Present by Wayne Harvey State Manager QLD & PNG National Healthcare and Pharma Sector Manager AS/NZS 4187:2014 Steam Implications By Graeme Harley & Henry Biggelaar While Spirax Sarco Australia has attempted to make the information in this presentation as accurate as possible, the information in this presentation is for personal and/or educational use only and is provided in good faith without any express or implied warranty. There is no guarantee given that the information provided applies to any specific plant, process or organisation. Spirax Sarco Pty Limited does not accept responsibility for any loss or damage occasioned by use of the information. Readers should at all times seek independent and specific advice on their steam systems. Use of the information contained in this presentation is at the risk of the reader. #HFMC17
Objectives 1. Review the Australia Standards and Changes 2. Requirements to satisify the standards 3. Steam Quality 4. Steam Purity 5. Steam Quality versus Purity #HFMC17
Standards Requirements • Australian Commission on Safety and Quality in Healthcare • Standard 3 – Preventing and Controlling Healthcare Associated Infections #HFMC17
Australian Standards Prior to 2014, the Australian Standards were: • AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities • AS 1410:2003 Sterilizers – Steam - Pre-vacuum #HFMC17
Australian Standards • AS/NZS 4187:2003 referred to AS 1410:2003, which had methodology and limits for steam quality testing in line with EN 285 • However AS/NZS 4187:2003 also included limits for the values placed on dryness value and superheat that differ from those in AS 1410:2003, and so EN 285 • AS/NZS 4187:2003 and AS 1410:2003 had limited detail on steam purity, with AS 1410:2003 giving recommendations on feedwater for steam generators only #HFMC17
Australian Standards • AS/NZS 4187 was revised with the current standard being AS/NZS 4187:2014 • AS/NZS 4187:2014 no longer refers to AS/NZS 1410, and instead references the following standards: • EN 285 Sterilization – Steam Sterilizers – Large Sterilizers • ISO 17665 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices Part 2: Guidance on the application of ISO 17665-1 • CFPP 01-01 Part C* [Choice Framework for local Policies and Procedures 01-01 – Management and decontamination of surgical instruments (medical devices) used in acute care, Part C: Steam sterilization] #HFMC17 *CFPP 01-01 Part C has been replaced by HTM 01-01 Part C
Standards and Requirements for HSO’s AS/NZS 4187:2014 Key Points AS/NZS 4187:2014 • The requirements of this Standard are applicable to all HSO’s • The standard does not reiterate all of the technical requirements already defined in National or International Standards. For ISO 17665-2 Example the standard refers directly to EN 285 and ISO 17665 • New validation requirements for Washer Disinfectors • Increased focus on steam purity and clean steam #HFMC17
Standards and Requirements for HSO’s AS/NZS 4187:2014 Key Points Validation Washer Disinfectors validated to ISO 15883 Steam sterilization validated to ISO 17665 – Part 1 #HFMC17
Standards and Requirements for HSO’s AS/NZS 4187:2014 Key Points Steam Steam Quality Steam quality tests, e.g. steam dryness value, super heat and non-condensable gases tests shall be conducted as part of IQ or OQ and in accordance with EN 285 • Minimum steam dryness value is 0.95 (AS/NZS 4187:2003 required 0.97) • Superheat limit of 25 ° C above atmospheric conditions for the expanded steam (AS/NZS 4187:2003 required less than 2 ° C superheat in the steam supply) • The volume of non-condensable gases should not exceed 3.5% of the volume of condensed steam AS/NZS 4187:2014 is now fully aligned with EN 285 and ISO 17665 #HFMC17
Standards and Requirements for HSO’s AS/NZS 4187:2014 Key Points Steam Steam Purity The focus on steam purity and the move to clean steam is a major update in AS/NZS 4187:2014, which now has the following requirements: • Water supplied to the steam generator is in accordance with EN 285 Table B.1 • Steam purity tests shall be conducted as part of IQ or OQ and in accordance with the requirements of EN 285 (see also Table 10.1) and the results shall not exceed the limits specified in EN 285 Table E.2 #HFMC17
