All TechTips
Comparison of Alanine and Red 4034 Dosimetry Systems
This TechTip compares various attributes of the Alanine and Red 4034 dosimetry systems
Considerations After Experiencing a Dose Audit Failure
In the case of a dose audit failure, a complete failure investigation should be conducted to determine the cause of failure. This TechTip covers considerations after experiencing a dose audit failure
Considerations When Establishing a Maximum Sterilization Dose for Radiation Processing
Per ISO 11137, products sterilized by X-ray, gamma, and E-beam irradiation require a documented and validated dose range. A dose range is composed of: A minimum dose based on the microbiologic considerations (type and quantity of organisms and their re
Cumulative Radiation Dosing
Radiation dose is cumulative and the effect of absorbed dose on the destruction of micro-organisms is cumulative. Learn more about considerations for cumulative dosing.
Custom laboratory and in-line test equipment.
We build a wide range of laboratory and in-line test equipment to suit our customers’ exact needs.
Defining a Family of Products to Economize Package Testing
Does every medical device’s packaging system need to be tested separately?
Ethylene Oxide Master File Pilot Program FAQ
Q: What is the Ethylene Oxide (EO) Sterilization Master File Pilot Program? A: In an effort to advance innovation in medical device sterilization with ethylene oxide (EO) and reduce the threat of shortages of EO-sterilized medical devices by providing
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.