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Bowie-Dick-Simulation (BDS) Tests

STEAM PENETRATION




EU-Version
Simulating 7 kg cotton pack according to EN ISO 11140-4 and hollow load test according to EN 867-5



EU-Version
Simulating 7 kg cotton pack according to EN ISO 11140-4



USA-Version
Simulating 4 kg cotton pack according to ISO 11140-5

Application

The Steri-Record Bowie-Dick-Simulation (BDS) Test is daily used after start up as a functionality check (type test, no sterility test) for steam sterilizers. It has to be carried out in an empty sterilizer chamber. The BDS test is no substitution for routine monitoring. For routine monitoring indicators class 5 or 6 in each load or Batch Monitoring Systems (BMS) validated according to the load configuration should be used. Table top sterilizers according to EN 13060 type B do not require a Bowie-Dick Test but a hollow load type test according to EN 867-5. However some sterilizer manufacturers request the daily use of a BDS-test during start-up. The Compact-PCD® (colour: blue) combines the BDand hollow load test in one test.

Product Description

All three gke Steri-Record BDS-Tests are class 2 indicators according to EN ISO 11140-1 consisting of a “specific test load“ so-called Process Challenge Device = PCD and an “indicator system“ (indicator strip) inside.

All gke BDS-tests are class 2 indicators according to EN ISO 11140-1.gke offers three different BDS-Tests with the following performance characteristics. The table below shows the conformity of the gke-BDS Tests.

All above mentioned BDS-Tests can be used in BD test programs at 132-137°C, 1-3.5 min or 121°C, 15-30 min. If these BD-cycle are not available, a normal cycle of 134°C for up to 9 min may be used.

Operation Description

A gke BD indicator strip has to be placed into the PTFE holder of the Compact-PCD®and the cap has to be tightened. The test device should be placed close to the bottom and near the door of the chamber on a stainless steel tray into an empty sterilizer chamber. This test can be used in Bowie-Dick-Test programs at 132-137°C (270-279°F); 1 – 3.5 min or 121°C (250 °F); 15 min. If this BD-cycle is not available, a normal cycle of 132-137°C for up to 9 min may be used without losing sensitivity.If all six bars of the chemical indicator turn from yellow to black it is an indication of sufficient steam penetration inside the PCD. A positive result ensures that the sterilizer works according to the sterilizer specifications.

Performance Characteristics
The sterilizer standards EN 285 and AAMI /ANSI ST79 describe three different type tests:

  • 1. American BD-Test
    Air removal test according to AAMI/ANSI ST79 (4 kg test pack) and validated according to the test method of ISO 11140-1 + 5.
  • 2. European BD-Test
    Air removal and steam penetration test validated according to the test method of EN ISO 11140-1 + 4 with reference to the 7 kg test pack in EN 285.
  • 3. Hollow load test described in EN 867-5 required as an additional type test in EN 285.

Benefits

  •  The innovative patented “multi-stage” design of the Compact-PCD®, colour blue, simulates the porous Bowie-Dick cotton pack and the Helix-Test.
  •  To be used in 132-137°C and 121°C-BowieDick-Test programs according to EN 285 and EN ISO 11140-3. The test may also be used in old sterilizers without Bowie-Dick Test programs and longer sterilization times without losing sensibility.
  •  Simple application – the chemical indicator may be easily removed and evaluated on completion of each cycle.
  •  Easy interpretation of the results due to precise colour change.
  •  Continuous reproducibility of the results.
  •  The graduated colour change of the indicator bars informs about the magnitude of air removal and steam penetration inside the sterilizer and non-condensable gases in steam.
  •  Environmentally friendly, no unnecessary waste.
  •  Indicator strips can be disposed with normal garbage.
  •  The indicator colour chemistry is a nonreversible chemical reaction and remains colour-fast over time.
  •  All gke chemical indicators are protected from bleeding by a polymer binder and surface coating.
  •  Cost-effective due to multiple use of the PCD.
  •  The screw-cap consists of a highly thermal resistant material and stainless steel sandwichconstruction that protects hands from high temperatures.
  • gke self-adhesive labels simplify recording with the gke Steri-Record® documentation system.

Order Information

Each start-up kit contains one Compact-PCD® and 100 integrating indicator strips as well as a documentation sheet to be copied before daily use. Test devices are available separately as well. The indicator strips are available as refill packs and contain a seal ring for replacement in the screw cap.

1.Air removal and steam penetration test validated according to the test method of EN ISO 11140-4 + 1 Class 2 with reference to the 7 kg test pack in EN 285 and the hollow load test exceeding the requirements of EN 867-5 .

2. Air removal and steam penetration test validated according to the test method of EN ISO 11140-4 + 1 Class 2 with reference to the 7 kg test pack in EN 285.

3. Air removal test according to AAMI/ANSI ST79 (4 kg test pack) and validated according to the test method of ISO 11140-5 + 1 Class 2

4. Indicator strip refill packs for all above mentioned BDS-Tests .