Contract Steam Sterilization

Biotest Laboratories offers contract steam sterilization services on-site for products such as medical devices, diagnostics, drug delivery systems and components.

Our Customers utilize our contract steam sterilization services for product release, product compatibility studies and sterilization validation.

Steam sterilization services offered include:

  • Qualification studies
  • Product compatibility
  • R&D testing
  • Routine contract steam sterilization
  • Validation

In addition, Biotest Laboratories assists in qualifying steam sterilization cycles to be recommended to health care facilities for re-sterilization or sterilization of products sold non-sterile. Research and development testing for early phase product design and for new materials is also routinely provided.

Steam cycles using prevacuum, purge-pulse, air-cool and gravity can accommodate most packaging designs for Class II & III devices, pharmaceuticals and ophthalmic products. In addition, various programmable cycles provide a wide range of steam cycle process development. The installation of multiple sterilizers with the same cycle design allows for back-up and cross validation capabilities to assure continuous production capacity.

Gamma Irradiation and Ethylene Oxide Sterilization Services
Contract gamma irradiation and ethylene oxide sterilization services are also available through STERIS Isomedix Services.

The gamma process can effectively sterilize a wide variety of products composed of different materials, with varying densities, configurations and orientations. Learn more about gamma irradiation sterilization.

A wide variety of materials and components commonly used in the manufacture of disposable healthcare products may undergo ethylene oxide sterilization in their final breathable packaging configuration. Learn more about ethylene oxide sterilization.