Technical Specification For CheckWeigher

PHARMADEEP TURNKEY CONSULTANTS & ENGINEERS PVT. LTD.
B-509, Lodha Supremus-II, Near Dosti Pinnacle, Road No 22, Wagle Estate, Thane
(W)
Client Name: M/s. PSA Chemicals & Pharmaceutical Pvt. Ltd.
Document No: Date: 07/23/19
Document Name: Technical Specification for CheckWeigher. Rev. No.: 00
1 INTRODUCTION
1.1 DESCRIPTION OF DOCUMENT

The technical specification specifies the requirements for Technical Specification for
Checkweigher in the Pharmaceutical facility from the user’s M/s. PSA Ltd, point of
view.
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1.2 ABBREVIATION
API Active Pharmaceutical Ingredient
cGMP Current Good Manufacturing Practice
FAT Factory Acceptance Test
USFDA United States for Food and Drug Administration
CFR Code of Federal Regulation
GAMP Good Automated Manufacturing Practice
HMI Human Machine Interface
IPC In-Process Container
IQ Installation Qualification
N/A Not Applicable
OQ Operational Qualification
PC Personal Computer
PED Pressure Equipment Directive
PLC Programmable Logic Controller
PQ Performance Qualification
QMS Quality Management System
QRS Quality Regulation System
SAT Site Acceptance Test
SCADA Supervisory Control And Data Acquisition
TS Technical Specification
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2 GENERAL
2.1 PURPOSE
The purpose of this document is to specify the requirements for the
Technical Specification for Checkweigher for the Pharmaceutical facility
in the Plant of M/s. PSA Ltd. Descriptions are given in terms of general
functions, appearance and capacity. Requirements are defined as
paragraphs to facilitate FAT, SAT, IQ and OQ.
The document is written by M/s. PHARMADEEP, THANE and the aim is
to provide the supplier the information needed to find a technical
solution. If required, the client, & PHARMADEEP and the supplier work
together to update the TS. It becomes a mandatory requirement of
the vendor/supplier to read the document carefully & quote
accordingly. Further, it shall be understood that the vendor has
accepted the TS as stated herein, unless he gives the deviation list
along with the offer.
2.2 DEFINITION
The document is defined to concern the specific system. This technical
specification is not valid for commercial purpose; the facts concerning
suppliers, deliveries and customer such as responsibility and
definitions of operation are described in commercial documents.
2.3 TESTING & QUALIFICATION

The items to be tested or the type of testing and qualification is
marked in the right column of the demand. Those demands without a
mark for testing are demands of the project and delivery. Demands
marked for example FAT/IQ means that control shall be done in FAT or
IQ.
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3 SCOPE OF WORK
3.1 DESCRIPTION
The purpose of Technical Specification for Checkweigher shall
be able to weight the cartons online and to reject the underweight and
overweight cartons in the Packaging area.
The section shall consist of:
Checkweigher – 05 Nos, Capacity- 1.00 Kg
3.2 SCOPE OF WORK
- Complete equipment according to this specification.

- FAT in the supplier’s factory.
- Installation, start-up and SAT at M/s. PSA Ltd., Pithampur
- Spare parts.
- Documentation.
- Qualification including protocols and execution.
4 REQUIREMENTS FOR ENVIRONMENT AND OPERATION
4.1 ENVIRONMENT AND UTILITIES TO BE USED
Layout
The Checkweigher shall be installed in a clean room area, grade E and
unclassified.
Physical condition and room classifications

Room temperature in D-area is 23 ±2 °C, relative humidity not more
than 55%.
Utilities
Requirements for utilities to be specified by the supplier.
Utility Temperat Pressure Temperature Pressure (bar) Peak/cycle
ure (°C) (bar, g) (°C) by by supplier
by supplier
supplier
Compressed air Ambient 5-6
PW N/A N/A
Factory Steam N/A N/A
Drain <60 N/A
Power 415 V, 3-phase, 50 Hz
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Service Power 230 V, 1-phase, 50 Hz -
4.2 NORMAL OPERATION

