Steam Sterilizer
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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 COMPILED BY Production:
PROTOCOL APPROVED BY
PROTOCOL AUTHORIZED BY
Quality Assurance:
Unit Head:
Date:
Date:
Quality Control: Engineering: Safety:
Date:
Page 1 of 24
Cipla Goa
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. Page 2 of 24
Cipla Goa
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: 1.0 1.1.
Critical variables Acceptance Criteria Process / Product Parameters The system should be Sterilization should assure the total able to sterilize the destruction of microbial load load. (To be assured by supplier)
1.2.
Operation
1.3.
Working capacity of Autoclaves.
Auto / Manual Should be completely PLC operated Double Door Sterilizer Volume : 1130 Litres. Working Pressure: 2.1 kg/cm2
2.0. 2.1.
Location Suitability Availability of utilities at location.
Utility connections should be available.
2.2.
Size of Autoclave.
900 mm ×1050 mm × 1200 mm
2.3.
Room condition
Should be able to meet the requirement of Clean environment
2.4.
3.0
Weight of Autoclave (in working condition).
Should be less than the load bearing capacity of the area. i.e. 1000 kg / sq.m
DESIGN QUALIFICATION Critical variables Acceptance Criteria Key Design Features
Page 3 of 24
References Process requirement Process requirement Process requirement
cGMP requirements Process requirement cGMP requirements Process requirement
References
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 3.1.
3.2. 3.3.
3.4. 3.5. 3.6
3.7.
3.8. 3.9
Material of Construction
Chamber : SS 316L Jacket : SS 304 Door (Contact area) : SS 316L Insulation : Glass wool Supports : SS 304 Tray : SS 316L (To be assured by supplier) Doors Hinge doors (To be assured by supplier) Pneumatic Valves Should be provided in Steam In Jacket Line Steam In Chamber Line Air Vent Line Vacuum Break Line Chamber condensate Line Chamber vacuum line (To be assured by supplier) Solenoid Valves Should be provided in Vacuum pump sealing water line (To be assured by supplier) Pumps Vacuum pump with motor should be provided (To be assured by supplier) Pressure Gauges Should be provided for Sterile side panel sheet and Non-Sterile side panel 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) Temperature Sensor PT-100 Sensor (0 to 200°C) should be provided in chamber drain line[Dual element] & chamber [single element] (To be assured by supplier) Pressure Switch Should be provided for Jacket and Air (To be assured by supplier) Gaskets Silicon made gasket should be provided for Doors (To be assured by supplier) DESIGN QUALIFICATION
Critical variables 3.10. Steam Trap
Acceptance Criteria Should be provided in Jacket and Chamber condensate line (To be assured by supplier) Page 4 of 24
Process requirement
Process requirement cGMP guidelines
Process requirement
cGMP guidelines
Process requirement Process requirement Process requirement
References cGMP guidelines
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 3.11
Strainer
3.12
Air Vent Filter
3.13.
PLC unit
Should be provided in Chamber condensate line and Steam in Jacket line (To be assured by supplier) Should be provided in Vacuum Break line (To be assured by supplier) Should be provided for: • HPHV Cycle. • Leak Test Cycle. • Bowie and Dick Test Cycle • Initial Pulsation, Initial Vacuum holding time, Preheating hold time, Preheating hold temp., Sterile hold 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)
Page 5 of 24
cGMP guidelines cGMP guidelines
Equipment Literature
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER DESIGN QUALIFICATION Critical variables 3.14 Strip Chart Recorder
3.15.
Manual override
3.16.
Hooter
4.0. 4.1.
Safety Insulation of Hot parts
4.2.
Hydraulic Test pressure
4.3.
Emergency OFF
4.4.
Electrical wiring and Earthing
4.5.
Door Interlocks
5.0. 5.1.
Vendor Selection Selection of Vendor for supplying the Autoclave
Acceptance Criteria 6 points strip chart recorder with alphanumeric printing and continuous plotting of Temperature from 2 monitoring sensors. Switch for manual override with individual luminous type switches for each function.
References Process requirement
Audio alarm with mute option at different set levels.
Process requirement
Glass Wool Insulation of Hot parts should be done wherever possible (To be assured by supplier) Jacket – As per ASME Chamber – As per ASME (To be assured by supplier) Emergency OFF switch on control panel.
Safety Precaution
Earthing to be provided to control panel and pumps. Electrical wiring as per safety guidelines Door interlocks during process, Positive pressure locking of both doors, Door open indicator lamps on either side.
