SAP Products
Steris manufacturers of world class quality Sterility Assurance products for Pharmaceutical / Biotech / cosmetic industries.
Sterility Assurance Products like TST Bowie Dick Test Pack, Self Contained Biological Indicators, Spore Strips etc, Chemical Class 6 Indicators like TST calibrated for 12,15,20,25 and 30 minutes.
A steam penetration test for daily use in pre-vacuum STEAM sterilizers working at 1210 C-124 o C upto 8.3 Minutes as required in EN ISO 17665-1:2006 Conforms to: 1S0 11140-4:2007 class 2
The Browne TST Bowie Dick Single Use Test Packis an accepted method of testing the steam penetration and air removal capability of a vacuum steriliser. The TST indicator system is diagnostic which helps you to speed up fault detection and steriliser repair times. This Saves you time and money.
The Browne TST Bowie Dick Single Use test pack the most stringently tested and monitored test pack available worldwide. Combining the Bowie & Dick concept with Advanced TST technology monitoring Time, Steam and Temperature.
Availability:- TST Bowie Dick Test Pack 1210 C-124 o C upto 8.3 Minutes Order Code—2310
Conformsto EN867-4 (The European standard for alternative BD Tests)Manufactured to ISO 9001:2000 & ISO 13485:2003 Yellow to dark blue/purple colour change. Single use/disposable.
Instructions for use
Important: The TST Bowie Dick Test should be performed at the beginning of each working day or each shift, whichever comes first.
- Pre-heat the sterilizer by running one complete cycle.
- Record relevant test cycle information on the outside of the pack in the space provided if required.
- Place the Browne TST Bowie Dick Test Pack horizontally between 100 and 200mm over the chamber drain or as near as practically possible on a perforated support, in a pre-heated empty sterilizer.
- Run a cycle of the machine using the same air removal stage as that to be used for sterile product production, at 134°C-137°C for up to 3.5 minutes. The pack should be immediately removed from the sterilizer and the results checked.
Pass Result
If the sterilizer air removal stage is functioning correctly and enabling rapid and even steam penetration, the ink pattern on the TST indicator sheet will have changed from yellow to a blue/purple colour.
Fail Result
If even and rapid steam penetration did not occur, the ink pattern on the test sheet will show a yellow or brown colour towards the centre of the pack.
Note:
- Care should be taken as the TST pack may be warm.
- Exposure to 134°C-137°C for greaterthan 3.5 minutes invalidates the test.
- The test sheets located inthe centre of the pack.
Browne TST Control Cycle Verification (Emulating) Indicators provide the most specific information of any chemical indicator available. All Indicators have been calibrated to perform to the predefined parameters of a particular process, helping the end users detect process failure by confirming that all of the predetermined cycle parameters have occurred at point of placement in each tray, pack or pouch.
Using the latest Intelligent Ink Technology, the Browne TST Control Cycle Verification Indicator will change from yellow fo a uniform blue/purple on exposure to an effective sterilization cycle.
TST Control Cycle Verification (Emulating) Indicators
Non-toxic — Lead Free
Browne TST Control Cycle Verification (Emulating) Indicators incorporate the unique TST Intelligent Ink technology. Lead free and non-toxic, this patented ink technology is both safe to use and environmentally friendly.
Accurate, Consistent, Reliable
- Conform to ISO 11140-1 Class 6
- Independently certified by British Standards Institution (BSI)
Browne TST Control Cycle Verification (Emulating) Indicators conform to ISO 11140-1,Class 6 and are manufactured in an ISO 9001:2000 and EN ISO 13485:2003 environment.
Albert Browne Ltd was the first company in the world to be able to display the British Standards Institution (BSI) Kitemark on Class 6 emulating indicators for cycle verification. BSI not only undertook the independent testing, but also examined all the necessary production control systems in place, to ensure consistency of manufacture. This arguably makes Browne TST Control Cycle Verification (Emulating) Indicators the most stringently tested indicators available worldwide.
Class 6 — Cycle Verification — What it means to you
International Standards Organisation (ISO) provides six classifications of chemical indicator in their document ISO 11140-1, from the simplest Class 1 Process Indicators such as autoclave tape to Class 6 Cycle Verification (Emulating) Indicators.
Sterilization cycles have been scientifically calculated to provide the best
chance of achieving sterility, so it makes sense to use a chemical indicator that
has the capability to verify these cycles — the only type of indicator that can, is
the Class 6 TST Control Cycle Verification (Emulating) Indicator.
To make sure you get the accuracy you need, Browne has a range of class 6
indicators to suit any cycle profile :-