Gamma Sterilization Dose Auditing for ANSI/AAMI/ISO 11137:2006 Method 1
Learn about the steps required for an ANSI/AAMI/ISO 11137-1: 2006 and –2: 2006 quarterly dose audit
Gamma Sterilization Validation Key Steps to Dose Auditing
Selection of the dose setting method depends on the bioburden of the product & the maximum dose at which the product can retain its form, fit & functionality
Gamma Sterilization Validations VDmax 25 and Method 1
When gamma irradiation is selected for product sterilization, the dose at which the product is irradiated must be established and validated in accordance with appropriate AAMI standards
HALT Testing Case Study
Rigorous Highly Accelerated Life Testing (HALT) prevented telecommunications company from a complete product recall.
How to Optimize Packaging Solutions to Avoid Costly Delays in Device Development
In the development of a medical device, packaging, when treated as an afterthought, can become a time consuming and expensive problem to remedy.
Introduction to Gamma Irradiation Processing
Learn about the basics of gamma irradiation including how it is used, limitations and typical processing cycles
Irradiation Glossary of Terms
View an alphabetical list of terms relating to gamma irradiation sterilization
Irradiation of Active Pharmaceutical Ingredients and Pharmaceutical Fillers
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
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.