To guarantee patient and consumer safety, biopharmaceutical and cosmetics companies must undergo extremely strict manufacturing and production environment inspections, in which diagnostic tests play a major part.
- Microbiological testing ensures that biopharmaceutical and cosmetic products are safe and meet the required quality standards:
- sterility tests for medical products such as injectables (vaccines, etc.) and biological products such as cell cultures (biotechnology),
- sterility tests for clean rooms used to manufacture sterile products,
- tests for medical products and what are known as "non-sterile" products (ointments, cosmetics, etc.).
- To ensure production safety, the entire production process must be checked regularly. Numerous microbiological tests are carried out: storage, raw materials, products during processing, finished products, production environment (water, air, surfaces, operators).
The role of diagnostics
- bioMérieux offers a wide range of innovative solutions to meet the needs of each of these extremely demanding sectors:
- environmental control,
- sterility testing,
- aseptic filling simulation (MFT: media fill test),
- culture media fertility testing,
- identification and typing of microorganisms,
- alternative methods for microbial detection.
- bioMérieux solutions are developed, validated and manufactured throughout the world at ISO 9001 certified sites and in accordance with GMPs (good manufacturing practices).
- Each new product is validated according to rigorous performance criteria, as per our customers' expectations, and defined by:
- European, Japanese and American pharmacopeias,
- ISO standards.