Industry Articles

Articles from Industry Publications

Effect of Gamma and X-ray Irradiation on Polymers Commonly Used in Healthcare Products
Philip Roxby, Hervé Michel, Céline Huart, and Samuel Dorey
Biomedical Instrumentation & Technology

Power of Parametric: Methods to Validate Ethylene Oxide Sterilization Parametric Release.
Elise Coakley, Liliana De Alba Nunez, Abigail Honetschlager, Daniel Howell, Scott Jelley, Nicole McLees, and Rosa I. Vale Mercado.
Biomedical Instrumentation & Technology

Principles of Parametric Release: Emphasis on Data Collection and Interpretation.
Brian McEvoy, Ana Maksimovic, Daniel Howell, and Hervé Michel.
Biomedical Instrumentation & Technology

Geobacillus stearothermophilus and Bacillus atrophaeus spores exhibit linear inactivation kinetic performance when treated with an industrial scale vaporized hydrogen peroxide (VH2O2) sterilization process.
Brian McEvoy, Ana Maksimovic and Neil J. Rowan.
This study aims to determine the inactivation kinetics of Geobacillus stearothermophilus and Bacillus atrophaeus biological indicators, treated with vaporized hydrogen peroxide (VH2O2) at an industrial scale. There is an assumption that sterilization processes generate linear kinetic plots of treated biological indicators that are used for informing probability-based decision-making by the MedTech industry for effective sterilization treatments; however, this has not been reported for sterilization using VH2O2.

Studies on the comparative effectiveness of X-rays, gamma rays and electron beams to inactivate microorganisms at different dose rates in industrial sterilization of medical devices.
Brian McEvoy, Ana Maksimovic, Daniel Howell, Pierre Reppert, Damien Ryan, Neil Rowan and Hervé Michel.
These findings from a novel single study encompassing all available industrial radiation technologies for the purpose of medical devices sterilization, advance our understanding of microbial destruction as related to exposure to important sterilization modalities, which will help inform future applicability of these technologies for emerging industry opportunities.

Potential Induced Radioactivity in Materials Processed with X-ray Energy Above 5 MeV
Hervé Michel, Thomas Kroc, Brian J. McEvoy, Deepak Patil, Pierre Reppert, and Mark A. Smith
Section 5.1.2 of ANSI/AAMI/ISO 11137-1 states that “the potential for induced radioactivity in product shall be assessed.” This article describes how compliance with this requirement may be achieved using qualified test methods.

Advancing the Sustainable Use of Ethylene Oxide through Process Validation
Brian McEvoy, Stacy Bohl Wiehle, Ken Gordon, Gerry Kearns, Paulo Laranjeira, and Nicole McLees
This article presents relevant experiences and describes challenges and considerations encountered in delivering EO process optimization.

X-ray: An Effective Photon
This article brings X-ray sterilization into focus by sharing knowledge and experience gained over the past 10 years at the STERIS Daniken site, with an aim to identify opportunities for future medical device sterilization.

Vaporized Hydrogen Peroxide: A Well-Known Technology with a New Application
Recent developments in chamber design and process development provide new opportunities for Vaporized Hydrogen Peroxide sterilization processing.

A Case Study of gamma-irradiated oxybutynine
We’re happy to publish the Application Note concerning the research carried out by our team at the Pharmaceutical Testing Laboratory in Utrecht, in conjunction with colleagues at the STERIS Gamma Sterilization site in Ede, NL and the Bruker research lab in Bremen, on irradiated Oxybutynine

Polymer Materials Selection for Radiation-Sterilized Products
Medical Device & Diagnostic Industry

Guide to Irradiation and Sterilization Validation of Single-Use Bioprocess Systems
Bio-Process International

Effect of Sterilization on the Mechanical Properties of Silicone Rubbers
BioProcess International

Sterilization Methods Stand the Test of Time
Medical Device & Diagnostic Industry

What Came First… Packaging Materials or Sterilization Techniques?
Pharmaceutical & Medical Packaging News

Perspectives on Combination Products
Medical Design Technology