Process requirement
Safety Precaution Safety Precaution Safety Precaution Safety Precaution
Selection of Vendor should be done on cGMP the basis of review of vendor. guidelines 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
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 Page 7 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 7. Recommendation:
8. Design qualification signing off:
PRODUCTION
Date:
ENGINEERING
Date:
SAFETY
Date:
QUALITY CONTROL
Date :
QUALITY ASSURANCE
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
UNIT HEAD
Date:
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
1.0.
Checks Material of Construction
Acceptance Criteria
Observations
Chamber : SS 316L Jacket
: SS 304
Door (Contact area): SS 316L Supports :
SS 304
Tray
SS 316
:
2.0.
Doors
3.0.
Pneumatic Valves
4.0
Solenoid Valves
5.0
Pump
6.0
Pressure Gauges
7.0
Temperature Sensor
8.0
Gaskets
9.0
Steam trap
10.0
Strainer
11.0
Air Vent Filter
12.0
PLC with display converter Strip chart recorder
13.0
Should meet specification
Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification and Should meet specification Should meet specification
Checked By :
Date :
14.0
Checks Strip chart recorder
Acceptance Criteria Should meet specification
15.0
Manual override
Should meet specification Page 9 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 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
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 1.0. Location Suitability 1.1. Place of Installation
Acceptance Criteria As per proposed lay out / designated area
1.2. Availability of Utilities at location
Should be available
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) Should be sufficient for easy operation, cleaning, sanitization and maintenance
1.5. Working space around the Steam Sterilizer
Page 11 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER INSTALLATION QUALIFICATION Checks Acceptance Criteria 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 unit
2.3. Installation of doors
2.4. Installation of Pressure gauges 2.5. Installation of Temperature Sensor
•
As per approved drawing Should have a slight slope towards non clean side Engg. / Production / QA to certify the correct installation. 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. As per approved drawing Engg. / Production / QA to certify the correct installation. As per approved drawing 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
As per approved drawing
Installation of Pressure Switch
Engg. / Production / QA to certify the correct installation.
Page 12 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER INSTALLATION QUALIFICATION 2.8
2.9
Checks Installation of all pneumatic valves
Acceptance Criteria Should be installed in 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.
Installation of Steam Trap
Should be installed in chamber and jacket condensate line Engg. / Production / QA to certify the correct installation.
2.10
Installation of Strainer
Should be installed in chamber condensate and steam in jacket line Engg. / Production / QA to certify the correct installation.
2.11
Installation of Air vent filter
Should be installed in vacuum break line Engg. / Production / QA to certify the correct installation.
2.12
Installation of Venting valve
Should be installed in bleeder line Engg. / Production / QA to certify the correct installation.
2.13
Installation of PLC UNIT
As per approved drawing Engg. / Production / QA to certify the correct installation.
Page 13 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER INSTALLATION QUALIFICATION 2.14
Checks Strip Chart Recorder
Acceptance Criteria Model µR1000 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
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)
Pure Steam
3.5. Drain Line
Closed Drain line to be provided. (Engineering to certify.)
Page 14 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER INSTALLATION QUALIFICATION Checks 4.0. Safety 4.1. Hydrostatic Testing of Chamber, Jacket
Hydrostatic test pressure should be as per ASME
4.2
To be provided
4.3
4.4 4.5
Safety locking of doors through limit switches Safety valves chamber. Pressure regulating valves Emergency switch on panel board Electrical wiring and Earthing
5.0. General Checks 5.1. Grouting and mounting of all components of Steam Sterilizer 5.2
Equipment should be properly balanced
5.3
All the metal parts should be properly grounded Welding of joints
5.4
Acceptance Criteria
To be provided
To be provided Engg. / Production / Safety to certify the correct installation. Should be proper Engg. / Production / Safety / QA to certify Should be proper Engg. / Production / Safety / QA to certify Should be proper Engg. / Production / Safety / QA to certify Should be proper Engg. / Production / Safety / QA to certify
4. References:
5. Documents to be attached:
INSTALLATION QUALIFICATION Page 15 of 24
Observations
Cipla Goa
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: PRODUCTION
Date:
ENGINEERING
Date:
SAFETY
Date:
QUALITY CONTROL
Date :
QUALITY ASSURANCE
Date:
UNIT HEAD
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. Page 16 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 2. Critical variables to be checked: Checks Acceptance Criteria 1.0 Put ‘ON’ the mains of the PLC display comes ‘ON’. panel box. (Ensure system is in Auto mode) 1.1
2.0 2.1 2.2
Observations
Operate the Steam PLC displays each Sterilizer as per parameter during entry and manufacturer manual / SOP. gives display and printout of all parameters. And Check for Functioning of all pressure Should be satisfactory gauges and temperature On Operation sensor 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 valves
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 line valve Open the compressed air valve.