Standards and Requirements for HSO’s AS/NZS 4187:2014 Key Points Steam However, EN 285 was revised in 2015 and: • Table E.2 was removed • Table 4 was added Table 4 is almost identical to Table A.1 in ISO 17665-2, which deals with contaminants with regard to corrosion, so is looking at clean steam EN 285:2015 requires: “steam that does not contain contaminants in quantities that can impair the sterilization process or harm or contaminate the sterilizer or sterilized load” #HFMC17
Testing Steam Quality and Purity #HFMC17
Steam Quality Tests The three tests done to determine steam quality are: 1. Dryness Value Testing 2. Non-Condensable Gas (NCG) Testing 3. Superheat Testing Steam Quality Testing is fairly well entrenched and there is little change here, apart from dryness value and super heat test limits aligning with EN 285 and ISO 17665 #HFMC17
Steam Quality Test Points The test points for the steam should be as close to the sterilizer as possible, but before the final separator and pressure reduction into the sterilizer. #HFMC17
Steam Quality - Test Points Detail Three test points are required in the steam supply to the sterilizer. #HFMC17
Steam Purity Testing Steam purity and clean steam is a more recent inclusion in the standard, so there is a need to understand the requirements. AS/NZS 4187:2014 refers to EN 285, and also ISO 17665 – EN 285 contains methodology for sampling steam condensate – EN 285:2006+A2:2009 had two tables regarding limits on steam contaminants; • Table E.2 - Contaminates in condensate from steam used by the sterilizer to be considered in relation to contamination of the load • Table B.2 - Contaminants in condensate from steam supply to the sterilizer measured at the sterilizer inlet – EN 285:2015 has a single table regarding limits on steam contaminants; • Table 4 - Suggested maximum values of contaminants in condensate from steam supply to the sterilizer chamber – Unlike Table E.2, Table 4 does not refer to Bacterial Endotoxins (Pyrogens), so can be considered with regard to corrosion of materials (the requirement for clean steam) #HFMC17
Steam Purity Testing – ISO 17665-2:2009 has two tables regarding limits on steam contaminants; • Table A.1 - Contaminates in condensate measured at the steam inlet to the sterilizer to be considered in relationship to the corrosion of materials • Table A.2 - Contaminants in condensate from steam used by the sterilizer to be considered in relation to contamination of the load – ISO 17665-2:2009 Table A.1 and A.2 are the same as table B.2 and E.2 (respectively) in EN 285:2006+A2:2009 – EN 285:2015 Table 4 is identical to ISO 17665-2:2009 Table A.1, except Table A.1 has a lower conductivity limit (<= 3 μ S/cm at 25°C table A.1 compared to <= 4.3 μ S/cm at 20°C Table 4) #HFMC17
Steam Purity Testing – EN 285:2006+A2:2009 and EN 285:2015 both also contain a table on feedwater contaminants; • Table B.1 - Contaminants in feed water supplied to a dedicated steam generator – These tables are identical in both revisions of EN 285, except that there is a lower level of Chloride allowable in EN 285:2015 #HFMC17
Steam Purity Testing Contamination with regard to Load ISO 17665-2:2009 – This should be regarded as the minimum steam purity requirement and includes testing for Bacterial Endotoxins (Pyrogens) – AS/NZS 4187:2014 references Table E.2 of EN285:2006+A2:2009, which is the same as Table A.2 in ISO 17665-2:2009 – Table E.2 has been removed from EN285:2015, so to keep in line with the intent of AS/NZS 4187:2014 testing for contamination with regard to Load should be done to Table A.2 of ISO 17665-2:2009 – Table 10.1 of AS/NZS 4187:2014 indicates annual testing #HFMC17
Steam Purity Testing Contamination with regard to Corrosion – ISO 17665-2:2009 For a clean steam generator the steam purity still needs to meet the requirements of contamination with regard to Load, and in addition should also meet the requirements of contamination with regard to Corrosion – Testing for contamination with regard to Corrosion should be done to Table A.1 of ISO 17665-2:2009 (which is almost identical to Table 4 in EN 285:2015) (Conductivity limit of EN285 Table 4 is 4.3 μ S/cm at 20 ° C) #HFMC17
Feedwater Purity Testing EN 285:2015 – For a clean steam generator the Feedwater should also be tested (as per Table 10.1 of AS/NZS 4187:2014) – Feedwater for a dedicated generator should be tested to Table B.1 of EN 285:2015 #HFMC17
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