Enzyme Indicator technology is transforming the validation process in pharmaceutical manufacturing and other applications including healthcare, such as pharmacy compounding and research.
Whether designing manufacturing facilities, building bespoke equipment or managing quality assurance of pharmaceutical production our product is an effective advanced measurement of bio-decontamination efficacy in clean room settings and sterile environments where high levels of sterility are required.
Traditionally, the incubation period for bio-decontamination results has been up to seven days, and with binary results. Quantifiable results from Enzyme Indicators offer the ability to measure bio-decontamination performance in just 60 seconds per indicator.
This ensures that when processing with end users and developing a cycle, manufacturers already have full confidence in the outcome.
How does Enzyme Indicator technology 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 Value. The higher the Relative Light Value, the more enzyme is left on the strip – which means that the bio-decontamination is less effective.
A lower Relative Light Value indicates 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 that’s 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 accurate information across repeat cycles.
How to get Enzyme Indicator technology
Protak is the only manufacturer of enzyme indicator technology. To find out more, just get in contact with us to arrange a presentation from a member of our team. They’ll get to know your organisation and its goals before highlighting how EIs can support your business.
Email us at contact@protakscientific.com to get started.
