Know what's inside:
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 / 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.