Below is the HTM01-05 Periodic Test Schedule for Benchtop Sterilisers that should be followed if manufacturer or PCT recommendations are not available.
It is a generic schedule created from the methods within the various legislative guidelines used to create HTM01-05.
HTM01-05 Periodic Testing & Validation Schedule for Benchtop Sterilisers
Daily Requirements
Daily Control Test
What is it?
This is an observational test that records the operation of the machine and demonstrates that the process is repeatable by compairing the results against previous tests. The observer should note the length of the cycle along with the temperatures and pressure reached using the machines own display. A successful test should demonstrate that correct temperatures as stated in the machines own manual are being reached, that the door cannot be opened during the cycle if the machine has a lid, and that a ‘Cycle Complete’ indication is provided.
Steam Penetration Test
What is it?
Only required for vacuum sterilizers (Type S & Type B), the test demonstrates the machines ability to remove all air from the chamber before applying steam to the load. If air is present in the chamber this will form pockets and prevent steam from contacting parts of the load.
Weekly Requirements
Air Leakage Test
What is it?
This test proves that the machine will fail a cycle if a leak is detected. Many modern machines are able to perform this test at the push of a button and if this is the case the results should be recorded. Older machines require a leak to be induced manually and this can only be performed by a qualified validation engineer due to the dangers involved in altering a high pressure vessel. If an engineer is required then the test must be performed quarterly during the CPD Engineer Validation.
Quarterly Requirements
CPD Engineer Validation
What is it?
Not to be confused with a machine service. A machine validation proves that the machine is performing as dictated in HTM01-05 and creates a ‘snapshot’ of machine performance. The proceedure should be carried out by a qualified validation engineer. HTM guidelines require that four performance validation ‘snapshots’ are required during an annual period as this procedure is more likely to identify any problems with the machines performance. A validation report should be issued by the engineer after each proceedure for filing with the machines records as evidence of machine performance.
Annual Requirements
Repeat all Quarterly Requirements
What is it?
Annual tests are a repeat of all quarterly requirements.
HTM01-05 states that manufacturer guidelines should take precedent over the schedule listed above and should be sought out to ensure that any machine specific testing and validation requirements are being carried out.
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