is suitable to perform sterilization of solids and porous materials and is
fitted with control/utility programs.
Some of the above-mentioned applications can be carried out only if suitable equipment options are
purchased and installed.

Sterilizer is fitted with a steam generator suitable for production of high quality steam, free of impurities and
oxides, to assure the autoclave self-feeding.

2. STANDARDS AND GUIDELINES


Autoclave with relevant steam generator are designed, manufactured and tested in compliance with UNI EN
ISO 9001 and UNI EN ISO 13485 Quality Management Systems procedures, following cGMP requirements
and cGAMP Guidelines.
De Lamas document Applicable Standards, Directives and Guidelines Doc. ID : DLSTD-00-G_0000 is
applicable to De Lamas scope of supply.

3. DESIGN AND OPERATING CONDITIONS


Sterilizer DLV CAB type, with relevant steam generator DLSG/O/E/C type, is designed, manufactured and
tested according to European Pressure Equipment Directive (P.E.D.) No.97/23/EC.
Structural calculations and relevant realization consider following parameters:
Autoclave body :
design pressure : 3,5 bar abs.
design temperature : 138,2C
max. operating pressure : 3,5 bar abs.
max. operating temperature : 138,2C
Steam generator :
accumulation/evaporator body design pressure : 5 bar abs.
accumulation/evaporator body design temperature : 152C
accumulation/evaporator body max. operating pressure : 5 bar abs.
accumulation/evaporator body max. operating temperature : 152C
Autoclave and relevant steam generator are tested according to parameters and criteria fixed by the
applicable pressure vessels code.

Document ID : PEFS-00-G_DLV CAB Rev.5 Date : May 24, 2013 Page No.42 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

3.1 Optionals

Following items are out of the scope of supply and can be quoted on request:
equipment design for operation at higher pressure/temperature
equipment design, manufacture and test in compliance with other pressure vessels codes

4. DIMENSIONAL DATA

4.1 CAPACITIES

CHAMBER VOLUME : lts. 170


USEFUL CAPACITY : lts. 157

4.2 CHAMBER INTERNAL DIMENSIONS

DIAMETER : mm.500
HEIGHT : mm.800

4.3 EQUIPMENT OVERALL DIMENSIONS

See preliminary lay-out dwg.

5. CONSTRUCTION FEATURES

5.1 AUTOCLAVE BODY

The autoclave body, cylindrical vertical double-wall type, has following main features:
Internal body (chamber + lid) made of highly satin finish (Ra < 0,375 m) high thickness AISI 316L
stainless steel sheet with no edges to avoid undesired accumulation of solid particles and to allow
easy cleaning.
All internal components have been carefully designed to avoid pockets or sharp edges.
Shell, made of AISI 304 stainless steel, covering the whole external chamber, which forms a jacket
used for heating, load drying and eventual cooling (by water circulation)
Set of outlet/inlet connections for supply of the utilities made of AISI 316L stainless steel
One special port, with clamp connection, for access of thermocouples or flexible temperature sensors
Pt 100 Ohm to be used for validation activities
One perforated shelf, on chamber bottom, made of AISI 316L stainless steel, to allow load easy
support

5.1.1 Optionals

Following items are out of the scope of supply and can be quoted on request:
mirror polished internal finishing Ra < 0,375 m
autoclave body active surfaces passivation according to De Lamas procedure No.IO75-01 and
ASTM No.A967 Standard Specification for Chemical Passivation Treatments for stainless
steel parts (where applicable)
temperature sensors coupling device (probeholder) in AISI 316L stainless steel, fitted with tri-
clamp connection, for passage of up to No.32 thermocouples
special connection, with double inlet adapter, for access of thermocouples or flexible
temperature sensors Pt 100 Ohm to be used for validation activities
device useful for heating/dehumidification of chamber incoming air and improve drying
performances, mainly composed of a steam powered exchanger with relevant ancillary devices
and accessories for a correct operation (ref. heating/ dehumification option)
ventilator system useful to grant the best heat distribution, speed up load cooling operations in
counterpressure and improve drying performances in the respective cycles (ref. fan option)

Document ID : PEFS-00-G_DLV CAB Rev.5 Date : May 24, 2013 Page No.43 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

5.2 LID

Autoclave is fitted with horizontally swivelling lid.


