Steam Sterilizer

Cipla
Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
CODE No. : OCP-022
LOCATION : POWDER INJECTABLE
AREA : COMPONENT STERILISATION AREA
MAKE : METAL CHEM INDUSTRIES
MACHINE SERIAL NO : 215
PROTOCOL No. : EQ/OCP-022/01
The purpose of this document is to qualify the Steam Sterilizer.

This Document provides evidence that the equipment is functional and is
Installed according to design specifications, performs as designed and
Complies with the Standard Operating Procedure and thus meets
The cGMP obligations.
PROTOCOL PROTOCOL PROTOCOL

COMPILED BY APPROVED BY AUTHORIZED BY
Production: Quality Assurance: Unit Head:
Quality Control:
Engineering:
Safety:
Date: Date: Date:
Page 1 of 24
Cipla
Goa

CONTENTS
1. Design qualification
2. Checklist for equipment on receipt
3. Installation qualification
4. Operational qualification
5. Performance qualification
6. Equipment Hand over Certificate
DESIGN QUALIFICATION
1. Purpose :
The purpose of Design qualification is to ensure that all the critical aspects of Process
/ Product requirements, cGMP and safety have been considered in designing Steam
Sterilizer and are properly documented.
Page 2 of 24
Cipla
Goa
2. Project requirements:
To design a Steam Sterilizer which will be installed in component area of injection
department to use for sterilization.
3. Critical variables to be met:
Critical variables Acceptance Criteria References

1.0 Process / Product Parameters
1.1. The system should be Sterilization should assure the total Process
able to sterilize the destruction of microbial load requirement
load. (To be assured by supplier)
1.2. Operation Auto / Manual Process

Should be completely PLC operated requirement
Double Door Sterilizer
1.3. Working capacity of Volume : 1130 Litres. Process
Autoclaves. Working Pressure: 2.1 kg/cm2 requirement
2.0. Location Suitability

2.1. Availability of utilities Utility connections should be
at location. available. cGMP
requirements
2.2. Size of Autoclave. 900 mm ×1050 mm × 1200 mm Process
requirement
2.3. Room condition Should be able to meet the
requirement of Clean environment cGMP
requirements
2.4. Weight of Autoclave Should be less than the load bearing Process
(in working condition). capacity of the area. i.e. 1000 kg / requirement
sq.m
3.0 Key Design Features
Page 3 of 24
Cipla
Goa

3.1. Material of Chamber : SS 316L Process
Construction Jacket : SS 304 requirement
Door (Contact area) : SS 316L
Insulation : Glass wool
Supports : SS 304
Tray : SS 316L
(To be assured by supplier)
3.2. Doors Hinge doors Process
(To be assured by supplier) requirement
3.3. Pneumatic Valves Should be provided in cGMP
Steam In Jacket Line guidelines
Steam In Chamber Line
Air Vent Line
Vacuum Break Line
Chamber condensate Line
Chamber vacuum line
3.4. Solenoid Valves Should be provided in Process
Vacuum pump sealing water line requirement
3.5. Pumps Vacuum pump with motor should be
provided
3.6 Pressure Gauges Should be provided for Sterile side cGMP
panel sheet and Non-Sterile side panel guidelines
sheet
Pure Steam line
Non sterile side :0-4.2 kg/cm2 (jacket)
Sterile side 0-4.2 kg/cm2 (Jacket)
Compound pressure gauge
Non sterile –1to 3.5 kg/cm2 (chamber)
Sterile side -1to 3.5 kg/cm2 (chamber)
3.7. Temperature Sensor PT-100 Sensor (0 to 200°C) should be Process
provided in chamber drain line[Dual requirement
element] & chamber [single element]
3.8. Pressure Switch Should be provided for Jacket and Air Process
(To be assured by supplier) requirement
3.9 Gaskets Silicon made gasket should be Process
provided for Doors requirement

