Installation Qualification of Sterilizing and Depyrogenation Tunnel (Protocol)

Installation Qualification of Sterilizing and Depyrogenation Tunnel is done to ensure that the Sterilizing and depyrogenating tunnel system received matches the Design specification and also to ensure that it is properly and safely installed.

Installation Qualification of Sterilizing and Depyrogenation Tunnel
Equipment Name:Steripack Sterilizing and Depyrogenation Tunnel
Equipment No.:EQI/XX/XXX/01
Protocol Reference No.
Report No.
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 Checklist
5.4Identification Of Major Components
5.5Verification of material of construction
5.6Identification Of Supporting Utilities
5.7Identification Of Control And Safety Devices
5.8Identification of Standard operating procedure (SOP)
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:

The signing of this approval page of the Protocol indicates agreement with the qualification approach described in this document. If a modification to the qualification approach becomes necessary, an addendum shall be prepared and approved. The protocol cannot be used for execution unless approved by the following authorities.

This Installation Qualification protocol of Sterilizing and Depyrogenation Tunnel. Has been reviewed and approved by the following persons:

Related: SOP for Operation and cleaning of Tunnel sterilizer

FUNCTIONNAMEDEPARTMENTSIGNATUREDATE
PREPARED BY QUALITY ASSURANCE  
REVIEWED BY PROJECT / 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 Sterilizing and depyrogenating tunnel and define the qualification requirements and acceptance criteria for the Sterilizing and depyrogenating tunnel. Successful completion of these qualification requirements will provide assurance that the Sterilizing and depyrogenating tunnel was installed as required in the Injection area.
2.2PURPOSE: 
 The purpose of this protocol is to establish documentary evidence to ensure that the Sterilizing and depyrogenating tunnel system received matches the Design specification and also to ensure that it is properly and safely installed. The Sterilizing and depyrogenating tunnel is used for sterilizing and depyrogenating of free-standing vials having a height of less than 100mm using the laminar air flow principle and the short-time sterilization method. The equipment shall operate under a dust-free environment and conditions as per the GMP requirements.
2.3SCOPE: 
 This Protocol is applicable to the installation of a Sterilizing and Depyrogenation Tunnel at the sterile injectable manufacturing facility in XYZ Pharmaceutical.
2.4RESPONSIBILITY: 
 Mention responsible person and Their Department.
2.5EXECUTION TEAM:
 The satisfactory installation of the Sterilizing and depyrogenating tunnel shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Sterilizing and depyrogenating tunnel is installed and is satisfactorily integrated. The execution team is responsible for the execution of the installation of the Sterilizing and depyrogenating tunnel. The execution team comprises of:
DEPARTMENTDESIGNATIONNAMESIGNATUREDATE
PROJECTS / ENGINEERING    
PRODUCTION    
QUALITY ASSURANCE    
3.0ACCEPTANCE CRITERIA:
3.1The Sterilizing and Depyrogenation Tunnel shall meet the system description given in the design qualification.
3.2The Sterilizing and depyrogenating tunnel shall meet with the acceptance criteria mentioned under the topic “Identification of major components”.
3.3Material of construction compiles with test certificate.
3.4The Sterilizing and depyrogenating tunnel system shall be operated by manual /PLC.
4.0REVALIDATION CRITERIA:
 The Sterilizing and depyrogenating tunnel has to be revalidated if:
 💡There are any major changes in system components which affect the performance of the system.
💡After major breakdown maintenance is carried out.
💡Shifting of the equipment from one location to another.
💡Any Major modification in the existing equipment/line.
💡As per the revalidation date and schedule.
5.0INSTALLATION QUALIFICATION PROCEDURE:
5.1SYSTEM DESCRIPTION:
  • Sterilizing and depyrogenating tunnel enables the integration of the process of sterilization and depyrogenation of washed empty vials for sterile, continuous automatic sterilizing in which all steps are performed under class 100 conditions.
  • The Tunnel is comprised of four zones, i.e. Drying zone, sterilizing zone, cooling zone, and Stabilizing zone.
  • Drying, cooling, and stabilizing zones are essentially once-pass-through Laminar flow units comprising as standard features, Pre-filters, motor blower assembly, and HEPA filters.
  • Extract and exhaust blowers are provided under the conveyor connected to the ambient using a common duct.
