All TechTips
Starch Irradiation
This TechTip focuses on why some starches require irradiation, effects of radiation on starches, and suggestions for evaluating minimum and maximum doses
Sterility Assurance Levels (SALs): Irradiation
This TechTip provides information on the selection of an appropriate Sterility Assurance Level (SAL) for medical devices
Study on the Impact of EO Concentration on Product Residuals
A study was carried out to compare the impact, if any, of EO concentration on product EO residual levels determined in accordance with ISO10993-7.
Sustainable EO® Frequently Asked Questions
As part of our commitment to providing innovative and sustainable solutions, STERIS AST has developed the Sustainable EO® sterilization services program.
The Basics of Bioburden Testing
What is bioburden? Bioburden is the quantity and types of native bacterial and fungal flora present on or in a device, substrate, or chemical (test unit). Bioburden plays a large role in determining what is necessary to achieve sterility, and can impac
The Basics of Medical Device Packaging
When developing a sterile barrier system for medical devices, there are several aspects that need to be considered in choosing packaging and qualifying your sterile barrier system (SBS)
The Importance of Risk Assessment
Due to the all-consuming nature of designing a brand new product, developers are frequently more focused on functionality than risk.
Transfer of Ionizing Radiation Technologies for Medical Devices Based on Guidance in ISO 11137-1, ISO 13004, and AAMI TIR 104
This TechTip will address transfer types and areas of consideration. Considerations should also be given to specific product requirements and registrations, as the information provided is based primarily on guidance in ISO 11137 and may not cover all the requirements and registrations specific to a manufactured product.
Transfer of Sterilization Dose, Verification Dose or Maximum Acceptable Dose Between Radiation Sources
This document answers many of the FAQs regarding radiation source transfers and addresses possible transfer types and areas for consideration.
Transferring of the Verification Dose from Electron Beam Technology to Photon Technology (Gamma or X-ray)
Background A verification (dose audit) or sterilization dose experiment requires a narrow and specific dose range to be applied to the samples used for tests of sterility as evidence that the routine minimum dose remains appropriate for delivering the