AUTOCLAVE VALIDATION (VERTICAL)

 VALIDATION OF VERTICAL AUTOCLAVE EQUIPMENT ID – ------

 

PROTOCOL CONTENTS

S. No.	Description	Page No.
1.0	Protocol approval	3
2.0	Overview	4
2.1	Objective	4
2.2	Purpose	4
2.3	Scope	4
3.0	Responsibility and Validation team	4
4.0	Training	5
5.0	Equipment/System description	5
6.0	Validation Procedures	6
6.1	Flow charts	6
6.2	Validation Matrix	7
6.3	Pre – validation test requirements	7
6.4	Verification of Calibration of gauges	8
6.5	Empty Chamber Heat Distribution Studies	8
6.6	Loaded Chamber Heat Penetration Studies	10
6.7	Developmental Approach	15
7.0	Discrepancy and corrective action report	14
8.0	References	14
9.0	Summary	14
10.0	Conclusions	15
11.0	Attachment	15
12.0	Revalidation Criteria	15
13.0	Revision History	16

1.0                        PROTOCOL APPROVAL

Signing of this approval page of protocol indicates agreement with the qualification approach described in this document. If any modification in the equipment qualification approach becomes necessary, a revision through change control shall be prepared, checked and approved. This protocol cannot be executed unless approved by following personnel.
Department	Name	Designation	Signature /Date
Prepared by
Microbiology
Quality Assurance
Reviewed by
HOD-Engineering
HOD-Production
HOD-Microbiology
Quality Assurance
Authorised by
HOD – QA

 

2.0                        Overview

The Vertical autoclave is used to decontaminate the media containing petri-plates, bottles, sterility canisters and the media test tubes before media discard.

2.1                        Objective

This protocol is designed to establish sufficient data, to assure that the Vertical Autoclave (QCVAC-01) is suitable for decontaminating the defined load patterns when operated in accordance with the established standard operating procedure as per SOP.

2.2                        Purpose

The purpose of this protocol is to help the operating personnel to plan the validation activities so as to demonstrate that the vertical autoclave operates consistently to decontaminate the media and there are no remaining microbes alive in the media (which is to be discarded).

2.3                        Scope

This Performance Qualification Protocol is applicable for the Laboratory Vertical Autoclave (QCVAC-01) installed in Microbiology section at ----------

3.0                        Responsibilities and validation team

Responsibilities: The group comprising of representatives from each of the following departments and they shall be responsible for the overall compliance with this protocol.

Department	Responsibility
Engineering & Utility	Arranging for execution and recording of the following activities
	·         Calibration of gauges and instruments ·         Periodic calibration of data logger during validation ·         Review of protocol and report ·         Coordination with validation activities and maintaining records.
Microbiology	·     Execution and collection of data. ·     Participate and provide the necessary support for the validation. ·     Carryout the analysis of the Biological indicators. ·     Review of Protocol by department HOD/ In charge
Out side contractor	·   Participate and Provide necessary support for the validation activity   (as applicable).
Quality Assurance	·   Verifying the compliance of existing procedures to the outcome of validation. ·   Preparation, Review of protocol and report. ·   Provide training to concern personnel on the execution of validation activities. ·   HOD is responsible for final approval of protocol and report.

 

4.0                        Training

The validation team member shall be trained on the protocol execution of validation activity and report compilation. The training record shall be attached.( format No.QAGN006/F08)

5.0                        Equipment Description

5.1                        Equipment Detail:

Equipment Name	Vertical Autoclave
Make	Equitron
Serial Number	7431FA.14B
Equipment ID	QCVAC-01
Location	Microbiology Lab

5.1.1                  Vertical Autoclave is used for the Decontamination of used materials in microbiology area.

5.1.2                  Vertical Autoclave is Vertical cylindrical vessel, it can be operated in auto mode and having the jacketed chamber with one round lid. As per defined load pattern, objects, which are to be decontaminated, should be loaded vertically.            

5.2                        Working Principle

5.2.1                  The steam is prepared by pouring purified water into the autoclave upto the Heater cover X stand inside. This prepares steam at 121ºC.              

