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Glass Washer Disinfector Qualification Overview

A Glass Washer is used in medical and pharmaceutical environments to clean process equipment before sterilization, or to remove debris and contaminants from process equipment and tools before reuse.

Qualification

Qualification

Typically, a washer uses a rotating water spray system, thus making the use of wired dataloggers challenging. Additionally, washers do not usually have a validation port that would allow for the secure installation of thermocouples, so the use of wireless dataloggers for washer qualification is very convenient.

The validation process typically requires four thermometric tests to be executed on an empty chamber, and then four thermometric tests to be executed on a chamber containing a standardized load. The temperature results from the mappings allow for the calculation of a lethality value. The required lethality is dependent on the items undergoing cleaning and the contaminants to which they’ve been exposed. Finally, the rinse water conductivity is measured and must meet acceptable limits set by the end user.

Methodology

Ellab offers several wireless validation solutions for the qualification of washer disinfectors:

  • TrackSense™ Lab Quad Semiflex temperature sensors allow for multiple locations within the chamber to be monitored from one data logger, with an accuracy of ±0.1°C and a range of -30°C to 100°C.
  • TrackSense™ Pro Combi Conductivity sensor, with an accuracy of ±2.5% down to ±0.1 µS/cm.

Our validation staff can assist with the qualification of a washer disinfector, from the execution of the manufacturers’ protocol through IOQ to final report release.

Standards and Guidelines

  • ISO 15883 – Includes general guidance for the performance of washer-disinfectors used for the cleaning of medical devices and other purposes related to medical device, pharmaceutical and biotech processes

Manufacturers

  • Steel Co.
  • Tuttnauer
  • Endo-Technik
  • Beli-Med
  • Cisa
  • Getinge
  • Miele Professional
  • Matachana
  • Euronda
  • Medivators
  • Sondina
  • Prestige Medical
  • BHT
  • Medisafe

Ellab Inc.
303 E 17th Ave, Suite 10, Denver CO 80203
Phone: +1-303-425-3370
Email: usa@ellab.com

Additional Locations:
New Hampshire - Texas

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