Quality and Microbiological Testing

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

SteriPack's expertise:

sterile barrier testing, sterility, bioburden and LAL tests. 

medical devices microbiological testing