5.2.2                  This cycle is controlled by a Microprocessor which controls the heating coil when the temperature goes above set temperature range.

5.2.3                  The Vertical autoclave has one temperature sensor which controls the functioning.

6.0                        Validation Test Procedures

6.1                        Flow Chart

 

6.2   Validation Matrix

6.2.1     Frequency of periodic monitoring is 1Year ± 30Days

6.2.2     The following test matrix is prepared for the Periodic Monitoring  and Periodic Monitoring  of Autoclave cum Bung Processor.

Sr. No.	Test Description	Periodic Monitoring
		Performance Qualification	Revalidation
		No. of Cycle	No. of Cycle
	Developmental Run*	1	1
	Empty chamber Heat Distribution Study	3	1
	Loaded Chamber Heat Penetration Study
	a)      Petriplate and Bottle Load	3	1
	b)      Test Tube and Bottle Load	3	1

           

* Incase of new load introduction one developmental run shall be taken.

Note: - Any Change in Load pattern/process/items three consecutive run are required successful validation.

6.3                        Pre-validation test requirements:

6.3.1                  Following instruments shall be required for the validation of Vertical autoclave used in the Microbiology Area.

·         Calibrated data loggers

·         Calibrated Temperature mapping probes.

·         Geobacillus stearothermophillus i.e. Biological Indicator Strips/Ampoules

6.3.2                  The Decontamination autoclave shall be qualified after verification of the documented evidence (obtained as per the methods outlined in this protocol) assuring that the equipment is meeting the desired performance attributes consistently.

6.3.3                  The following pre-validation tests shall be performed:

S. No.	Description of Activity	Frequency
1.	Verification of calibration status of various Instruments associated with Decontamination Autoclave.	Before start of the Validation  activity.
2.	Verification of calibration status of data Logger & sensors	Before start of the Validation   activity.

6.4                        Verification of calibration of gauges and Instruments:

6.4.1                  It is necessary to verify and ensure the Calibration status of Gauges and instruments, before carrying out validation tests.

Instrument	Range	I.D. No.	Location	Calibrated Date	Next Due Date
Pressure Gauge	2.1 Kg/cm²; 0 – 30 psi	QCVPG-01	Lid of Autoclave
Temperature Controller	0 – 150 ºC	QCVTC-01	With HMI
Temperature Sensor	0 – 150 ºC	QCVTS-01	With HMI
Data logger
Data logger & Sensors in loop				Pre- Calibration	Post- Calibration

6.4.2                  Testing and measuring instruments related to equipment shall be verified, recorded in the report for the verification of their calibration status.

6.5                        Empty Chamber Heat Distribution Studies

6.5.1                  Objective

6.5.1.1            The Autoclave is capable of attaining a temperature of 121.1°C during the decontamination hold period of 30 minutes.

6.5.1.2            Analyze the temperature profile and identify the cold spot.

6.5.2                  Procedure

6.5.2.1            Set the temperature of 122°C for 30 minutes decontamination cycle.

6.5.2.2            Prepare at least 06 Nos. calibrated temperature mapping probe with location and channel tag.

6.5.2.3            Pass 06 No. temperature mapping probe into chamber through the validation port of the Autoclave.  Seal the port with silicone sealant so that steam leakage does not take place.  Suspend the probes in the chamber in different position as per the drawing no. 1 and ensure that probes do not touch any metallic surface.

6.5.2.4            Connect the probes to a suitable data logger, which can scan and print the actual temperature observed at different locations with respect to time.

6.5.2.5            Operate the Vertical Autoclave as per SOP No. QC-SP-340.

6.5.2.6            The decontamination hold time for an empty chamber shall be 30 minutes.

6.5.2.7            Start the data logger to record actual temperatures within the decontamination chamber with respect to time at a scan time of NMT 15 sec interval.

6.5.2.8            After completion of cycle connect the data logger to the computer system and download the data and calculate Fo value of each temperature mapping location.

6.5.2.9            Compile the data generated during the qualification test for a complete evaluation of the system.

6.5.2.10        Prepare summary and conclusion of the performance qualification test, which will be finally approved by Head - Quality Assurance.

