Process Challenge Devices – Small Steam Sterilisers
For Dentists, Ophthalmologists, Skin Cancer Clinics, Cosmetic Clinics, Podiatrists
The gke Orange Process Challenge Device (PCD) conforms to EN 867-5 and tests the air removal and steam penetration of B Type Benchtop Sterilisers.
The chemical indicators and device together form a Type 2 indicator system according to EN ISO 11140-1.
The patented devices consist of an external highly durable case containing an internal stainless-steel tube/helix connected to a capsule that holds the indicator. Due to the high durability of the materials the devices can be used for several thousand applications saving you money and limiting environmental waste.
The gke Orange Device can be used for both the Daily Air Removal and Steam Penetration Test / Bowie Dick Test / Helix Test as well as for routine monitoring of every load.
Monitoring sterilisers in “Office-based” Practices
Currently in Australia “Office-based practices” fall under the Australian / New Zealand Standard AS/NZS 4815:2006 – “Office-based health care facilities – reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment.”
“Office-based” practices by definition means “The provision of health care services in sites outside routine hospital in-patient and operating room settings. Such sites include private consulting rooms and health clinics.” Office-based practices include dentists, podiatrists, ophthalmologists, skin cancer clinics, cosmetic clinics and beauty therapists, tattooists and body piercers, veterinary practices, etc.
Typically, in these facilities small steam sterilisers or “benchtop sterilisers” are used for the reprocessing of instruments. These sterilisers utilise different cycle types depending on the requirements of the goods to be sterilised. These cycle types include B Type, N Type and S Type.
The gke range of products are most applicable to the B Type cycle which is used when steam sterilising wrapped or unwrapped goods of a porous, solid or hollow nature.
Bowie Dick Test, Helix Test or Daily Air Removal / Steam Penetration Test?
AS/NZS 4815:2006 requests that an “air removal and steam penetration test” be conducted daily in an empty chamber upon start-up of the steriliser. This test is a functionality check of the steriliser to ensure performance in accordance with the requirements of the standard for small steam sterilisers.
The requirements in AS/NZS 4815:2006 are derived from the International Standards written for small steam sterilisers – EN 13060 – “Small steam sterilisers” and EN 867-5:2001 – “Non-biological systems for use in sterilizers – Part 5: Specifications for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S.”
EN 867-5:2001 describes the test device to be used when testing B Type small steam sterilisers in accordance with ISO 13060.
The Bowie Dick Test was derived in 1963 to test large steam sterilisers for the presence of air or inadequate air removal and steam penetration. The test is defined in the standard EN 285 as a 7kg cotton pack with indicator page inside and serves as a “type test” / functionality check of a large steam steriliser to ensure adequate air removal and steam penetration. This test was for porous loads in large steam sterilisers and compared to hollow devices, has different air removal and steam penetration characteristics.
Therefore, to ensure adequate sterilisation of hollow devices, in 2008 a hollow load test device according to EN 867-5 was added to EN 285 as a second type test.
In small steam sterilisers the original Bowie Dick Test (7kg cotton pack) cannot be used because of its size, furthermore a test to this specification it is not required in the standard for small steam sterilisers EN 13060. The type test / functionality test for small steam sterilisers (Type B) is the hollow load test defined in EN 867-5.
Many small steam sterilisers have a cycle called “Bowie Dick Test Program.” The Helix-Test according to EN 867-5 may be used in this test cycle. By completing this test daily upon start-up, the user is assured the steriliser is ready for operation and that the steriliser has met the requirements of the standard for performance.
Therefore, the terminology Bowie Dick Test or Helix Test or Daily Air Removal and Steam Penetration Test are synonymous when referring to benchtop sterilisers.
The gke Orange Device is suitable to monitor this cycle / daily start-up test.
Routine Monitoring of Benchtop Sterilisers
If the daily start-up test (Bowie Dick Test or Helix Test or Daily Air Removal and Steam Penetration Test) has been successful, this is no substitute for routine monitoring and ensuring each load inside the steriliser has been successfully sterilised.
The gke Orange Device is suitable for use in the back-to-back monitoring of every load to detect insufficient air removal, leaks and/or non-condensable gases (NCG) in steam.
- Easy interpretation of the results due to a precise colour change
- The graduated colour change of the indicator provides information about the magnitude of air removal and steam penetration inside the steriliser and non-condensable gases in the steam
- Cost effective due to high durability of device, no need to replace the device after a limited number of cycles
- Less storage space required for the products in the CSSD
- Adhesive backing for ease of documentation of results
- Limited environmental waste due to the durability of the device and size of the indicator
|F200-026||Compact PCD – Orange, Oval||1|
|F211-252||Batch Monitoring System Indicator Strips (Steam)||250|
|F211-255||Batch Monitoring System Indicator Strips (Steam)||500|
Declarations of Conformity and Product Directions for Use can be supplied upon request.