Qualification and monitoring of manufacturing and sterilization

Qualification and monitoring of manufacturing and sterilization processes and packaging systems

We provide testing, qualification, monitoring and evaluation services for

Manufacturing processes, qualification and monitoring (ISO 14971, ISO 13485)

  • Product hygiene / water hygiene (bioburden, endotoxins, particulates)
  • Production conditions / cleanroom (air-borne contamination, surface bacterial contamination)
  • Cleanliness after pre-cleaning, final cleaning and/or clean production (bioburden, endotoxins, particulates, toxic contamination / chemical residues)

Sterilization processes, microbiological performance qualification (ISO 14937)

  • Ethylene oxide (ISO 11135) incl. residual¬†analysis (ISO 10993-7)
  • Radiation (ISO 11137)
  • Steam (ISO 17665)
  • Dry heat (ISO 20857)

Packaging systems, qualification (ISO 11607)

  • Package integrity, accelerated ageing and mechanical¬†treatment
  • Microbial barrier testing, seal integrity, material qualification
  • Toxic properties

Are you seeking efficient, certain qualification and monitoring of your processes?
We provide support in defining test parameters and sampling strategies.

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