6.5.3                  Acceptance Criteria

6.5.3.1            The temperature at each temperature mapping probe should be within the range of 121.1°C to 124°C during the decontamination hold period of 30 min.

6.5.3.2            The minimum Fo should be 30 min (based on process lethality during the decontamination cycle).

6.5.3.3            The pressure during decontamination hold period should be 1.1 - 1.2 Kg/cm².Observation and Result

6.5.3.4            d

6.6                        Loaded Chamber Heat Penetration Studies

6.6.1                  Objective

6.6.1.1            The Autoclave is capable of attaining a temperature of 121.1°C within the defined loads during the decontamination hold period of 30 minutes.

6.6.1.2            Find out the cold spot if any.

6.6.2                  Load Description

Sr. No.	Load Description	Material	Quantity (Maximum Load)
1	Petri plate and bottle Load (Media Load- 1)	Petriplate	Full Autoclavable bag (80 nos.)
		Bottles	05 Nos.
		Spreader	10 Nos.
		10 ml Test tubes (Small)	1 Stand (40 nos)
		Tips	1 Box (50 tips)
		Sterility Canisters	10 Box
2	Test Tubes and bottle load (Media Load- 2)	100 ml Test Tubes (Large)	2 Full Stand (20 nos. Each)
		Bottles	05 Nos.
		Spreader	10 Nos.
		10 ml Test Tubes (Small)	1 Stand (40 nos)
		Tips	1 box (50 tips each)
		Sterility Canisters	10

6.6.3                  Procedure

6.6.3.1            Set the temperature of 122°C for 30 minutes decontamination cycle.

6.6.3.2            Prepare at least 06 Nos. calibrated temperature mapping probe with location tag.

6.6.3.3            Load the chamber Pass 06 No. temperature mapping probe into chamber through the validation port of the Autoclave.  Seal the port with silicone sealant so that steam leakage does not take place.  Suspend the probes in the chamber in different position as per the photographic representation and ensure that probes do not touch any metallic surface.

6.6.3.4            Connect the probes to a suitable data logger, which can scan and print the actual temperature with respect to time.

6.6.3.5            Attach the Biological Indicators to each probe as per the drawing no. 2

6.6.3.6            Operate the Vertical Autoclave as per SOP No. QC-SP-340.

6.6.3.7            The decontamination hold time for loaded chamber heat penetration shall be 30 minutes.

6.6.3.8            Start the data logger to record actual temperatures within the decontamination chamber with respect to time at a scan time of NMT 15 sec interval.

6.6.3.9            After completion of cycle connect the data logger to computer system and download the data and calculate Fo value of each temperature mapping location.

6.6.3.10        Compile the data generated during the qualification test for complete evaluation of the system.

6.6.3.11        Prepare summary and conclusion of the performance qualification test, which will be finally approved by Head - Quality Assurance.

6.6.4                  Acceptance Criteria

6.6.4.1            The temperature at each temperature mapping probe inside the load should be within the range of 121.1°C to 124°C during the decontamination hold period of 30 min.

6.6.4.2            The minimum Fo should be 30 min (based on process lethality during the decontamination cycle).

6.6.4.3            No growth should observe in exposed biological indicators after incubation at specified temperature and duration. The positive control should show growth after incubation.