3.10. Steam Trap Should be provided in Jacket and cGMP
Chamber condensate line guidelines
Page 4 of 24
Cipla
Goa

3.11 Strainer Should be provided in Chamber cGMP
condensate line and Steam in Jacket guidelines
line
3.12 Air Vent Filter Should be provided in Vacuum Break cGMP
line guidelines
3.13. PLC unit Should be provided for:
• HPHV Cycle.
• Leak Test Cycle.
• Bowie and Dick Test Cycle
• Initial Pulsation, Initial Vacuum
holding time, Preheating hold time, Equipment
Preheating hold temp., Sterile hold Literature
temp., Sterile hold time, Drying
Vacuum hold time, Door open temp.,
Initial and Final Vacuum value, Final
cooling of Sterilizer and Printing time
• PID LOOP should be incorporated to
avoid excessive use of energy during
heating and sterilizing
• Provision for 10 Program memory
• RS 232 Port should be provided for
data logging
Page 5 of 24
Cipla
Goa


3.14 Strip Chart Recorder 6 points strip chart recorder with Process
alphanumeric printing and continuous requirement
plotting of Temperature from 2
monitoring sensors.
3.15. Manual override Switch for manual override with Process
individual luminous type switches for requirement
each function.
3.16. Hooter Audio alarm with mute option at different Process

set levels. requirement
4.0. Safety
4.1. Insulation of Hot parts Glass Wool Insulation of Hot parts Safety
should be done wherever possible Precaution
4.2. Hydraulic Test Jacket – As per ASME Safety
pressure Chamber – As per ASME Precaution
4.3. Emergency OFF Emergency OFF switch on control panel. Safety
Precaution
4.4. Electrical wiring and Earthing to be provided to control panel Safety
Earthing and pumps. Precaution
Electrical wiring as per safety guidelines
4.5. Door Interlocks Door interlocks during process, Safety
Positive pressure locking of both doors, Precaution
Door open indicator lamps on either
side.
5.0. Vendor Selection
5.1. Selection of Vendor Selection of Vendor should be done on cGMP
for supplying the the basis of review of vendor. guidelines
Autoclave Criteria for review should include vendor
background (general/financial), technical
know how, quality standards, inspection
of site, costing, feed back from market
(customers already using the equipment)
Page 6 of 24
Cipla
Goa

4. References:
5. Documents to be attached:
1. CER Copy of Steam Sterilizer,

2. Technical details for Equipment requirement with Engineering drawings,
3. Approved design and specifications,
4. Minutes of meeting held with the supplier, if any.
5. Purchase Order Copy
6. Any other relevant documents
6. Review (Inclusive of follow up action, if any):
Page 7 of 24
Cipla
Goa
7. Recommendation:
8. Design qualification signing off:
QUALITY QUALITY
PRODUCTION ENGINEERING SAFETY UNIT HEAD
CONTROL ASSURANCE
Date: Date: Date: Date : Date: Date:
CHECKLIST FOR INSPECTION OF

STEAM STERILIZER
(To be checked on receipt of the equipment)
(List made as per Manual given by the Vendor prior to installation)
Page 8 of 24
Cipla
Goa
Checks Acceptance Criteria Observations

1.0. Material of Construction
Chamber : SS 316L
Jacket : SS 304
Should meet
Door (Contact area): SS specification
316L
Supports : SS 304
Tray : SS 316
2.0. Doors Should meet

specification
3.0. Pneumatic Valves Should meet
specification
4.0 Solenoid Valves Should meet
specification
5.0 Pump Should meet
specification
6.0 Pressure Gauges Should meet
specification
7.0 Temperature Sensor Should meet
specification
8.0 Gaskets Should meet
specification
9.0 Steam trap Should meet
specification
10.0 Strainer Should meet
specification
11.0 Air Vent Filter Should meet
specification
12.0 PLC with display and Should meet
converter specification
13.0 Strip chart recorder Should meet
specification
Checked By : Date :

14.0 Strip chart recorder Should meet specification
15.0 Manual override Should meet specification
Page 9 of 24
Cipla
Goa

16.0 Hooter Should meet specification
17.0 List of spares Should be tallied with

supply
18.0 Operating Manual Given by Vendor
Checked By :
Date :
Documents to be attached
1. Visit Report (if any).
2. Equipment’s Manual
3. MOC Certificates.
4. Manufacturer test reports
5. Calibration certificates
Page 10 of 24
Cipla
Goa

