Enzyme Indicators

Transforming the H₂O₂ bio-decontamination process in multiple sectors globally

Enzyme Indicators are the only bio-decontamination rapid validation tool to rapidly measure bio-decontamination performance.

Offering a fast, cost effective, accurate and safe alternative to traditional methods, Enzyme Indicator validation technology can be effectively applied in any sector where gaseous H₂O₂ bio-decontamination is used.

Whether designing manufacturing facilities, building bespoke equipment or managing quality assurance of pharmaceutical production, Enzyme Indicators are an effective measure of bio-decontamination efficacy in cleanroom settings and sterile environments where high levels of sterility are required.

Benefits of Enzyme Indicator technology

Enzyme Indicator technology offers a number of significant advantages over traditional approaches to bio-decontamination validation, enabling you to boost efficacy, reduce the risk of errors and cut costs.

Instant Quantifiable Performance Data

Our Enzyme Indicators to provide instant, quantifiable results, with the repeatable, automated process taking around 60 seconds. By comparison, traditional methods require a seven-day incubation period before results can be achieved.

Cycle Efficacy Assurance

Validation failures can lead to expensive and lengthy investigations, causing lost production hours and potential batch rejection, which is particularly damaging when handling high-value products. EIs’ instant results eliminate the risks of traditional ‘run to fail’ validation approaches, while the quantifiable results enable optimisation of cycle design based on data. 

Continued Process Verification

Enzyme Indicators’ bio-decontamination processes are assessed prior to production starting and product being committed, which allows for re-processing if the decontamination were to fail. No product has to be committed to the manufacturing process due to failed decontamination cutting costs and waste.

Proactive prevention
of Decontamination Failure

EIs work alongside our bespoke Athena® software to deliver real-time, quantifiable results for cycle efficacy and compliance reporting. Through enhanced audit and review features, along with data archive facilities during validation cycles, this acts as an early warning system allowing proactive planning and execution to occur.

How does Enzyme Indicator Technology work?

Our Enzyme Indicators contain an enzyme that is inactivated during the bio-decontamination process, translating this into real-time quantifiable results and data. 

Adenylate Kinase (AK)

Adenylate Kinase is an enzyme found in all living cells and is responsible for energy management. Its presence and activity can be measured using bioluminescence. 

Thermostable Adenylate Kinase (tAK)

Due to its thermophilic origin, tAK is an extremely stable enzyme with a high tolerance to processes that would quickly inactivate most other enzymes, such as high temperature and oxidising agents. This means it has a predictable inactivation profile that can be measured across a wide dynamic range. These characteristics make tAK ideal as a surrogate marker for monitoring bio-decontamination processes.

Watch this webinar

How Pfizer utilises Enzyme Indicator technology for bio-decontamination validation.

Melanie Eggers, Sterilisation Validation Project Support Engineer at Pfizer Belgium, explains how Pfizer has adopted Enzyme Indicator (EI) technology for its VHP bio-decontamination procedures. She outlines the differences in EIs compared to more traditional Biological Indicators and the way in which Pfizer utilises the technology. Melanie also explores how the detailed data EIs provide assist with cycle development, requalification, investigations and validation.

How to get Enzyme Indicator Technology

Protak Scientific is the only manufacturer of Enzyme Indicator technology. To find out more, contact us to arrange a presentation. Our team will get work with you to understand your bio-decontamination challenges and requirements. Delivering solutions to support your validation strategy.

How to use Enzyme Indicator Technology

Enzyme Indicator technology can be used for any bio-decontamination cycle that would conventionally use biological indicators to measure performance, especially those using gaseous hydrogen peroxide. 

It works by placing the indicators in challenge locations throughout the area to be bio-decontaminated. Once the cycle concludes, Enzyme Indicators can then be quantifiably measured using a bioluminescent reaction captured the PR2A Luminometer reader, which generates a Relative Light Unit (RLU) Value. The higher the value, the more enzyme is left on the strip, whereas a lower Relative Light Unit Value indicates less enzyme is left on the indicator. The lower the value, the more effective the bio-decontamination.

Working with our Athena® software, this process provides a quantifiable value that can be analysed and used to improve future performance. 

Placement of Enzyme Indicators uses the same methodology as traditional technologies. However, because EIs provide unparalleled data on localised bio-decontamination efficacy, they allow for a more effective mapping strategy that allows for a focus on particular locations of interest.

Our Real-Time Digital Data and Validation Software

Protak Athena™, our bespoke software delivers real-time quantifiable results for cycle efficacy with FDA CFR part 21, part 11 compliance reporting.  

Athena™ is used alongside Enzyme Indicators to deliver advanced reporting capability, enhanced audit and review features along with data archive facilities during validation cycles. It can act as an early warning system allowing proactive execution and planning to occur.