6.6.4.4            The pressure during decontamination hold period should be between 1.1 - 1.2 Kg/cm².

6.6.4.5            Record the observations and results in the enclosed Annexure - II.

6.6.5                  Photographic Representation Location of temperature sensor and biological indicator

6.6.5.1            Petriplate and bottle load

External Sensor 

Biological Indicator Strip

6.6.6                  Justification for the probe location

Sr.No	Load Description	Probe No	Probe Location	Justification
01	Empty Cycle	01	Lower frame left side	Inside Chamber to monitor temperature profile at Lower frame left side
		02	Lower frame right side	Inside Chamber to monitor temperature profile at Lower frame right side
		03	Middle of chamber	Inside Chamber to monitor temperature profile at Middle of chamber
		04	Middle of chamber	Inside Chamber to monitor temperature profile at Middle of chamber
		05	Upper frame in the middle	Inside Chamber to monitor temperature profile at Upper frame in the middle
		06	Inside chamber with  external  probe	Inside Chamber to monitor temperature profile at Inside chamber with  external  probe
02	Petriplate and  bottle load (Media Load- 1)	01	Lower frame inside the Petriplates	Inside the load to monitor temperature profile at Lower frame inside the Petriplates
		02	Upper frame inside the Bottle	Inside the load to monitor temperature profile at Upper frame inside the Bottle
		03	Upper frame near the Spreader	Inside the load to monitor temperature profile at Upper frame near the Spreader
		04	Upper frame inside Test tube	Inside the load to monitor temperature profile at Upper frame near the Spreader
		05	Upper frame inside Sterility canisters	Inside the load to monitor temperature profile at Upper frame inside Sterility canisters
		06	Inside Chamber with external probe	Inside Chamber With RTDs to monitor temperature profile at Inside Chamber with external probe
03	Test tubes  and  bottle load (Media Load- 2)	01	Upper frame inside the  Large Test tubes	Inside the load to monitor temperature profile at Upper frame inside the  Large Test tubes
		02	Upper frame inside the bottle	Inside the load to monitor temperature profile at Upper frame inside the bottle
		03	Upper frame inside Spreader	Inside the load to monitor temperature profile at Upper frame inside Spreader
		04	Lower frame inside the small test tubes	Inside the load to monitor temperature profile at Lower frame inside the small test tubes
		05	Lower frame Inside Sterility Canister	Inside the load to monitor temperature profile at Lower frame Inside Sterility Canister
		06	Inside Chamber with external probe	Inside Chamber With RTDs to monitor temperature profile at Inside Chamber with external probe

 

 

6.7                        Developmental Approach Study

6.7.1                  Developmental studies shall be carried out for assessing the parameters at different set parameters and time intervals to achieve the predefined objective/approach.

6.7.2                  The developmental study to be continued up to achieving of the defined goal,

6.7.3                  After achieving the defined goal the cycle shall be repeated 3 times to validate the defined parameters or changes in load or process.

6.7.4                  The complete details of the developmental study shall be recorded in Annexure - III

7.0                        Discrepancy and corrective Action Report

Any discrepancies observed during the validation of the equipment shall be justified in the summary report. Corrective actions of the same shall also be included. For resolving the discrepancy an action plan shall be developed.

8.0                        References

SOP on operation, Calibration, Cleaning and Maintenance of Vertical autoclave.

9.0                        Summary

The validation report shall include a summary of validation activities describing the following in brief

9.1                        Protocol reference

9.2                        Dates of validation activities

9.3                        Confirmation of calibration and preventive maintenance status of instruments, probes and Vertical Autoclave.

9.4                        Heat Distribution Study

9.5                        Heat Penetration Study

9.6                        Brief on result obtained

9.7                        Log reduction of Biological Indicators

10.0                    Conclusion

The validation report shall include statement for conclusion of the validation activity based on result and observation from the validation activity.

11.0                    Attachment

The following are the attachments which shall be used for collecting and evaluating the raw data.

Sr. No	Test data sheet	Title	Pages
1	Annexure – I	Empty Chamber Heat Distribution	5 Pages
2	Annexure – II	Loaded Chamber Heat Penetration	6 Pages
3	Annexure – III	Developmental Approach Study	5 Pages

12.0                    Revalidation Criteria

Revalidation criteria is as follows

·         If any major changes or modification in the system.

·         If any Major changes have been done in the respective room or module, which is affecting the environmental condition.

·         If there is a contamination problem.

·         At the time of relocation or Re-qualification.

·         At an yearly frequency as per schedule.

13.0                    Revision History

Document No.	Effective Date	Nature of Change/ Reason for Revision
PRT/VL/VAC/01/00	20-07-2013	1        New Protocol
PRT/VL/VAC/01/01	22-07-2014	1        Removal of typographical error 2        Introduction of validation Matrix 3        Addition of the Developmental Approach Study 4        Explanation of Procedure i.e. a)   Changes of the decontamination set temperature from  1220C to 121.1 and b)   Replacement of the word decontamination with decontamination.