Sterility assurance level
The term sterilization confidence level (Engl. Sterility assurance level , so often short SAL ) is used mainly in the pharmaceutical manufacturing sterile application products and refers to the probability that a single product is still contaminated after the sterilization process.
meaning
The SAL value is also used to evaluate the sterilization process. A process with a low SAL value is very safe.
Legal requirements
According to the European Pharmacopoeia , the SAL value for parenterals should be a maximum of 10 −6 . This means that in the production of, for example, ampoules under a million, a maximum of one may be contaminated with a viable germ.
literature
- Mosley, Gregg (May 2008), Sterility Assurance Level (SAL) - The term and its definition continues to cause confusion in the industry (PDF; 2.0 MB) , PMF Newsletter (Pharmaceutical Microbiology Forum) 14 (5)