Cipla

Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER

CODE No. LOCATION AREA MAKE MACHINE SERIAL NO PROTOCOL No.

: OCP-022 : POWDER INJECTABLE : COMPONENT STERILISATION AREA : METAL CHEM INDUSTRIES : 215 : 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: Quality Control: Engineering: Safety:

PROTOCOL APPROVED BY
Quality Assurance:

PROTOCOL AUTHORIZED BY
Unit Head:

Date:

Date:

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) Operation Working capacity of Autoclaves. Location Suitability Availability of utilities at location. Size of Autoclave. Room condition Weight of Autoclave (in working condition). Auto / Manual Should be completely PLC operated Double Door Sterilizer Volume : 1130 Litres. Working Pressure: 2.1 kg/cm2 Utility connections should be available. 900 mm ×1050 mm × 1200 mm Should be able to meet the requirement of Clean environment Should be less than the load bearing capacity of the area. i.e. 1000 kg / sq.m References Process requirement Process requirement Process requirement

1.2. 1.3. 2.0. 2.1. 2.2. 2.3. 2.4.

cGMP requirements Process requirement cGMP requirements Process requirement

3.0

DESIGN QUALIFICATION Critical variables Acceptance Criteria Key Design Features

References

Page 3 of 24

Cipla
Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
3.1. 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 Acceptance Criteria Should be provided in Jacket and Chamber condensate line (To be assured by supplier)
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Process requirement

3.2. 3.3.

Process requirement cGMP guidelines

3.4. 3.5. 3.6

Process requirement

cGMP guidelines

3.7.

Process requirement Process requirement Process requirement

3.8. 3.9

Critical variables 3.10. Steam Trap

References cGMP guidelines

Cipla
Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
3.11 Strainer 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) cGMP guidelines cGMP guidelines

3.12 3.13.

Air Vent Filter PLC unit

Equipment Literature

Page 5 of 24

Cipla
Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
DESIGN QUALIFICATION Critical variables 3.14 Strip Chart Recorder 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. Audio alarm with mute option at different set levels. 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. 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. References Process requirement Process requirement Process requirement Safety Precaution Safety Precaution Safety Precaution Safety Precaution Safety Precaution

3.15.

Manual override

3.16. 4.0. 4.1. 4.2. 4.3. 4.4. 4.5.

Hooter Safety Insulation of Hot parts Hydraulic Test pressure Emergency OFF Electrical wiring and Earthing Door Interlocks

5.0. 5.1.

Vendor Selection Selection of Vendor for supplying the Autoclave

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:
QUALITY CONTROL QUALITY ASSURANCE

PRODUCTION

ENGINEERING

SAFETY

UNIT HEAD

Date:

Date:

Date:

Date :

Date:

Date:

(To be checked on receipt of the equipment)
(List made as per Manual given by the Vendor prior to installation) Page 8 of 24

CHECKLIST FOR INSPECTION OF STEAM STERILIZER

Cipla
Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
Checks Material of Construction Chamber : SS 316L Jacket : SS 304 Should meet specification Acceptance Criteria Observations

1.0.

Door (Contact area): SS 316L Supports : Tray 2.0. 3.0. 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 13.0 Doors Pneumatic Valves Solenoid Valves Pump Pressure Gauges Temperature Sensor Gaskets Steam trap Strainer Air Vent Filter PLC with display converter Strip chart recorder : SS 304 SS 316

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 Date : Acceptance Criteria Should meet specification Should meet specification
Page 9 of 24

Checked By : 14.0 15.0 Checks Strip chart recorder Manual override

Observations

Cipla
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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
16.0 17.0 18.0 Hooter List of spares Operating Manual Should meet specification Should be tallied with supply 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 2.2 2.3 2.4 Model Manufacturer Machine Serial No. Code No. : DS/DD/215 : METAL CHEM INDUSTRIES : 215 : OCP-22

3. Critical Variables to be met : Checks 1.0. Location Suitability 1.1. Place of Installation 1.2. Availability of Utilities at location 1.3. Room Condition 1.4. Illumination Acceptance Criteria As per proposed lay out / designated area Should be available Controlled / Clean environment should be provided 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 Observations

1.5. Working space around the Steam Sterilizer

Page 11 of 24

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 •

Observations

2.3. Installation of doors

2.4. Installation of Pressure gauges 2.5. Installation of Temperature Sensor 2.6. Installation of Pump

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. Should be properly mounted and balanced as per approved drawing Engg. / Production / QA to certify the correct installation. As per approved drawing Engg. / Production / QA to certify the correct installation.