The PLC shows ‘Air pressure low’ The PLC displays Normal mode.
2.7
Run the programmed HPHV cycle as per SOP.
The cycle is completed as programmed (check printout and chart)
Should be satisfactory On Operation.
OPERATIONAL QUALIFICATION 2.8
Checks Open door No. 1 (Non sterile side)
Acceptance Criteria Does not open.
Page 17 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 2.8
Open door No. 2
Door opens
2.9
Conduct leak test in cold condition (Ambient temperature)
Drop in vacuum for 10 minutes < 10mm of Hg/min. (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. (Check print out and chart) • Fast exhaust • Slow exhaust • Leak test
3.0 3.1
Watch Dog cycle on PLC Start the HPHV cycle Close the control valve on vacuum line during ‘INITIAL VACUUM ON’.
3.2
Close the steam valve during ‘PREHEATING ON’
Buzzer sounds if set temperature is not obtained in 15 minutes. Buzzer stops when acknowledged.
3.3
Close the steam valve during ‘HEATING ON’
Buzzer sounds if the sterilisation temperature is not attained within 30 minutes.
3.4
Skip function During any phase of cycle press skip button for 10 seconds.
The phase of the cycle is skipped PLC shows ‘SKIP’ followed by ‘SKIP OPERATED’.
Buzzer sounds if vacuum is not reached in 15 minutes. Buzzer stops when acknowledged.
Page 18 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER OPERATIONAL QUALIFICATION Checks Emergency ‘OFF’ During any phase of cycle press ‘Emergency OFF’ button on panel board and release the switch after 1 minute.
Acceptance Criteria The PLC display gets ‘OFF’ and display shows. “DO YOU WANT TO CONTINUE (Y/N) ( 1/2) when emergency button is released.
3.6
Carry out Leak Test cycle for 10 minutes.
Leak Test should pass over pressure not more than 1mm of Hg during 10 minutes hold.
3.7
Run HPHV cycle carry out Heat distribution study during sterile hold with the help of temperature mapping device.
Temperature distribution throughout the chamber should be uniform.
3.8
Run HPHV cycle and carry out Bowie and dick test for Heat penetration.
The colour change on Bowie dick sheet should be uniform. (Pale yellow before Heat penetration and black after Heat penetration.)
3.9
Carry out Heat distribution study with the help of data logger.
•
3.5
• •
Should be within ±3°C Temp. band with the 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
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER OPERATIONAL QUALIFICATION 4.0. 4.1
Checks Safety Functions Hydrostatic Test
Acceptance Criteria Should be as per design criteria
4.2
Functioning of door interlocking
Should be as per design criteria
4.3
Functioning of safety valve Documentation Standard Operating Procedure (SOP)
Should be satisfactory on operation
5.0
6.0
Observations
SOP for Cleaning and Operation Should be available
Ref. SOP No. Cleaning / Sanitization: Operation: PPM :
SOP for Planned Preventive Maintenance should be available Training should be given to the concerned personnel on Steam Sterilizer for operation, cleaning and maintenance.
Training
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 : Page 20 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
6. Review ( Inclusive of follow up action, if any ):
7. Recommendations:
8. Operation Qualification Signing off :
PRODUCTION
Date:
ENGINEERING
Date:
SAFETY
Date:
QUALITY CONTROL
Date :
QUALITY ASSURANCE
Date:
UNIT HEAD
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. Page 21 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 2. Performance Checks 1.0
2.0
Checks Operate the equipment in HPHV cycle as per SOP • Empty load I • Empty load II • Empty load III • Full load (Porous) • Full load (Non Porous)
Acceptance Criteria All the cycles should complete as desired.
Validate the Steriliser as per Protocol
Observations
Ref. Protocol No. : The validation should be carried out successfully.
3.0
Record the finding in validation Report
Ref. Report No. :
Page 22 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
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: PRODUCTION
Date:
ENGINEERING
Date:
SAFETY
Date:
QUALITY CONTROL
Date :
Page 23 of 24
QUALITY ASSURANCE
Date:
UNIT HEAD
Date:
Cipla Goa
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 :_______________
Page 24 of 24
Date:________
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 COMPILED BY Production:
PROTOCOL APPROVED BY
PROTOCOL AUTHORIZED BY
Quality Assurance:
Unit Head:
Date:
Date:
Quality Control: Engineering: Safety:
Date:
Page 1 of 24
Cipla Goa
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. Page 2 of 24
Cipla Goa
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: 1.0 1.1.
