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Manufacturing / Monitoring

GBA MDS - Qualification and monitoring of manufacturing and sterilization processes and packaging systems

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 (bioburden, endotoxins, particulates)
  • Water hygiene (bioburden, endotoxins, particulates, cytotoxicity, TOC)
  • 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)
  • Moist heat / Steam (ISO 17665)
  • Dry heat (ISO 20857)

Packaging systems, qualification (ISO 11607)

  • Packaging validation/proof of maintenance of the sterility assurance level: Integrity of the sterile barrier system (visual, microbial barrier testing, seal integrity) as well as accelerated ageing and mechanical treatment
  • 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.

Contact us

Are you seeking efficient, certain qualification and monitoring of your processes?

kontakt@mdservices.de

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