Microbiology

• Bioburden

  • Bacteria and yeasts / moulds
  • Identification of microorganisms
  • Validation of bioburden estimation

• Environmental monitoring

  • Establishment of a hygienic program including sampling plan
  • Sampling
  • Particle count
  • Microbial count of air
  • Microbial count of surfaces, personal
  • Identification of microorganisms

• Examination of production water

  • Microbial count
  • Specific microorganisms
  • Endotoxins

• Pyrogenicity / endotoxins

  • LAL test (gel clot, turbidimetric technique)
  • Pyrogen test (partnered service)
  • Monocyte activation assay
  • Validation of depyrogenation with dry heat using endotoxins

• Test for sterility

  • Within validation of sterilization process
  • As batch release test (facultatively)

• Identification of microorganims

  • Macroscopically and microscopically examination
  • Biochemical determination (API)
  • Molecular biological determination (partnered service)

• Evaluation of bioindicators

  • Providing of all types of bioindicators (produced by a partner)
  • Evaluation of quality (test for microbial count and identity)
  • Evaluation after application of the sterilization process (qualitative, quantitative)

• Sterilisation processes

  • Ethylene oxide, irraditation, moist heat, dry heat etc.
  • Performance qualification using bioindicators (EtO, moist heat etc.) or testing bioburden, sterility (irradiation)

• Test for antimicrobial efficacy

  • Antimicrobial preservative testing
  • Proliferation assay (antimicrobial efficacy of coated surfaces)
  • Antibiotics assay
  • Test for growth inhibition on agar plates or in media (standardized or tailor-made studies)

• Evaluation of reusables for the applied cleaning,disinfection and sterilization procedure

  • Manual cleaning and / or disinfection
  • Automatic cleaning and / or disinfection
  • Sterilization (moist heat, ethylene oxide, plasma)
  • Microbiological and biochemical methods