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 isInstalled according to design specifications, performs as designed and

Complies with the Standard Operating Procedure and thus meets The cGMP obligations.

PROTOCOLCOMPILED BY

PROTOCOLAPPROVED BY

PROTOCOLAUTHORIZED BY

Production:

Quality Control:

Engineering:

Safety:

Quality Assurance: Unit Head:

Date: Date: Date:

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CONTENTS

1. Design qualification

2. Checklist for equipment on receipt

3. Installation qualification

4. Operational qualification

5. Performance qualification

6. Equipment Hand over Certificate

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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.

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 References1.0 Process / Product Parameters1.1. The system should be

able to sterilize the load.

Sterilization should assure the total destruction of microbial load (To be assured by supplier)

Process requirement

1.2. Operation Auto / ManualShould be completely PLC operatedDouble Door Sterilizer

Process requirement

1.3. Working capacity of Autoclaves.

Volume : 1130 Litres. Working Pressure: 2.1 kg/cm2

Processrequirement

2.0. Location Suitability 2.1. Availability of utilities at

location.Utility connections should be available. cGMP

requirements2.2. 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

requirements2.4. Weight of Autoclave

(in working condition).Should be less than the load bearing capacity of the area. i.e. 1000 kg / sq.m

Process requirement


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Critical variables Acceptance Criteria References3.0 Key Design Features 3.1. Material of

Construction Chamber : SS 316LJacket : SS 304Door (Contact area) : SS 316LInsulation : Glass woolSupports : SS 304Tray : SS 316L (To be assured by supplier)

Process requirement

3.2. Doors Hinge doors(To be assured by supplier)

Process requirement

3.3. Pneumatic Valves Should be provided inSteam In Jacket LineSteam In Chamber LineAir Vent LineVacuum Break LineChamber condensate LineChamber vacuum line(To be assured by supplier)

cGMP guidelines

3.4. Solenoid Valves Should be provided inVacuum pump sealing water line(To be assured by supplier)

Process requirement

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 panel sheet and Non-Sterile side panel sheetPure Steam lineNon 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)

cGMP guidelines

3.7. 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)

Process requirement

3.8. Pressure Switch Should be provided for Jacket and Air(To be assured by supplier)

Process requirement

3.9 Gaskets Silicon made gasket should be provided for Doors(To be assured by supplier)

Process requirement


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Critical variables Acceptance Criteria References3.10. Steam Trap Should be provided in Jacket and

Chamber condensate line (To be assured by supplier)

cGMP guidelines

3.11 Strainer Should be provided in Chamber condensate line and Steam in Jacket line(To be assured by supplier)

cGMP guidelines

3.12 Air Vent Filter Should be provided in Vacuum Break line(To be assured by supplier)

cGMP 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, 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)

Equipment Literature

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Critical variables Acceptance Criteria References3.14 Strip Chart Recorder 6 points strip chart recorder with

alphanumeric printing and continuous plotting of Temperature from 2 monitoring sensors.

Process requirement

3.15. Manual override Switch for manual override with individual luminous type switches for each function.

Process requirement

3.16. Hooter Audio alarm with mute option at different set levels.

Process requirement

4.0. Safety 4.1. Insulation of Hot parts Glass Wool Insulation of Hot parts

should be done wherever possible(To be assured by supplier)

Safety Precaution

4.2. Hydraulic Test pressure

Jacket – As per ASMEChamber – As per ASME(To be assured by supplier)

Safety Precaution

4.3. Emergency OFF Emergency OFF switch on control panel. Safety Precaution

4.4. Electrical wiring and Earthing

Earthing to be provided to control panel and pumps.Electrical wiring as per safety guidelines

Safety Precaution

4.5. Door Interlocks Door interlocks during process,Positive pressure locking of both doors, Door open indicator lamps on either side.

Safety Precaution

5.0. Vendor Selection5.1. Selection of Vendor

for supplying the Autoclave

Selection of Vendor should be done on the basis of review of vendor.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)

cGMP guidelines

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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 Copy6. Any other relevant documents

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

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7. Recommendation:

8. Design qualification signing off:

PRODUCTION ENGINEERING SAFETYQUALITY

CONTROLQUALITY

ASSURANCEUNIT HEAD

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

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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)

Checks Acceptance Criteria Observations1.0. Material of Construction

Chamber : SS 316L

Jacket : SS 304

Door (Contact area): SS 316L

Supports : SS 304

Tray : SS 316

Should meet specification

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 converter

Should meet specification

13.0 Strip chart recorder Should meet specification

Checked By : Date : of 24

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Checks Acceptance Criteria Observations14.0 Strip chart recorder Should meet specification

15.0 Manual override Should meet specification

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 attached1. Visit Report (if any).2. Equipment’s Manual3. MOC Certificates.4. Manufacturer test reports5. Calibration certificates

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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 Observations1.0. Location Suitability1.1. Place of Installation 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)

1.5. Working space around the Steam Sterilizer

Should be sufficient for easy operation, cleaning, sanitization and maintenance

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Checks Acceptance Criteria Observations2.0. Equipment Installation2.1. All the parts Should be identified, intact and

cleanedAll the MOC of contact part should be tested as per SOP

2.2. Verify erection main unit

As per approved drawing

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 Pressure gauges

As per approved drawingEngg. / Production / QA to certify the correct installation.

2.5. Installation of Temperature Sensor


2.6. Installation of Pump Should be properly mounted and balanced as per approved drawingEngg. / Production / QA to certify the correct installation.

2.7 Installation of Pressure Switch

As per approved drawing


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Checks Acceptance Criteria Observations2.8 Installation of all

pneumatic valvesShould be installed inSteam In Jacket LineSteam In Chamber LineAir Vent LineVacuum Break LineChamber condensate LineChamber vacuum lineEngg. / Production / QA to certify the correct installation.

2.9 Installation of Steam Trap

Should be installed in chamber and jacket condensate line


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

2.12 Installation of Venting valve

Should be installed in bleeder lineEngg. / Production / QA to certify the correct installation.

2.13 Installation of PLC UNIT


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Checks Acceptance Criteria Observations2.14 Strip Chart

RecorderModel 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 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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Checks Acceptance Criteria Observations4.0. Safety4.1. Hydrostatic Testing of

Chamber, JacketHydrostatic test pressure should be as per ASME

4.2 Safety locking of doors through limit switches

To be provided

4.3 Safety valves chamber.Pressure regulating valves

To be provided

4.4 Emergency switch on panel board

To be provided

4.5 Electrical wiring and Earthing

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

5.0. General Checks 5.1. Grouting and

mounting of all components of Steam Sterilizer

Should be proper Engg. / Production / Safety / QA to certify

5.2 Equipment should be properly balanced


5.3 All the metal parts should be properly grounded


5.4 Welding of joints Should be proper Engg. / Production / Safety / QA to certify

4. References:

5. Documents to be attached:

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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:


CONTROLQUALITY

ASSURANCEUNIT HEAD


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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.2. Critical variables to be checked:

Checks Acceptance Criteria Observations1.0 Put ‘ON’ the mains of the

panel box. (Ensure system is in Auto mode)

PLC display comes ‘ON’.

1.1 Operate the Steam Sterilizer as per manufacturer manual / SOP.

PLC displays each parameter during entry and gives display and printout of all parameters.

2.0 And Check for2.1 Functioning of all pressure

gauges and temperature sensor

Should be satisfactory On Operation

2.2 Functioning of Pump Should be satisfactoryOn Operation.

2.3 Functioning of all pneumatic valves

Should be satisfactoryOn Operation.

2.4 Functioning of all solenoid valves

Should be satisfactoryOn Operation.

2.5 Programme the cycle on the PLC as per manual / SOP

PLC displays each 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)

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OPERATIONAL QUALIFICATION

Checks Acceptance Criteria Observations2.8 Open door No. 1 (Non

sterile side)Does not open.

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 Fast exhaust Slow exhaust Leak test

Cycles run as desired.(Check print out and chart)

3.0 Watch Dog cycle on PLC3.1 Start the HPHV cycle

Close the control valve on vacuum line during ‘INITIAL VACUUM ON’.

Buzzer sounds if vacuum is not reached in 15 minutes. Buzzer stops when acknowledged.

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 functionDuring any phase of cycle press skip button for 10 seconds.

The phase of the cycle is skipped PLC shows ‘SKIP’ followed by ‘SKIP OPERATED’.

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Checks Acceptance Criteria Observations3.5 Emergency ‘OFF’

During any phase of cycle press ‘Emergency OFF’ button on panel board and release the switch after 1 minute.

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.

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.

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Checks Acceptance Criteria Observations4.0. Safety Functions4.1 Hydrostatic Test Should be as per design

criteria

4.2 Functioning of door interlocking

Should be as per design criteria

4.3 Functioning of safety valve Should be satisfactory on operation

5.0 DocumentationStandard Operating Procedure (SOP)

SOP for Cleaning and Operation Should be available

SOP for Planned Preventive Maintenance should be available

Ref. SOP No. Cleaning / Sanitization:Operation:PPM :

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.

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

7. Recommendations:

8. Operation Qualification Signing off :


CONTROLQUALITY

ASSURANCEUNIT HEAD


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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.

2. Performance Checks

Checks Acceptance Criteria Observations1.0 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)

All the cycles should complete as desired.

2.0 Validate the Steriliser as per Protocol

The validation should be carried out successfully.

Ref. Protocol No. :

3.0 Record the finding in validation Report

Ref. Report No. :

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3. References :


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

6. Document to be attached :

7. Recommendations :

8. Performance qualification signing off:


CONTROLQUALITY

ASSURANCEUNIT HEAD


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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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steam sterilizer

Documents

metal chem

formally agreed

heat distribution

approved drawing

leak test

ss 316l jacket

chamber condensate

jacket line