AAMI recently published AAMI CR513:2024; Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing. The new guidance updates best practices and outlines acceptable alternative approaches to radiation sterilization validation and routine control for single-use systems in pharmaceutical and biopharmaceutical...
AAMI recently published AAMI CR513:2024; Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing. The new guidance updates best practices and outlines acceptable alternative approaches to radiation sterilization validation and routine control for single-use systems in pharmaceutical and biopharmaceutical...
The iia article ‘Global Healthcare and Nuclear Power’ has been published in the May 2024 edition of Nuclear Engineering International. The article aims to highlight the critical applications of cobalt-60 and the contribution that is made by the nuclear industry in supporting healthcare. It also summarises...
AAMI recently published a collection of 11 articles on the issues of resistance and barriers to changing sterilization modalities, the tools and resources available to aid the transition between modalities, and the efficient use available sterilization capacity. ‘Industrial Sterilization: Process optimisation and sterilisation modality changes’...
The European Medicines Agency recently published its document ‘Questions and Answers on the use of X-ray sterilisation processes for Single Use Systems (SUS) used in pharmaceutical manufacturing’. This document is triggered by market and industry factors that are stimulating the evaluation of technologies such as...
TRAD Tests & radiations, a member of iia, has announced the release of RayXpert® version 1.9 with improvements and new features. RayXpert is the most used modeling tool based on a Monte Carlo calculation method. It allows users to accurately simulate a sterilisation or reticulation process...
In order to meet the sterilisation requirements associated with continuing growth in medical device manufacturing, STERIS has announced plans for additional electron beam processing capacity at its facility in Biassono, Italy. The planned investment complements the existing EO, e-beam and testing services that are available...
The 10th International Workshop on Radiation Processing is organized by ASTM Committee E61 on Radiation Processing. The workshop will be held in conjunction with the standards development meetings of the committee. Attendance will be limited to the first 75 participants who register. Visit the iia events...
James Scongack of Bruce Power gave a keynote presentation at IMRP18 in Vancouver. Several years later the International Irradiation Association (iia) was one of a small number of organisations that supported the formation of the Canadian Nuclear Isotope Council (CNIC). Today iia continues to support...
A team from STERIS, led by Brian McEvoy, have published 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. The paper has been published in the July 2023 edition of...
The board of SfFSAP continues to evolve to support the work that is being completed by the SfSAP Steering Group and Operational Working Groups. Three new board appointments were confirmed on Monday 23 January 2023: Amanda Benedict - Vice President Standards and Sterilisation at the...
The Society for Sterility Assurance Professionals made significant progress during 2022. The latest newsletter highlights some of the progress that has been achieved. January 2023 Newsletter ...
Texas A&M university are hosting two hands-on e-beam technology workshop during 2023. The first focuses on the use of eBeam and X-ray technologies in the medical device, pharmaceutical, and biotechnology industries. The second is focused on the use of eBeam and X-ray technologies in the fresh food,...
The latest iia publication - The development of radiation processing in Latin America and the Caribbean Region is now available in the publications section of our website. Latin America and the Caribbean Region have an established history of scientific research and the commercial application of radiation processing....
Conversations in the healthcare community increasingly refer to challenges in accessing sufficient sterilisation capacity. In recent years organisations, including the IAEA, have referred to alternative technologies suggesting that the market is looking to switch from gamma to alternatives including EB and X-ray. In reality the healthcare...
Johnson and Johnson first hosted the Kilmer conference in 1976. The conference brings together invited professionals in microbiology, quality assurance, assurance of sterility and infection control from industry, academia, regulatory authorities and healthcare delivery organisations. Previous conferences focused on advances in terminal sterilisation and aseptic processing,...
On June 7, 2022, the FDA announced it was considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation. The FDA is considering this pilot program due to global supply chain constraints and to...
