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
*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.
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.
*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
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.