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Installation Qualification of Steam Sterilizer cum Bung Processor (Protocol)

The purpose of the Installation Qualification of Steam Sterilizer cum Bung Processor protocol is to establish documentary evidence to ensure that it received matches the Design specification and also to ensure that it is properly and safely installed.

💡Related Topics: Area Qualification Protocol in Pharmaceuticals

Installation Qualification of Steam Sterilizer cum Bung Processor

Protocol Contents for Steam Sterilizer cum Bung Processor IQ:

SERIAL NO.ITEM DESCRIPTION
1.0PROTOCOL APPROVAL
2.0OVERVIEW:
2.1Objective
2.2Purpose
2.3Scope
2.4Responsibility
2.5Execution Team
3.0ACCEPTANCE CRITERIA
4.0REVALIDATION CRITERIA
5.0INSTALLATION QUALIFICATION PROCEDURE
5.1System Description
5.2Instruction for Filling the Checklist
5.3Installation Check-List
5.4Identification Of Major Components
5.5Verification of material of construction
5.6Identification of Supporting Utilities.
5.7Identification Of Safety Feature(s)
5.8Identification of standard operating procedure
5.9Identification Of Component to be Calibrated
5.10Verification of Drawings and Documents
5.11Abbreviations
5.12Deficiency And Corrective Action(s) Report(s)
5.13Annexure(s)
6.0INSTALLATION QUALIFICATION FINAL REPORT
6.1Summary
6.2Conclusion
6.3Final report approval
1.0PROTOCOL APPROVAL:

When signing this approval Protocol, it shows that you agree with the qualification approach described in this document. If a modification to the qualification approach is necessary, it shall be prepared and approved as an addendum. The protocol cannot be used for execution unless the following authorities approve it.

This Installation Qualification protocol for Steam Sterilizer cum bung processor has been reviewed and approved by the following persons:

FUNCTIONNAMEDEPARTMENTSIGNATUREDATE
PREPARED BY QUALITY ASSURANCE  
REVIEWED BY PROJECTS / ENGINEERING  
REVIEWED BY PRODUCTION  
APPROVED BY QUALITY ASSURANCE  
2.0OVERVIEW:
2.1OBJECTIVE: 
 The objective of developing and executing this protocol is to collect sufficient data pertaining to the Steam Sterilizer cum bung processor and define the qualification requirements and acceptance criteria for the unit. Successful completion of these qualification requirements will provide assurance that the Steam Sterilizer cum bung processor was installed as required in the manufacturing area.
2.2PURPOSE: 
 The purpose of this protocol is to establish documentary evidence to ensure that the Steam Sterilizer cum bung processor received matches the Design specification and also to ensure that it is properly and safely installed.
2.3SCOPE: 
 This Protocol is applicable to the installation of a Steam Sterilizer cum bung processor at the tablet manufacturing facility in XYZ Pharmaceutical & the subsequent documentation.
2.4RESPONSIBILITY: 
 The following shall be responsible; Quality Assurance officer / Executive – For preparation of protocol / Execution  Projects / Engineering Head – For execution  Production Head – For execution support Quality Assurance Head – For adequacy and final approval.
2.5EXECUTION TEAM:
 The satisfactory installation of the Steam Sterilizer cum bung processor shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Steam Sterilizer cum bung processor is installed and is satisfactorily integrated. The execution team is responsible for the execution of the installation of the Steam Sterilizer cum bung processor. The execution team comprises of:
DEPARTMENTDESIGNATIONNAMESIGNATUREDATE
PROJECTS / ENGINEERING    
PRODUCTION    
QUALITY ASSURANCE    
3.0ACCEPTANCE CRITERIA:
3.1The equipment shall fulfill all the selection criteria and its individual application.
3.2The equipment shall comply with the specification mentioned in the user requirement specification.
3.3It shall be complying with all the designed specifications.
3.4The Material Of Construction (MOC) shall comply with the specification.
3.5All supporting electric and non-electric utilities of specified capacities are to be near the place of installation.
4.0REVALIDATION CRITERIA:
 The machine has to be revalidated if:
 💡 There are any major changes in system components, that affect the performance of the system.
💡 After major breakdown maintenance is carried out.
💡 As per the revalidation date and schedule.
5.0INSTALLATION QUALIFICATION PROCEDURE:
5.1SYSTEM DESCRIPTION:

The Principle of Steam Sterilizer cum bung processor is designed for steam sterilization of various types of dry goods products such as machine parts, garments, rubber stoppers, media fills, components and pressure vessels, etc.

