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.
November 11, 2026
ISO 10993-7:2026 introduces significant updates to the evaluation of ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals in EO-sterilized medical devices.
Download Whitepaper/Case StudyOctober 29, 2026
Sterilization modalities and medical device packaging are deeply interdependent decisions that should be evaluated together from the earliest stages of product development.
Download Whitepaper/Case StudyApril 1, 2026
Sterigenics empowering pharmaceutical innovators to confidently deliver sterile, patient ready auto injectors, by assisting them in solving complex design and stability challenges with a customized ethylene oxide (EO) surface sterilization...
Download Whitepaper/Case StudyJuly 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 Whitepaper/Case StudyMarch 4, 2022
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 Whitepaper/Case StudyDecember 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 Whitepaper/Case StudyOctober 20, 2021
In the medical device industry there are 3 methods to establish the sterilization dose of a medical device …
Download Whitepaper/Case StudyMay 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 Whitepaper/Case StudyApril 7, 2021
Medical device manufacturers using ionizing radiation (gamma, electron beam or X-Ray) for sterilization purposes should establish the maximum acceptable dose...
Download Whitepaper/Case StudyJanuary 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 Whitepaper/Case Study
