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Bioburden Testing

Bioburden testing is a regulatory requirement for investigational new drug submissions and is critical for process development of biologics and medical devices. It can provide an accurate basis for calculating effective sterilisation doses for a given therapeutic and will provide the quantity of viable microorganisms in or on a therapeutic, medical device or raw material before sterilisation.

Bioburden testing is applicable for:

  • Bulk Lot Release Testing
  • Final Product Release Testing
  • Raw Material Testing
  • Medical Devices

Contact an expert about your bioburden testing needs.

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