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 FO value and acceptance criteria of steam sterilizer
validation in pharmaceutical industry.
FO 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 atdifferent locations of the sterilizer chamber.
- Loaded chamber heat Distribution & penetration studies for each sterilization loadof fixed loading pattern
*๐๐จ๐ฐ๐ข๐-๐๐ข๐๐ค ๐๐๐ฌ๐ญ ๐๐จ๐ซ ๐ฌ๐ญ๐๐๐ฆ ๐ฉ๐๐ง๐๐ญ๐ซ๐๐ญ๐ข๐จ๐ง
๐๐๐ฃ๐๐๐ญ๐ข๐ฏ๐: 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.
๐๐ฆ๐ฉ๐ญ๐ฒ ๐๐ก๐๐ฆ๐๐๐ซ ๐๐๐๐ญ ๐๐ข๐ฌ๐ญ๐ซ๐ข๐๐ฎ๐ญ๐ข๐จ๐ง ๐๐ญ๐ฎ๐๐ข๐๐ฌ
๐๐๐ฃ๐๐๐ญ๐ข๐ฏ๐: The objective of this test is to ensure that, The sterilizer is capable of attaining a
temperature of 121 ยฐC during the sterilization hold period with the steam pressure.
Any location where the temperature indicator is placed, not achieving the minimum
sterilization temperature of 121ยฐC 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 ยฐC to 124 ยฐC during the
sterilization hold period.
*๐๐จ๐๐๐๐ ๐๐ก๐๐ฆ๐๐๐ซ ๐๐๐๐ญ ๐๐ข๐ฌ๐ญ๐ซ๐ข๐๐ฎ๐ญ๐ข๐จ๐ง & ๐๐๐ง๐๐ญ๐ซ๐๐ญ๐ข๐จ๐ง ๐๐ญ๐ฎ๐๐ข๐๐ฌ
๐๐๐ฃ๐๐๐ญ๐ข๐ฏ๐: 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
Any location where the temperature indicator is placed, not achieving the minimum
sterilization temperature of 121ยฐC during sterilization temperature hold period will
be considered as a cold spot.
