Autoclave is used for sterilization of various articles in sterile manufacturing.
Autoclave validation including
steam penetration, heat distribution and penetration, bio-challenge study, estimation of F0 value and acceptance criteria of steam sterilizer validation in pharmaceutical industry.
F0 value is used to determine the exposure time of material for sterilization at a particular temperature.
Sterilization process in the pharmaceutical industry in an autoclave will be considered qualified for consistent and reliable performance (validated) on successful completion of the following tests -
- Vaccum Leak test
- Bowie-Dick Test for steam penetration.
- Empty Chamber Heat distribution studies with temperature mapping probe at different locations of the sterilizer chamber.
- Loaded chamber heat Distribution & penetration studies for each sterilization load of fixed loading pattern
A) Bowie-Dick test for Steam Penetration
Objective
The objective of this test is to ensure that the vacuum pulses applied the sterilization hold period are sufficient to remove the entrapped air to
facilitate rapid and sufficient steam penetration into all parts of the load and maintaining these conditions for the specified temperature holding time.
Acceptance Criteria
If air is available , The indicator will show different color as compared to the color on the remaining part of the test paper,
B) Empty Chamber Heat Distribution Studies
Objective
The objective of this test is to ensure that, The sterilizer is capable of attaining a temperature of 121 °C during the sterilization hold period with the steam pressure .
Any location where the temperature indicator is placed, not achieving the minimum sterilization temperature of 121°C throughout the sterilization temperature hold will be considered as a cold spot.
Acceptance Criteria
There should be the uniform distribution of heat in the sterilizer chamber during the sterilization hold period and the temperature at each temperature mapping probes should be within the range of 121 °C to 124 °C during the sterilization hold period.
C) Loaded Chamber Heat Distribution & Penetration Studies
Objective
The objective of this test is to ensure that, the steam is sufficiently penetrating into the innermost portions of the load subjected for sterilization to achieve the desired temperature of 121 °C during the complete sterilization hold period with the steam pressure
Acceptance Criteria
If Sterilization temperature (121 °C) is not achieved throughout the cycle, load configuration or size of the load has to be reviewed and cycle to be repeated.
Any location where the temperature indicator is placed, not achieving the minimum sterilization temperature of 121°C during sterilization temperature hold period will be considered as a cold spot.
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