The lid moving is made manually while the locking/unlocking operations are automatically managed
directly by the control system.
Opening/closing system, of De Lamas exclusive design, guarantees best sealing and smooth and safe
operation with no physical effort.
Lid forged and milled profile is made of high thickness AISI 304 stainless steel.
Lid peripheral sealing gasket, with special profile, is in silicone rubber withstanding high operating
temperatures. Gasket is housed in a milled gasket seat which prevents any leakage.
Gasket pushing towards the lid is made by compressed air thrust behind the gasket itself.

5.3 STEAM GENERATOR

Steam generator, directly connected to the jacket, is horizontal type and has following main features:
internal accumulation/evaporator body, made of AISI 316L stainless steel with pickled finishing
heating group consisting of one or more armored electrical resistances, in Incoloy 800, easy to be
removed, directly immersed in feedwater. In order to avoid disturbs to power supply line, total power
is subdivided into steps controlled and managed by timer and safety pressostat switch.

5.3.1 Optionals

Following items are out of the scope of supply and can be quoted on request:
generator body active surfaces passivation according to De Lamas procedure No.IO75-01 and
ASTM No.A967 Standard Specification for Chemical Passivation Treatments for stainless
steel parts (where applicable)
autoclave arrangement for combinated heating : electrical (from built-in steam generator) or by
process steam from factory utility line. Switching for required type of heating is performed
through a 3-way manual valve fitted with limit switch in order to monitor relevant position
(ref. steam from factory line option)

On request, autoclave can be foreseen for the sole operation through process steam from factory
utility line and, therefore, without steam generator.

5.4 INSULATION/LAGGING

The whole autoclave and generator bodies are insulated by a suitable asbestos free and chlorine free
insulating material blanket useful for personnel protection and for heat loss prevention.
Such blanket can be easily removed/re-located for inspection/maintenance without any special tool.
Insulation assures a temperature on external surfaces lower than 40C with ambient temperature of
22C.

5.5 PANELING

Autoclave is fitted with a self-standing structure, with castors, made of satin finish AISI 304 stainless
steel and thermoformed plastic material (ABS).

5.6 PIPING SYSTEM

The hydraulic system connected with the sterilization chamber and relevant feeding circuits is made of
AISI 316/AISI 316L/PTFE.
Hot pipes are insulated by special material to reduce heat loss (cellular silicone).
Gaskets are made of teflon/silicone.
Main components:
One set of pneumatic on/off valves
One set of solenoid valves for process fluids
Automatic steam traps to discharge condensate and cold air
One pneumatic valve for steam pressure regulation inside the chamber
One strainer filter located on the chamber drain

Document ID : PEFS-00-G_DLV CAB Rev.5 Date : May 24, 2013 Page No.44 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - E
Egypt

One heat exxchanger to coool down conddensates prior to entry into the
t vacuum puump
One vacuum m pump groupp consisting of o a liquid rin
ng vacuum puump with releevant accessorries. Max.
vacuum to beb reached: 4 kPa
Three m
marked safetyy valves, testeed and approvved according to applicablee pressure vesssels code,
protecting thhe chamber, thhe jacket and the steam gen nerator, with external
e parts made of brasss
One systemm for pre-treatted water autoomatic filling to the steam generator com mplete of mag gnet drive
gear pump, valves and acccessories for a correct operration

