STATUS IN WALES - Health in Wales

1 For queries on the STATUS of this document contact or telephone 029 2031 5512 October 2013 Health TECHNICAL MEMORANDUM 2031 Clean steam for sterilization 1997 STATUS IN WALES ARCHIVED This document was superseded by Welsh Health Technical Memorandum 01-01 Decontamination of medical devices within acute services 2013 Clean steam forsterilizationHealth Technical Memorandum 2031 London: The Stationery Office Crown copyright 1997. Published with permission of NHS Estates, an Executive Agency of the Department of Health , on behalf of the Controller of Her Majesty s Stationery for reproduction should be made in writing to The Copyright Unit, Her Majesty s Stationery Office, St Clements House, 2 16 Colegate, Norwich NR3 published 1997 ISBN 0-11-322033-2 Standing order serviceAre you making full use of The Stationery Office sStanding Order Service?

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4 It is designedto supplement the guidance on steamquality in HTM 2010, Sterilization .The contents of this HTM in terms ofmanagement policy and operationalpolicy are endorsed by:a. the Welsh Office for the NHS inWales;b. the Health and Personal SocialServices Management Executivein Northern Ireland;c. the NHS in Scotland EstatesEnvironment to legislation appearing inthe main text of this guidance apply tothe United Kingdom as a whole, exceptwhere marginal notes indicate variationsfor Scotland or Northern Ireland. Whereappropriate, marginal notes are alsoused to amplify the this publicationExecutive summaryThe quality of steam supplied to a sterilizer can have amajor influence on the efficacy of the sterilization process,the quality of the sterile product and the longevity andserviceability of the sterilizer and its associated concern for steam quality has traditionally focusedon its physical characteristics notably dryness and thepresence of non-condensable gases new EuropeanStandards supporting legislation governing themanufacture of medical devices require morecomprehensive control of the purity of the HTM discusses the nature.

5 Effects and sources ofchemical and biochemical contaminants in steam, andproposes a readily achievable purity specification for clean steam to be used for sterilization. Thespecification is designed to meet regulatory requirementsfor medicinal products and medical devices withoutincurring excessive steam is defined as steam whose condensate meetsthe purity requirements of Water for Injections BP(including a limit on pyrogens) with additionalspecifications to protect against corrosion of materialsused in the construction of sterilizers and medical guidance is given on the generation of cleansteam from the following sources:a. from the existing mains steam supplies commonlyused in hospitals;b.

6 From dedicated clean-steam generators;c. in sterilizers with an internal steam supply, such astransportable sterilizers for unwrapped instrumentsand minor modifications and adjustments to operatingpractices, it should be possible to obtain clean steam fromthe majority of mains steam services currently installed inNHS hospitals. However, the necessary assurance that thesupply continues to meet clean-steam specifications willrequire frequent testing of steam and feedwater samplesand close supervision of plant normally outside the controlof the User of the sterilizer .In the longer term a dedicated clean-steam generator,solely supplying one or more sterilizers, is likely to prove amore reliable and economical source of clean is given on the validation and periodic testing ofclean-steam supplies, with guidance on methods of takingsteam and water samples for analysis.

7 Confirmation that asupply complies with the clean-steam specificationrequires a number of laboratory tests, most of which arebased on those of the British Pharmacopoeia and are wellwithin the capacity of any hospital this publicationExecutive summary1. Responsibilitiespage Key regarding clean steam2. Contamination in steam suppliespage Why does contamination matter? Adverse affects on Adverse effects on vulnerable to of Public water Boiler feedwater Steam distribution system3. Steam quality requirementspage Regulatory Medicinal Medical of HTM 285 Health and Sterilizer Routine monitoring4.

8 Clean steam in practicepage How steam is Summary of requirements for clean steam from the mains steam Boiler design and Distribution Quality steam from a clean-steam Moisture Feedwater generated clean Feedwater A practical Good operating practice5. Testing for compliancepage Where to take Validation and periodic Mains steam Validation Periodic clean-steam Validation Periodic generated clean steam6. Samplingpage Sampling Sampling for field for laboratory of samples for laboratory Sample Identification of Packaging and transport7.

9 Analysis of samplespage Testing of Reporting of Alternative on the Concentrations; residue on evaporation Acidity or Heavy Phosphate and Electrical conductivityGlossarypage 48 Abbreviationspage 51 Bibliographypage 52 Appendix 1 Useful addresses page 55 Appendix 2 Operation and maintenance of clean-steam generatorspage MaintenanceAppendix 3 Pyrogenspage Bacterial Clinical Detection and Generation of bacterial Regulatory Requirements for clean SummaryAppendix 4 Tests for clean steampage Laboratory tests for chemical or ( ppm) and metals ( ppm) ( ppm) Nitrate ( ppm) Oxidisable Residue on evaporation (30 ppm)

10 Laboratory test for Standard Sensitivity of the Interfering Test for bacterial endotoxin in the Interpretation of Field test for electrical conductivityAbout NHSE statespage chapter reviews the roles of the key personnel associated with theoperation of a sterilizer and summarises their responsibilities with regard toclean following key personnel are referred to in this HTM. Furtherinformation, including qualifications and general areas of responsibility, can befound in HTM 2010: Part defined as the person with ultimate managementresponsibility, including allocation of resources and the appointment ofpersonnel, for the organisation in which the sterilizer is on the nature of the organisation, this role may be filled bythe general manager, chief executive, laboratory director or other person ofsimilar authority.