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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:

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER


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.
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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

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

DESIGN QUALIFICATION
Critical variables Acceptance Criteria References
3.0 Key Design Features

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER


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
(To be assured by supplier)
3.4. Solenoid Valves Should be provided in Process
Vacuum pump sealing water line requirement
(To be assured by supplier)
3.5. Pumps Vacuum pump with motor should be
provided
(To be assured by supplier)
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)
(To be assured by supplier)
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]
(To be assured by supplier)
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
(To be assured by supplier)
DESIGN QUALIFICATION

Critical variables Acceptance Criteria References


3.10. Steam Trap Should be provided in Jacket and cGMP
Chamber condensate line guidelines
(To be assured by supplier)
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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER


3.11 Strainer Should be provided in Chamber cGMP
condensate line and Steam in Jacket guidelines
line
(To be assured by supplier)
3.12 Air Vent Filter Should be provided in Vacuum Break cGMP
line guidelines
(To be assured by supplier)
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
(To be assured by supplier)

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER


DESIGN QUALIFICATION

Critical variables Acceptance Criteria References


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
(To be assured by supplier)
4.2. Hydraulic Test Jacket – As per ASME Safety
pressure Chamber – As per ASME Precaution
(To be assured by supplier)
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)

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER


DESIGN QUALIFICATION

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):

DESIGN QUALIFICATION

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

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)
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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

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 :

Checks Acceptance Criteria Observations


14.0 Strip chart recorder Should meet specification

15.0 Manual override Should meet specification

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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

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Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER


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 :

Checks Acceptance Criteria Observations


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

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER


INSTALLATION QUALIFICATION

Checks Acceptance Criteria Observations


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
certify the correct installation.
2.5. Installation of As per approved drawing
Temperature Sensor Engg. / Production / QA to
certify the correct installation.

2.6. Installation of Pump Should be properly mounted


and balanced as per approved
drawing
Engg. / Production / QA to
certify the correct installation.

2.7 Installation of As per approved drawing


Pressure Switch
Engg. / Production / QA to
certify the correct installation.

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

INSTALLATION QUALIFICATION

Checks Acceptance Criteria Observations


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
Engg. / Production / QA to
certify the correct installation.

2.9 Installation of Steam Should be installed in chamber


Trap and jacket condensate line

Engg. / Production / QA to
certify the correct installation.

2.10 Installation of Should be installed in chamber


Strainer condensate and steam in
jacket line
Engg. / Production / QA to
certify the correct installation.

2.11 Installation of Air Should be installed in vacuum


vent filter break line
Engg. / Production / QA to
certify the correct installation.

2.12 Installation of Should be installed in bleeder


Venting valve line
Engg. / Production / QA to
certify the correct installation.

2.13 Installation of PLC As per approved drawing


UNIT Engg. / Production / QA to
certify the correct installation.

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

INSTALLATION QUALIFICATION

Checks Acceptance Criteria Observations


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]
(Engineering to certify)

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
(Engineering to certify)

3.5. Drain Line Closed Drain line to be


provided.
(Engineering to certify.)

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER


INSTALLATION QUALIFICATION

Checks Acceptance Criteria Observations


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:

INSTALLATION QUALIFICATION

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

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
PRODUCTION ENGINEERING SAFETY UNIT HEAD
CONTROL ASSURANCE

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

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.
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2. Critical variables to be checked:
Checks Acceptance Criteria Observations
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)

OPERATIONAL QUALIFICATION

Checks Acceptance Criteria Observations


2.8 Open door No. 1 (Non Does not open.
sterile side)

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER


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’.

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER


OPERATIONAL QUALIFICATION

Checks Acceptance Criteria Observations


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.

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER


OPERATIONAL QUALIFICATION

Checks Acceptance Criteria Observations


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.

OPERATIONAL QUALIFICATION

5. Any changes made against the formally agreed parameters :


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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

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

7. Recommendations:

8. Operation Qualification Signing off :

QUALITY QUALITY
PRODUCTION ENGINEERING SAFETY UNIT HEAD
CONTROL ASSURANCE

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

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.
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2. Performance Checks

Checks Acceptance Criteria Observations


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

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3. References :

4. Any changes made against the formally agreed parameters :

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

6. Document to be attached :

7. Recommendations :

8. Performance qualification signing off:

QUALITY QUALITY
PRODUCTION ENGINEERING SAFETY UNIT HEAD
CONTROL ASSURANCE

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

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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

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:________

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