Overview
ABSTRACT
Read this article from a comprehensive knowledge base, updated and supplemented with articles reviewed by scientific committees.
Read the articleAUTHORS
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Delphine VERJAT-TRANNOY : Pharmacist, Pharmacie centrale des hôpitaux de Paris
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Cyril VADROT : Pharmacist, Pharmacie centrale des hôpitaux de Paris
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Corinne DANAN : French Food Safety Agency AFSSA
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Alain RACHON : European Aseptic Process Manager, Millipore SAS
INTRODUCTION
This dossier describes the various microbiological methods used in the preparation of sterile products such as injectable drugs and sterile, apyrogenic medical devices.
Whatever the method used to prepare sterile products, regulations require that sterility and, where applicable, apyrogenicity of products be verified during validation and, in some cases, during routine checks. Paragraph 1 describes the main principles of sterility control, pyrogen testing and endotoxin determination in products.
Most products are rendered sterile by terminal sterilization. Whatever the process, terminal sterilization must be microbiologically validated. Paragraph 2 describes the biological methods to be used for this validation (initial contamination and biological indicators), depending on the type of sterilization.
Finally, for products that need to be sterile but cannot withstand conventional sterilization, there are alternative techniques such as sterilizing filtration: paragraph 3 describes micro-organism retention tests designed to verify the effectiveness of the filters used.
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CAN BE ALSO FOUND IN:
Microbiology analysis
Routine biological controls applied to injectable drugs and sterile, non-pyrogenic medical devices
References
Paragraph 1
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