  • A stainless steel Wire Loop conveyor transfers vials through drying, sterilizing, cooling, and stabilizing zones under non-turbulent class 100 fresh air.
  • Container-controlled partition wall adjustment panels are provided at the entry and exit of the sterilizing zone.
  • In the Infeed area air taken from the room is prefiltered and aspirated by a blower through a HEPA filter. A laminar flow of air is sent vertically down onto the containers.
  • Containers passed in the drying zone they are preheated up to 90-110°C by the hot air bleeding out of the sterilizing zone. the air along with water vapor is picked up underneath of the conveyor belt by the extract blower and ejected to the outside.
  • Dried containers are moved over to the sterilizing zone. The sterilizing zone mainly comprises of resistance heating elements, HEPA filters, and temperature-regulating devices.
  • Hot filtered air is re-circulated in the sterilization zone, which sweeps the containers from top to bottom.
  • Differences exist in the hot air temperature and conveyor speed settings depending on the total mass of the glass required to be sterilized and cooled.
  • Equal pressure drop across the filter enables in creation of an extremely even distribution of air circulation.
  • This uniformly distributed hot air sterilizes and depyrogenates the containers. In the cooling and stabilization zones, containers are subjected to a Laminar flow of HEPA-filtered air taken from the room.
  • The airflow is profiled in such a way that the glass temperature as it excited the sterilizing zone would be transitioned at a nearly linear rate.
  • Stabilizing zone is used as a transition area separating the critical filling area and washing area.
  • Conveyor system is controlled by the container accumulation at the infeed and the set temperature for the conveyor starts.
  • SS wire Loop conveyor is driven by a gear motor with an AC frequency-controlled drive and tension roller for maintaining the correct tension of the conveyor belt.
  • Control and recording systems for the parameters governing the sterilizing process such as air temperature, belt speed, and holding time are standard features.
  • Sterilizing and depyrogenating tunnel is equipped and controlled with an Allen Bradley PLC and MMI (Man Machine Interface) which in conjunction with RTDs, Infeed / Outfeed Proximity switches, Dot Matrix printers, and Allen Bradley frequency converter (Variable speed drive) make the operations fully automatic.
  • Mode of operation enables to opt a) Auto mode b) Semi-auto mode c) Maintenance mode.
  • In the Auto mode, the operation of the tunnel is fully automatic. The tunnel starts and stops at a predetermined time. All blowers are running continuously except the sterilizing zone turbine, which cuts off when the temperature reaches 90°C.
  • Tunnel can be operated manually and automatically in Semi-auto mode.
  • In the Maintenance mode, all operations are being done manually.
5.2INSTRUCTION FOR FILLING THE CHECKLIST:
5.2.1 In 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
 Verify that the “As Built” drawing is complete and represents the design concept.   
 Verify that major components are securely anchored and shockproof.   
 Verify that there is no observable physical damage.   
 Verify that there is sufficient room provided for servicing.   
 All-access ports are examined and cleared of any debris.   
 Equipment identification nameplate visible.   
 Verify that all piping and electrical connections are done according to the drawings.   
 Safe electrical connections.   
 A wiring diagram affixed to the inside section of the control panel.   
 Units installed on the foundation are secure in place as per the manufacturer’s recommendations.   
 Check the dimensions: 3960 mm (L) X 1525mm (W) X 2340mm(H)   
5.4IDENTIFICATION OF MAJOR COMPONENTS:
Describe each critical component and check them and fill out the inspection checklist.
System componentsDesign SpecificationsComplies / does not complyChecked By (Sign.)Date
Equipment descriptionName: Steripak sterilizing and depyrogenating tunnel, Make: Teknopak, Model: V – 900 H2 C3, Output: 150 vials/minute of 5 ml to 30 ml vials.   
Drying zone
Use full conveyor width900 mm   
Effective drying zone length710 mm   
Pre-filter 5 micron.Size: 25” x 16” x 3”   
HEPA filterSize: 42” x 24” x 3”   
Magnehelic gaugeQty: One No.     
Range:  0-50 mm
   
Main motor3 Phage, 2.25 KW, 960 RPM, Make – Bharat Bijlee limited   
Sterilizing Zone
Effective dry zone length1220 mm   
HEPA filterSize: 42” x 18” x 6”   
Magnehelic gaugeQty: One No.
Range:  0-50 mm
   
