HTM 01-05 Steam Penetration Test

What is it?

This test validates the vacuum and steam penetration of the cycle and is only required for vacuum sterilisers (Type S & Type B). It is not performed on a non-vacuum Type N steriliser.

HTM 01-05

Steam Penetration Test

The test is performed to ensure that the steam penetration of the cycle is efficient when processing wrapped or hollow loads.

This is achieved by validating that air and/or non-condensable gases in the chamber that impair sterilisation have been removed sufficiently by the vacuum stage of the cycle.

With air and/or non-condensable gases removed, the steam can then penetrate the entire load rapidly and evenly.

 

What Equipment and Materials are Required?

  • Benchtop Steriliser Log Book
  • Steam Penetration Test (Helix Device or Bowie Dick Pack)
 D = Day | W =Weekly | Q = Quarterly | Y = Yearly | CP(D) = Competent Person (Decontamination) | ENG = Engineer
 * Check with the machine manufacturer whether this test should be performed with either a Helix or Bowie Dick Pack

When is it Performed, and by Who?

Document Specific Title Reference Installation & Commission Periodic Testing
D W Q Y
HTM 01-05 Steam Penetration Test
(Type B and Type S only)
Table on page
56 Refers to
MDA DB 2002(06

SUPPLIER
or
ENGINEER

USER

USER

CP(D)
or
ENG

CP(D)
or
ENG

 

What is the Procedure, and Pass/Fail Criteria

Document Test Procedure Pass or Fail Criteria
HTM 01-05

Using a Helix Device

Although generic instructions for use are provided here, the specific instructions provided with the product should be used.

The test should be performed in a preheated chamber at the start of the day/shift and with only the Helix device placed on an instrument tray and the normal chamber furniture present.

1. Unscrew the cap of the Helix device.

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 device into a pre-heated chamber with only the test and the furniture present.

6. Run a vacuum cycle for processing instruments or the machines specific HELIX/BOWIE DICK cycle if available.

7. Once the cycle is complete, carefully remove the test. Remember that it will be hot.

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

The test is a pass if there is uniform colour change on the ink.

This validates that the vacuum stage was able to remove all the air from inside the Helix for the steam to then enter all the way to the test strip and change the colour of the ink during sterilisation.

The test is a fail if there are still traces of the original colour on the ink.

This indicates that air was not sufficiently removed from the Helix by the vacuum stage and this prevented steam from contacting part or all of the ink during sterilisation.

Using a Bowie Dick Pack

Although generic instructions for use are provided here, the specific instructions provided with the product should be used.

The test should be performed in a preheated chamber at the start of the day/shift and with only the Bowie Dick Pack placed on an instrument tray and the normal chamber furniture present.

1. Place the Bowie Dick Pack into a pre-heated chamber with only the test and the furniture present.

The pack is made up of many layers of porous material with an indicator sheet in the middle.

2. Run a vacuum cycle for processing instruments or the machines specific HELIX/BOWIE DICK cycle if available.

3. Once the cycle is complete, carefully remove the test. Remember that it will be hot.

4. Remove the indicator sheet from the pack and examine.

The test is a pass if there is uniform colour change on the indicator sheet.

This validates that the vacuum stage was able to remove all the air from inside the pack for the steam to then enter all the way to the indicator sheet and change the colour of the ink during sterilisation.

The test is a fail if there are still traces of the original colour on the ink.

This indicates that air was not sufficiently removed from the pack by the vacuum stage and this prevented steam from contacting part or all of the ink during sterilisation.