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Machine Qualification: Hands On, How to Do It

In three previous articles for NewSplash, I talked about installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). In this article we go from those first principles to hands-on execution of these activities. This specific application is for a washer-disinfector.

Installation qualification
Here’s the nitty gritty: IQ involves cataloging the state of the equipment delivered to you and the suitability of the utilities attached to it and their connections.

  • Is the unit delivered exactly what you ordered?
    • Through-wall decontamination/clean side mounting with double doors or a single door?
    • Automatic power doors that close on pressing Start and open on the clean side after the cycle is complete?
    • Door interlocks to ensure that both cannot be opened at the same time?
    • Connection to conveyors?
    • Number of rack shelves?
    • Automatic/manual cycle selection?
    • RO water capable for final rinse/all cycle phases?
    • Steam or electric heating?
    • Number of detergent/consumable pumps?
  • Are the utilities correct?
    • Three-phase power used?
      • If so, does/do the motor(s) turn in the correct direction?
      • Are the amperage and voltage delivered to the washer correct per its rough-in drawing/installation instructions?
      • Is there a local disconnect to allow shutdown of power to safely service the machine?
      • Are the wires to the machine sized large enough to handle the power?
      • Is the grounding correctly done?
    • Single-phase power
      • Are the amperage and voltage delivered to the washer correct per its rough-in drawing/installation instructions?
      • Is there a local disconnect to allow shutdown of power to safely service the machine?
      • Are the wires to the machine sized large enough to handle the power?
      • Is the grounding correctly done?
    • Cold and hot (if any) utility water supply
      • Correct pressure?
      • Correct flow capacity?
      • Water quality measured to allow correct dosing of consumables?
    • Critical water supply
      • Correct pressure?
      • Correct flow capacity?
      • Suitable piping material?
    • Steam (if any)
      • Correct pressure?
      • Correct flow capacity?
    • Drain
      • Correctly sized?
      • Air break present and correct?
    • Compressed air (if any)
      • Oil-free?
      • Correct pressure?
      • Adequate flow?
    • Machine aspects
      • Are there any sensors (temperature, pressure) that need calibration?
        • Have they been calibrated after installation?
        • Has documentation including traceability of the standards used been supplied?
      • Detergent/consumable pumps
        • Have the doses been set for the detergent pumps in accordance with the water quality and detergent IFU?
        • Has the dose of lubricant been set for the pump in accordance with the lubricant IFU?

Operational qualification
OQ involves proving that the washer can run the cycles you expect it to run, and run them correctly. For each cycle and rack type, you should run three cycles in a row and compile information that proves this, as follows:

  • Check the cycle definitions to see that the cycle phases in each are programmed correctly.
  • For each rack type, run three of each cycle that will be used with that rack and catalog the following. If the cycle executes as specified, you have a successful trial for that part of the OQ.
    • Cycle phase duration
      • Also cycle phase duration at temperature, since warmup should not count toward the phase’s execution
    • Cycle phase temperature
    • Dosing of the right detergent or lubricant in the cycle phase
    • Drying success
  • For each error condition listed in the manual, simulate the error and ensure that the machine responds in the way the manual says it does.
    • Blocked door
    • No water
    • No compressed air
    • No steam, etc.

Performance qualification
Here, you test the machine’s ability to actually clean, since that is what washers are supposed to do. This can be done with empty or loaded racks. It is best to do this first with empty racks and commercially available cleaning indicators, since if you can’t clean them with no load, you won’t be able to clean them with a load. For lumen adapters, a lumen process-challenge device (PCD) should be used to test the lumen cleaning capability.

For testing with a load, the load should be typical of the use of the washer. Indicators should be placed in the load-in areas where you expect them to be hard to clean and areas where you expect them to be easy to clean. In the following positioning guide, each indicator is positioned where a scissors icon is shown. This gives you a thorough examination of the cleaning capability of the washer.

Again, three runs for each cycle type. Unless you are using validation-grade cleaning indicators, like the Aseptium VeriTest, you want nothing less than complete cleaning of the indicators used in the test.

What’s in the report?

  • Washer manufacturer, model number, serial number, year (and month, if available) of construction.
  • Location in the building.
  • Who did the testing.
  • Standards to which you tested.
  • All of the data shown above.
    • If you want to get really serious, contact me for a copy of the German guidelines (in English, of course).
  • Any deviations from expected performance and how they were resolved.

If you have any deviations that have to do with cleaning performance, you will have to optimize your cycles. “Optimize”? Your installations are unique. The water quality and other aspects of the utilities and cycle execution may not allow for proper cleaning. But that is the subject of the next article.

If this is done thoroughly, you will know that your machine will work in your facility on day one that it is released to start being used for instrument processing. Therefore, you will know that it should always be capable of that level of performance if proper maintenance is carried out. And, in this model, you will need to do an abbreviated requalification annually. Or after major repair. Or after changing detergents. Not because I am being mean. But because you want to be sure that the performance you expect is still there.

Reference

  1. “Guidelines for Validation and Routine Monitoring of Automated Cleaning and Disinfection Processes for Heat-Resistant Medical Devices as Well as Advice on Selecting Washer-Disinfectors,” Second Edition, Zentral Sterilisation: International Journal of Sterile Supply 15, no. 2 (May 2007), http://www.deconidi.ie/html/educ/recommendations/central-service-recommendation-200705_en.pdf.

Dr. Jonathan Wilder has worked with all thermal and chemical sterilization methods, as well as cleaning and disinfection methodologies, bringing his background in physical chemistry and surface physics to bear upon difficult problems in the field. He has been an active participant in U.S. and international standards development since 1998 through AAMI. As of January 2018, he is the cochair of the U.S. standards-making committee for hospital steam sterilizers.

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