Enzyme Indicators (EI’s) are an industry-changing advance in measuring decontamination performance. We believe they will change the world. No longer will the pharmaceutical industry suffer financial losses, wasted man hours and the burden of high risks. EI’s offer a fast, cost effective, accurate and risk-free alternative.
So here are the technical details about this new science, where it comes from and how it works…
Adenylate kinase is an enzyme; its presence and activity can be measured using a rapid and sensitive luminescence assay. The technology originated from the isolation of thermostable Adenylate Kinase (tAK) from thermophilic bacteria found in hot springs (Sulpholobus acidocaldarius).
tAK isa remarkably stable enzyme that has a high tolerance to processes that would quickly inactivate most other proteins such as high temperature and oxidising agents. The enzyme has a predictable inactivation profile which can be measured across a wide dynamic range. These characteristics make tAK ideal as a surrogate marker for monitoring decontamination processes.
tAK is applied to a non-hazardous, non-toxic carrier in an ultra-controlled manufacturing process that allows manipulation to pico grams of application. Endotoxins are removed from the Adenylate Kinase prior to application on the carrier. tAK Enzyme Indicator strips have a shelf life of six months at room temperature conditions. tAK Enzyme Indicator strips are supplied complete and ready to use.
The tAK Enzyme Indicators are supplied with a specially designed carrier that allows safe, simple placement in a wide variety of configurations. The indicators can be easily ejected from their carriers straight into their reading tube without the requirement for handling. Each individual test is supplied complete and ready for operation.
The tAK Enzyme Indicators use a luciferin/luciferase reaction to provide instant quantifiable results. The enzyme catalyses a reaction that produces light and the amount of light produced is directly comparable to the amount of remaining tAK activity on the indicator. The light output is measured using a luminometer and provides a quantifiable numerical value. The process takes less than 60 seconds. The custom designed readers offer a fully automatic process – enabling data to be fully validated.
Protak Enzyme Indicator readers offer the ultimate in data capture and ease of use. With three models currently available, the most popular is the ‘Twin Shot’ automatic injection and automatic reading model.
Protak EI readers link to conventional PC hardware and capture a range of data for the ultimate in decontamination verification information. All models offer intuitive features and data manipulation configurations.