Manufacturing / Monitoring

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.