Critical variables Acceptance Criteria Process / Product Parameters The system should be Sterilization should assure the total able to sterilize the destruction of microbial load load. (To be assured by supplier)
1.2.
Operation
1.3.
Working capacity of Autoclaves.
Auto / Manual Should be completely PLC operated Double Door Sterilizer Volume : 1130 Litres. Working Pressure: 2.1 kg/cm2
2.0. 2.1.
Location Suitability Availability of utilities at location.
Utility connections should be available.
2.2.
Size of Autoclave.
900 mm ×1050 mm × 1200 mm
2.3.
Room condition
Should be able to meet the requirement of Clean environment
2.4.
3.0
Weight of Autoclave (in working condition).
Should be less than the load bearing capacity of the area. i.e. 1000 kg / sq.m
DESIGN QUALIFICATION Critical variables Acceptance Criteria Key Design Features
Page 3 of 24
References Process requirement Process requirement Process requirement
cGMP requirements Process requirement cGMP requirements Process requirement
References
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 3.1.
3.2. 3.3.
3.4. 3.5. 3.6
3.7.
3.8. 3.9
Material of Construction
Chamber : SS 316L Jacket : SS 304 Door (Contact area) : SS 316L Insulation : Glass wool Supports : SS 304 Tray : SS 316L (To be assured by supplier) Doors Hinge doors (To be assured by supplier) Pneumatic Valves Should be provided in Steam In Jacket Line Steam In Chamber Line Air Vent Line Vacuum Break Line Chamber condensate Line Chamber vacuum line (To be assured by supplier) Solenoid Valves Should be provided in Vacuum pump sealing water line (To be assured by supplier) Pumps Vacuum pump with motor should be provided (To be assured by supplier) Pressure Gauges Should be provided for Sterile side panel sheet and Non-Sterile side panel 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) Temperature Sensor PT-100 Sensor (0 to 200°C) should be provided in chamber drain line[Dual element] & chamber [single element] (To be assured by supplier) Pressure Switch Should be provided for Jacket and Air (To be assured by supplier) Gaskets Silicon made gasket should be provided for Doors (To be assured by supplier) DESIGN QUALIFICATION
Critical variables 3.10. Steam Trap
Acceptance Criteria Should be provided in Jacket and Chamber condensate line (To be assured by supplier) Page 4 of 24
Process requirement
Process requirement cGMP guidelines
Process requirement
cGMP guidelines
Process requirement Process requirement Process requirement
References cGMP guidelines
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 3.11
Strainer
3.12
Air Vent Filter
3.13.
PLC unit
Should be provided in Chamber condensate line and Steam in Jacket line (To be assured by supplier) Should be provided in Vacuum Break line (To be assured by supplier) Should be provided for: • HPHV Cycle. • Leak Test Cycle. • Bowie and Dick Test Cycle • Initial Pulsation, Initial Vacuum holding time, Preheating hold time, Preheating hold temp., Sterile hold 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)
Page 5 of 24
cGMP guidelines cGMP guidelines
Equipment Literature
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER DESIGN QUALIFICATION Critical variables 3.14 Strip Chart Recorder
3.15.
Manual override
3.16.
Hooter
4.0. 4.1.
Safety Insulation of Hot parts
4.2.
Hydraulic Test pressure
4.3.
Emergency OFF
4.4.
Electrical wiring and Earthing
4.5.
Door Interlocks
5.0. 5.1.
Vendor Selection Selection of Vendor for supplying the Autoclave
Acceptance Criteria 6 points strip chart recorder with alphanumeric printing and continuous plotting of Temperature from 2 monitoring sensors. Switch for manual override with individual luminous type switches for each function.
References Process requirement
Audio alarm with mute option at different set levels.
Process requirement
Glass Wool Insulation of Hot parts should be done wherever possible (To be assured by supplier) Jacket – As per ASME Chamber – As per ASME (To be assured by supplier) Emergency OFF switch on control panel.
Safety Precaution
Earthing to be provided to control panel and pumps. Electrical wiring as per safety guidelines Door interlocks during process, Positive pressure locking of both doors, Door open indicator lamps on either side.
