Confirmation at the highest level: our processes and packages are validated and meet the highest standards.
We subject our certified systems and ambient conditions, as well as all cleaning and production processes, to a continuous validation procedure.
PRODUCT HYGIENE AND STERILITY
- Process-level validation, ISO 11737-1, ISO 10993, bioburden/endotoxin test
- Final product validation, USP 23 “85”, cytotoxicity, GC/MS,TOC, XPS, etc.
- Low-dose method, ISO 11137, AAMI-TIR 27, bioburden/sterility tests
- VDmax method, EN 552, EN 556
Ethylene oxide sterilization
- Half-cycle method, EN 550, EN 1422, bioburden/sterility tests
- EO/ECH residue determination, ISO 10993-7, extraction, GC/ID analysis
PACKAGING, PRODUCT PROTECTION AND STERILITY MAINTENANCE
- Test for high sterility, ISO 11607, EN 868-1, dye/internal pressure tests
- Test for transport simulation, ASTM D3078/F1929, ISTA, peel/bursting pressure, E. coli stress
Food storage validation
- Test for stress, ISO 11607, EN 868-1, dye/internal pressure tests
- Test for accelerated/real-time aging, ISTA, ASTM F-1 980, E. coli stress