Quality Requirements
1) Checkweigher shall be preset and able to weight the cartons FAT, OQ, PQ
online and to reject the underweight and overweight cartons
in the Packaging area.
Capacity
Checkweigher in the Secondary Packaging/ Pkg. Hall,
1) FAT, OQ, PQ
Capacity- 1.00 Kg
Preliminaries
1) The Cartons/blister which pre-weighs will be of different -
weights, sizes & shapes.
Process/operation
1) Checkweigher shall be mounted on adjustable legs and shall FAT, IQ
be easily linked with packing conveyor belt / Cartonator.
2) Machine shall able to weight the cartons after packing of FAT, IQ, OQ
blisters/Strips.
3) Cartons which are overweight shall be rejected with the alarm. FAT, IQ, OQ
4) Cartons which are under weight shall be rejected with the FAT, IQ
alarm.
5) Machine shall equip with one rejection assembly & shall be FAT, IQ, OQ
collected in rejection bin.
6) Rejection shall be of pneumatic cylinder type or of FAT, IQ, OQ
compressed air blow.
7) Online printing unit shall be provided for printing of weight of FAT, IQ, OQ
all cartons with final summary for all underweight, overweight
and good cartons.
Quality Control
1) It shall be enabled to maintain the Readability, linearity and FAT/OQ, PQ
Corner Reading for accuracy. The standard deviation of the
balance shall specify the accuracy for three readings.
2) Acceptable weighing range shall be ±0.2gms. FAT/OQ, PQ
Cleaning / sanitation / sterilization

The Checkweigher shall be designed with an accent on FAT, IQ,
1) cleanliness & easy accessibility to all parts to ensure easy OQ
maintenance and cleaning for changeover.
The equipment shall be easily accessible for manual cleaning of FAT, OQ
2) the outside surfaces.
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Instrumentation
The system shall be equipped with safety switches, which stops FAT, IQ,
1) the machine immediately OQ
The controlling of the Machine will be done by using PLC system. FAT, IQ,
2) The input parameters can be set and displayed on the viewing OQ
panel
At least the following measurements shall be measured FAT, IQ,
3) automatically (on-line), continuously shown on HMI printer: OQ
- Carton left over roll feedback
- Auto data storage on power failure
- Date, Day, Time, Operator Name, Batch Number details
- Diagnosis record
- Digital rate indicator (units/minute)
- Inlet pressure and supply of compressed air
- Jog / run selector
- Password
- Reject counter
- Run indicator light
- Speed adjustment
4.3 NECESSARY PROGRAMME
Preferred programming tool for PLC program and for HMI FAT, IQ
application is Mitsubishi.
PLC Screen Should Display auto fault on the screen to view the FAT, IQ
exact location of the error.
Total number of recipes (different placement arrangement, no. FAT, IQ, OQ
of tracks) to be stored in the control system memory is 50.
4.4 CONTROL SYSTEM
The machine shall be equipped with a PLC, an operator panel FAT, IQ
and a remote mobile hand panel used for machine settings.
The PLC controls the process and acquires data from it. Via FAT, OQ
HMI the operator can feed parameters and control commands
for PLC. HMI visualises the functioning of the equipment to
operator.
The system shall be able to log data from the process and FAT, OQ
operator actions.
The system has ability to manage several user levels, ID’s and FAT, OQ
passwords.
The system must have a local stop capability that shuts the FAT, OQ
system down in an orderly manner.
The PLC-unit shall be equipped with sequence programs for FAT, IQ, OQ
starting and stopping the entire machine, for controlling the
normal operation. Delivery shall include programming tools for
all software.
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All text signs on control knobs, switches, operator panel etc FAT, IQ
shall be in English language.
4.5 ERATION IN HAZARD SITUATIONS

Utility failure
1) The control system shall work such that a utility failure (such as FAT,OQ
electricity, compressed air, nitrogen, etc.) does not break the
system or cause hazardous situations for persons that are inside
the plant. (Attention to be paid to valve positions, interlocks,
sequence supervision times and alarm settings.)
2) PLC and HMI programs must retain on electric power failure. FAT,OQ
System recovery after power failure must be possible for operator
via HMI and without any programming tools.
3) The stored data must retain on electric power failure. FAT,OQ
4) When reconnected after an electric power failure, the system FAT,OQ
must not start automatically any control actions without operator
input.
Emergency stop
1) Emergency stop must stop the complete machine immediately in FAT,OQ
a safe way.
2) Emergency stop buttons must be positioned so that operator can FAT,IQ
reach the stop from all sides of the machine.
3) Restart after operator shall perform emergency stop from the HMI FAT,OQ
in an easy and safe way.
4) All operator settings shall be unchanged and restored after an FAT,OQ
emergency stop.
Error handling
1) If hardware failure occurs, the complete machine must stop FAT,OQ
immediately in a safe way.
Alarms
1) All alarms shall be indicated by a light column. FAT,IQ
A Alarms (stops the machine immediately)
1) - Emergency stop FAT,OQ
2) - Carton / Blister Under weight FAT,OQ
3) - Carton / Blister overweight FAT,OQ
4) - Failure of misfeed check mechanism FAT,OQ
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4.5.1.1 B Alarms (informative alarms)

