Below you will find Panel guides & publications available for download:
2024 IMRP poster on Sterilisation Dose Audit Positives The activities and initial conclusions of the Irradiation Panel Microbiology Working Group project on Sterilisation Dose Audit Positives is available to download. This poster was nominated for the Best Overall Poster Award at the recent 2024 IMRP Conference in Costa Rica. It summarises data obtained from several anonymised manufacturers, contract laboratories and irradiation facilities highlighting the microorganisms that were found and the root causes identified. The Task Group continues to compile data and is looking for additional contributors to provide samples and data to facilitate wider sharing of experiences. Sterilisation Dose Audit Positives IMRP2[...] Adobe Acrobat document [305.9 KB]
Guidance document on establishing timeframes for testing associated with the requirements of ISO 11137/11737/13004 The Microbiology Working Group of the Irradiation Panel has issued new guidance on how to establish and justify timeframes for microbiological testing associated with bioburden determination and dose audit testing. Guidance on timeline of microbial testin[...] Adobe Acrobat document [299.6 KB]
Introduction and overview of methods for performance qualification (PQ) dose mapping based on ISO 11137-1 (ISO 2006). Dose_mapping_report_July_2022.pdf Adobe Acrobat document [1.4 MB]
Document comparing 2019 and 2009 version of ISO 11737-2 Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilisation process ISO11737-2_2019vs2009 assessment FINAL.p[...] Adobe Acrobat document [405.7 KB]
Document comparing the 2018 and 2006 version of ISO 11737-1 Microbiological methods - Determination of a population of microorganisms on products Differences ISO11737-1 2018 and 2006 ver[...] Adobe Acrobat document [760.2 KB]
Guidance document on what is required under ISO 11137 to change irradiation modality, for example from gamma to X-ray Change of Irradiation Modalities Final.p[...] Adobe Acrobat document [567.1 KB]
Updated guide on the use of Statistical Process Control methods in Radiation Sterilisation Updated to reflect ISO 11137 Part 3 2017 terminology Panel SPC Method 2018.pdf Adobe Acrobat document [450.2 KB]
Guide on differences between ISO 11137 part 3 new 2017 version and previous 2006 Panel ISO11137-3 2017vs2006.pdf Adobe Acrobat document [597.9 KB]
Feedback by the Panel to the EU as part of the consultation on the legal framework for Food Irradiation, October 2017 Panel feedback to EU legal framework con[...] Adobe Acrobat document [316.0 KB]
Database of D10 values of microbial resistances to gamma irradiation in EXCEL format Contains the same data as the database (.mdb) file available below but in more convenient format Micro_D10_referencedata.xls Microsoft Excel sheet [693.0 KB]
Guide to establishing the maximum acceptable dose under ISO 11137 Part 1 Guide establish Dmaxacc.pdf Adobe Acrobat document [224.0 KB]
Database of D10 values of microbial resistances to gamma irradiation Compressed (WinZip) Microsoft Access database file (.mdb) gamma resist D10 db.zip Compressed archive in ZIP format [294.5 KB]