Microbiology analysis - Sterile products

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.