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SRACA QLD Annual Conference Townsville 2015. Presentation Aim – To provide an interpretation of the validation protocols and procedures related to AS/NZS 4187:2014 Washer Disinfectors. Presenter – Peter Francis Getinge Australia Pty Ltd. VALIDATION. Something that is ”VALID ”.
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SRACA QLD Annual ConferenceTownsville 2015 Presentation Aim – To provide an interpretation of the validation protocols and procedures related to AS/NZS 4187:2014 Washer Disinfectors Presenter – Peter Francis Getinge Australia Pty Ltd
VALIDATION Something that is ”VALID” What is ”VALIDATION” CORROBORATION APPLICABLE LEGALIZATION CONVINCING JUSTIFICATION COMPELLING RATIONAL LEGITIMATE SUBSTANTIATION OFFICIAL SUPPORT LEGAL CONFIRMATION SUITABLE
Washer Validation AS/NZS 4187:2014– Validation and RouteenTesting
Installation Qualification – I.Q. Aligned to AS/NZS 4187:2014 • Verification of services & installed environments • Water supply quality • Verification of washer disinfector specification
Installation Qualification – I.Q. Treated Water Quality
Operation Qualification – O.Q. Aligned to AS/NZS 4187:2014 • Calibration of temperature and pressure analogue inputs • Verifying accuracy of chemical dosage • Safety checks • Door interlock checks Link
Performance Qualification – P.Q. Aligned to AS/NZS 4187:2014 Clause 7.4.3 – AS/NZS 4187:2014
Performance Qualification – P.Q. Aligned to AS/NZS 4187:2014 • Thermometric test • Load temperature test – 4 x Successful cycles • Cleaning efficacy test – 2 x Successful cycles (Loads, chamber walls and loading equipment) • Chemical residual test Link
Performance Re-Qualification – P.R-Q. Clause 7.4.3 – AS/NZS 4187:2014 Aligned to AS/NZS 4187:2014 Clause 6.1.5 – ISO 15883
Performance Re-Qualification – P.R-Q. Aligned to AS/NZS 4187:2014 Performance Re-Qualification to include all P.Q. activities plus calibration of temperature and pressure analogue inputs
Routine Tests Aligned to AS/NZS 4187:2014 • Monthly • Supply water quality testing • Quarterly • Verifying accuracy of chemical dosage