BioPharma Applications

 

Introduction

bioMérieux Industry provides a wide range of solutions for microbiological control entirely dedicated to the pharmaceutical, cosmetic/personnal care and biotechnology industries. From the microbial monitoring of air and surfaces to automated identification, bioMérieux offers a full array of integrated solutions to provide efficient and reproducible microbiological results.

The bioMérieux pharmaceutical range includes:

  • Environmental control with ready-to-use irradiated culture media and air IDEAL® 3P.
  • Identification of microorganisms using the API® manual range or VITEK® 2 technology.
  • Sterility and in-process testing with Pharmacopoeia-compliant culture broth or using the BacT/ALERT® 3D Microbial Detection System.

bioMérieux solutions have been developed, validated and manufactured worldwide in ISO 9001 (v2000) facilities following our Corporate Design Control procedure. All facilities are compliant with the FDA Good Manufacturing Practices, cGMP 21 CFR Part 820. Development and Validation files are archived in our Design History Files, which are fully accessible upon audit request.

Each new product is validated following the stringent performance criteria expected by our customers and set by regulatory bodies such as:

  • the FDA,
  • the US, European and Japanese Pharmacopoeias, and
  • ISO Standards.