TechTips

This TechTip looks at issues that must be considered when irradiating APIs and pharmaceutical fillers, benefits of terminal sterilization, characteristics that lead to successful sterilization, areas that incite concern or special care in designing a sterilization plan and tools to improve success rates

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 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.

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.

Q1: What actions need to be performed if bioburden test results come back significantly elevated compared to the product’s historical/trend data? Answer: Routine monitoring of product-specific bioburden levels should be followed by trending and statist

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.