All TechTips
Irradiations Effect on Cannabis
Background As an agricultural product, cannabis can be exposed to contamination with pathogenic fungi, bacteria, yeast, and mold during growing, drying, packaging, and/or delivery, which may put consumers at health risks. For example, fatal pulmonary A
Laboratory Testing of Human Tissue
Laboratory testing of human tissue requires special consideration to ensure safe product handling and accurate results. This TechTip addresses those considerations that should be addressed by both the donor organization and the test laboratory.
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.