1) - Failure of auto feeding device FAT,OQ
2) - Deviation in compressed air pressure than the preset condition FAT,OQ
3) - Rejection of Cartons/Boxes FAT,OQ
4) - Failure of misfeed check mechanism FAT,OQ
5) - High pressure drop (blocked filter) low pressure drop (filter FAT,OQ
damage) across the filters in the compressed air line
5 TECHNICAL SPECIFICATIONS
5.1 MATERIAL SPECIFICATION AND DEMAND OF SURFACE FINISH
Material and surface finish of parts in contact with the product

1) All contact parts shall be made of stainless steel AISI 316L or FAT,IQ
compatible.
2) The contact surface finish shall be matt polished with 320 Grit FAT,IQ
(0.35Ra).
Material and surface finish of parts not in contact with the product
1) Stainless steel AISI 304 or equivalent shall be used in surfaces that FAT /IQ
are not in contact with the product with 180 Grit (0.85Ra) mat finish.
Material and surface finish of outer surface.

1) All material used in the equipment shall be of durable type. FAT/ IQ
2) The outer surface shall be matt finish and easily cleanable. FAT /IQ
Non-metallic materials
1) Hoses, gaskets, diaphragms and O-rings in direct contact with the FAT,IQ
product shall be PTFE and/or EPDM, Kalrez® or Silicone.
2) All non-metallic materials used in the equipment shall be of durable FAT
type and must withstand cleaning with Iso propyl alcohol and
detergents.
3) Hoses in contact, if any with the product or clean utilities shall be FAT,IQ
food grade quality, anti-static.
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Insulation material
1) Insulation of the equipment to be specified by the supplier if -
applicable.
Material of the signs and name plates

All materials used in the equipment shall be of durable type and FAT
1) must withstand cleaning with Iso propyl alcohol and detergents.
The signs and name plates shall be made of stainless steel AISI 304 FAT,IQ
2) or compatible with at least the following information: Item number of
the equipment given by the purchaser, manufacturer's type; size
and serial number, manufacturing year; material, other information
requested by the authorities.
5.2 DEMAND OF CONSTRUCTION
General
Working height of the Units shall be 800mm above the floor and FAT,IQ
1) variable at ± 200 mm. If more, a suitable service platform has to be
provided for the equipment.
The Units shall be equipped with anti-static parts in contact with the FAT,IQ
2) product.
All the machines should rest on levelling screws provided with pads FAT,IQ
3) to enable proper levelling of the machine on the production floor.
Checkweigher (non-Flameproof)
1) The unit must belong to standard cGMP design. FAT,IQ
2) The Machine shall be mounted on anti-vibratory pads. FAT,IQ

3) All electrical devices shall be of non flameproof. FAT,IQ
4) Guards shall be provided for avoiding carton fall on the floor. FAT,IQ,OQ
5) The machine shall be designed for easy manual cleaning & FAT,OQ
material movement & better validation.
6) Machine acceptable weighing range shall be ±0.2gms FAT,IQ,PQ
7) Measurement data for calibration and adjustment performed shall FAT,IQ,OQ
be easily recorded via PC or Printer
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Pipes and hoses

1) Utilities are provided according to installation drawings. FAT
Hygienic design
1) The equipment shall be easily accessible for cleaning. FAT
2) The floor under/around the equipment shall be easily accessible for FAT /SAT
cleaning.
Cleaning – outer surface of equipment

