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Apart from the physical measurements we carry out during the performance qualification, we can also provide a direct proof required by several guidelines that the SAL (Sterility Assurance Level) aimed for/required has been reached which enables a correlation to be evaluated between the microbiological kill rate and the predicted microbiological kill rate derived from the temperature loading.
“Bioindicators are to be used to monitor steam sterilization. The sterilization process should be designed to ensure an adequate kill rate. Proof must be provided that a safety level of 10-6 or better has been achieved, using a biological indicator as per ISO 11138-3.
The number and position of the bioindicators introduced should match the number of temperature sensors used. We collaborate with DAkkS certified testing laboratories in evaluating the bioindicators introduced during the PQ tests.
(EU-GMP Annex 1 and Ph.Eur.) (FDA Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products) (EN ISO 17665-1:2006 (D))
(EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 15: Qualification and Validation)
(5.1.5 European Pharmacopeia)
We would be glad to advise you about the micrological testing of your steam sterilization processes we can offer.
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