An introduction to Protak Scientific and Enzyme Indicators
Protak Scientific manufacture ‘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 (EI’s) are an advanced validation tool in measuring bio-decontamination performance instantly. EI’s offer a fast, cost effective, accurate and safe alternative to conventional methods.
Our Enzyme Indicator technology can be effectively applied in any industry sector where gaseous bio-decontamination is used throughout the validation process.
Whether designing manufacturing facilities, building bespoke equipment or managing quality assurance of pharmaceutical production our product is an effective measure of bio-decontamination efficacy in clean room settings and sterile environments where high levels of sterility are required.
Accurate and Rapid Results
Protak’s Enzyme Indicator advanced technology offers significantly more information about the bio-decontamination process. Conventional methods give binary results, whilst EI technology provides linear, numerical values which can generate long-term statistical data.
Enzyme indicator technology also acts as an early warning system, allowing for performance monitoring, threshold release and automatic data capture. Most importantly, this ensures the 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.
This is an enzyme found in all living cells and is responsible for energy management; its presence and activity can be measured using a rapid and sensitive luminescence assay. The technology originated from the isolation of Thermostable Adenylate Kinase (tAK) harvested for a thermophilic bacteria.
Thermostable Adenylate Kinase (TAK):
Due to it’s thermophilic origin, tAK is an extremely stable enzyme that has a high tolerance to processes that would quickly inactivate most other enzymes such as high temperature and oxidising agents.
The enzyme has a predictable inactivation profile which can be measured across a wide dynamic range. These characteristics make tAK ideal as a surrogate marker for monitoring decontamination processes.
The introduction of reagents
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 use Enzyme Indicator Technology
Enzyme indicator advanced technology is essential for any bio-decontamination process using gaseous hydrogen peroxide, as well as any cycle in which you would conventionally use biological indicators to measure performance.
The product contains adenylate kinase (AK), an enzyme responsible for energy management within all living cells. In its thermostable state (tAK), it becomes extremely durable and unaffected by conditions that would otherwise denature it, such as high temperatures and oxidising agents.
Simply place the indicators in challenge locations throughout the decontamination area. Once the cycle concludes, the advanced technology will produce light, which can be measured using a luminometer.
The light emitted is directly proportional to the presence and activity of the enzyme. To achieve this, adenosine diphosphate (ADP) is introduced to the test tube. In turn, residual tAK is then converted into adenosine triphosphate (ATP), yielding a bioluminescent reaction.
The Enzyme Indicators are placed using the same methodology as traditional technologies, usually with tape to the surface of the enclosure space at locations of interest. EIs however, provide unparalleled data on localised bio-decontamination efficacy which allows a more effective mapping and understanding of the locations of interest to define ongoing challenge locations for the validation process.
Instant Quantifiable Performance Data
Our Enzyme Indicators use a luciferin/luciferase reaction to provide instant quantifiable results. The enzyme catalyses a reaction that produces light and the amount of light produced is directly comparable to the amount of remaining tAK activity on the indicator.
The light output is measured using a luminometer and provides a quantifiable numerical value. The process takes around 60 seconds. The Protak PR2A luminometer offers an automatic process – enabling data to be accurately and repeatedly collected.
Cycle Efficacy Assurance
When high-value products are handled the risk of validation failures can lead to expensive and lengthy failure investigations, causing lost production hours and potential batch rejection. Our Enzyme Indicators eliminate the traditional ‘run to fail’ validation approach as data is provided instantly. The quantifiable results enable optimisation of cycle design based on data.
Continued Process Verification
With 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 destroyed 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, there are less product recalls and a full product manufacturing and decontamination history is available.
Proactive prevention of Decontamination Failure
We’ve developed Athena 2.0 our bespoke software that 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.
Verification using Enzyme Indicators will highlight a decline in decontamination performance before it reaches a critical set-point. Preventative maintenance can be carried out before risk to batch processing occurs and the product has to be destroyed.
FASTER – Bio-decontamination results in 60 seconds
Enzyme Indicators are an advanced validation tool in measuring rapid gaseous bio-decontamination in around 60 seconds, compared to the traditional validation tool with a 7 day incubation period. Measuring performance instantly, reducing cost, saving time, improving efficacy.
Every cycle can be validated immediately resulting in faster product release, immediate batch verification.
SMARTER – Immediate Quantifiable Results
Athena, our bespoke software is used alongside Enzyme Indicators to deliver advanced reporting capability, enhanced audit and review features along with data archive facilities during validation cycles and the delivery of “challenge area” specific decontamination data that can be stored electronically reducing the risk of manual data records.
SAFER – Increased or Enhanced Performance Assurance
The results enable optimisation of cycle design based on data and quantifiable efficacy on multiple surface types and challenge points simultaneously. Our Enzyme Indicators reduce risk of routine cycle failures and impact upon production, eliminating false positives and providing safer bio-decontamination.
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.