Method 1 Quarterly Dose Audits: Interpretation of Results
This TechTip provides guidelines for interpreting results of a Method 1 audit
Micro Intervascular Catheter Liquid Flow/Leak Test System
A leading international medical devices manufacturer planned to automate a manual device functionality test.
Monitoring of Delivered Dose Using Reference Dosimetry
Monitoring of the minimum delivered dose position for healthcare products is required per industry standards (i.e. ANSI/AAMI/ISO 11137)
Overview of a Gamma Irradiation Validation
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
Overview of a Parametric Release Validation for EO Sterilization
Learn about the steps included in a parametric release validation, as well as special considerations for parametric release
Overview of an E-Beam Irradiation Validation For Healthcare Products
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.
Overview of an Ethylene Oxide Validation
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.
Overview of Ethylene Oxide Residuals
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.
Overview Of Sterilization Technology Comparison
Learn more about our global offering, which includes electron beam, gamma, X-ray, and ethylene oxide technologies
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.