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VALIDATION OF DRY HEAT STERILIZATION METHODS


5.2   Heat distribution
Test objective

To evaluate the heating characteristics of the tunnel, carrier system, and sterilization medium employed under loaded conditions

Test method

Distribution thermocouples shall be located in each run as described in IQ empty tunnel heat distribution runs.

All distribution runs shall be performed, monitored, and documented in accordance with the respective sterilizer operating procedure.

SOP No. Val. 700.20            Effective date: mm/dd/yyyy

Approved by:

Acceptance criteria
All distribution runs must meet the parameter requirements of the corre­sponding specification and established production sterilization cycle.

5.3   Heat penetration
Test objective

To evaluate the heating characteristics of items within the tunnel when subjected to the sterilization medium

To evaluate the relative heating characteristics of items and refer­ence thermocouples where applicable

To establish production work order sterilization parameters

Test method
Heat penetration runs may be conducted in conjunction with required heat distribution runs.

Thermocouple or temperature sensor probes shall be placed within the penetration test containers in accordance with established written container preparation procedures. Test containers may be trays, pans, commodities, etc., depending upon the testing required.

Thermocouple and temperature sensor probe placement within the containers shall be documented.

Where applicable, thermocouple placement shall be in the con­tainer cold zone, as determined from generated container map­ping studies.

Each heat penetration run shall include thermocouple temperature sensor probe containers distributed throughout the tunnel, per planned and traceable location diagram.

The number of heat penetration test containers per run shall agree with that required for heat distribution thermocouples.

If previous empty tunnel heat distribution test runs have identified hot or cold zones, at least one of the penetration test containers must be placed in each of these zones per run.

The heat penetration sample containers shall be loaded into the tunnel carrier in an orientation consistent with planned production run loading and the corresponding container heat mapping study loading method.

Acceptance criteria
All heat penetration data collected during each run must meet the requirements for the corresponding specification.

The production operating ranges and windows established from the heat penetration runs must assure all products in the test runs will meet the calculated requirements for the corresponding spec­ification. If a satisfactory operating range is not established using minimum and maximum loading parameters, intermediate loading conditions must be tested.

Where tunnel peak dwell temperature and time are to be used for routine production cycle control, or as back-up control, correlation of sterilizer peak dwell time and temperature with the hottest and coldest profile container must be shown for each run, where applicable.

SOP No. Val. 700.20            Effective date: mm/dd/yyyy

Approved by:

5.4   Componentry microbial or pyrogen challenges
Test objective
To confirm the biological relationship between parametrically determined process lethalities, by demonstrating the ability of the sterilizer to effec­tively reduce the challenge material to an acceptable level

Test method
1.   Componentry microbial challenges

The number of challenge containers, preparation methods, spore crop type, and inoculation levels described in the appropriate documentation shall be followed in the production of test items for each run.
Heat penetration test containers of corresponding container size and type and fill volume shall be placed adjacent to the challenge test items in each run.
At least one set of microbial challenge or penetration test containers shall be placed in the sterilizer cold zone per run (where applicable).
Test container placement shall be defined per planned and traceable location diagrams.
Maximum sterilizer loading configurations shall be used when conducting challenge test runs.
The corresponding production cycle time and temperature con­trol parameters that deliver subminimal specification conditions shall be utilized when conducting the challenge runs.
If absolute minimum time and minimal temperature parameters are not used during the componentry challenge runs, manufac­turing order parameter limits must reflect the parameters used during these runs.

2.   Componentry pyrogen challenges
The number of challenge containers, preparation methods, endotoxin identification, and inoculation levels described in the appropriate documentation shall be followed in the production of test items for each run.
Heat penetration test containers of corresponding container size and type and fill volume shall be placed adjacent to the challenge test items in each run.
At least one set of pyrogen challenge or penetration test containers shall be placed in the sterilizer cold zone per run where applicable.
Test container placement shall be defined per planned and traceable location diagrams.
Maximum sterilizer loading configuration shall be used when conducting challenge test runs in allother sterilizers.
The corresponding production cycle time and temperature con­trol parameters that deliver sub minimal specification conditions shall be utilized when conducting the challenge runs.
Acceptance criteria
A minimum microbial challenge spore log reduction of equal to or greater than six must beshown for each run.
A minimum pyrogen challenge must be equal to or greater than three log reductions for each run.
At least 15% ofthe required functional container time and temper­ature values must show subminimal process conditions, per run.
Coldzone temperature correction must be used where applicable.

5.5   Support documentation
The following documents shall be included in each operational qualification certification package, as applicable:
Sterilizer operating procedure
Current sterilizer utilization list
Copies of the specifications used during the OQ function test runs
Copies of all penetration distribution and challenge thermocouple placement diagrams

SOP No. Val. 700.20            Effective date: mm/dd/yyyy

Approved by:

Description of the bulking items used, whereapplicable

Copies of allmicrobial challenge protocols, which should include identification ofthe types, crop numbers, and D values for the biological indicators used

Copies of all pyrogen challenge protocols, which should include materials used, lot number, sensitivity, and inoculation levels

Key test and equipment instrumentation pre- and post calibration status supporting each function

Test data summaries
The temperature data collected during each operational qualification run shall be summarized so that the following information, as applicable, can be readily determined for each run:
Sterilizer heat-up time
Duration of sterilizer peak dwell
Minimum and maximum sterilizer temperatures during peak dwell
Sterilizer cool-down time
Commodity or component heat-up time
Peak dwell residence time or carrier speed
Minimum and maximum item temperature during peak dwell

Process Engineering Change Qualification
Modifications to sterilizer equipment systems shall be accompanied by initiation and completion of a formal engineering change request and authorization documentation package. Plant engineering, manufacturing and quality assurance shall be responsible for determining whether a change impacts the certified functions of the sterilizer.

Frequency
Initial validation: three times
Revalidation: twice per year

Reasons for Revision
Effective date: mm/dd/yy
First time issued for your company, affiliates, and contract manu­facturers.
[Althea Mcleary;]

REFERENCE
1.    Agalloco James, Carleton Frederick J, “Validation Of Pharmaceutical Process” 3rd Edition, Published By Informa healthcare, New York, Page No.223-225
2.    Sharma P.P. “Practice GMPs A Guide For cGMP Compliance” 5th Edition 2006 Published By Vandana Publication Pvt. Ltd. Delhi. Page No.286-288
3.    Hugo And Russell’s Pharmaceutical microbiology” 7th Edition, Published By Blackwell Sciences, Page No.355-356, 366-370
4.    Nash Robert A, Wachter Alfred H, Pharmaceutical Process Validation” Volume 129, 3rd Edition Published By Marcel Dekker, New York, Page No. 102-110
5.    Sharma P.P, Validation In Pharmaceutical Industry, 1st Edition 2007, Published By Vandna Publication Pvt. Ltd, Delhi Page No. 303-309.

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