Sterilizer is designed for moist heat sterilization by using pure steam. Sterilizer designed by completely PLC operated with manual override in case of emergency. PLC is equipped with different cycles as per the requirements of the material i.e. for sterilization of garments, sterilization of empty glass flasks, rubber stoppers, machine parts, media for process simulation, and components the system description is divided into the following sections:

General, Technical summary along with Mechanical Construction, Design and Manufacturing Process, Control System, Cycle Operation, Documentation, Maintenance and recommended spare parts, Troubleshooting, etc.

The action of steam sterilizer on all the materials placed within the chamber is that the steam penetrates into the microorganisms present on and within the material thereby transferring the latent steam, which in turn will coagulate with the proteins, imparting a lethal effect on the organism, which will lead to the destruction of the organism.  

The steam sterilizer is made up of an SS sheet which is welded with a U-profile SS jacket. The sterilization chamber is provided with two vertical sliding doors which are also made up of SS reinforced with MS support structure. The door is operated with the help of pneumatic cylinders. When both door reaches at the end position the gaskets are pushed out automatically with the help of compressed air ejectors. When the gaskets retract the sterilizer chamber door slides automatically. The door sealing is made effective with the help of a tubular silicon rubber gasket. To ensure proper sealing the gaskets are activated with compressed air and retracted with the help of vacuum.

The sterilization chamber is insulated with resin-bonded glass wool, which helps in reducing the heat loss to the environment and ensures uniform distribution of temperature inside the chamber. This insulation is cladded with SS cover plate.

To ensure a leak-tight partition between the Sterile area (Class A unloading side) and the loading side an SS flush panel is provided on the partition wall and the outer cover of the steam sterilizer. All the joints, crevices are filled with silicon sealant to prevent leakages. The autoclave holds the vacuum with a rate of NMT 13 mbar per 10 minutes. All the automatic valves are closed when the autoclave chamber is at the ambient pressure. During the vacuum cycle except the vacuum valve, all other valves are closed.

The sterilizing grade filter is placed in a class A environment and connected to a chamber for the purpose of vacuum break. The filter is suitable for integrity testing and steam sterilization. Both the vertical sliding doors have an interlocking system in which the door does not open simultaneously. The doors do not open in any case during sterilization. The steam sterilizer has the ability to stand with a maximum of 3.0 kg /cm2 pressure. The steam sterilizer has a safety valve, which will blow off if 0.5 kg/cm2 exceeds than the working pressure. The system has an emergency stop so as to stop all the physical movement and operation of the machinery immediately, which is located along with the control panel.

