Protak’s Enzyme Indicator technology is the alternative to traditional bio-decontamination validation processes, providing advanced and quantifiable results within just 60 seconds per indicator.
Conventional processes have required an incubation period of seven days before analysts can view results. Moreover, that information would simply confirm whether or not microbial growth has occurred in a single challenge location.
Enzyme Indicators offer a much more detailed view of the enclosure space, monitoring efficiency across all challenge areas in just a matter of minutes. This means aseptic manufacturing organisations can have full confidence in their bio-decontamination and validation processes.
Furthermore, our advanced technology offers significantly more information about the bio-decontamination process. Instead of binary results, Enzyme Indicators yield quantitative numerical values, therefore facilitating long-term trending.
Validation using this method will highlight a decline in decontamination performance before it reaches a critical set point. As a result, preventative maintenance can be carried out before any risk to batch processing occurs and the product has to be destroyed.
How do Enzyme Indicators work?
Protak’s Indicators contain thermostable adenylate kinase (tAK) – an enzyme that is inactivated during the bio-decontamination process. In turn, this is measured and translated into real-time quantifiable results.
Once removed from the decontamination area and inserted into the reader our Enzyme Indicators generate a bioluminescent reaction.
The first reagent, Luciferin, and its enzyme partner Luciferase are introduced to the process via injection into the test tube containing the indicator, which acts as a marker of the enzyme and produces light.
A second reagent, ADP, is introduced to measure how much of the active enzyme is left. As the residual tAK converts the ADP into ATP, light is produced. Upon the introduction of the ADP, Protak’s PR2A built-in photometer captures the light reaction and generates a relative light value. The higher this figure, the more enzyme remains on the strip and, consequently, the less effective the bio-decontamination process has been.
Conversely, a lower relative light value means that less enzyme remains on the indicator, showing the bio-decontamination process was more effective.
Enzyme Indicator technology determines the efficiency of bio-decontamination by highlighting the differences in location of any challenge areas used, creating a model of efficacy for the process and enclosure space that’s monitored.
The quantifiable data achieved with Protak’s Enzyme Indicator technology is something conventional methods cannot provide. Our advanced technology can process information and yield results automatically, leading to greater precision and accuracy across repeat cycles.
Getting started with Enzyme Indicator technology
To boost the efficiency of your bio-decontamination validation process, simply reach out to Protak and let’s have a conversation. We’ll arrange a presentation and get to know your organisation, as well as identify the specific ways in which Enzyme Indicator technology can bring benefit.