All parts which face the clean room environment must be made of FAT
1) durable type and withstand cleaning with Iso propyl alcohol and
detergents. The outer surface shall be easy to clean, without
grooves and pockets to reduce risk of contamination
Insulation
All hot and cold surfaces if any, which may cause a risk of injury, FAT
1) must be insulated or protected by suitable means.
Supplier to specify heat emission from the system/equipment FAT,IQ
2) during maximum operating temperature.
Identification of equipment
Separate pieces of equipment like motors, gearboxes, instruments, FAT,IQ
1) valves, etc. shall be supplied with equipment nameplate according
to supplier standards approved M/s. PSA Ltd., Pithampur.
The equipment item numbers have to be used in all documentation FAT,IQ
2) of this purchase. Later the item numbers are going to serve the
maintenance.
The name plate shall have at least the following information: Item FAT,IQ
3) number of the equipment given by the purchaser, manufacturer’s
type; size and serial number, manufacturing year, material, and
other information requested by the authorities.
Noise level
Noise level of the equipment, shall be as low as possible, and must FAT , OQ
1) not exceed 50 dB (A) measured at operator working places.
The vibration level of the equipment shall fulfil the requirements FAT , OQ
2) according to ISO 10816.
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Dispatch
Before packing and dispatch all equipment must be well cleaned FAT, SAT
1) inside as well as outside and dried.
Before packing and dispatch connections - like inlet and outlet ports FAT, SAT
2) - shall be sealed.
5.3 DEMANDS OF INSTRUMENTATION
General
The instrument enclosure materials shall be made of durable type IQ
1) and must withstand cleaning with Iso propyl alcohol and detergents.
The instrument cabling materials, including cables, racks, clamps FAT/IQ
2) and other components, shall be made of durable type and must
withstand cleaning with Iso propyl alcohol and detergents.
Measurement inaccuracy including repeatability and hysteresis FAT,IQ,
3) must be within 1.0% of the range. OQ
4) Minimum protection class of equipment is IP67. FAT,IQ
All wiring installations shall be marked in both ends as well as on IQ
5) the connection plinths.
There shall be enough cable to allow calibration of instruments “in FAT
6) place”.
Hygienic
1) The instrument enclosures shall be designed to minimise risk of FAT
contamination and for easy cleaning.
2) The instrument devices shall be in accessible positions to enable FAT
service and cleaning.
3) The instrument cabling shall be installed in a way that the risk of FAT
contamination is minimised.
4) In the clean room, the cables shall be encapsulated. IQ
Calibration
1) All transmitting instruments shall be 3-point calibrated upon IQ
delivery (incl. traceable calibration protocol). All indicating
instruments shall be delivered with at least a measuring accuracy
statement.
2) All transmitting instruments shall be 3-point recalibrated in place OQ
after installation. All indicating instruments shall at least be checked
in place.
3) The supplier shall deliver basic data for issuing an SOP for IQ
recalibration.
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5.4 DEMANDS OF THE CONTROL EQUIPMENT
General
1) System components shall be suitable for this application. Industrial FAT
components of high quality shall be preferred.
2) System must be equipped with Ethernet communication card in FAT,IQ
order to in the future transfer relevant data (e.g. statuses,
measurements and alarms) to higher-level systems (e.g. SCADA and
Data Server).
3) Transport protocol of the Ethernet is TCP/IP. Transfer rate is >100 FAT,IQ
Mbit/s.
4) The machine shall be equipped with a PLC unit. FAT
5) The machine shall be equipped with a process printer. The FAT,IQ
printouts shall be archive-persistent.
6) The program structure must be modular and well-defined. Graphical FAT
representation shall be preferred. Attention shall be paid to
readability of program code.
7) Alarms and critical process parameters shall continuously be printed FAT,IQ,
on the system printer during processing. OQ
Programmable control systems

1) Preferred PLC type is Mitsubishi. FAT,IQ
2) The cycle time of the PLC program must be  100 ms. IQ,OQ
3) Profibus DP is preferred if fieldbus is used. FAT,IQ
PLC must have 10 % spare I/O of each type (DI, DO, AI, AO) after
4) FAT,IQ
SAT
5) PLC must have 30 % free memory space after SAT. FAT,IQ
HMI (Human machine interface)

1) Preferred operator panel is graphical colour panel of type Beiger. FAT,IQ
HMI graphics and text design must be clear and unambiguous for
2) FAT
operator.
3) Screen update time must be less than 3 seconds. FAT,OQ
4) System must have at least 3 different access levels: FAT,OQ
5) Level 1 - Operator Access
- Input of operator’s password (on a local level)
- Input of verifying operator’s password (on a local level)
- Equipment operation
- To allow viewing and reset of all equipment alarms
- To allow viewing of all equipment set points (including alarms)
- View and reset product counters
6) Level 2 - Maintenance Access
- Cycling and checking of line system and subsystems
7) Level 3 - Supervisor Access, Level 1 Access +
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- To allow changing of all equipment set points (including alarms).