5.2INSTRUCTION FOR FILLING THE CHECKLIST
5.2.1In case of compliance of the test use the word ‘Complies’ otherwise use ‘Does not comply‘ to indicate non-compliance.
5.2.2For identification of the components of the equipment and utilities use the word ‘’yes’’ to show its presence and use ‘No’ to indicate the absence of the identity
5.2.3Give detailed information in the summary and conclusion part of the Installation Qualification report.
5.2.4Whichever column is blank or not used ‘NA’ shall be used.
5.3INSTALLATION CHECKLIST:
 The installation checklist is as follows:
Sr. NO.STATEMENTYES / NOCHECKED BY (SIGN)DATE
01Safety valve for chamber   
02Safety valve for jacket   
03Air pressure regulator   
04Gasket air pressure regulator   
05Air pressure switch   
06Gasket vacuum switch   
07Vacuum valve   
08Pure steam supply   
09Sealing water for vacuum pump   
10Compressed air supply   
11Header outlet (Drain connection)   
12Chamber vacuum line   
13Validation probe   
14 WFI (Distilled water)   
15Purified water   
16Detergent Solution   
17Silicon solution   
18Air heater nozzle & piping connection   
19Electric power supply   
20Electric connection between power & Control panel etc.   
21Pneumatic instruments tubing   
22Pneumatic connection leakages   
23Duct flanges bolted connections   
24System interlock functioning   
 a) Emergency   
 b) Air pressure low   
 c) Power failure   
 d) Door open temperature not reached   
 e) Sterile or non-sterile door open   
 f) Control temperature sensor faulty   
 i) Final vacuum problem   
 g) Door Between   
 h) Initial vacuum problem   
 j) Preheating temperature problem   
 k) Pressure release problem   
 l) Vacuum release problem   
 m) Gasket release problem   
 n) Sterile temperature problem   
 o) Chamber pressure high   
 p) Water level problem   
25Properly Mounted and Supported   
26Properly labeled and identified   
5.4IDENTIFICATION OF MAJOR COMPONENTS:
 Describe each critical component and check them and fill out the inspection checklist.
System ComponentsDesign SpecificationComplies / Does Not ComplyChecked By(Sign)Date
1) Validation gland adaptorSize – 2” Triclover   
No of holes – 8 nos.   
Gland – Silicon   
Gland diameter – 6MM   
MOC – SS 316L   
Make – Pharmalab   
Qty – 02   
Location 1 – At the left side of chamber   
Location 2 – At the right side of chamber   
2) Sampling valve Size – 25 MM   
MOC – SS 316L   
Diaphragm – Silicon   
Operation – Manual   
Make – Pharmalab   
Qty – 01   
Location – Chamber condensate line   
3) Safety valveSize – ¾” BSP female   
MOC – SS 316L   
Make – Shakti   
 Range – 0 – 43 PSI   
 Type – Spring loaded   
Qty – 02   
Location 1 – on the chamber   
Location 2 – on the jacket   
4) Compound pressure gaugeDial size – 4”   
Range – -1 to 3.5 kg/cm2   
Make – Waree   
Mounting – Panel mounting   
End connection – 3/8” BSP   
MOC – Body: SS304Movement: SS304Burden socket: SS316L   
Type – Analogue   
Qty – 02   
Location 1 – on front facia at sterile side   
Location 2 – on front facia at non-sterile side   
5) Compound pressure gaugeDial size – 2 – ½”   
Range – -1 to 3.5 kg/cm2   
Make – Warre   
Mounting – Panel mounting   
End connection – ¼” BSP   
 MOC – Body: SS304 Movement: SS304 Burdon socket:SS316L   
Type – Analogue   
Qty – 02   
Location 1 – On front facia at non-sterile side   
Location 2 – On front facia at non-sterile side   
6) 2 Way pneumatic valveMake – Micro pneumatics   
Model – 2 way, 3 p/c   
MOC of working parts- SS 316L   
MOC of the body – SS 316   
Type–ball valve with full bore   
Size – ½”   
Seal – P.T.F.E   
Actuator – single acting (spring return)   
Operation – pneumatically operated   
Solenoid valve – 24 V AC   
Qty – 08   
Location 1 – At the venting line   
Location 2 – At the vacuum break line   
Location 3 – At the side drain line   
Location 4 – At the side drain bypass line   
Location 5 – At the air agitation line   
Location 6 – At the side spray line   
Location 7 – At the silicon line   
Location 8 – At the detergent line   
7) 2 Way pneumatic valveMake – Micro pneumatics   
Model – 2 way, 3 p/c   
MOC of working parts- SS 316L   
MOC of the body – SS 316   
Type–ball valve with full bore   
Size – 1”   
Seal – P.T.F.E   
Actuator – single-acting   
(spring return)   
Operation – pneumatically operated   
Solenoid valve – 24 V AC   
Qty – 10   
 Location 1 – Steam inlet to chamber   
Location 2 – Steam inlet to jacket   
Location 3 – At the chamber condensate line   
Location 4 – At the chamber vacuum line   
Location 5 – At the steam agitation line   
Location 6 – At the drain line   
Location 7 – At the main drain line   