Process requirement
Safety Precaution Safety Precaution Safety Precaution Safety Precaution
Selection of Vendor should be done on cGMP the basis of review of vendor. guidelines 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
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 Page 7 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 7. Recommendation:
8. Design qualification signing off:
PRODUCTION
Date:
ENGINEERING
Date:
SAFETY
Date:
QUALITY CONTROL
Date :
QUALITY ASSURANCE
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
UNIT HEAD
Date:
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
1.0.
Checks Material of Construction
Acceptance Criteria
Observations
Chamber : SS 316L Jacket
: SS 304
Door (Contact area): SS 316L Supports :
SS 304
Tray
SS 316
:
2.0.
Doors
3.0.
Pneumatic Valves
4.0
Solenoid Valves
5.0
Pump
6.0
Pressure Gauges
7.0
Temperature Sensor
8.0
Gaskets
9.0
Steam trap
10.0
Strainer
11.0
Air Vent Filter
12.0
PLC with display converter Strip chart recorder
13.0
Should meet specification
Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification Should meet specification and Should meet specification Should meet specification
Checked By :
Date :
14.0
Checks Strip chart recorder
Acceptance Criteria Should meet specification
15.0
Manual override
Should meet specification Page 9 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 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
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 1.0. Location Suitability 1.1. Place of Installation
Acceptance Criteria As per proposed lay out / designated area
1.2. Availability of Utilities at location
Should be available
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) Should be sufficient for easy operation, cleaning, sanitization and maintenance
1.5. Working space around the Steam Sterilizer
Page 11 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER INSTALLATION QUALIFICATION Checks Acceptance Criteria 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 unit
2.3. Installation of doors
2.4. Installation of Pressure gauges 2.5. Installation of Temperature Sensor
•
As per approved drawing Should have a slight slope towards non clean side Engg. / Production / QA to certify the correct installation. 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. As per approved drawing Engg. / Production / QA to certify the correct installation. As per approved drawing 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
As per approved drawing
Installation of Pressure Switch
Engg. / Production / QA to certify the correct installation.
Page 12 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER INSTALLATION QUALIFICATION 2.8
2.9
Checks Installation of all pneumatic valves
Acceptance Criteria Should be installed in 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.
Installation of Steam Trap
Should be installed in chamber and jacket condensate line Engg. / Production / QA to certify the correct installation.
2.10
Installation of Strainer
Should be installed in chamber condensate and steam in jacket line Engg. / Production / QA to certify the correct installation.
2.11
Installation of Air vent filter
Should be installed in vacuum break line Engg. / Production / QA to certify the correct installation.
2.12
Installation of Venting valve
Should be installed in bleeder line Engg. / Production / QA to certify the correct installation.
2.13
Installation of PLC UNIT
As per approved drawing Engg. / Production / QA to certify the correct installation.
Page 13 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER INSTALLATION QUALIFICATION 2.14
Checks Strip Chart Recorder
Acceptance Criteria Model µR1000 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
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)
Pure Steam
3.5. Drain Line
Closed Drain line to be provided. (Engineering to certify.)
Page 14 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER INSTALLATION QUALIFICATION Checks 4.0. Safety 4.1. Hydrostatic Testing of Chamber, Jacket
Hydrostatic test pressure should be as per ASME
4.2
To be provided
4.3
4.4 4.5
Safety locking of doors through limit switches Safety valves chamber. Pressure regulating valves Emergency switch on panel board Electrical wiring and Earthing
5.0. General Checks 5.1. Grouting and mounting of all components of Steam Sterilizer 5.2
Equipment should be properly balanced
5.3
All the metal parts should be properly grounded Welding of joints
5.4
Acceptance Criteria
To be provided
To be provided Engg. / Production / Safety to certify the correct installation. Should be proper Engg. / Production / Safety / QA to certify Should be proper Engg. / Production / Safety / QA to certify Should be proper Engg. / Production / Safety / QA to certify Should be proper Engg. / Production / Safety / QA to certify
4. References:
5. Documents to be attached:
INSTALLATION QUALIFICATION Page 15 of 24
Observations
Cipla Goa
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: PRODUCTION
Date:
ENGINEERING
Date:
SAFETY
Date:
QUALITY CONTROL
Date :
QUALITY ASSURANCE
Date:
UNIT HEAD
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. Page 16 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 2. Critical variables to be checked: Checks Acceptance Criteria 1.0 Put ‘ON’ the mains of the PLC display comes ‘ON’. panel box. (Ensure system is in Auto mode) 1.1
2.0 2.1 2.2
Observations
Operate the Steam PLC displays each Sterilizer as per parameter during entry and manufacturer manual / SOP. gives display and printout of all parameters. And Check for Functioning of all pressure Should be satisfactory gauges and temperature On Operation sensor 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 valves
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 line valve Open the compressed air valve.
