Biopharmaceutical Control

To ensure consumer and patient safety, the pharmaceutical and cosmetic industries comply with stringent regulations governing manufacturing and the production environment. We develop a wide range of tests to monitor the sterility of pharmaceutical products and their aseptic environment, and to identify microorganisms.

PHARMACEUTICAL AND COSMETIC PRODUCTS: COMPLYING WITH STRICT REGULATIONS

Strict regulations govern the production of pharmaceutical and cosmetic products. Our R&D teams design and develop innovative products that must comply with the current regulations from the European, American and Japanese Pharmacopoeias, as well as the relevant ISO standards.

In addition, the company’s R&D teams anticipate changes in regulations and incorporate them at an early stage of product development. To help industry meet proposed guidelines from the FDA concerning Process Analytical Technologies (PAT), bioMérieux’s R&D develops alternative, high performance microbiology methods:

  • BacT/ALERT® 3D for rapid and automated microbial detection
  • VITEK® 2 Compact for identification
  • DiversiLab™ for microbial genotyping

These are just some of the many solutions we bring to the biopharmaceutical industries.

INJECTABLE MEDICINES: MONITORING STERILITY

The sterility of medical products that are injected or enter into contact with sterile areas of the human body must be verified at numerous stages before commercialization. Tests are carried out on raw materials, during production, and on finished products. Our BacT/ALERT® 3D microbial detection system provides results in 2 to 5 days instead of the 14 days usually needed when using conventional methods. Innovative packaging for culture media that respect the Pharmacopoeia is another novel feature that we develop to enhance the safety and reproducibility of sterility testing.

IDENTIFICATION AND MICROBIAL GENOTYPING

In the field of microbial identification, we are have developed a rapid and fully automated system for the characterization of organisms isolated from pharmaceutical samples: the VITEK® 2 Compact platform, which offers improved accuracy and an expanded menu, was specially designed for the routine identification of environmental isolates* based on FDA recommendations.

DiversiLab™, our microbial genotyping system, provides characterization of isolates after identification. These products make it possible to track the spread and source of microbial contamination, thus meeting the standards of the European Pharmacopoeia and the FDA.

*Isolate: an isolated sample of a single type of bacteria.

NON-STERILE PHARMACEUTICAL PRODUCT TESTING

For non-sterile pharmaceutical products, microbiological controls are carried out according to the standards of performance described in the new texts from the European (EP5 Chap. 2.6.12/13), American (USP29 Chap. 61/62) and Japanese (JP15 Chap. 35.1/2) Pharmacopoeias.

ENVIRONMENTAL MONITORING

Programs for the environmental monitoring of clean areas are used for hygiene monitoring of surfaces, air and personnel. These monitoring programs aim at identifying possible routes of contamination in order to take corrective actions before contamination occurs. bioMérieux is regularly enhancing a broad range of tests to monitor surfaces, air and personnel. The 3P™ range of culture media was developed to allow storage at room temperature while guaranteeing high growth performance on a large range of environmental isolates.

The microbiological quality of air in critical environments can also be monitored with the air IDEAL® 3P™ air sampler, which was validated and certified ISO 14698 by an external expert laboratory.

MEETING SPECIAL MANUFACTURING NEEDS

bioMérieux experts can also respond to specific requests by developing tailor-made formulations, filling volumes and custom-designed packaging to meet our customers’ needs.

Pioneering diagnostics