Location 8 – At the water recirculation line   
Location 9 – At the D.M. water inlet line   
Location 10 – At the distilled water inlet line   
8) Pressure gaugeDial size – 4”   
Range – 0 to 4.2 kg/cm2   
Make – Warre   
Mounting – Panel mounting   
End connection – 3/8” BSP   
MOC – Body: SS3304Movement: SS304Burden socket: SS316L   
Type – Analogue   
Qty – 02   
 Location 1 – Panel mount at the sterile side   
Location 2 – Panel mount at the non-sterile side   
9) Air pressure switchMake – Orion   
Model – MGH07CB10   
Range – 0.5 to 7 kg/cm2   
Diff. pressure – 0.4 kg/cm2   
MOC – Brass   
Diaphragm – Teflon   
Qty – 01   
Location – On the outlet of the air pressure regulator   
10) Air vacuum switchMake – Orion   
Model – MNV00CB11   
Range –100 to 750mm of hg   
Diff. pressure – 100 mm of hg   
MOC – Brass   
Diaphragm – Teflon   
Qty – 02   
Location 1 – Door -1 gasket vacuum line   
Location 2 – Door – 2 gasket vacuum line   
11) Jacket pressure switchMake – Orion   
Model – MAH03CS10   
Range – 0.2 to 2.6 kg/cm2   
Diff. pressure – 0.2 to 1.5 kg/cm2   
Test pressure – 12 kg/cm2   
End connection – ¼” BSP female   
Qty – 01   
Location – On the jacket   
12) Float-type steam trapSize – 15NB   
Model – FT-14CI-10   
Make – Spirax   
Type – Balanced pressure thermostatic trap   
Max. Working pressure – 13 kg/cm2   
Max working temperature – 120c   
MOC – body: C.I.Cover: C.I. Valve seat: SS 410   
Qty – 02   
Location 1 – chamber condensate line   
Location 2 – jacket condensate line   
13) Pressure transmitterMake – Keller   
Model – 23 R   
MOC – SS 316L   
Range – -1 to 3 kg/cm2   
Mounting – direct mounting   
Output – 4 to 20 mA   
Qty – 01   
Location – On the chamber   
14) Vacuum pumpMake – Vindivac   
Model – RTZ, 3HP   
RPM – 2850   
Vacuum capacity – 710 mm of hg   
Flow rate – 50 M3 /hr   
Qty – 01   
Location – Service floor   
15) Vent filter with housingHousing model – ZLK9010G23H4   
Model – SLK7002PFRP   
Rating – 0.2 micron   
Make – Pall   
 Filter length – 5”   
Medium – PTFE   
MOC – SS316L   
Housing gasket – Silicon   
Qty – 01   
Location – at the sterile side in the vacuum break line   
16) Air pressure regulatorMake – Festo / SMC   
Model – ¼”   
Size – ¼” mm   
Qty – 01   
Location – Main airline   
17) Gasket air pressure regulatorModel – ¼”   
Make – Festo / SMC   
Size – ¼”   
Qty – 01   
Location – air gasket sealing line   
18) Non return valveMake – VB   
Size – 25mm   
MOC – SS316L   
Qty – 01   
Location – at the chamber vacuum line   
19) Needle valveMake – shakti   
 Size – ½” BSP female   
MOC – SS316L   
Qty – 01   
Location – at the chamber condensate bypass line   
20) Ball valveSize – 3/8”   
Model – 3 piece   
MOC – SS316L   
Qty – 02   
Location 1 – at the jacket condensate bypass line   
Location 2 – at the side of the chamber for sampling   
21) Temperature sensorMake – techno   
Class – A   
MOC – SS316L   
Seath size – 4.5 mm   
Length of seath – 55mm   
Range – 0degree – 200 degree   
Type – PT 100   
Element – Dual   
Qty – 05   
Connection – Triclover   
Location 1 – at the chamber condensate line   
Location 2 – at the left side of the chamber – top   
Location 3 – at the left side of the chamber – bottom   
Location 4 – at the right side of the chamber – top   
Location 5 – at the right side of the chamber – bottom   
22) StrainerMake – Shakti / karan   
MOC – SS304   
Size – ½” BSP female   
Qty – 02   
Location 01 – at the chamber condensate line   
Location 02 – at the jacket condensate line   
23) Solenoid valveSize – ¼” BSPF   
Make – SMC / Aira   
Volt – 24V AC   
MOC – Brass   
Qty – 05   
Location 1 – at the inlet of the vacuum pump   
Location 2 at the door – 1 gasket seal line   
 Location 3 – at the door –2 gasket seal line   
Location 4 – at the door – 1 gasket vacuum line   
Location 5 – at the door – 2 gasket vacuum line   
24) Door limit switchModel – JLSL – 2   
Make – Jay Balaji   
Contact – 1 NO + 1 NC   
Qty – 04   
Location 1 – at the sterile side door open the position   
Location 2 – at the sterile side door close the position   
Location 3 – at the non-sterile side door open position   
Location 4 – at the non-sterile side door close the position   
25) Door safety switchModel – JLSPBA   
Make – Jay Balaji   
Contact – 1 NO + 1 NC   
Qty – 04   
Location 1 – on the sterile side door   
Location 2 – on the sterile side door   
Location 3 – on non-side door   
Location 4 – on the non-sterile side door   
26) PrinterModel – LX 300   
Make – Epson   
Type – Dot matrix   
Qty – 01   
Location – at the bottom box of the control panel   
27) Chart recorderModel – 4102M   
