Medical Device Qualified Supplier Directory
Steri-Tek Company Profile
Qualifications: ISO 13485, FDA Registered, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America
Steri-Tek is the San Francisco Bay Area and Silicon Valley’s leader in E-beam sterilization and X-ray irradiation for complex products and sensitive materials.
E-Beam/X-ray irradiation is a proven and accepted form of terminal sterilization. The mechanism for sterilization is the effect of high energy electrons striking and breaking up the RNA/DNA of the bioburden.
The relationship between the flexibility of E-Beam/X-ray and the sterilization requirements for sensitive materials/complex devices is rapidly evolving to become a key advantage to manufacturers of combination products, drugs/biologics, bioabsorbables, implantables and other complex products.
Sterilization is used for killing unwanted microorganisms in medical devices, healthcare products, pharmaceuticals and combination drug devices. There are many types of sterilization to choose from depending on your product and requirements: gamma, E-Beam autoclaving, ETO and dry heat. But now there is a new kid on the block that addresses many of the limitations with current, popular techniques, X-ray sterilization. (While ‘new’, X-ray has been in ISO 11137 prior to 1994 and due to improvements in efficiencies and technology, X-ray is now the clear choice over gamma).
Like gamma and E-Beam sterilization, X-ray sterilization uses irradiation to disrupt the DNA of microorganisms on the product. The X-rays are high-energy, high-frequency, short-wavelength electromagnetic photons. This allows for X-ray sterilization to offer the best features of gamma and E-beam
Routine Sterilization Processing (48 Hr. Standard)
Processing for Accuracy and Accountability
Steri-Tek understands that irradiation is only part of a sterilization process. Both the product geometry in the shipper box and the shipper box count are just as important for a validated sterilization process. At Steri-Tek all production boxes are weighed, measured and labeled as a check of conformance to the original dose map and to ensure lot traceability. Boxes off-weight, or suspect in any way, are followed up by a call to the responsible party at the customer’s site for disposition prior to processing.
For more information contact Steri-Tek