SteriPack Contract Manufacturing offers a variety of functional testing services with custom made testing jigs & equipment, dimensional testing and microbiological testing including bioburden, sterility and endotoxin testing to assure compliance of product safety.
SteriPack covers a wide range of testing at ISO 17025 accredited Laboratory assisting with the demands for product and material testing requirements.
Accredited microbiological laboratory testing fields:
- Bioburden ISO 11737-1
- Sterility ISO 11737-2
- Endotoxin Ph.Eur./ USP
- Purified water Ph.Eur
- Environmental/ clean room testing ISO 14644, ISO 14698 (air, surfaces, personnel)
Quality laboratory testing to meet quality requirements for medical devices:
- Dimensional control by 2D optical microscopes and measuring devices
- 3D Dimensional control by CMM coordinate measuring machine
- 3D external and internal dimensional control by CT scanner X-ray computed tomography
- Sterile Barrier testing according to 11607-1, 2 (peel off, dye penetration, seal strength, bubble leak, vacuum, accelerated aging, real time aging, transportation simulation tests)
- Tensile test
- Torque test
sterile barrier testing, sterility, bioburden and LAL tests.