Steriliser Validation Services

In-A-Tick has been working with Steam Consulting to revise and establish our test regime and reporting format, to meet the requirements of Australian Standard AS/NZS 4187:2014, International Standard ISO EN 17665, and also our clients accreditation needs.

Instrumentation

iat customer feedbackBy combining the latest test instrumentation/technology from EBRO and the assistance of a local CSSD technician, the validation cycles are run using standard cycles and packs. Up to 12 temperatures and 1 chamber pressure are all profiled and recorded simultaneously and transmitted wirelessly to a computer, which plots the responses and generates the report.

The validation of selected sterilisation process, for the common load configurations and patterns is initiated with data and test results, is automatically comprehensively analysed and interpreted. The sensors are all certified in terms of calibration to a traceable source.

iat wireless emro loggers

Wireless EBRO loggers

Performance Qualification Report

The performance qualification report includes the following:

  1. Identification of the Steriliser.
  2. Location of cold spot from Heat Distribution studies, Leak test and Bowie & Dick test results
  3. Description of the type of load and its loading pattern within the sterilisation chamber, including colour photos, and the cycle details
  4. Location and position of all sensors and biological indicators. This is represented in the report by an image showing locations of sensors diagrammatically in three dimensions.
  5. Results of all process parameters, including biological including the time and date when each of the three performance qualification cycles were run.

    iat steriliser print out

  6. Copies of local sterilisation documentation and steriliser print-outs
  7. If any cycle failed, the results of the investigation into the failure and any recommendations/comments will be recorded
  8. Name and signature of the person undertaking performance qualification
  9. Copies of calibration certificates for the sensors used

iat calibration certificate

For further information and bookings, please contact:

Miranda Coombs, National Manager IAT Compliance Testing Services
T 1800 765833 (1800 SOLVED)
M +61 408 367 169
E mcoombs@in-a-tick.com.au