How this product helps you comply with HTM 01-05 (2013 Edition)

• Although HTM 01-05 does not state that indicator strips are required, most steriliser manufacturers recommend their use for easy and economic process validation. HTM 01-05 however does state that ‘manufacturers guidelines should always be followed.’

Manufacturer Recommendations for Testing Sterilisers

HTM 01-05 does not require the use of cycle indicators as a stand-alone test to comply with the validation schedule for benchtop sterilisers.

However, most manufacturers recommend their use to monitor the sterilsation process. Recommendations can vary from using one test strip in the first cycle of the day to using a test strip in every cycle.

Isopharm would recommend the following:

• If the steriliser has a recording device attached, such as a printer or data logger monitoring cycles, use a single test strip in the first cycle of the day.
• If the steriliser has no recording device fitted, use a test strip in every cycle.

Reasons Why the Test May Fail

Should the test fail a re-test should be performed. If the test fails a second time, a diagnosis of both the method of sterilisation and method of testing is required.

The complaince team at Isopharm is also available to discuss the test and test method.

Possible fail reasons for Browne TST Sterilisation Indicator Strips are:

Diagnosing the Method of Sterilisation

• Check that the steriliser has been validated within the period specified by the manufacturer.
• Check how the instruments and test strip were loaded onto the tray. Instruments should be placed neatly with no overlap.

Diagnosing the Method of Test

• Check that the test product used is within the expiry date provided.
• Check that the test product is being stored as manufacturer recommendations.