KEYBIO - Microbiological Risk Management
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Consulting - Audits - Training

Stratégic support

KEYBIO also goes well beyond testing processes by establishing partnerships with its clients using a global approach to microbiological risk control that includes three core offers:

  • Consulting:
    Twenty years of experience in microbiology as well as KEYBIO’s extensive contribution in the COFRAC and AFNOR activities (CEN and ISO standards) have given KEYBIO significant expertise on the demands and expectations of industry partners and the ability to anticipate and satisfy the needs of a constantly changing sector.

    > Areas of expertise

    • Proposal of specific and relevant methods to solve problems encountered.
    • Implementation of self-testing plans.
    • Assistance in choosing disinfectants and implementation of cleaning and disinfection plans.
    • Explanation of methods and results.
    • Contaminant detection and implementation of corrective actions.
    • Regulatory watch.
    • Development of biocide, cosmetic, and medical device applications (microbiology section).
    • Expertise in evaluating applications.
    • Assistance in designing a microbiology laboratory.
    • Implementation of quality management systems.
    • Implementation of the HACCP system (microbiology risk).
  • Audits:
    An audit is an independent and objective assessment that provides a company with an assessment of operations control and recommendations to add value.

    > Areas of expertise

    • Microbiological risk assessment in manufacturing units.
    • Microbiology laboratory quality management according to BPF and NF EN 17025 standards.
    • Skills assessment and ongoing training for personnel involved in microbiological quality control.
    • Cleaning and disinfection of facilities and equipment.
  • Training:
    KEYBIO Laboratory is an approved training organization N° 93 13 0457713 that offers customized training sessions in a special facility designed for hands-on training. The trainings are organized around three major themes: Quality Management/BPF, General Microbiology, and Test Practices.

    > Areas of expertise

    • Quality Management/BPF
      • NF EN ISO / CEI 17025 standards.
      • Good Manufacturing Practices in drug testing.
      • Good Laboratory Practices in microbiology.
      • Microbiological risk control.
      • Qualification and ongoing training for microbiology technicians.
      • Sterile medical devices:
        validation of sterilization and microbiological tests.
    • General microbiology
      • Microbiological quality control.
      • Foundations of microbiology in industry.
      • Disinfectants and their use in disinfecting facilities and equipment.
      • Contamination prevention for staff and hygiene rules.
      • Microbial strain management.
      • Foundations of microorganism identification.
    • Test practices
      • Assessment of antimicrobial efficacy of antiseptics and disinfectants.
      • Sterility tests for sterile products.
      • Microbiological testing for non-sterile products.
      • Validation of analytic methods for pharmaceutical products.
      • Cosmetic microbiological testing.
      • Efficacy assessment of preservatives according to Pharmacopeia reference standards.
      • Assessment of antimicrobial protection for cosmetic formulations following NF T 75-611 standards.