Automatic Control Test: Sterilisers

The Automatic Control Test is carried out daily/weekly by the user and quarterly/yearly by a validation engineer, depending on the manufacturers periodic test schedule.

What Is It?

This is an observational test that records the operation of the machine and demonstrates that the process is repeatable by comparing the results against previous tests. Key stages of the sterilisation cycle are validated, such as cycle length, and that the temperature is as required by the manufacturer.

When Is It Performed?

The Automatic Control Test is carried out daily/weekly by the user and quarterly/yearly by a validation engineer, depending on the manufacturers periodic test schedule.

Test
Document Reference Periodic Testing
D W Q Y
Automatic Control Test HTM 01-05 15.3

User

 

 

User

 

 

CP(D)
or
ENG 

 

CP(D)
or
ENG

WHTM 01-05 15.3
SDCEP 6.2

D = Day | W =Weekly | Q = Quarterly | Y = Yearly | CP(D) = Competent Person (Decontamination) | ENG = Engineer

How is it Done?

Watch our movie on how to perform this test:

Each individual stage is also explained below:

Step 1

To perform the test manually, start a routine cycle.

Make sure that the door locking mechanism is initiated.

Step 2

Be ready with your stopwatch. You will need to time the length of the sterilisation holding time. This will be indicated by your steriliser.

When the sterilisation cycle starts begin your stopwatch.

Step 3

During the sterilisation holding time, record the minimum and maximum temperatures, and the pressure displayed.

Step 4

As with the start of the sterilisation holding time, your steriliser will also inform you when this has completed. When the holding time has elapsed, stop your stopwatch.

In order to pass the test the holding time must have been for a minimum of 3 minutes between a temperature of 134°C and 137°C. The display must also provide an indication of ‘Cycle Complete’.

Step 5

You will need to record in the steriliser log book the cycle number, the length of the holding time, the minimum and maximum temperatures and pressure noted during that period. A record of who carried out the test is also required.

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