All TechTips
Parametric Release for Ethylene Oxide Sterilized Devices
This TechTip provides an overview of the parametric release process, including microbiology requirements, equipment requirements, process analysis and load configuration.
Performance Qualification of Ethylene Oxide Sterilization Process Method C
Overview and detailed steps of Process Method C, the most commonly used method for an ethylene oxide performance qualification.
Product Adoption for Ethylene Oxide Sterilization
Do improvements to your medical device impact a currently-validated EO process? View our TechTip to learn about product adoption for ethylene oxide sterilization
Product Packaging Considerations for Gamma Processing
This TechTip focuses on what Customers need to know before initiating changes to product packaging in order to ensure that the efficiency and effectiveness of the gamma process is maintained
Product Qualification for Gamma Processing
This overview covers steps and other considerations for the qualification of new medical devices that will be processed with gamma radiation.
Products Commonly Treated with Irradiation
View a sample list of products commonly treated with gamma irradiation, examples where gamma is the method of choice and factors preventing the use of other sterilization technologies
Putting it to the Test (Method Validation)
Failure to maintain consistent and traceable test processes at all stages of the product lifecycle is a recipe for disaster, according to the test engineers.
Radiation Dose Setting: Single Lot vs. Full Validation of Minimum Sterilization Dose
This TechTip will explain the differences between single lot validations and full validations of minimum sterilization dose, and outline the advantages and disadvantages of each of these approaches to dose setting.
Radiation Processing for Glass Coloration / Discoloration
Glass is particularly susceptible to radiation-induced coloration/discoloration due to its amorphous, non-crystalline structure. Learn how irradiation affects the color properties of products containing glass
Radiation Sterilization Master File Pilot Program FAQ
Q1: What is the Radiation Sterilization Master File Pilot Program? A:The Radiation Sterilization Master File Pilot Program (Pilot Program) is a voluntary program that intends to allow companies that terminally sterilize single-use medical devices using