Steris Isomedix Services

STERIS Isomedix Services to add small volume ethylene oxide processing in California

September 30, 2015 By MassDevice

STERIS Isomedix Services is pleased to announce the expansion of its existing Temecula, California ethylene oxide sterilization facility to include small volume processing. The expansion will add four small ethylene oxide chambers of various sizes to the existing medium-sized chambers already in use at the Temecula facility. “With the addition of small-volume processing, we are […]

INTRODUCTION TO GAMMA PROCESSING

September 19, 2014 By Brian Johnson Leave a Comment

Gamma radiation are high-energy photons are emitted from an isotope source (e.g., Cobalt 60). These photons can create ionization (electron disruptions) throughout a product.

This whitepaper will illustrate the process of using gamma processing in the sterilization of medical devices.

Anatomy of an Ethylene Oxide Sterilization Process

September 19, 2014 By Brian Johnson Leave a Comment

There are many advantages to understanding an ethylene oxide (EO or EtO) sterilization process when considering the different sterilization options. A knowledge of the process may prevent unnecessary product testing or may identify product changes which may be required prior to attempting to sterilize with EO. The following information, although generic in nature, is designed to provide basic information on the ethylene oxide sterilization process.

Product Qualification for Gamma Processing

September 19, 2014 By Brian Johnson Leave a Comment

This overview covers steps and other considerations for the qualification of new medical devices that will be processed with gamma radiation. The order listed is the approximate order in which various steps will be accomplished. However, it should be recognized that there may be considerable overlap between one or more steps.

FDA warns Steris Isomedix on QA, data manipulation issues

June 4, 2014 By Arezu Sarvestani Leave a Comment

Steris’s (NYSE:STE) Isomedix division is in the FDA’s hotseat after inspectors turned up incidents in which employees faked data on testing for medical devices.

MEDICAL DEVICE STERILIZATION Seminars Offered By STERIS Isomedix Services

March 12, 2013 By MassDevice Contributors Network Leave a Comment

Join STERIS Isomedix Services for our TechTeam seminars on topics critical to success in medical device sterilization. Our seminars provide attendees the opportunity to gain an in-depth understanding of the relationship between sterilization and medical device design, validation, manufacturing and packaging.

In addition to the TechTeam experts from STERIS Isomedix Services, the seminar will feature thought leaders from around the industry. Seminar topics include:

Evolution of Sterilization Validation
History of sterilization microbiology and how we got to where we are now

MEDICAL DEVICE STERILIZATION SEMINAR & FACILITY TOUR OFFERED BY STERIS ISOMEDIX SERVICES

June 13, 2012 By MassDevice Contributors Network Leave a Comment

Join STERIS Isomedix Services for a TechTeam seminar on topics critical to success in medical device sterilization. The event, being held September 11-12 in Mahwah, New Jersey, will provide attendees the opportunity to gain an in-depth understanding of the relationship between sterilization and medical device design, validation, manufacturing and packaging.