DECONTAMINATION
4 kg pack, for example. The pack should have an adequate number of sheets to not only add mass, but also to allow space or a void to allow for the creation of an air pocket if air is present; around 200 is ideal. As these sheets capture the air, they allow for a more accurate result and a greater sensitivity to steam penetration faults. There are some very well-established suppliers of sterility assurance products such as the Bowie Dick that can provide guidance in selecting the right solution for each facility. Steris’ Albert Browne brand has been established for over 100 years.
Electronic Bowie Dick Tests This option has many things in common with the traditional Bowie Dick test pack. They are steam penetration tests that verify rapid and even steam penetration into a defined load. The test is independent of the steam steriliser and is used in an otherwise empty steriliser chamber, at the beginning of each day that the steriliser is used. Unlike the traditional Bowie Dick test pack, they do not use a chemical indicator and therefore they cannot meet all of the requirements of EN ISO 11140-4. Some manufacturers do use the test methods that are given in EN ISO 11140-4:2007, as a basis of their performance, but as they are electronic tests, they cannot conform.
A concerted approach of periodic validation, daily steam penetration testing with a Bowie Dick test at the commencement of each day, and use of an air detector for each cycle, ensure the most rigorous yet cost-effective means of catching those critical fails.
Electronic Bowie Dick tests vary in design but often the way in which they present the result is more complex to interpret than a simple colour change, such as, for example, yellow to blue.
Some systems offer a collection of different light formations delivered by LEDs rather than a simple pass/fail. This data often needs time to process and download, leading to a short delay before the result is available rather than the instant result from the traditional pack. They can, however, be reused providing an advantage over the traditional single-use Bowie Dick test, but once used they must often be left for a period, for example two hours, before they can be used again.
Air Detectors
Unlike the Bowie Dick and the electronic Bowie Dick Test, air detectors are not steam
penetration tests, they are detectors of residual air in the steam steriliser. They are designed to work on every cycle in a loaded chamber, and as such, their sensitivity can be compromised by the nature of the load that is in the chamber. They rely upon several methods to ‘predict’ if there was likely to be inadequate air removal and steam penetration. The test is integral to the steam steriliser and is not independent of the steriliser control; in fact, air detectors are often used to abort the cycle if predetermined parameters are not achieved during the air removal stage of the steriliser cycle. They work by measuring the presence
of air, either by measuring temperature, pressure or steam condensate and are calibrated to alarm if there is enough air to prevent proper sterilisation. Their requirements are given in the steam steriliser
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