Validation of steam sterilizers is vital in ensuring safe and compliant sterilization in every cycle – as such several standards define acceptable validation tests.
The ISO standard 17665-1 demands that a steam penetration test be performed daily before the first sterilization cycle. The EN 285 standard defines how the test device should be positioned in the chamber. The ISO 11140-4 standard specifies using an indicator which can identify poor steam penetration.
The EBI 16 electronic Bowie Dick dataloggers by Ebro allow you to meet all of these demands for full compliance, and in a fast, simple and safe manner.
The system also includes evaluation of the results and saving of all data for a complete picture of the autoclave sterilizer performance.
Electronic Bowie Dick method – saving time and improving accuracy
The EBI 16 test system by Ebro offers a complete analysis solution, including intelligent software to recognize all important parameters and evaluate them automatically.
Where the traditional chemical Bowie Dick test sometimes gave wrong or doubtful results due to the chemical indicators being stored incorrectly, or colour changes being ambiguous, this electronic method means all results are always certain.
The system also presents great time savings as documentation is generated automatically through the software. A complete, detailed and permanent documentation trail is ensured.
The system consists of the Bowie Dick test logger (EBI 16) plus a winlog.med software.
EBI 16 – Hardware
The EBI 16 is the logger itself which is placed in the chamber during a sterilization cycle. Due to the compact size it can be used in small applications such as dental surgeries or other medical professions where bench top size autoclaves are used.
EBI 16 key features;
- After one cycle the EBI 16 takes approximately 35 minutes to cool before it can be used again in another test.
- Data can be recorded for up to 115 minutes.
- Can be used for up to 500 cycles (overall use time of 24 months)
- Battery can be changed by the user
- After 500 cycles or 2 years return the unit to the factory for replacement
The only other hardware item required is the interface to allow the EBI 16 to be connected to a PC. To begin testing we would recommend one of the starter kits which includes the EBI 16 logger, an interface and the software – so you are ready to begin testing out of the box.
Winlog.med – Software
One of the biggest advantages is the user-friendly software. This recognizes failures and evaluates the test automatically, so you receive only a clear “pass” or “fail” result.
All functions are displayed in the familiar Windows ribbon design for ease of use. The software allows you to specify different user rights for each personal login, and a simplified user interface can be set for routine tests.
To run evaluations with the software, the EBI 16 is placed onto the interface. A graphic display shows all the measurements and the result dialog will be displayed and will generate a report. An electronic signature allows results to be archived.
The report can be exported in a variety of formats and contains the overall results as well as details of individual phases within the sterilization.
To find out more about the EBI 16 electronic Bowie Dick system for sterilizer validation just follow the links above or contact us;