5
5.6.1 Option
nals

wing items are out of the scoope of supply and can be quuoted on requeest:
Follow
devicce suitable to cool drain iff the temperatu ure becomes toot high compposed of a tan nk, fed by
serviice water, madde of AISI 3004 stainless steeel, with relevvant ancillary devices (cooling water
sprayy nozzles, onn/off valve, thhermostat for temperature regulation,
r ettc.) (ref. dra
ain cooler
optioon)
presssure reducing unit, fitted withw relevant valves,
v safety valve and accessories, for incoming
comppressed air to the chamber (ref. ( compreessed air presssure reducin ng unit option n)
strainner filter to be
b located upsstream the so oftened water for vacuum ppump incoming line in
orderr to avoid eveentual entrainm ment of impurrities (ref. sofftened water strainer optiion)
presssure reducing unit, fitted withw relevant valves,
v safety valve and accessories, for incoming
process steam to the chamberr/jacket only in case of autoclave arrranged for co ombinated
heatiing (electricall/steam from factory
f utility
y line) or for sole
s operationn through proccess steam
from
m factory utilityy line (ref. stteam pressurre reducing unit u option)
strainner filter to bee located upstrream the proccess steam incooming line in order to avoid d eventual
entraainment of im mpurities only
o in case of autoclavee arranged foor combinateed heating
(elecctrical/steam from
f factory utility line) or
o for sole opperation througgh process stteam from
factoory utility linee (ref. steam strainer optiion)

5.7 FLUIDS
F FIL
LTRATION

5
5.7.1 AIR FILTER
F

Autocllave is standaard fitted withh an air inlet filter,


f with 0,222 micron carrtridge, for prrocess air,
atmosppheric air (for pressure balaance) and vacuuum break
The abbsolute filter is assembledd and equipp ped with Stabli coupliings for conn nection to
Sartoccheck, Pallttronic or othher similar tesst system (out of De Lamaas scope of supply)
s in
order to perform WIIT

5.7.1.11 Optionals

Following items
i are out of
o the scope of
o supply and can
c be quotedd on request:
Sterilize-In-Place of thhe air filter (PR
ROGRAM J) - (ref. filter sterilization option)
air filtrattion system upstream
u vaccuum pump composed
c off filtering uniit, valves,
temperatuure sensor, anncillary devicces for a corrrect operationn and relevan nt S/W, to
perform automatic
a PROOGRAM A_L LP to performm decontaminaation of materiials at low
pathogennic risk Biological ageents group 1 or 2 of thhe European Directive
2000/54/E EC
NOTE: Such configguration is no ot suitable forr treatment oof high pathog genic risk
materials (B
Biological ag gents group 3 or 4 of thhe European Directive
2000/54/EC)) and, thereefore, De Lama is not liable for such un-
appropriate use
u of the auto oclave.

6. SAFE
ETY DEVIC
CES
Follow
wing devices are installed:
devvice preventingg lid opening with pressure in the chamb
ber

Docum
ment ID : PEFS-00-G_DLV CAB
C Rev.5 Date : May
y 24, 2013 Page No.4
45 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

device preventing cycle start if the lid is not perfectly closed or the lid gasket is not in perfect seal
condition (no pressure in the sealing gasket)
device which locks the lid when the sterilization cycle is in progress
device preventing fluids inlet into the chamber in case of chamber internal temperature higher than 70C
safety level sensor, with capacitive probe, to shut-off heating group of the steam generator in case of water
lack

7. INSTRUMENTATION
Sterilizer is equipped with following instrumentation:

7.1 PRESSURE INDICATORS

One bourdon pressure/vacuum gauge, range -1 +5 barg, for pressure indication inside the
sterilization chamber
One bourdon pressure/vacuum gauge, range -1 +5 barg, for pressure indication inside the jacket
One bourdon pressure/vacuum gauge, range -1 +5 barg, for pressure indication inside the steam
generator

7.2 PRESSURE INSTRUMENTS

One pressure transmitter, to control and regulate the pressure inside the chamber, with a standard
normalized 4-20 mA output and an end-scale 5 abs. bar. Sensor is mounted directly on the sterilizer
chamber. The pressure sensor is thermal compensated around the operating temperature (100130C).

