TechTips

Failure to maintain consistent and traceable test processes at all stages of the product lifecycle is a recipe for disaster, according to the test engineers.

This TechTip will explain the differences between single lot validations and full validations of minimum sterilization dose, and outline the advantages and disadvantages of each of these approaches to dose setting.

Glass is particularly susceptible to radiation-induced coloration/discoloration due to its amorphous, non-crystalline structure. Learn how irradiation affects the color properties of products containing glass

Q1: What is the Radiation Sterilization Master File Pilot Program? A:The Radiation Sterilization Master File Pilot Program (Pilot Program) is a voluntary program that intends to allow companies that terminally sterilize single-use medical devices using

Learn about units of measure used in radiation processing, including a conversion table

Industrial radiation facilities are designed to achieve a dose uniformity inside a process load between the sterilization (minimum) dose and the maximal acceptable dose established during the validation process. To demonstrate continued effectiveness o

This TechTip discusses the overall requirements, use of surrogate materials and application of reference dosimetry during routine gamma irradiation

This TechTip reviews the variables that should be considered to assure the EO sterilization process is effective each and every time.

This article will review the top seven items to consider from a reprocessing point of view in the design and commercialization of reusable instrumentation.

Background The reusable medical device cleaning process is the process of physically removing contaminants from a device to ensure the safety and effectiveness at the point of use. The validation of the cleaning process, including relevant soils and so