TechTips

This TechTip provides guidelines for interpreting results of a Method 1 audit

A leading international medical devices manufacturer planned to automate a manual device functionality test.

Monitoring of the minimum delivered dose position for healthcare products is required per industry standards (i.e. ANSI/AAMI/ISO 11137)

This TechTip will provide a step-by-step overview of a gamma irradiation validation process that complies with the standards established in ANSI/AAMI/ISO 11137-2006

Learn about the steps included in a parametric release validation, as well as special considerations for parametric release

Prior to beginning routine processing with electron beam (E-beam) irradiation, a product with a sterile claim needs to complete a validation process to ensure the sterility assurance level claimed is achieved.

This TechTip provides a step-by-step overview of an ethylene oxide validation process that complies with the guidelines established in 11135 using a Half Cycle Overkill Approach.

Sterilizing medical devices with ethylene oxide (EO) is a common practice primarily due to its extensive material compatibility. This TechTip discusses the residues that may be found after EO processing and residual reduction methods.

Learn more about our global offering, which includes electron beam, gamma, X-ray, and ethylene oxide technologies

This TechTip provides an overview of the parametric release process, including microbiology requirements, equipment requirements, process analysis and load configuration.