An introduction to Protak Scientific and Enzyme Indicators
Protak Scientific manufactures ‘Enzyme Indicators’ – the unique, advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
Our Enzyme Indicators
Enzyme Indicators (EIs) are an advanced validation tool to instantly measure bio-decontamination performance.
Offering a fast, cost effective, accurate and safe alternative to conventional methods,
EI validation technology can be effectively applied in any sector where gaseous bio-decontamination is used.
Whether designing manufacturing facilities, building bespoke equipment or managing quality assurance of pharmaceutical production, EIs are an effective measure of bio-decontamination efficacy in cleanroom settings and sterile environments where high levels of sterility are required.
Accurate and Rapid Results
Protak’s advanced Enzyme Indicator technology offers significantly more information about the bio-decontamination process. Conventional methods give binary results, whereas EI technology provides, numerical values that can generate long-term data for comparison.
Enzyme Indicator technology also acts as an early warning system, allowing for performance monitoring, threshold release and automatic data capture. This ensures any bio-decontamination remains within validated conditions.
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.
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.
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 decontaminated. Once the cycle concludes, they can then be quantifiably measured using a bioluminescent reaction captured by a photometer, 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 Protak’s bespoke 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.
The benefits of Protak’s 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.
Enzyme Indicators assure complete, continued process verification for all manufacturing processes. The product is not released without decontamination assurances, resulting in fewer product recalls and a full product manufacturing and decontamination history.
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.
EI validation will highlight any decline in decontamination performance before it reaches a critical level. This enables preventative maintenance to be carried out before any risk to batch processing occurs.
FASTER – Bio-decontamination results in 60 seconds
SMARTER – Immediate Quantifiable Results
SAFER – Increased or Enhanced Performance Assurance
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.
