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

• HTM 01-05 has the steam penetration test as a daily requirement. This test can only be performed on vacuum sterilisers, with the aid of a Helix or Bowie-Dick. (HTM 01-05 2013 edition. Section 4.16) Some manufacturer’s recommend the steam penetration test to be complete at a different frequency. Please seek manufacturer’s advice on the steam penetration test, or download for FREE a validation test schedule (VTS) on the Isopharm website.

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

Possible fail reasons for Valisafe Bowie Dick Packs are:

Diagnosing the Method of Sterilisation

• Check that the steriliser has been validated within the period specified by the manufacturer.
• Check that the steriliser under test is performing a vacuum cycle.

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.