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Defining a Family of Products to Economize Package Testing
Does every medical device’s packaging system need to be tested separately?
Ethylene Oxide Sterilization Glossary
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.
FAQ: Sample Submission For Irradiation At The Radiation Technology Center
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.
Food Industry Case Study
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.
Food Industry Case Study
Discovering transport issues led a well-known food company to achieve substantial savings.
From ISO 594 to ISO 80369: Making Sense of the Latest Luer Requirements
STERIS has prepared a short white paper outlining the most important requirements to adhere to for achieving compliance with ISO 80369-7.
Gamma Sterilization Dose Auditing for ANSI/AAMI/ISO 11137-2:2006 VDmax25
Learn about the steps required for an ANSI/AAMI/ISO 11137-1: 2006 and –2: 2006 quarterly dose audit
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