- To alter the system clock
8) The PLC shall be locked when the operator key is not inserted in the FAT,OQ
machine.
9) Users must be automatically logged out after a configurable time FAT,OQ
period of inactivity
10) There must be a possibility to step through sequences manually FAT,OQ
(user with correct access level).
11) Latest alarm must be displayed on alarm list in HMI screen. FAT,OQ
12) The alarm message must include at least tag name, time and date, FAT,OQ
explanation of alarm.
13) There must be a possibility to define Low and High alarm limits for FAT,OQ
measurements.
14) HMI must have a alarm page which shows all alarms. FAT,OQ
15) There must be a configurable time delay and hysteresis for FAT,OQ
measurements alarm limits to avoid oscillating alarms
16) Minimum length of the passwords is 8 characters and maximum FAT/OQ
validity period is 60 days (shall be configurable parameters).
Control cabinets
1) The control cabinet shall contain all electrical and control FAT
components including main switch and fuses, breakers and
contactors for all motors, relays and timers, step down transformers
for single phase and control voltage.
2) The control cabinet is placed next to the machine. FAT, IQ
3) The surface of control cabinets shall be as the rest of the machine. FAT/IQ
4) Cabinets shall be equipped with lightning and 415VAC outlets for FAT
service. They shall not be disconnected by the main supply
disconnect device. Floor cabinets shall be provided with a base.
I/O
1) 7 potential free contacts for possibility to export signals, alarms. FAT,IQ
2) I/O testing shall be performed on all analogue and digital inputs and OQ
outputs to prove that:
- the whole loop from the HMI to the object works
- the HMI has the correct tag numbers for each object
- relevant alarms are printed on the HMI
Marking
1) All equipment in the control system shall be marked so they can be FAT,IQ
identified.
2) Program and wiring diagrams must use the same tag names for FAT,IQ
instruments as in the functional specification.
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6 MAINTENANCE, SPARE PARTS
6.1 MAINTENANCE
The machine shall be built with intention for quick and easy access for FAT
service and maintenance.
The supplier shall provide customer an adequate training for operation OQ
and maintenance.
A maintenance agreement shall be proposed by the supplier. OQ
6.2 SPARE PARTS

Spare parts, recommended for two years of normal operation. FAT,IQ
Special tools necessary for service and maintenance shall be stated as FAT,IQ
a separate post in the quotation.
The supplier shall provide a list of recommended spare parts of the FAT,IQ
control system.
7 LEGISLATION AND STANDARDS

The equipment shall be validated and used in accordance with cGMP
(&USFDA Standard) requirements for medical device/pharmaceuticals.
7.1 STANDARDS TO BE FOLLOWED
General Laws and Directives
The supplier shall comply with and work in accordance to an DR

1) established and documented QMS.
The supplier’s QMS shall be certified to a recognised quality standard DR
2) e.g. ISO 9001, cGMP or QSR.
Noise level measurements shall be carried out according to ISO 3746. OQ
3)
Electrotechnical standards
1) The supplier shall comply with the standard EN 60204-1 Machine FAT
safety, Electric equipment of machines.
2) Vibrations according to ISO 10816. FAT
3) Equipment shall also meet 73/23/EEC Low Voltage Directive and FAT
89/336/EEC EMC Directive.
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Laws and Standards Concerning Preparation of Pharmaceuticals and Medical

Device
The Checkweigher shall fulfil all cGMP (& USFDA Standard) FAT
1) requirements for pharmaceutical manufacturing.
7.2 REGULATIONS AND REQUIREMENTS
1) The supplier develops, manufactures and delivers the equipment FAT,IQ

and the associated documentation and service according to this
URS.
2) M/s. PSA Ltd shall be entitled to inspect and audit the supplier’s FAT,IQ
QMS and the facilities, if desired, prior to any business agreements.
3) The supplier takes full responsibility for the function of the FAT,IQ
machine.
8 VALIDATION AND OTHER CONTROL AND TESTING MEASURES