INSTALLATION QUALIFICATION
1. Purpose:
The purpose of Installation Qualification is to establish that the equipment and
components are as per the specifications and are installed as per the approved design.
2. Equipment Details
2.1 Model : DS/DD/215
2.2 Manufacturer : METAL CHEM INDUSTRIES
2.3 Machine Serial No. : 215
2.4 Code No. : OCP-22
3. Critical Variables to be met :

1.0. Location Suitability
1.1. Place of Installation As per proposed lay out /
designated area
1.2. Availability of Utilities Should be available

at location
1.3. Room Condition Controlled / Clean environment

should be provided
1.4. Illumination Proper illumination with light

fittings as per the cGMP
requirement & illumination
above 300 lux
(Engineering to certify)
1.5. Working space Should be sufficient for easy
around the Steam operation, cleaning,
Sterilizer sanitization and maintenance
Page 11 of 24
Cipla
Goa


2.0. Equipment Installation
2.1. All the parts Should be identified, intact and
cleaned
All the MOC of contact part
should be tested as per SOP
2.2. Verify erection main • As per approved drawing

unit • Should have a slight slope
towards non clean side
Engg. / Production / QA to
certify the correct installation.
2.3. Installation of doors Doors and gasket should lock
properly, cross bars to operate
smoothly.
Limit switch should activate in
closed position.
Pneumatic cylinder to be fixed
for locking.
2.4. Installation of As per approved drawing
Pressure gauges Engg. / Production / QA to
2.5. Installation of As per approved drawing
Temperature Sensor Engg. / Production / QA to
2.6. Installation of Pump Should be properly mounted

and balanced as per approved
drawing
2.7 Installation of As per approved drawing

Pressure Switch
Page 12 of 24
Cipla
Goa

2.8 Installation of all Should be installed in
pneumatic valves Steam In Jacket Line
Steam In Chamber Line
Air Vent Line
Vacuum Break Line
Chamber condensate Line
Chamber vacuum line
2.9 Installation of Steam Should be installed in chamber

Trap and jacket condensate line
2.10 Installation of Should be installed in chamber

Strainer condensate and steam in
jacket line
2.11 Installation of Air Should be installed in vacuum

vent filter break line
2.12 Installation of Should be installed in bleeder

Venting valve line
2.13 Installation of PLC As per approved drawing

UNIT Engg. / Production / QA to
Page 13 of 24
Cipla
Goa

2.14 Strip Chart Model µR1000
Recorder Location: non sterile facial
plate
2.15 Printer 300 serial port

Location: Panel Box
2.16 Panel Box SS 304 with properly traced

connections as per circuit
diagram
3.0. Utilities Required

3.1. Electrical Supply Should be 4 wires3 phase /
415 V +1 earthing,3 PH / 50
Hz (Engineering to certify)
3.3. Compressed air Festo Pneumatic tubing

connection [PU6]
3.4 Pure Steam Steam supply with pressure

indicator, requisite pipe line,
drain line, insulations should
be provided for sterilization
at pressure NLT 2.5 kg/cm2
3.5. Drain Line Closed Drain line to be

provided.
(Engineering to certify.)
Page 14 of 24
Cipla
Goa


4.0. Safety
4.1. Hydrostatic Testing of Hydrostatic test pressure
Chamber, Jacket should be as per ASME
4.2 Safety locking of To be provided

doors through limit
switches
4.3 Safety valves To be provided
chamber.
Pressure regulating
valves
4.4 Emergency switch on To be provided
panel board
4.5 Electrical wiring and Engg. / Production / Safety to
Earthing certify the correct installation.
5.0. General Checks

5.1. Grouting and Should be proper
mounting of all Engg. / Production / Safety /
components of Steam QA to certify
Sterilizer
5.2 Equipment should be Should be proper

properly balanced Engg. / Production / Safety /
QA to certify
5.3 All the metal parts Should be proper
should be properly Engg. / Production / Safety /
grounded QA to certify
5.4 Welding of joints Should be proper
Engg. / Production / Safety /
QA to certify
4. References:
5. Documents to be attached:
Page 15 of 24
Cipla
Goa
6. Any changes made against the formally agreed parameters :
7. Review ( Inclusive of follow up action, if any ):
8. Recommendations:
9. Installation qualification signing off:
QUALITY QUALITY
CONTROL ASSURANCE
OPERATIONAL QUALIFICATION
1. Purpose:
The purpose of operation Qualification is to establish that the entire system as a whole
is functioning with respect to electrical and instrumentation as specified.
Page 16 of 24
Cipla
Goa