2.7

Installation of Pressure Switch

Page 12 of 24

Cipla
Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
INSTALLATION QUALIFICATION 2.8 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. 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. Should be installed in vacuum break line Engg. / Production / QA to certify the correct installation. Should be installed in bleeder line Engg. / Production / QA to certify the correct installation. As per approved drawing Engg. / Production / QA to certify the correct installation. Observations

2.9

Installation of Steam Trap

2.11

Installation of Air vent filter

2.12

Installation of Venting valve

2.13

Installation of PLC UNIT

Page 13 of 24

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 300 serial port Location: Panel Box SS 304 with properly traced connections as per circuit diagram Observations

2.15

Printer

2.16

Panel Box

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) 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) Closed Drain line to be provided. (Engineering to certify.)

3.4

Pure Steam

3.5. Drain Line

Page 14 of 24

Cipla
Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
INSTALLATION QUALIFICATION Checks 4.0. Safety 4.1. Hydrostatic Testing of Chamber, Jacket 4.2 4.3 Safety locking of doors through limit switches Safety valves chamber. Pressure regulating valves Emergency switch on panel board Electrical wiring and Earthing Acceptance Criteria Hydrostatic test pressure should be as per ASME To be provided To be provided Observations

4.4 4.5

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

5.0. General Checks 5.1. Grouting and mounting of all components of Steam Sterilizer 5.2 5.3 5.4 Equipment should be properly balanced All the metal parts should be properly grounded Welding of joints

4. References:

5. Documents to be attached:

INSTALLATION QUALIFICATION
Page 15 of 24

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 ENGINEERING SAFETY QUALITY CONTROL QUALITY ASSURANCE UNIT HEAD

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.
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 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. Functioning of all pneumatic Should be satisfactory valves On Operation. Functioning of all solenoid valves Should be satisfactory On Operation. Observations

2.0 2.1 2.2 2.3 2.4 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. Close the compressed air line valve Open the compressed air valve. Run the programmed HPHV cycle as per SOP. The PLC shows ‘Air pressure low’ The PLC displays Normal mode. The cycle is completed as programmed (check printout and chart)

2.6

2.7

OPERATIONAL QUALIFICATION 2.8 Checks Open door No. 1 (Non sterile side) Acceptance Criteria Does not open. Observations

Page 17 of 24

Cipla
Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
2.8 2.9 Open door No. 2 Conduct leak test in cold condition (Ambient temperature) Door opens 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 Watch Dog cycle on PLC Start the HPHV cycle Close the control valve on vacuum line during ‘INITIAL VACUUM ON’. Close the steam valve during ‘PREHEATING ON’

3.0 3.1

Buzzer sounds if vacuum is not reached in 15 minutes. Buzzer stops when acknowledged. Buzzer sounds if set temperature is not obtained in 15 minutes. Buzzer stops when acknowledged. Buzzer sounds if the sterilisation temperature is not attained within 30 minutes. The phase of the cycle is skipped PLC shows ‘SKIP’ followed by ‘SKIP OPERATED’.

3.2

3.3

Close the steam valve during ‘HEATING ON’

3.4

Skip function During any phase of cycle press skip button for 10 seconds.

Page 18 of 24

Cipla
Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
OPERATIONAL QUALIFICATION 3.5 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. Observations

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. Run HPHV cycle and carry out Bowie and dick test for Heat penetration.

Temperature distribution throughout the chamber should be uniform.

3.8

The colour change on Bowie dick sheet should be uniform. (Pale yellow before Heat penetration and black after Heat penetration.) • 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.

3.9

Carry out Heat distribution study with the help of data logger.

• •

Page 19 of 24

Cipla
Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
OPERATIONAL QUALIFICATION 4.0. 4.1 4.2 4.3 5.0 Checks Safety Functions Hydrostatic Test Functioning of door interlocking Functioning of safety valve Documentation Standard Operating Procedure (SOP) Acceptance Criteria Should be as per design criteria Should be as per design criteria Should be satisfactory on operation SOP for Cleaning and Operation Should be available SOP for Planned Preventive Maintenance should be available Training should be given to the concerned personnel on Steam Sterilizer for operation, cleaning and maintenance. Ref. SOP No. Cleaning / Sanitization: Operation: PPM : Observations

6.0

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

ENGINEERING

SAFETY

QUALITY CONTROL

QUALITY ASSURANCE

UNIT HEAD

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.
Page 21 of 24

Cipla
Goa

QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
2. Performance Checks 1.0 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) Validate the Steriliser as per Protocol The validation should be carried out successfully. 3.0 Record the finding in validation Report Ref. Report No. : Acceptance Criteria All the cycles should complete as desired. Observations

2.0

Ref. Protocol 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 ENGINEERING SAFETY QUALITY CONTROL QUALITY ASSURANCE UNIT HEAD

Date:

Date:

Date:

Date :

Date:

Date:

Page 23 of 24

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:_______________ Engineering:______________ Safety : _________________ Quality Control : _____________ Quality Assurance:_________ Unit Head :_______________ Date:________ Date:________ Date:________ Date:________ Date:________ Date:________

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