M/s. PSA Ltd shall have access to all documentation concerning to the
Checkweigher.
8.1 DQ
1) When the order is placed, the Design Qualification shall be performed -
for the Checkweigher, before the procurement and installation and
construction can be started.
2) The supplier is responsible for delivering the documentation needed -
for the qualification to M/s. PSA Ltd.
3) M/s. PSA Ltd or their representative will issue a DQ protocol and report -
and perform the inspection.
4) The supplier, M/s. PSA Ltd and/or their representative shall attend DQ. -
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8.2 FAT
1) The supplier shall provide test protocols for FAT covering requirements -
in the TS. The test protocols shall be reviewed and approved by M/s.
PSA Ltd before the FAT is performed.
2) FAT shall be performed at the supplier’s facility by the supplier with -
attendance of. M/s. PSA Ltd personnel. The FAT has to be successfully
completed prior to delivery.
3) The operational performance of the equipment shall be verified during -
the FAT in complete tests.
FAT shall be performed with products supplied by M/s. PSA Ltd if -
4) applicable.
8.3 SAT
1) The supplier shall provide test protocols for SAT covering requirements -
in the TS. The test protocols shall be reviewed and approved by M/s.
PSA Ltd before the SAT is performed.
2) The supplier shall perform the SAT with attendance of M/s. PSA Ltd -
personnel.
3) The SAT shall include 3 day training for the M/s. PSA Ltd personnel. -
SAT shall include all FAT test and the tests specified in this document. -
4)
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8.4 DELIVERY INSPECTION

1) Supplier shall perform documented delivery inspection upon IQ
delivery of the Checkweigher.
8.5 INSTALLATION CHECK
An installation check shall be performed before IQ to ensure that the

equipment has been installed so that IQ can be performed successfully.
8.6 SETTING-TO-WORK AND OPTIMISATION

The equipment shall be set to work before OQ commences in -
order to ”trim in” the equipment.
8.7 IQ and OQ
The supplier shall provide test protocols for IQ and OQ covering -
requirements in the TS. The test protocols shall be reviewed and
approved by M/s. PSA Ltd before the IQ/OQ are performed.
The supplier shall perform the IQ and OQ at M/s. PSA Ltd with -
attendance of M/s. PSA Ltd personnel and write corresponding
reports.
M/s. PSA Ltd or representative will approve IQ/OQ. -
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9 DOCUMENTATION
Description of documents to be followed to be delivered and the content of

those.
9.1 GENERAL
1) All documentation for the system encompassed in this IQ
specification shall explicitly be marked with a unique name,
identity number and version number.
2) The documentation should be in English if nothing else required. FAT,IQ
3) There shall be a specified list of all delivered documents, such as FAT,IQ
testing protocols, drawings and specifications.
4) The documentation shall be delivered in original and three copies -
as well as on CD. Drawings shall be compatible with AutoCAD LT.
5) The design documentation, user requirements and Single line -
diagram (SLD), and the functional descriptions and programme
specifications of the control system, shall be maintained during
the whole operating time of the system.
6) There shall be SOPs for e.g. operation and maintenance of the OQ,PQ
system with auxiliary equipment.
9.2 DOCUMENTATION PACKAGE FOR OFFER
Documentation
1) Preliminary functional specification -
2) Installation drawings -
3) Dimensions for space needed for installation -
4) Machine size dimensions and weight -
5) Project and quality documentation -
9.3 DOCUMENTATION PACKAGE, FINAL
Drawings
1) Mechanical/Machine drawings on disc compatible with AutoCAD LT FAT,IQ
2) Layout drawing of the machine showing space for open doors and FAT,IQ
connectors for in-feed, out-feed and utilities
3) Pneumatic drawings FAT,IQ
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Electrical and control diagrams

1) Single line drawings for electrical distribution FAT,IQ
2) Circuit diagrams FAT,IQ
3) Coupling diagrams FAT,IQ
4) Cable list FAT,IQ
5) Equipment location drawings for electrical equipment and FAT,IQ
instruments
6) Equipment manuals for electrical equipment and instruments FAT,IQ
Certificates
1) Material certificates (EN 10204-3.1.B) for all metallic parts in contact FAT,IQ
with the product.
2) Material certificates/statements for all non-metallic parts/gaskets in FAT,IQ
contact with the product.
3) Certificates and/or measurement protocols for surface finish for all FAT,IQ
metallic parts in contact with the product.
4) Noise level certificate/measuring protocol FAT,SAT
5) Calibration certificates FAT,IQ, OQ
6) Training certificate OQ
7) Certificate of archive-proof print out FAT,IQ
Lists
1) Lists of all equipment, components and instruments FAT,IQ
Data sheets
1) Data sheets for equipment, components and instruments FAT,IQ
2) Data sheets for main components of the control system FAT,IQ
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Spare part lists

