Enzyme Indicators are the new biotechnology for advanced validation in aseptic pharmaceutical manufacturing, offering the ability to measure bio-decontamination performance in just 60 seconds per indicator.
Traditional methods require a seven-day incubation period before any results can be recorded. However, Protak’s Enzyme Indicators are accompanied by our bespoke Athena® software, meaning that every cycle can be analysed immediately, using an on-site reader and with real-time, quantifiable data.
We supply Enzyme Indicator technology to more than half of the largest organisations in the pharmaceutical industry, including AstraZeneca, Sanofi, Pfizer and many other manufacturers involved in the production of sterile medicinal products and medical devices.
How does Enzyme Indicator technology help?
Enzyme Indicators are a low-risk, alternative to conventional bio-decontamination validation measures. The technology can routinely assess the process before production commences, removing the need to commit expensive materials to a process that might fail.
Moreover, Enzyme Indicator technology completely eliminates the risk of false positive results, allowing you to be fully confident in your bio-decontamination validation. Ultimately, this smart technology is saving aseptic manufacturers time and money, improving quality control and leading to an overall increase in efficiency.
How do Enzyme Indicators work?
Protak’s indicators contain an enzyme that is inactivated during the bio-decontamination process, translating this into real-time quantifiable results and data. 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.
To measure how much active enzyme is left, the second reagent, ADP, is introduced and as the residual tAK starts to convert the ADP into ATP, more light is produced.
At the introduction of the ADP, the PR2A built-in photometer captures the light reaction and generates a Relative Light Unit Value. The higher the Relative Light Unit Value, the more enzyme is left on the strip – which means that the bio-decontamination is less effective.
A lower Relative Light Unit Value means less enzyme is left on the indicator, showing that the bio-decontamination is more effective.
This determines the effectiveness of the decontamination by highlighting the differences in location of any challenge areas used, leading to a model of bio-decontamination efficacy for the process and enclosure space being monitored.
In short, a luminometer measures the light and provides a quantifiable value delivered through Protak’s bespoke Athena® software – something conventional biological indicators cannot do.
Protak’s advanced technology can process data and yield results automatically, leading to non-linear information across repeat cycles.To get started with Enzyme Indicator technology for your organisation, simply get in touch with Protak today.
