Microbiological Analysis – Medical Devices

  • Determination of the bioburden of a medical device in accordance with NF EN ISO 11737-1
  • Sterility test in accordance with NF EN ISO 11737-2
  • Sterility test in accordance with pharmacopoeias
  • Determination of bacterial endotoxins in accordance with NF EN ISO 11737-3 and/or pharmacopoeias
  • Determination and/or justification of a dose for sterilization by irradiation in accordance with NF EN ISO 11137-. 2
  • Quarterly dose audit for radiation sterilization according to NF EN ISO 11137-2
  • Microbial identification
  • Antibiotic dosing
  • Verification of biological indicator population
  • Revelation of biological indicators (sterility test)
  • Incubation and counting of environmental microbiological samples in cleanroom (air, surface, water, compressed gases)
  • Microbiological quality of purified and/or injectable process water
  • Antimicrobial efficacy

Any other test, please contact us.

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