7.3 TEMPERATURE SENSORS

One 4-wire temperature sensor Pt 100 Ohm complying with European Standards CEI EN 60751:1998
(precision: better than Class A) - located in the chamber drain - to control temperature inside the
chamber
One 4-wire temperature sensor Pt 100 Ohm, complying with European Standards CEI EN
60751:1998 (precision: better than Class A) to control and regulate temperature inside the jacket
One 4-wire temperature sensor Pt 100 Ohm complying with European Standards CEI EN 60751:1998
(precision: better than Class A) to control and regulate temperature inside the steam generator

7.3.1 Optionals

Following items are out of scope of supply and can be quoted on request:
additional temperature sensors Pt 100 Ohm for temperature control inside the chamber
(number of sensors can be increased according to type of control system and number of
installed field sensors)

7.4 LEVEL INSTRUMENTS

capacitive level sensor, connected to the control system, for automatic control of water inside the
steam generator evaporator body
capacitive level sensor, connected to the control system, to shut-off heating group of the steam
generator in case of water lack

8. OPTIONAL AUTOCLAVE CONFIGURATIONS (quoted on request)


To perform treatment of some specific types of loads, sterilizer can be fitted with following additional
configurations:

8.1 AIR/STEAM MIXTURE VERSION

Autoclave can be designed to enable Customer to use the same equipment to run two different types of
process cycles : the conventional steam sterilization combined with the air/steam mixture suitable for

Document ID : PEFS-00-G_DLV CAB Rev.5 Date : May 24, 2013 Page No.46 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

treatment of pressure/temperature sensitive products such as plastic containers, products in blister


packs, pre-filled syringes, etc. Autoclave in such configuration (model DLV CAB-AV) features:
chamber structure suitable to withstand sterilization in overpressure condition (4,5 bar abs.)
ventilator group which provides for air/steam mixture forced circulation and homogenization
throughout the chamber, heat transfer during the heating phase, internal temperature uniform
distribution during the cycle phases, speed up load cooling operations in counterpressure and improve
drying performances in the respective cycles.
Ventilator is composed of one high efficiency fan, made of AISI 316L stainless steel, equipped with
relevant accessories and ancillary devices for a correct operation. Fan is embedded into the closing
lid, without affecting the available working area into the chamber, and is fitted with a cowling, made
of AISI 316L stainless steel punched and bent sheet, in order to assure homogeneous distribution of
air/steam fluid on product
S/W to perform automatic PROGRAM M_F

8.2 HIGH PATHOGEN VERSION

The materials at high pathogenic risk - Biological agents group 3 or 4 of the European Directive
2000/54/EC have to be submitted to a specific treatment before being re-used, disposed or re-cycled in
order to avoid any risk of pollution/contamination for the Operators, the working area and the
environment (including sewer lines).
After such treatment load is safe and ready to be re-used or disposed.

Typical applications:

materials coming from the pharmaceutical field (e.g. from laboratories for production of vaccines,
serums, etc.)
products coming from research and/or microbiology laboratories (e.g. diagnostic or biotechnological
products or manufacturing wastes)
products coming from the hospitals (e.g. materials outcoming from infectious diseases areas)
highly resistant pathogenic organisms (e.g. from Creutzfeldt-Jakob disease bovine spongiform
encephalopathy well-known as mad cow disease and from correlated syndromes)

Should Customer require to perform treatment of high pathogenic risk loads, autoclave can be designed
to combine the conventional steam sterilization with the air/steam mixture sterilization (Customer is
enabled to use the same equipment to run two different types of process cycles) - (ref. high pathogen
option).

