Dig deeper into topics and the science behind our services, as well as ways we can help solve your business challenges.
Dig deeper into topics and the science behind our services, as well as ways we can help solve your business challenges.
July 27, 2022
A developmental chamber is usually smaller than a production chamber and used to perform studies to support Ethylene Oxide validation. This white paper discusses use of a developmental chamber for...
Download WhitepaperDecember 6, 2021
As defined in Section 12 of ISO 11135:2014, a new or modified (“candidate”) product can be added to a validated Ethylene Oxide (EO) sterilization process
Download WhitepaperOctober 20, 2021
In the medical device industry there are 3 methods to establish the sterilization dose of a medical device …
Download WhitepaperMay 27, 2021
In the medical device industry, sterilization processing is performed to obtain a Sterility Assurance Level (SAL) as required by regulatory authorities to designate the treated product as “sterile”. When SAL...
Download WhitepaperApril 7, 2021
Medical device manufacturers using ionizing radiation (gamma, electron beam or X-Ray) for sterilization purposes should establish the maximum acceptable dose...
Download WhitepaperJanuary 4, 2021
The Covid-19 global pandemic of 2020 has brought into sharp focus the critical role that the medical device supply chain plays in the terms of bringing safe, effective healthcare to...
Download WhitepaperOctober 20, 2020
Each polymer reacts differently to ionizing radiation. Thus, it is important to verify that the maximum administered dose will not have a detrimental effect on the product’s function or the...
Download WhitepaperNovember 30, 2018
Sterilizing medical devices via ethylene oxide gas is an effective and common practice within the industry. EO gas is active at a relatively low temperature compared to other methods, such...
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