2. Critical variables to be checked:
1.0 Put ‘ON’ the mains of the PLC display comes ‘ON’.
panel box.
(Ensure system is in Auto
mode)
1.1 Operate the Steam PLC displays each

Sterilizer as per parameter during entry and
manufacturer manual / SOP. gives display and printout of
all parameters.
2.0 And Check for
2.1 Functioning of all pressure Should be satisfactory
gauges and temperature On Operation
sensor
2.2 Functioning of Pump Should be satisfactory
On Operation.
2.3 Functioning of all pneumatic Should be satisfactory

valves On Operation.
2.4 Functioning of all solenoid Should be satisfactory

valves On Operation.
2.5 Programme the cycle on the PLC displays each

PLC as per manual / SOP parameter during entry and
gives display and printout of
all parameters.
2.6 Close the compressed air The PLC shows ‘Air

line valve pressure low’
Open the compressed air The PLC displays Normal
valve. mode.
2.7 Run the programmed HPHV The cycle is completed as

cycle as per SOP. programmed (check printout
and chart)

2.8 Open door No. 1 (Non Does not open.
sterile side)
Page 17 of 24
Cipla
Goa

2.8 Open door No. 2 Door opens
2.9 Conduct leak test in cold Drop in vacuum for 10

condition minutes < 10mm of Hg/min.
(Ambient temperature) (Vacuum –0.7 kg/sqcm)
Vacuum pump starts and
stops as per programmed
cycle. (Check print out)
2.10 Run all programmed cycles Cycles run as desired.

• Fast exhaust (Check print out and chart)
• Slow exhaust
• Leak test
3.0 Watch Dog cycle on PLC

3.1 Start the HPHV cycle Buzzer sounds if vacuum is
Close the control valve on not reached in 15 minutes.
vacuum line during Buzzer stops when
‘INITIAL VACUUM ON’. acknowledged.
3.2 Close the steam valve Buzzer sounds if set

during ‘PREHEATING ON’ temperature is not
obtained in 15 minutes.
Buzzer stops when
acknowledged.
3.3 Close the steam valve Buzzer sounds if the

during ‘HEATING ON’ sterilisation temperature is
not attained within 30
minutes.
3.4 Skip function The phase of the cycle is

During any phase of cycle skipped PLC shows ‘SKIP’
press skip button for 10 followed by ‘SKIP
seconds. OPERATED’.
Page 18 of 24
Cipla
Goa


3.5 Emergency ‘OFF’ The PLC display gets
During any phase of cycle ‘OFF’ and display shows.
press ‘Emergency OFF’ “DO YOU WANT TO
button on panel board and CONTINUE (Y/N) ( 1/2)
release the switch after 1 when emergency button
minute. is released.
3.6 Carry out Leak Test cycle Leak Test should pass
for 10 minutes. over pressure not more
than 1mm of Hg during
10 minutes hold.
3.7 Run HPHV cycle carry out Temperature distribution

Heat distribution study throughout the chamber
during sterile hold with the should be uniform.
help of temperature
mapping device.
3.8 Run HPHV cycle and carry The colour change on

out Bowie and dick test for Bowie dick sheet should
Heat penetration. be uniform.
(Pale yellow before Heat
penetration and black
after Heat penetration.)
3.9 Carry out Heat distribution • Should be within ±3°C

study with the help of data Temp. band with the
logger. sterilisation
temperature as the
lower limit.
• Should not fluctuate
by more than ±1°C.
• Should not differ from
one another by more
than ±2°C.
Page 19 of 24
Cipla
Goa


4.0. Safety Functions
4.1 Hydrostatic Test Should be as per design
criteria
4.2 Functioning of door Should be as per design

interlocking criteria
4.3 Functioning of safety Should be satisfactory on

valve operation
5.0 Documentation
Standard Operating SOP for Cleaning and Ref. SOP No.
Procedure (SOP) Operation Cleaning / Sanitization:
Should be available Operation:
PPM :
SOP for Planned
Preventive Maintenance
should be available
6.0 Training Training should be given
to the concerned
personnel on
Steam Sterilizer for
operation, cleaning and
maintenance.
3. References :
4. Documents to be attached :
Calibration report and certificate of Pressure gauges, Temperature
1. Training reports.