Autoclave in configuration for treatment of high pathogenic risk materials (model DLV CAB-HP)
features:
chamber structure suitable to withstand sterilization in overpressure condition (4,95 bar abs.)
no evacuation of fluids before being sterilized
no venting of contaminated air till the end of the sterilization process
homogenization of the air/steam mixture throughout the chamber by the application of a ventilator
group which is useful to assure the internal temperature uniform distribution during the cycle different
phases, speed up load cooling operations in counterpressure and improve drying performances in the
respective cycles.
Ventilator is composed of one high efficiency fan, made of AISI 316L stainless steel, equipped with
relevant accessories and ancillary devices for a correct operation. Fan is embedded into the closing
lid, without affecting the available working area into the chamber, and is fitted with a cowling, made
of AISI 316L stainless steel punched and bent sheet, in order to assure homogeneous distribution of
air/steam fluid on product
S/W to perform following automatic programs:
PROGRAM A_HP : air/steam mixture sterilization/decontamination of solids at high pathogenic
(standard) risk maximum temperature : 138C
PROGRAM F_HP : air/steam mixture sterilization/decontamination of liquid products/materials
(optional) at high pathogenic risk - maximum temperature: 138C

Document ID : PEFS-00-G_DLV CAB Rev.5 Date : May 24, 2013 Page No.47 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

9. ELECTRICAL SYSTEM
For electricals, De Lama document Electrical specification vertical and monobloc sterilizers Doc. ID :
ELSV-00-G_0000 is applicable to De Lamas scope of supply.

10. CONTROL AND MANAGEMENT SYSTEM


For automation, De Lama document Process control system specification OLIMPYA/WP-TS - Doc. ID :
PCSS-00-G_WPTS is applicable to De Lamas scope of supply.

11. WORKING PROGRAMS


High flexibility of the control and management system enables performance of automatic control/utility
programs and automatic sterilization and/or decontamination programs.
Customer is free to store different cycles within installed programs. User can, therefore, create a Customized
library of cycles, stored with identification file names, with different parameters (e.g.: time, temperature,
vacuum, pressure, etc.) which can be selected by the Operator according to type of load.
In alternative to programs management with storage of time and temperature parameters, sterilization phase
can be managed and regulated by means of the F0 exponential function to a programmed value.
Process regulation by the F0 function is described, in detail, in De Lama document F0 function Doc. ID :
F0-00-G_0000
The sterilization programs, indicated as optional, require, in addition to the implementation of relevant S/W
useful to perform them, even a suitable H/W and equipment configuration.
Optional programs which might be useful for Customer applications are separately quoted in the economical
offer.

LIBRARY OF STANDARD STORED PROGRAMS:

CONTROL/UTILITY PROGRAM:

PROGRAM I : Chamber vacuum leakage test according to European Standard EN 285

STERILIZATION PROGRAMS:

PROGRAM A : Sterilization of solids and porous materials with initial pulsated vacuum and
final pulsated drying

LIBRARY OF OPTIONAL STORABLE PROGRAMS:

CONTROL/UTILITY PROGRAMS:

PROGRAM BD : Bowie-Dick test according to European Standard EN 285


PROGRAM J : Sterilize-In-Place of the air filter

STERILIZATION PROGRAMS:

PROGRAM A_T : Sterilization of rubber stoppers with final drying by sterile hot/dehumidified
air (air heating carried out through a suitable device mainly composed of a
steam powered exchanger)
PROGRAM A/S : Sterilization of solids and porous materials with initial vacuum, final drying
under vacuum and subsequent product rapid cooling SUPERCOOLING (*)
PROGRAM B : Sterilization of ampoules with initial vacuum, vacuum seal test phase and
final cooling by inlet of sterile compressed air for counterpressure inside
the chamber and sterile demineralized water spray on load
PROGRAM BA : Sterilization of ampoules with initial vacuum, vacuum seal test phase,
cooling by inlet of sterile compressed air for counterpressure inside the
chamber + sterile demineralized water spray on load, subsequent drying
and final cooling by water circulation inside the jacket

Document ID : PEFS-00-G_DLV CAB Rev.5 Date : May 24, 2013 Page No.48 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

PROGRAM BA_T : Sterilization of ampoules with initial vacuum, vacuum seal test phase,
cooling by inlet of sterile compressed air for counterpressure inside the
chamber + sterile demineralized water spray on load, subsequent drying by
sterile hot air (air heating carried out through a suitable device mainly
composed of a steam powered exchanger) and final cooling by water
circulation inside the jacket
PROGRAM F : Sterilization of liquid solutions and/or culture media in sealed/unsealed
glass or non-deformable containers, with initial vacuum and final cooling
by inlet of sterile compressed air for counterpressure inside the chamber
and water circulation inside the jacket
PROGRAM F_C : Sterilization of liquid solutions and/or culture media in sealed/unsealed
glass or non-deformable containers, with initial vacuum and final cooling
by inlet of sterile compressed air for counterpressure inside the chamber,
water circulation inside the jacket + sterile demineralized water spray on
load
PROGRAM T_A : Tyndallization for solids
PROGRAM T_F : Tyndallization for liquid materials/products

(*) SUPERCOOLING is a cooling system of DE LAMAs original design (H/W and S/W) which enables
extraction of sterilized products at a temperature (approx. 40 C) which is compatible with Operators
handling.

DECONTAMINATION PROGRAMS

To prevent any risk of pollution/contamination for the Operators/environment, the air extracted from the
chamber can be filtered by a air filtration system, located upstream vacuum pump, composed of filtering
unit, valves, temperature sensor and ancillary devices for a correct operation.
Such additional device, useful to perform decontamination of materials at low pathogenic risk
Biological agents group 1 or 2 of the European Directive 2000/54/EC - can be integrated in the autoclave
and used in conjuction with all programs which include a air removal phase.

11.1 DESCRIPTION OF STANDARD STORED PROGRAMS

11.1.1 DESCRIPTION OF CONTROL/UTILITY PROGRAM

I : Chamber vacuum leakage test according to European Standard EN 285

Sequence:

plant arrangement to operating conditions with empty chamber and closed lid
vacuum pump start and operation up to programmed residual value of 70 mbar
N.B. : vacuum of 70 mbar can be achieved with feeding water to vacuum
pump having temperature 20C
vacuum pump stop
vacuum holding for stabilization, at the reached value, for a programmed time of
5 minutes. If the pressure rises over a programmed value, an alarm signal is
activated
chamber vacuum leakage test phase, with vacuum holding at the value reached
after stabilization, for a programmed time of 10 minutes
verification that during such period pressure does not rise, over programmed
residual value, of 13 mbar. On the contrary, an alarm signal is activated
air inlet through sterile filter for pressure balance
end of cycle

Document ID : PEFS-00-G_DLV CAB Rev.5 Date : May 24, 2013 Page No.49 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - Egypt

11.1.2 DESCRIPTION OF STERILIZATION PROGRAM

A : Sterilization of solids (e.g. empty glassware, test tubes, rubber stoppers,


instruments, flasks, surgical instruments, machine parts, empty containers, filters,
rubber materials) and porous materials (e.g. textiles, etc.) with initial pulsated
vacuum and final pulsated drying

Sequence:

jacket heating
phase of initial pulsated vacuum inside the chamber, with settable values of
vacuum, pressure and number of vacuum/steam inlet pulsations
steam inlet inside the chamber for heating
air and condensate elimination by vacuum pump
achievement of programmed temperature value (in the coldest point)
programmed temperature holding for a fixed time for stabilization
start of sterilization phase with calculation of programmed phase time
end of sterilization phase
stop of steam inlet inside the chamber
steam exhaust from the chamber up to a programmed pressure value
phase of final pulsated vacuum inside the chamber, for load drying, with settable
values of vacuum, sterile inlet air pressure and drying lenght
air inlet through sterile filter for pressure balance
end of cycle

12. TECHNICAL PERFORMANCES

12.1 TEMPERATURE UNIFORMITY INSIDE THE EMPTY CHAMBER

Inside the empty sterilization chamber of a monobloc saturated steam sterilizer DLV CAB type in
standard execution, the temperature difference between the hottest point and the coldest one will not be
higher than 0,5C compared with the reference temperature.

