Validation and routine testing of the ultrasonic · PDF fileWelcome ! Medisafe Research...
Transcript of Validation and routine testing of the ultrasonic · PDF fileWelcome ! Medisafe Research...
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Welcome !
Medisafe ResearchValidation of the Ultrasonic
Process
world leaders in decontamination of complex instruments…
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Standards
• HTM 2030 - Guidance being used as a standard..
• EN ISO 15883 - Washer-disinfectors
Both call for Validation!
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The link between BSE and vCJD was established in 1996…
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Validation & Routine Testing• Manufacturers ValidationManufacturers Validation
• Installation & CommissioningInstallation & Commissioning
• DailyDaily TestsTests¹¹
• Weekly Weekly TestsTests¹¹
• QuarterlyQuarterly Tests and ValidationTests and Validation¹¹
• Annual Annual ValidationValidation¹¹
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Manufacturers Validation• Manufacturers are obliged to test machines
prior to delivery• Test results are to be available to the
customer
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Installation & Commissioning• Installation checks and tests to ensure safe
and effective operation of the machine
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Daily Tests¹¹
• To be carried out by the user– Automatic Control Test– Remove & Clean Strainers and Filters
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Weekly Tests¹¹
• Weekly Safety Checks• Carry Out Daily Tests• Cleaning Efficacy Test By Soil Residue
Detection
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Quarterly Tests¹¹
• Weekly Safety Checks• Automatic Control Test• (Verification of Calibration of WD
Instruments)• Test For Ultrasonic Activity• Cleaning Efficacy Test
– Test Soil– Reference Load
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Yearly & Revalidation Tests¹¹
• In addition to Quarterly Tests:– Water System– Drainage– Doors & Interlocks– Fault Interlock– Aerosol Discharge Test– Chemical Additive Dosing Tests– Cleaning Efficacy Test
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Yearly & Revalidation Tests¹¹
(Continued From Previous Page)– Chamber Wall Temperature Test– Load Carrier Temperature Test– Over Temperature Cut-Out Test– Thermometric Test For Disinfection– Load Dryness Test– Test for Ultrasonic Activity– Sound Pressure
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.
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Soil Residue Testing• Clearly defined Test Load of Instruments Clearly defined Test Load of Instruments
• Tests Correlate to BloodTests Correlate to Blood
• Simulates Protein RemovalSimulates Protein Removal
• Simulates Blood CoagulationSimulates Blood Coagulation
• Quantifiable Test ResultsQuantifiable Test Results
• Convenient and Easy to useConvenient and Easy to use
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Soil Residue Testing
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A Regular Laparoscopic instrument
Medisafe`s “See Thru” indicator Laparoscopic instrument
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Lumen Test
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Field distribution in two different Ultrasonic bathes
Ultrasonic Cleaner #1 at Z= 65mm
Ultrasonic Cleaner #2 at Z= 65mm
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Foil Testing in Action!
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Alternative methods…• Gives Indication of:Gives Indication of:
• Ultrasonic Cleaning Performance.Ultrasonic Cleaning Performance.
• Energy Levels throughout the tank.Energy Levels throughout the tank.
• Potential wash “over” load.Potential wash “over” load.
• Required time for “de-gas”Required time for “de-gas”
• Used for optimisation “fine tuning” !Used for optimisation “fine tuning” !
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More alternatives…..• Measures ultrasonic activity• Quantifies the results• Manual process
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Field distribution in two different Ultrasonic bathes
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Front
Front
1.503.18B
1.282.10A
PlateWire BasketPosition
Time Taken for Colour Change (min:sec): Time Taken for Colour Change (min:sec):
Time Taken for Colour Change – (Mins:sec’s)
Standard SI Digital
Wire Basket: 10mm ofofice 1mm wire
Flat Plate: 0.6mm guage stainless steel
Temp:28 Degrees Celcius
Test MethodPereg – Sonoc Check
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What about….???……ultrasonic units that incorporate a
disinfection phase???
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A combination of tests!• Classified as a Washer/Disinfector
• Further design considerations
• Protein residue testing
• Thermometric testing
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With thanks…….
• Klaus Roth/SMP
References…..¹¹ HTM 2030, Validation & Verification, p52, NHS Estates, 1997
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Thank you !Questions are Welcome…
world leaders in decontamination of complex instruments…