Blog
Biological indicators (BIs) are essential tools for monitoring the efficacy of terminal sterilization processes. These indicators contain highly resistant microorganisms that are intended to be more difficult to kill.
September 05, 2024
Blog
That is the big question. Fortunately, when you boil it down to its essence, it’s actually quite easy to answer. There are only one or two questions that need to be asked and answered, and then the decision should be straightforward.
June 04, 2024
Blog
The goal of all sterilants is to either kill microorganisms or make them incapable of replicating.
February 29, 2024
Blog
This is a bit more complex question as it needs to take into account things like product and packaging materials and design, cost of the sterilization equipment and upkeep of that equipment, product transportation, sterilization indicator system, validation and...
December 02, 2023
Blog
Often the answer to that question dictates the method as one may only be able to use EO (or another gaseous niche method), or radiation may be the only method that works.
September 01, 2023
Blog
On November 7 PMP News published the article, "How to Make the Choice between Ethylene Oxide or E-Beam Sterilization," by Freelance Journalist Camilla Andersson. It was also included in the Medical Packaging Community.
June 01, 2023
Blog
EO is the most popular and growing slightly because it is the most material friendly. As devices get more complex (e.g. combination products, custom kits, others), they may be made of multiple materials, some of which may not be compatible with radiation.
March 02, 2023
Blog
1) There is no regulatory requirement to perform 30 cycles (or any number of cycles) to qualify parametric release. Other than the requirement to do direct measurements of ethylene oxide (EO) concentration and relative humidity (RH) using calibrated measurement devices...
May 17, 2022
Blog
How to Make the Choice between Ethylene Oxide or E-Beam Sterilization
February 25, 2022
Case Study
We're pleased to announce the completion of agreement to supply ethylene oxide sterilization chambers, Glygen™ environmental control systems and facility design services to a medical device manufacturer.
January 24, 2022
Blog
What is the sterility assurance level (SAL) when performing an ethylene oxide (EO) Overkill Method qualification using the half cycle approach where 10 biological indicators (BIs) were used, tested, and there was 0 positives obtained (complete kill).
August 23, 2019
Blog
The breakdown of industry sterilization is generally agreed to be roughly 52% ethylene oxide (EO) gas, 36% Gamma radiation, and 7% E-beam radiation.
June 21, 2019