13. TEST PRESSURE


Autoclave (meant as chamber and relevant fittings), with relevant steam generator, designed according to
pressure vessels code indicated in Paragraph 3, are tested for the following operating pressures:
chamber max. operating pressure : 3,5 abs. bar
jacket max. operating pressure : 3,5 abs. bar
generator evaporator/accumulation body max operating pressure : 5 abs. bar
Main weldings will be X-ray inspected in accordance with the applicable sections of relevant applicable
pressure vessels code.

14. TECHNICAL DATA, UTILITIES AND FLUIDS


Utilities necessary for sterilizer correct operation are those indicated in respective fluids data sheets and must
be available and in compliance with stated features (type, quality, quantity and pressure).

15. IDENTIFICATION DATA


The sterilizer is permanently provided with following readable data:
identification number
name of the manufacturer

Document ID : PEFS-00-G_DLV CAB Rev.5 Date : May 24, 2013 Page No.50 of No.51
Offer No. 8662

Date March 6, 2015

Customer Marcyrl - E
Egypt

maiin design dataa


marking withh identificationn of Control Body
B

16. DOC
CUMENTAT
TION
For documentation
d n, De Lama document
d Dee Lama docu
umentation lisst Doc. ID : DOC-00-G
G_0000 is
appliccable to De Laamas scope of
o supply.

17. NOT
TES
a) Affter the orderr, in phase of o executive design, De Lama
L will prrovide to determine equip
pment and
wgs. will be submitted to Customer forr approval
acccessories finaal constructionn dimensionss. Relevant dw
beefore construction
b) Dee Lama drawss Customer atttention on thee fact that, aftter equipmentt installation, Customer hass to bound
alll relevant safe
fety areas provviding, eventuually, suitablee barriers or devices
d and afffixing all saffety signs,
inside the depaartment. Furthhermore, Custtomer has to perform a traaining activityy to the operaators with
sppecific reference to safety prroblems relevvant to the new
w equipment
c) Too avoid limeestoning insidde the steam m generator use of feew
water of apprropriate chem
mical and
ghly recommended. Deminneralized or deionized
miicrobiologicall quality, preeferably pre-trreated, is hig
waater, free of voolatile additivves, is advisable

18. LOA
ADING/UNL
LOADING ACCESSOR
A RIES
Loadiing/uloading accessories
a arre characterized by a carefful constructioon, fully execcuted in stainnless steel,
whichh conforms to ergonomic crriteria and quaality standardss required for pharmaceutic
p al application
ns.

18.1 ROUND-SHA
R APED WIRE
E BASKET M
MW type

1
18.1.1 FEATURES

Mateerials
eleectropolished AISI 304 / AIISI 316 stainleess steel
Consstruction
Oppen top wire basket
b with ceentral lifting handle
h used
forr loading of vaarious materiaals

1
18.1.2 APPR
ROX. DIMEN
NSIONS

See dim
mensions in thhe priced offerr

19. OPTIONAL AC
CCESSORIE
ES
Follow
wing items aree out of scopee of supply andd can be quoteed on request::
a) ionns exchange automatic
a watter softener, coomposed of a tank, regeneraation control uunit and ionicc exchange
resins (ref. waater softener option)
o
b) coompressor fitteed with relevaant accessories, for feeding of compresseed air useful to assure lid seealing and
pnneumatic circuuit/instruments operation (reef. instrumeents air comp
pressor option n)
c) coompressor fittted with releevant accessories, for feed ding of comppressed air uuseful to perfform both
coounterpressuree inside the chhamber duringg working programs which foresee coolinng phases and d to assure
lidd sealing and pneumatic
p cirrcuit/instrumennts operation (ref. chamber and instru
uments air co
ompressor
opption)

Docum
ment ID : PEFS-00-G_DLV CAB
C Rev.5 Date : May
y 24, 2013 Page No.5
51 of No.51