TechTips

Does every medical device’s packaging system need to be tested separately?

A Glossary list of terms that may be used in discussions of ethylene oxide (EO) sterilization as recognized by medical device manufacturers inspected by the U.S. FDA. All definitions or explanations are to be taken as applied specifically in the context of EO sterilization processing.

The Radiation Technology Center (RTC) specializes in handling products requiring high precision irradiation dose delivery for validation, dose audit and research purposes. To help facilitate product submissions and improve product turn time this TechTip addresses questions that may arise when product is submitted for irradiation processing.

A major ice cream manufacturer was experiencing problems with a new packaging system. They had redesigned their plastic ice cream tubs as part of a cost-saving measure but had not tested the changes made prior to market distribution.

Discovering transport issues led a well-known food company to achieve substantial savings.

STERIS has prepared a short white paper outlining the most important requirements to adhere to for achieving compliance with ISO 80369-7.

Learn about the steps required for an ANSI/AAMI/ISO 11137-1: 2006 and –2: 2006 quarterly dose audit

Learn about the steps required for an ANSI/AAMI/ISO 11137-1: 2006 and –2: 2006 quarterly dose audit

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

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