References Autoclaves Defined Types of Autoclaves Cycle Types Validation Lethality and Sterility Assurance Level Revalidation Safety.
Procedure for 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. To qualify these tests the equipment should fulfill the acceptance criteria described in the individual test procedures.
After completion of the qualification tests all the data generated will be compiled together to evaluate ability of the steam sterilizer to sterilize different components at the set parameters and set loading pattern.
Objective of this test is to ensure that the vacuum pulses applied the sterilization hold period are sufficient to remove the entrapped air so as to facilitate rapid and even steam penetration into all parts of the load and maintaining these conditions for the specified temperature holding time (17 minutes at 121 deg.
Autoclave Maximum Registering Thermometers are for validating autoclaves by monitoring the highest temperature attained during a sterilization cycle.
These thermometers operate on the same principle as thermometers designed to measure fevers: the highest temperature attained is recorded, and doesn’t recede until the thermometer is shaken down.