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.