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)

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