The PLC shows ‘Air pressure low’ The PLC displays Normal mode.
2.7
Run the programmed HPHV cycle as per SOP.
The cycle is completed as programmed (check printout and chart)
Should be satisfactory On Operation.
OPERATIONAL QUALIFICATION 2.8
Checks Open door No. 1 (Non sterile side)
Acceptance Criteria Does not open.
Page 17 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 2.8
Open door No. 2
Door opens
2.9
Conduct leak test in cold condition (Ambient temperature)
Drop in vacuum for 10 minutes < 10mm of Hg/min. (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. (Check print out and chart) • Fast exhaust • Slow exhaust • Leak test
3.0 3.1
Watch Dog cycle on PLC Start the HPHV cycle Close the control valve on vacuum line during ‘INITIAL VACUUM ON’.
3.2
Close the steam valve during ‘PREHEATING ON’
Buzzer sounds if set temperature is not obtained in 15 minutes. Buzzer stops when acknowledged.
3.3
Close the steam valve during ‘HEATING ON’
Buzzer sounds if the sterilisation temperature is not attained within 30 minutes.
3.4
Skip function During any phase of cycle press skip button for 10 seconds.
The phase of the cycle is skipped PLC shows ‘SKIP’ followed by ‘SKIP OPERATED’.
Buzzer sounds if vacuum is not reached in 15 minutes. Buzzer stops when acknowledged.
Page 18 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER OPERATIONAL QUALIFICATION Checks Emergency ‘OFF’ During any phase of cycle press ‘Emergency OFF’ button on panel board and release the switch after 1 minute.
Acceptance Criteria The PLC display gets ‘OFF’ and display shows. “DO YOU WANT TO CONTINUE (Y/N) ( 1/2) when emergency button is released.
3.6
Carry out Leak Test cycle for 10 minutes.
Leak Test should pass over pressure not more than 1mm of Hg during 10 minutes hold.
3.7
Run HPHV cycle carry out Heat distribution study during sterile hold with the help of temperature mapping device.
Temperature distribution throughout the chamber should be uniform.
3.8
Run HPHV cycle and carry out Bowie and dick test for Heat penetration.
The colour change on Bowie dick sheet should be uniform. (Pale yellow before Heat penetration and black after Heat penetration.)
3.9
Carry out Heat distribution study with the help of data logger.
•
3.5
• •
Should be within ±3°C Temp. band with the 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
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER OPERATIONAL QUALIFICATION 4.0. 4.1
Checks Safety Functions Hydrostatic Test
Acceptance Criteria Should be as per design criteria
4.2
Functioning of door interlocking
Should be as per design criteria
4.3
Functioning of safety valve Documentation Standard Operating Procedure (SOP)
Should be satisfactory on operation
5.0
6.0
Observations
SOP for Cleaning and Operation Should be available
Ref. SOP No. Cleaning / Sanitization: Operation: PPM :
SOP for Planned Preventive Maintenance should be available Training should be given to the concerned personnel on Steam Sterilizer for operation, cleaning and maintenance.
Training
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 : Page 20 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
6. Review ( Inclusive of follow up action, if any ):
7. Recommendations:
8. Operation Qualification Signing off :
PRODUCTION
Date:
ENGINEERING
Date:
SAFETY
Date:
QUALITY CONTROL
Date :
QUALITY ASSURANCE
Date:
UNIT HEAD
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. Page 21 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 2. Performance Checks 1.0
2.0
Checks Operate the equipment in HPHV cycle as per SOP • Empty load I • Empty load II • Empty load III • Full load (Porous) • Full load (Non Porous)
Acceptance Criteria All the cycles should complete as desired.
Validate the Steriliser as per Protocol
Observations
Ref. Protocol No. : The validation should be carried out successfully.
3.0
Record the finding in validation Report
Ref. Report No. :
Page 22 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
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: PRODUCTION
Date:
ENGINEERING
Date:
SAFETY
Date:
QUALITY CONTROL
Date :
Page 23 of 24
QUALITY ASSURANCE
Date:
UNIT HEAD
Date:
Cipla Goa
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 :_______________
Page 24 of 24
Date:________
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