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WORLD CONGRESS OF STERILIZATION COMBINED MEETING WFHSS / AIOS

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WORLD CONGRESS OF STERILIZATION COMBINED MEETING WFHSS / AIOS

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  1. WORLD CONGRESS OF STERILIZATIONCOMBINED MEETINGWFHSS / AIOS Small Steam Sterilizers BS EN 1360:2004 KSVAS LTD

  2. L Kingston. Registered Authorised Person {Sterilizers}Member of :- • BSI - CH198 – Sterilization • CEN - TC 102 wg 2/3 – Steam Sterilizers • ISO - TC 198 wg 3 – Moist Heat Sterilization. • EPL/66 Safety of Measuring, Control and Laboratory Equipment. • BSI LBI 35- 1 KSVAS LTD

  3. SCOPE OF THE PRESENTATIONFOR THE CHANGES WITHIN BS EN 1360 • To provide a brief introduction to the update requirements and changes. • To introduce the current standard focusing on what is the requirement of small steam sterilizer: • Definition Small steam sterilizer:-Size one which is unable to accommodate sterilization module and has a chamber volume less than 60 litres Note One Sterilization module =300mmx 300mm x600mm KSVAS LTD

  4. SCOPE OF THE PRESENTATIONFOR THE CHANGES WITHIN BS EN 1360 • Sterilization cycle type:- classification of the process based on performance • Solid:- product not made from porous materials no recesses which present a greater or equal challenge than a hollow load (B) • Hollow load A :-single ended open space ratio of length to diameter of cavity greater than 1 less or equal 750 ( 1 ≤ L/D ≤ 750) or ( L ≤ 1 500mm) or ( 2 ≤ L/D ≤ 1 500 ) ( L ≤ 3000mm )which is not a hollow load (B) KSVAS LTD

  5. REVIEW OF THE CHANGES WITHIN BS EN 1360 • Hollow load B :- single ended open space ratio of length to diameter of cavity greater than 1 less or equal to 5 (1 ≤ L/D ≤ 5) Where diameter greater than or equal to 5mm(D ≥ 5mm or double ended where ratio length / diameter greater than equal to 2 less than10 (2 ≤ L/D ≤ 10) or (D ≥ 5mm) • Temperature measurement reference position:- identified by manufacture condition in useable space of chamber KSVAS LTD

  6. BS EN 1360– Structure B S N KSVAS LTD

  7. BS EN 1360– Structure S3 S1 S2 KSVAS LTD

  8. Operational ServicesPoints to be aware of : • Water Supply Steam Generation. • Designed to function with water free of contaminants • Cause no harm to sterilizer or the sterilizer load KSVAS LTD

  9. Operational Services Points to be aware of : • Water Used other than for Steam Generation. • Potable quality • Range specified manufacturer,including 15°C • Cooling Purposes • Vacuum systems • Total hardness value 0,7mmol/l2,0mmol/l KSVAS LTD

  10. Operational Services Points to be aware of : • Water reservoir if fitted • Pipe work shall be fitted with valve or other device / automatic to allow draining by operator reservoir and pipework • Manufacturers design shall facilitate cleaning filling and inspection • Indicate sufficient water for operating cycle or shall not be capable of starting cycle • Designed to prevent back siphoning to chamber KSVAS LTD

  11. BS EN 1360 PROCESS PERFORMANCE DATA Values Type testing KSVAS LTD

  12. BS EN 1360 PROCESS PERFORMANCE DATA Values Type testing KSVAS LTD

  13. BS EN 1360 PROCESS DATA limiting values to be recorded KSVAS LTD

  14. BS 1360 Sterilizers Process Evaluation System If fitted • Compare with validated cycle any change pressure or temperature time period that change occurs • Change beyond programme limits Shall cause an indicate Fault KSVAS LTD

  15. BS 1360 Sterilizers Process Evaluation System If fitted • Compare two independent temperature sensors sterilizer temperature instrument chamber and recorder ; or • Capable comparing theoretical steam temperature with chamber during the holding period Shall cause an indicate Fault KSVAS LTD

