The Medisure Service and Validation Procedure for Sterilizers is divided into three main sections.
a) STERILIZER SAFETY INSPECTION AND
PREVENTATIVE MAINTENANCE
Our servicing program is based on the recommendations as stipulated in the manufacturer’s service manual. A 30 point checklist is used and includes the cleaning of the Chamber, Reservoirs, Radiators and Filters. Replacement of the Hepa Bacterial Filter.
Safety Inspection of all Electrical and Pressure components. Cleaning and lubricating of components e.g. Solenoids, Pressure and Vacuum Pumps.
b) CALIBRATION, HEAT DISTRIBUTION AND
OPERATIONAL TEST.
For the Calibration Check, the three major parameters tested are Temperature, Pressure and Time. The accuracy of your sterilizer's gauges / digital displays are checked against our test instruments.
The Sterilizer is calibrated so that the coldest part of the chamber maintains a temperature above 134 deg C (for a 134 degC cycle) during sterilizing to ensure that minimum sterilizing temperature is maintained throughout the chamber.
For the Heat Distribution Check, the “Cold Spot” in the chamber is identified to enable you to complete your Load Validation Procedure. The Operational Check ensures that all functions on the sterilizer are working correctly.
c) STERILIZER LOAD VALIDATION (required for accreditation)
The Sterilizer Load Validation procedure is divided into 2 parts.
Part 1 - The Load Penetration Test
For the Load Penetration Test, one or more temperature test probes are placed inside a “Test Pack(s)” that are part of a load selected by the customer as being the most challenging to the sterilizer and the normal cycle for that load is run.
The time taken to reach sterilizing temperature and the actual time at sterilizing temperature within the Test Pack(s) are recorded to check that proper sterilization parameters are met. A second probe is placed inside the chamber “Cold Spot” as a reference.
Part 2 – Biological Testing
This Test is usually required to be performed by the person in charge of the sterilizer.
Three consecutive cycles are run with the “Test Pack(s)” and Challenge Load as outlined above.
With each cycle, at least two Biological Indicators are placed inside the sterilizer with the load.
One Biological Indicator is placed in the “Cold Spot” of The Sterilizer
One or more Biological Indicators are placed inside the “Test Pack(s)”
The six or more Biological Indicators and one “Control” Indicator (which is not sterilized) are sent to pathology for testing.
All Biological Indicators should return a negative result with the Control Indicator returning a Positive result.