Type  – 6 points strip chart recorder   
Input – channel –1pressure 0 to 10mv   
Channel–2 Temperature, PT-100   
Channel–3 Temperature, PT-100   
Channel–4 Temperature, PT-100   
Channel–5 Temperature, PT-100   
Channel–6 Temperature, PT-100   
Make – Eurotherm   
Qty – 01   
Location – on the paneling of non-sterile side   
28) Air agitation regulator with gaugeModel – ½”   
 Make – Festo / SMC   
Size – ½”   
Qty – 01   
Location – air agitation line   
29) Float switchType – magnetic   
Temp. range – 150 deg. C   
MOC – SS316L   
Make – Mahalakshmi/ crystal /punetectrol   
Qty – 01   
Location – at the side of the chamber   
30) Circulation water pumpModel – CHI-2-50   
Make – Grundfos   
MOC – SS316L   
Gasket – EPDM   
Qty – 01   
Location – recirculation water line   
31) Recirculation filter with housingFilter size – 40 microns   
Type – Wire mesh   
Filter length – 10” (INCH)   
Gasket – silicon   
Water flow rate – 2.5 to 3 CMH   
Make–Tec fill   
Housing MOC – SS316L   
Qty – 01   
Location – recirculation water line   
32) Drum motorType – Geared motor flange mounted   
HP – 0.75   
RPM – 16   
Service factor – 2.1   
Shaft diameter –  44 MM   
Frame size – NZ 3 90 L 8   
Make – Remi   
Qty – 01   
Location – on the chamber   
33) Dosing pumpModel – HC-100-04-05   
Type – Metering   
Diaphragm – Electronics   
Flow rate – 4LPH@ 5 Bar Pressure   
Make – AQUA   
Qty – 02   
Location 1 – at the inlet of the silicon line   
Location 2 – at the inlet of the detergent line   
34) Control panelModel – automatic with manual operation facility in case of PLC failure   
Enclosure – SS 304,1.6 mm thick with polycarbonate cover on MMI   
Panel location – 2 meters away from the machine   
Size in mm – approx 400 D X 1500 H   
PID controller – Model: MC5438 / P48UMake : Max-thermo / Radix   
PLC – Mitsubishi   
MMI – Beijer   
Temperature transmitter – Range: 0 to 200 deg CMake: RadixQty: 05 nos.   
Transformer – Bhatt Magnetic / Narmada   
3 pole rotary switch – sulzer   
Overload relay – L&T   
 ELCB + MCB – Hagger / Datar   
Signal distributor – Radix   
Contactor – L& T   
MCB – 3 Pole – Hagger / Indfoss / Datar   
6-channel relay module – Phonix / Brisk   
D.C. source – Meanwell   
2 way 4 pole switch – Sulzer   
Sr. No.ComponentMaterial of ConstructionMethod of verificationChecked By Sign / Date
1.Chamber 6mm Thick plateSS 316 LVisually with test certificate  
2.Jacket shell 10SWG sheetSS 316 LVisually with test certificate  
3.Door 14 mm thick plateSS 316 LVisually with test certificate  
4.10 x10 mm SQ. Bar for jacketSS 316 LVisually with test certificate  
5.Chamber 1” DIA RODSS 316 LVisually with test certificate  
6.Baffel plate 16 SWG sheetSS 316 LVisually with test certificate  
7.25 mm OD x 2 mm thick plateSS 316 LVisually with test certificate  
8.6 mm OD x 1 mm thick pipeSS 316 LVisually with test certificate      
9.¾” OD 16 SWG WT pipeSS 316 LVisually with test certificate  
10.Ø12.7 mm x 1 mm WT pipeSS 316 LVisually with test certificate  
5.6IDENTIFICATION OF SUPPORTING UTILITIES:
UTILITYPROPERLY IDENTIFIED & CONNECTED (YES/NO)CHECKED BY (SIGN)DATE
1) Electricity: Specification: 415 V, 3 Ph. 50 Hz Requirement: 5 KW   
2) Pure steam supply Specification:  3 kg/cm² pressure dry and saturated pure steam Consumption:  = 120 kg / Hr.   
3) Compressed Air Supply Specification: Dry, clean, and Filtered at 8 kg/cm² minimum pressure Requirement: 8 CFM   
5.7IDENTIFICATION OF SAFETY FEATURES:
 Identify and record the safety features (if any) and their function in the following tables:
Safety Features DescriptionFunctionIdentified By (Sign)Date
1) Door SafetyIn case of door open  
2) Emergency off, if activated stops the processFor Equipment & Operator Safety  
3) Control temperature sensor faultyProcess will stop  
4) Chamber safety against overpressure of the steamThe safety valve will open at 2.2 kg/cm2 pressure. PLC will cut off the steam supply control valve when the steam pressure in the chamber reaches at 2.2 kg/cm2 and the venting valve will get open to release the chamber pressure.  
5) Jacket safety against overpressure of the steamSafety valve open at 2.2 kg/cm2 pressure Jacket pressure switch  
5.8IDENTIFICATION OF STANDARD OPERATING PROCEDURE (SOP):
The following Standard Operating Procedures were identified as important for the effective performance of the Steam sterilizer cum bung processor. 
1 Operation and cleaning of Steam sterilizer cum bung processor
2Preventive maintenance of Steam sterilizer cum bung processor
5.9IDENTIFICATION OF COMPONENT TO BE CALIBRATED
1. Pressure gauge
2. Temperature sensors
3. Temperature transmitter

