Pioneering diagnostics

Biopharmaceuticals & cosmetics sectors

Diagnostic tests make it possible to test biopharmaceuticals and cosmetics to ensure compliance with strict regulations. bioMérieux provides solutions designed to meet the needs of these industries.  

The challenge

To guarantee the safety of patients and consumers, biopharmaceutical and cosmetic companies undergo extremely strict manufacturing and production environment inspections, in which diagnostic tests play a major role.

Microbiological testing ensures that biopharmaceutical and cosmetic products are safe and comply with quality standards:

  • sterility tests for medicines such as injectables (vaccines, for example) and biologics such as cell cultures;
  • sterility monitoring of the production environment in clean rooms where sterile products are manufactured;
  • tests for medicines and so-called "non-sterile" products (ointments and cosmetics).

To ensure production safety, several microbiological control tests are carried out across the entire production chain: storage, raw materials, products during processing, finished products and the 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 the following sectors:
    • environmental control of aseptic production: surfaces, air, machines, operators (COUNT-TACT® 3PTM, AIR IDEAL® TRACEABILITY, QUANTISWAB® ranges);
    • sterility tests for injectable pharmaceutical products or biological tissues, such as for grafts (CHEMUNEX, BACT/ALERT® 3D DIUAL-T, MEDIA FILL TEST 3PTM ranges and pre-poured media);
    • aseptic filling simulation (MFT),
    • culture media fertility testing,
    • identification and typing for investigation and corrective action if microorganisms are detected (API®, VITEK® 2 COMPACT, VITEK® MS ranges);
    • alternative methods for microbial detection.

bioMérieux’s solutions are developed, validated and manufactured throughout the world at ISO 9001-certified production sites.

Each new product is validated using strict performance criteria to satisfy our customers’ expectations and to comply with European, Japanese and American pharmacopeias and ISO standards.