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.

HTM 01-05 Steam Penetration Test Using An Isopharm Helix Test for Type B Vacuum Sterilisers

1. Unscrew the cap of the Helix.

2. Take a Test Strip and fold it in half with the ink on the inside.

3. Load the test strip into the cap fold first.

4. Screw the cap back into the Helix.

5. Place the Helix onto an instrument tray and into a pre-heated chamber.The chamber furniture should be present, but no instruments should be processed during the test.Run a vacuum cycle for processing instruments or the machines specific HELIX/BOWIE DICK cycle if available.

6. When the cycle has finished, carefully remove the Helix from the chamber.

7. Remove the Test Strip from the cap and examine.

8. A uniform colour change from yellow to blue indicates that all air was removed during the vacuum stage of the cycle. This enabled steam to then penetrate into the helix to the test strip in the cap and pass the test.

9. If the original colour remains visible and the colour change from yellow to blue is not uniform, this indicates that the vacuum stage was not able to remove all air from the Helix. This prevented steam from penetrating to the test strip in the cap and failed the test.

10. Complete the Steam Penetration Test table in the steriliser log book.

11. The test strip should be attached into the log book as further evidence of test result.

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 the Valisafe Helix Test for Type B Vacuum Sterilisers are:

Diagnosing the Method of Sterilisation

• Check that the steriliser has been validated within the period specified by the manufacturer.
• Check that the machine is a Type B vacuum steriliser. The test will not perform as intended in a Type S vacuum sterilsier.
• Check that the manufacturer specifies this as the correct method of test.

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.