1) A complete spare parts list shall be supplied, both for mechanical FAT,IQ
and electrical components/control system.
Software
1) Description of software architecture FAT,IQ
2) Programming standard FAT,IQ
3) Commented PC/PLC program in electronic form FAT,IQ
4) I/O-lists FAT,IQ
5) Alarm list FAT,IQ
6) Back-up copies of application programs FAT,IQ
7) Description of the application program, preferably by a flow chart FAT,IQ
80 Definition of menu tree in OP-panel FAT,IQ
9) List of program variables FAT,IQ
10) List of parameters that can be set by the operator FAT,IQ
11) List of alarm parameter settings FAT,IQ
12) List of max and min parameter values FAT,IQ
13) Definition of access levels and allowed parameter setting FAT,IQ
changes for each level
14) Functional specifications FAT,IQ
15) Hardware design specification FAT,IQ
16) Software design specification FAT,IQ
17) Instruction for backup and reload backup copies FAT,IQ
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Manuals and Maintenance Instructions

1) Operator manual in English and local language FAT,IQ
2) Installation and assembly instructions for all devices FAT,IQ
3) Programming manual FAT,IQ
4) User’s manuals for all components FAT,IQ
5) Trouble shooting guide FAT,IQ
6) Maintenance manual FAT,IQ
7) Safety instructions in English and local language FAT,IQ
8) Training documentation FAT,IQ
Qualification Protocols/Reports
1) DQ protocols and reports FAT,IQ
2) FAT protocol and report FAT,IQ
3) SAT protocol and report FAT,IQ
4) IQ protocol and report FAT,IQ
5) OQ protocol and report FAT,IQ
10 MAKE OF BOUGHT OUT ITEMS
Name of Components Make
1) PLC Mitsubishi
2) HMI Beiger
3) Ammeter / Voltmeter AE
4) Main Isolator, Contactors, HRC Fuses, MCB, O/L relay etc. L & T/ Siemens
5) Relays L & T/ Siemens
6) Overload relay L & T/ Siemens
7) Push Button / Lamps Teknic
8) Wires & cables Polycab
9) Terminals Connect well
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PHARMADEEP TURNKEY CONSULTANTS & ENGINEERS PVT. LTD.

1.1 DESCRIPTION OF DOCUMENT

2.3 TESTING & QUALIFICATION

The section shall consist of:

Checkweigher – 05 Nos, Capacity- 1.00 Kg

3.2 SCOPE OF WORK

- Complete equipment according to this specification.

4.1 ENVIRONMENT AND UTILITIES TO BE USED

Physical condition and room classifications

Service Power 230 V, 1-phase, 50 Hz -

4.2 NORMAL OPERATION

Cleaning / sanitation / sterilization

4.5 ERATION IN HAZARD SITUATIONS

4.5.1.1 B Alarms (informative alarms)

5.1 MATERIAL SPECIFICATION AND DEMAND OF SURFACE FINISH

Material and surface finish of parts in contact with the product

Material and surface finish of outer surface.

Material of the signs and name plates

5.2 DEMAND OF CONSTRUCTION

2) The Machine shall be mounted on anti-vibratory pads. FAT,IQ

Pipes and hoses

Cleaning – outer surface of equipment

5.3 DEMANDS OF INSTRUMENTATION

5.4 DEMANDS OF THE CONTROL EQUIPMENT

Programmable control systems

HMI (Human machine interface)

- To allow changing of all equipment set points (including alarms).

6 MAINTENANCE, SPARE PARTS

6.2 SPARE PARTS

7 LEGISLATION AND STANDARDS

7.1 STANDARDS TO BE FOLLOWED

General Laws and Directives

The supplier shall comply with and work in accordance to an DR

Laws and Standards Concerning Preparation of Pharmaceuticals and Medical

7.2 REGULATIONS AND REQUIREMENTS

1) The supplier develops, manufactures and delivers the equipment FAT,IQ

8 VALIDATION AND OTHER CONTROL AND TESTING MEASURES

8.4 DELIVERY INSPECTION

8.5 INSTALLATION CHECK

An installation check shall be performed before IQ to ensure that the

8.6 SETTING-TO-WORK AND OPTIMISATION

Description of documents to be followed to be delivered and the content of

9.2 DOCUMENTATION PACKAGE FOR OFFER

9.3 DOCUMENTATION PACKAGE, FINAL

Electrical and control diagrams

Spare part lists

Manuals and Maintenance Instructions

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