How do you determine the proper reference document for Steam Sterilizer Validation? Is it still practical to use an archived document? Why you should be using BS EN285 for Sterilizer Validation guidance.
For years the two most commonly used reference documents in Steam Sterilizer Validation were the Health Technical Memorandum 2010 (HTM2010/ 1994) and the British Standard BS EN285:2006. As of May 2012 HTM2010 was officially archived and replaced by Choice Framework for Local Policies and Procedures (CFPP) 01-01. Some companies still consult HTM2010 for Validation Guidance despite the documents ‘retirement’; a practice still considered acceptable.
The use of BS EN285 for Sterilizer Validation guidance is the only guidance necessary today for Sterilizer Validation. The farther we move from May 2012, the less relevance HTM2010 holds. And after a quick read through of CFPP 01-01 one will find that substituting it for HTM2010 is unnecessary as most of the Validation Test Requirements and Acceptance Criteria in this new standard indicates a direct reference to BS EN285. Additionally, CFPP 01-01 is a standard currently applicable to England only and has yet to even be embraced by the other members of the United Kingdom.
Written By: Fred Anderson, Senior Consultant