Page 20 of 24
Cipla
Goa
6. Review ( Inclusive of follow up action, if any ):
7. Recommendations:
8. Operation Qualification Signing off :
QUALITY QUALITY
CONTROL ASSURANCE
PERFORMANCE QUALIFICATION
1. Purpose :
The purpose of Performance Qualification is to confirm that the Steam Sterilizer is
capable of consistently performing as it is supposed to perform.
Page 21 of 24
Cipla
Goa
2. Performance Checks

1.0 Operate the All the cycles should complete
equipment in HPHV as desired.
cycle as per SOP
• Empty load I
• Empty load II
• Empty load III
• Full load
(Porous)
• Full load (Non
Porous)
2.0 Validate the Steriliser Ref. Protocol No. :

as per Protocol
The validation should be
carried out successfully.
3.0 Record the finding in Ref. Report No. :

validation Report
Page 22 of 24
Cipla
Goa
3. References :
5. Review ( Inclusive of follow up action, if any ) :
6. Document to be attached :
7. Recommendations :
8. Performance qualification signing off:
QUALITY QUALITY
CONTROL ASSURANCE
Page 23 of 24
Cipla
Goa
EQUIPMENT HANDOVER
CERTIFICATE
This is to certify that the ____________________

( Name of the Equipment) of Code No. __________,
Make _______________ located at _____________
has been Qualified and is herewith approved for
Regular Production as on ________ (Date)
Production:_______________ Date:________
Engineering:______________ Date:________
Safety : _________________ Date:________
Quality Control : _____________ Date:________
Quality Assurance:_________ Date:________
Unit Head :_______________ Date:________
Page 24 of 24

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Cipla

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

CODE No. : OCP-022

LOCATION : POWDER INJECTABLE

AREA : COMPONENT STERILISATION AREA

MAKE : METAL CHEM INDUSTRIES

MACHINE SERIAL NO : 215

PROTOCOL No. : EQ/OCP-022/01

The purpose of this document is to qualify the Steam Sterilizer.

PROTOCOL PROTOCOL PROTOCOL

Date: Date: Date:

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

2. Checklist for equipment on receipt

6. Equipment Hand over Certificate

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

3. Critical variables to be met:

Critical variables Acceptance Criteria References

1.2. Operation Auto / Manual Process

2.0. Location Suitability

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

Critical variables Acceptance Criteria References

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

Critical variables Acceptance Criteria References

3.16. Hooter Audio alarm with mute option at different Process

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

1. CER Copy of Steam Sterilizer,

6. Review (Inclusive of follow up action, if any):

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

8. Design qualification signing off:

Date: Date: Date: Date : Date: Date:

CHECKLIST FOR INSPECTION OF

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

Checks Acceptance Criteria Observations

2.0. Doors Should meet

Checks Acceptance Criteria Observations

15.0 Manual override Should meet specification

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

17.0 List of spares Should be tallied with

18.0 Operating Manual Given by Vendor

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

2.1 Model : DS/DD/215

2.2 Manufacturer : METAL CHEM INDUSTRIES

2.3 Machine Serial No. : 215

2.4 Code No. : OCP-22

3. Critical Variables to be met :

Checks Acceptance Criteria Observations

1.2. Availability of Utilities Should be available

1.3. Room Condition Controlled / Clean environment

1.4. Illumination Proper illumination with light

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

Checks Acceptance Criteria Observations

2.2. Verify erection main • As per approved drawing

2.6. Installation of Pump Should be properly mounted

2.7 Installation of As per approved drawing

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

Checks Acceptance Criteria Observations

2.9 Installation of Steam Should be installed in chamber

2.10 Installation of Should be installed in chamber

2.11 Installation of Air Should be installed in vacuum

2.12 Installation of Should be installed in bleeder

2.13 Installation of PLC As per approved drawing

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

Safety : _________ Date:

Quality Control : _____ Date:

Quality Assurance:_ Date:

Unit Head :_______ Date: