Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
CODE No.
: OCP-022
LOCATION
: POWDER INJECTABLE
AREA
: COMPONENT STERILISATION AREA
MAKE
: METAL METAL CHEM INDUSTRIES
MACHINE SERIAL NO
: 215
PROTOCOL No.
: EQ/OCP-022/01
The purpose of this document is to qualify the Steam Sterilizer. Sterilizer. This Document provides evidence that the equipment is functional and is Installed according to design specifications, 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
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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 cGMP and safety have have been considered in designing Steam Sterilizer and are properly documented. Page 2 of 24
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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 1 .0 Process / Pr Product Par Parameters 1.1. The system should be Sterilization should assure the total able to sterilize the destruction of microbial load load. (To (To be assured by supplier) supplier ) 1.2.
Operation
1.3.
Wo rking capacity of Autoclaves.
Auto / Manual Should be completely PLC operated Double Door Sterilizer Volume : 1130 Litres. Litr es. Working Pressure: 2.1 kg/cm2
2.0. 2.1.
Location Su Suitability Availability of ut 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
We ight of of Autoclave (in working condition).
Should be less than the load bearing capacity of the area. i.e. 1000 kg 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
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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 3.1.
3.2. 3.3.
3.4. 3.4.
3.5.
3 .6
3.7. 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 (To be assured by supplier) Doors Hinge doors (To (To be assured by supplier) 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 (To be assured by supplier) supplier ) Sole Soleno noid id Valves lves Shoul hould d be prov provid ided ed in Vacuum pump sealing water line (To (To be assured by supplier) supplier ) Pumps Vacuum pump with motor should be provided (To (To be assured by supplier) 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 Compound pressure gauge Non sterile –1to 3.5 kg/cm2 (chamber) Sterile side -1to 3.5 kg/cm2 (chamber) (To (To be assured by supplier) supplier ) Temper mperat atur ure e Sens Sensor or PT-1 PT-100 00 Sens Sensor or (0 to 200° 200°C) C) shou should ld be provided in chamber drain line[Dual element] & chamber [single element] (To (To be assured by supplier) Pressure Switch Should be provided for Jacket and Air (To (To be assured by supplier) supplier ) Gaskets Silicon made gasket should be provided for Doors (To (To be assured by supplier) supplier ) DESIGN QUALIFICATION
Critical variables 3.10. Steam Trap
Acceptance Criteria Should be provided in Jacket and Chamber condensate line (To (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 (To be assured by supplier) Should be provided in Vacuum Break line (To (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 memory RS 232 Port should be provided for data logging (To (To be assured by supplier)
cGMP guidelines
cGMP guidelines
• • • •
•
• •
Page 5 of 24
Equipment Literature
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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER DESIGN QUALIFICATION Critical variables 3.1 3.14 Strip rip Ch Chart art Re Recorde rder
3.15.
Manual override
3.16.
Hooter
4.0. 4.1. 4.1.
Safety Ins Insulat ulatio ion n of of Hot Hot part parts s
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 of Ve Vendor for supplying the Autoclave
Acceptance Criteria 6 poi poin nts strip rip ch chart rec recorde rder wi with alphanumeric printing and continuous plotting of Temperature Temperature from 2 monitoring sensors. Switch for manual ov override with individual luminous type switches for each function.
References Process requirement
Audio alarm with mute option at different set levels.
Process requirement
Gla Glass Wool ool Ins Insul ulat atio ion n of of Hot Hot par parts ts should be done wherever possible (To (To be assured by supplier) Jacket – As per ASME Chamber – As per ASME (To (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, how, quality standards, inspection of site, costing, feed back from market (customers already using the equipment)
Page 6 of 24
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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 Technical details detai ls for Equipment requirement with Engineering drawings, 3. Approved design and specifications, 4. Minutes of meeting held with the supplier, supplie r, if any. any. 5. Purchase Order Copy 6. Any other relevant documents documents
6. Review (Inclusive of follow up action, if any):
DESIGN QUALIFICATION Page 7 of 24
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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 7. Recommendation:
8. Design Design qual qualific ificatio ation n signi signing ng off: 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) e quipment) (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. 1.0.
Checks Mate Materi rial al of Cons Constr truc ucti tion on
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 15.0
Manu Manual al overr override ide
Shoul Should d meet meet spec specifi ifica catio tion n Page 9 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 16.0 16.0
Hoot Hooter er
Shoul Should d meet meet spec specifi ifica catio tion n
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
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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER INSTALLATION INSTALLATION QUALIFICATION 1. Purpose: The The purpo purpose se of Insta Installa llatio tion n Quali Qualific ficati ation on is to estab establis lish h that that the the equip equipme ment nt and 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. 1.0. Loca Locati tion on Suit Suitab abil ilit ity y 1.1. Place of of In Installation ion
Acceptance Criteria As per pro prop posed la lay out / designated area
1.2. 1.2. Availa vailabi bilit lity y of of Uti Utilit litie ies s 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 1.5. Work orking ing sp space around the Steam Sterilizer
Page 11 11 of 24
Observations
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER INSTALLATION INSTALLATION QUALIFICATION Checks Acceptance Criteria 2.0. 2.0. Equi Equipm pmen entt Inst Instal alla lati tion on 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. 2.2. Verify erify erec erecti tion on main ain unit
2.3. Installa Installation tion of doors doors
2.4. 2.4. Inst Instal alla lati tion on of Pressure gauges 2.5. 2.5. Inst Instal alla lati tion on 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 Doors and gasket gasket should 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. Installa Installation tion of Pump Pump
Should Should be properly properly moun mounted ted and balanced as per approved drawing Engg. / Production / QA to certify the correct installation.
2 .7
As per approved drawing
Installa llatio tion 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 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.
Installa llatio tion of Steam Trap
Should be installed in chamber and jacket condensate line Engg. / Production / QA to certify the correct installation.
2.1 2.10
Ins Installa allati tion on of Strainer
Should be installed in chamber condensate and steam in jacket line Engg. / Production / QA to certify the correct installation.
2.1 2.11
Inst Instal alla lati tion on of Air Air vent filter
Should be installed in vacuum break line Engg. / Production / QA to certify the correct installation.
2.1 2.12
Ins Installa allati tion on of Venting valve val ve
Should be installed in bleeder line Engg. / Production / QA to certify the correct installation.
2.13 2.13
Inst Instal alla lati tion on of PL 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 INSTALLATION QUALIFICATION 2.14
Checks Strip Ch 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. 3.0. Util Utilit itie ies s Requ Requir ired ed 3.1. Electric Electrical al Supply Supply Should Should be 4 wires3 wires3 phase 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 INSTALLATION QUALIFICATION Checks Acceptance Criteria 4.0. Safety 4.1. 4.1. Hydr Hydrost ostati atic c Testin esting g of Hydrostatic test pressure Chamber, Jacket should be as per ASME 4 .2
4 .3
4.4 4.4 4.5 4.5
Safety locking of of doors through limit switches Safety valves chamber. Pressure regulating valves Emergency ency switch tch on on panel board Elec lectric trica al wir wirin ing g an and Earthing
5.0. 5.0. Gene Generral Check ecks 5.1. Grouting an and mounting of all components of Steam Sterilizer 5.2 5.2
Equip uipment sh should ould be properly balanced
5.3 5.3
All the metal parts rts should be properly grounded We lding of joints
5 .4
To be provided
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 INSTALLATION QUALIFICATION Page 15 of 24
Observations
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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 6. Any changes changes made against a gainst the formally f ormally agreed parameters :
7. Review ( Inclusive Inclusive of follow up action, if any ):
8. Recommendations:
9. Installation qualification qualifi cation 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
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QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER 2. Critical variables variables to be checked: checked: Checks Acceptance Criteria 1.0 1.0 Put Put ‘O ‘ON’ the the ma mains ins of of the the PLC display comes ‘ON’. panel box. (Ensure system is in Auto mode) 1 .1
2 .0 2.1 2.1
2 .2
Observations
Operate th e Steam PLC displays each Sterilizer as per parameter during entry and manufacturer manual / SOP. gives display and printout of all parameters. And Check for Functio tionin ning of all all pres ressure ure Should be satisfactory gaug gauges es and and temp temper erat atur ure e On Operation sensor Functioning of Pump Should be satisfactory On Operation.
2.3 2.3
Func Functi tion onin ing g of of all all pne pneu umati matic c Should be satisfactory valves On Operation.
2.4 2.4
Func Functi tio oning ning of of all all sole soleno noid id valves
Should be satisfactory On Operation.
2.5 2.5
Prog Progra ram mme the the cyc cycle le on the the PLC as per manual / SOP
PLC displays each parameter during entry and gives display and printout of all parameters.
2.6 2.6
Clo Close the the co compress ressed ed air air line valve Open the compressed air valve.
The PLC shows ‘Air pressure low’ The PLC displays Normal mode.
2.7 2.7
Run Run the the prog progra ram mmed HPHV cycle as per SOP.
The cycle is completed as programmed programmed (check printout pr intout and chart)
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 le leak te test in in co 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 programmed cycle. (Check print out)
2.10 2.10
Run Run all all prog progra ram mmed cyc cycles les Fast exhaust Slow exhaust Leak test
Cycles run as desired. (Check print out and chart)
• • •
3 .0 3 .1
Watch Dog cycle on PLC Start th the HPHV cycle Close the control valve on vacuum line during ‘INITIAL VACUUM ON’.
3 .2
Close the steam valve during ‘PREHEATING ‘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 ‘HEATING ON’
Buzzer sounds if the sterilisation temperature is not attained within 30 minutes.
3 .4
Skip fu 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 3.6
Carry rry out Leak Test cy cycle cle for 10 minutes.
Leak Test should pass over pressure not more than 1mm of Hg during 10 minutes hold.
3 .7
Run HP HPHV cy cycle ca carry ou out Heat distribution study during sterile hold with the help of temperature mapping device.
Temperature distribution di stribution throughout the chamber should be uniform.
3 .8
Run HP HPHV cycle an and ca 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 3.9
Carry rry out Heat distr istrib ibut utiion 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 Fu Functions Hydrostatic Te Test
Acceptance Criteria Should be as per design criteria
4 .2
Functioning of of door interlocking
Should be as per design criteria
4 .3
Functioning ing 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 changes made against a gainst the formally f ormally agreed parameters : Page 20 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
6. Review ( Inclusive of follow up action, 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 supposed to perform. Page 21 of 24
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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)
Acceptance Criteria All the cycles should complete as desired.
Observations
• • • •
•
2.0 2.0
Valida lidate te the the Ste Steri rili lise ser r as per Protocol
Ref. Protocol No. : The validation should be carried out successfully. successfully.
3.0 3.0
Record the fin find ding ing in in validation Report
Ref. Report No. :
Page 22 of 24
Cipla Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
3. References :
4. Any changes changes made against a gainst the formally f ormally agreed parameters :
5. Review ( Inclusive of follow up action, 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:________