Turbine Motor3 Phage, 3.75 KW, 2880 RPM, Make – Bharat Bijlee limited   
Cooling Zone
Effective dry zone length1015 mm   
Pre-filter 5 micron.Size: 49” x 16” x 2”   
HEPA filterSize: 42” x 24” x 3”   
Magnehelic gaugeQty: One No.
Range: 0-50 mm
   
3 Phage, 3.75 KW, 1440 RPM, Make – Bharat Bijlee Limited Qty: 03 Nos.3 Phage, 3.75 KW, 1440 RPM, Make – (Company Name) Qty: 03 Nos.   
Stabilizing Zone
Effective dry zone length1015 mm   
Pre-filter 5 microns.Size: 25” x 16” x 3”   
HEPA filterSize: 42” x 24” x 3”   
Magnehelic gaugeQty: One No., Range:  0-50 mm   
LAF blower motor1 Phage, 0.5 HP, 1440 RPM, Make – (Company Name) Qty: 04 Nos.   
Impeller210 x 85 single   
Reduction gear boxMake: Elecon
Type: 3 NU                  
Speed ratio: 70:1
   
5.5MATERIAL OF CONSTRUCTION:
Sr. No.ComponentMaterial of ConstructionMethod of verificationChecked BySign / Date
1HEPA Filter modules for drying, sterilizing, cooling and stabilizing zoneSS 304Visually with test certificate 
2HEPA Filter protective grills above the conveyorSS 304Visually with test certificate 
3Side panels covering the conveyor sides from grills to conveyorSS 304Visually with test certificate 
4Loop conveyorSS 304Visually with test certificate 
5External panels covering the base frame and hot zoneSS 304Visually with test certificate 
6Control panelSS 304Visually with test certificate 
7Tray below conveyorSS 304Visually with test certificate 
8DiaphragmSS 304Visually with test certificate 
5.6IDENTIFICATION OF SUPPORTING UTILITIES:
Sr. No.UTILITYPROPERLY IDENTIFIED & CONNECTED (YES/NO)CHECKED BY (SIGN)DATE
1.Electrical supply415 V, 3 Phase, 50Hz    
5.7IDENTIFICATION OF SAFETY DEVICES:
 Identify and record the safety features (if any) and their function in the following tables:
Sr.No.Safety Devices DescriptionSpecified functionIdentified by(Sign.)Date
1.Control Panel And Man Machine Inter FaceCheck the control panel and the man-machine interface is installed without any damage.  
2.Check the keyboardsThe keyboard should be as per the diagram.  
3.Check the electric circuit of the machineThe electric circuit should be as per the circuit diagram given in the manual.  
4.Check for the overload safety devicesThe electric circuit should be provided with a miniature circuit breaker.  
5.Check for Earth connectionEarth connection should be provided.  
5.8IDENTIFICATION OF STANDARD OPERATING PROCEDURE (SOP)
The following Standard Operating Procedures were identified as important for the effective performance of the Steripack Sterilizing and Depyrogenation Tunnel. 
1.Operation and cleaning of Steripack Sterilizing and depyrogenating Tunnel.
2.Preventive maintenance of Steripack Sterilizing and depyrogenating Tunnel.
5.9IDENTIFICATION OF COMPONENT TO BE CALIBRATED:
Sr.No.Name of the InstrumentLocationSpecificationIdentified by (sign)Date
1.Magnahelic gaugeDrying zone0 – 50 mm of WC  
2.Magnahelic gaugeSterilization zone0 – 50 mm of WC  
3.Magnahelic gaugeCooling zone0 – 50 mm of WC  
4.Magnahelic gaugeStabilization zone0 – 50 mm of WC  
5.10VERIFICATION 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.
QA – Quality Assurance
M.O.C – Material of construction
SS – Stainless Steel
RPM – Revolutions per minute
SOP – Standard Operating Procedure
HOD – Head Of Department
PLC – Programmable Logic Controller
MMI – Man Machine Interface
SDT – Sterilizing and depyrogenating tunnel 
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:
 
 
 
 
 
 
 

5.13 Annexure(s):

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 conclusion for approval of the installation qualification report.
6.1SUMMARY
 
 
 
 
 
 
 
6.2CONCLUSION
 
 
 
 
 
 

6.3 FINAL REPORT APPROVAL

It has been confirmed that all tests required by the Sterilizing and Depyrogenating Tunnel protocol have been completed, reconciled, and attached to this protocol or included in the qualification summary report. It has been confirmed 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 for the Sterilizing and Depyrogenating Tunnel 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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