Pioneering diagnostics

Pharmacy, cosmetics and biotechnology

Diagnostic tests make it possible to check biopharmaceutical and cosmetic products to ensure compliance with stringent regulations.
 

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.

The challenge

  • 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.