The profile Sterilization Indicators
and biological indicators
The form of a biological indicator
Assured Sterility Level
Validation of Sterilization Process
Common Sterilization Methods
A sterilization method commonly used in the pharmaceutical industry
Use of biological indicators
Spore counting Sterilization indicators and biological indicators
Sterilization indicators and biological indicators sterilization refer to the method of using appropriate physical or chemical means to kill or remove live microorganisms in an article, thereby reducing the probability of survival of live microorganisms to the desired level of aseptic assurance.
Biological indicator is a kind of special living microbial products, which can be used to confirm the performance of sterilization equipment, the verification of sterilization procedures, the monitoring of sterilization effect in the production process, etc. Biological indicators used in sterilization verification are generally bacterial spores. The form of a biological indicator
A certain number of spores are attached to the inert carrier, such as filter paper strips, glass slides, stainless steel, plastic products, etc.
The spore suspension was sealed in the ampoule. Assured Sterility Level
The sterility of an item can only be expressed relative to the probability of living microorganisms in the item falling to an acceptable level, the SAL(Sterility Assurance Level).
Pharmacopoeias Europe and the United States require that Sal should not be greater than one part per million as the sterility guarantee of the final sterilized product, that is, Sal ≤10-6