5.10
VERIFICATION OF DRAWING AND DOCUMENTS:
 The following documents are reviewed and attached as listed below:
Sr. No.DRAWING AND DOCUMENT DETAILCHECKED BY (SIGN)DATE
    
    
    
    
    
    
5.11ABBREVIATIONS:
 Following Abbreviations are used in the installation qualification protocol of Steam sterilizer cum bung processor.
P & I: Piping and instrumentation
PLC: Programmable logic controller
S.S: Stainless steel
SSB: Steam sterilizer cum bung processor    
5.12DEFICIENCY AND CORRECTIVE ACTION (S) REPORT (S):
The following deficiency was identified and corrective actions were taken in consultation with the validation team.
Description of deficiency:      
 
 
 
 
 
 
 
Corrective action(s) taken:
 
 
 
 
 
 
 

 Reviewed By:

 Date:

5.13ANNEXURES
 Following Annexures are used in the installation qualification protocol of Steam sterilizer cum bung processor.
Sr.No.Annexure No.Title of Annexure
   
   
   
6.0INSTALLATION QUALIFICATION FINAL REPORT:
All the IQ data sheets and discrepancy reports shall be reviewed by the validation team to prepare a summary report. The summary of IQ shall be used to draw a conclusion for approval of the installation qualification report.
6.1SUMMARY
 
 
 
 
 
 
 
6.2CONCLUSION
 
 
 
 
 
 
 

6.3 FINAL REPORT APPROVAL

All tests required by this protocol have been verified as completed, reconciled, and attached to this protocol or included in the qualification summary report. It has been verified that all amendments and discrepancies are documented, approved, and attached to this protocol.

The signature in the block below indicates that all items in this qualification report of Steam sterilizer cum bung processor have been reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily resolved.

NAMEDESIGNATIONDEPARTMENTSIGNATUREDATE
  PROJECTS / ENGINEERING  
  PRODUCTION  
  QUALITY ASSURANCE  
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