  16. BS 1360 Sterilizers Process System Time – Temperature relationships:- STERILIZATION °C Minutes KSVAS LTD

  17. BS 1360 Sterilizers Process System Time – Temperature relationships:- Equilibration °C Seconds 30sec KSVAS LTD

  18. BS 1360 Sterilizers Process System Time – Temperature relationships:- Equilibration °C Seconds KSVAS LTD

  19. BS 1360 Sterilizers Process Cycle DATA AND LIMITING VALUES TO BE RECORDED START TIME END TIME HOLDING TIME HIGHEST & LOWEST VALUES PRESSURE TEMPERATURE 134°C T E M P E R A T U R E TOP OF PULSE TIME START DRYING END TIME AMBIENT PRESSURE TIME SECONDS -1BAR KSVAS LTD

  20. TYPE B cycle P (bar) 20 min ! ECO-B ECO-B 15 min 30-40 min Plateau Fractionated vacuum Drying KSVAS LTD

  21. BS 1360 Sterilizers Testing System Air Leakage Test Shall not cause rate pressure rise to exceed 0.13kPa/min{1.3mbar/min} when tested Requirement △p p3 - p2 = Ambient atmospheric pressure △p 10 P3 P2 P1 300sec 600sec f1 f2 f0 f3 Time in seconds KSVAS LTD

  22. BS 13060 STERILIZER Leak Test Reports PASS FAIL KSVAS LTD

  23. BS 1360 Sterilizers Performance ATTAINMENT STERILIZATION CONDITIONS All temperatures measured in useable space and load are not lower than the sterilizer selected temperature   Are not more than 4K above sterilization temperature selected Requirement:- Do not differ from each other by more than 2K  KSVAS LTD

  24. BS 1360 Sterilizers Performance TYPE TEST PROCEDURE Thermometric measurement Eight sensors shall be used  Test equipment requirements  One external pressure sensor Sensors connect to chamber Type tests shall be repeated Twice (three tests in all)  KSVAS LTD

  25. BS 1360 Sterilizers Testing Process Cycle Process Challenge Device & Chemical Indicator system for Hollow Load A Key 1 Capsule 2 Sealing 3 Indicator system 4 Connector 5 Open end 6 Tube KSVAS LTD

  26. BS 1360 Sterilizers Steam Testing • Steam pressure kPa (bar) Bore mm ± 0,02up to 400 (3)0,8up to 500 (4)0,6up to 800 (7)0,4 Bulkhead fitting Dimensions in millimetres KSVAS LTD

  27. BS EN 1360 Porous loadNon- Condensable Gases Exact position of the capillary tube inlet to sample from the sterilizer chamberhas been found to vary in position for collection of sample For measurement of non – condensable gases Apparatus Measurement Non-condensable gases KSVAS LTD

  28. BS 1360 Sterilizers Steam Testing Steam Service supply main steam • Steam pressure kPa (bar) Bore mm ± 0,02up to 400 (3)0,8up to 500 (4)0,6up to 800 (7)0,4 KSVAS LTD

  29. BS 1360 Sterilizers Steam Testing Steam Service supply main steam • Apparatus • for sampling • Steam • Condensate • for chemical • analysis KSVAS LTD

  30. BS 1360 Sterilizers Definition hollow space A Not hollow Objects which are not hollow Within standard cavity to diameter less than 1 Less than 1 Hollow A objects Cavity with length to diameter greater than 1 and greater than 5 for all objects 1 Greater than 5 KSVAS LTD

  31. BS 1360 Sterilizers Definition hollow space B Hollow B objects Ratio of the length of cavity to diameter greater than 1 and less than than 5 for both objects Example 8mm x 15mm KSVAS LTD

  32. BS EN 1360 Porous load WORKS / INSTALLATION TEST Small load textiles cotton sheets 450mm x 300mm Reduced test pack x Volume of more than 54 litres x Small porous load test single wrapped Diameter of at least 35 cm x Thermal Sensors x positions x KSVAS LTD

  33. BS EN 1360 Porous load TYPE TEST Small load textiles cotton sheets 450mm x 300mm Reduced test pack Volume of more than 54 litres Small porous load test single wrapped Diameter of at least 35 cm Thermal Sensors x positions KSVAS LTD

  34. SMALL STERILIZERSMoist Heat Sterilization • The future may be a combined standard applicable to all moist heat sterilizers • EN 13060 • EN 285 • In accordance with the Vienna agreement KSVAS LTD

  35. The Vienna Agreement • An agreement made between CEN and ISO to ensure harmonisation of standards published by the two organisations. Harmonisation of standards CEN & ISO KSVAS LTD

  36. BS 1360 Small Steam Sterilizers Thank you Question JUNE 2008 Time KSVAS LTD