Enzyme Indicator technology is the advanced tool for validation in aseptic pharmaceutical manufacturing. No longer is there a need to wait seven days for the incubation period of conventional bio-decontamination validation methods. Instead, Enzyme Indicators provide highly accurate, quantifiable results in around 60 seconds per indicator.
Protak is working with some of the most significant organisations in the pharmaceutical industry, including the likes of AstraZeneca, Novo Nordisk, Pfizer and many more. Combined with our bespoke Athena® software, our clients benefit from rapid results that help to optimise cycle design.
How does Enzyme Indicator technology 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.
Enzyme Indicator technology for your organisation
For more information, to arrange a presentation or to understand how Enzyme Indicator technology can support your organisation, reach out to us directly.
One of our experts will get to know your business and explain the specific benefits Enzyme Indicator technology can bring.
