When high-value products are handled, the risk of bio-decontamination validation failures can lead to expensive and lengthy failure investigations leading to lost production hours and potential batch rejection. Enzyme Indicators eliminate the traditional ‘run to fail’ validation approach as data is provided instantly.
The quantifiable results that Protak’s technology provides enable optimisation of cycle design based on data.
As Enzyme Indicators can be positioned in multiple critical locations, they offer significant advantages where bio-decontamination is used in complex environments, such as cleanrooms, isolators, Restrictive Access Barriers (RABs), transfer chambers and laboratories.
Enzyme Indicators (EIs) are an advanced validation tool for measuring bio-decontamination performance instantly. Gone are the seven-day incubation periods – EI technology is quick, cost-effective and highly accurate.
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 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 accurate information across repeat cycles.
Why are manufacturers choosing Enzyme Indicators?
There are several key benefits of using Enzyme Indicator technology instead of conventional methods. Essentially, Protak’s EIs are faster and more accurate, delivering immediate results and a comprehensive view of the efficacy of bio-decontamination processes – but there’s more to it than just that.
Instant, quantifiable data
Protak’s Enzyme Indicator advanced technology offers significantly more information about the bio-decontamination process. Conventional methods give binary results, whilst EI technology provides numerical values to quantify and detect changes to repeat cycles which can generate long-term statistical data.
Elimination of false positives
Pharmaceutical manufacturers risk losing a substantial amount of time from false positive results, leading to lengthy and expensive failure investigations. EI technology removes the risk entirely to provide an accurate overview of the bio-decontamination cycle.
Less wasted product
EI technology allows the bio-decontamination process to be confirmed prior to the commitment of product. So, if it were to fail, the need to destroy a product is removed.
For your organisation, this simply means you save money and waste less.
A proactive warning system – real-time data
We’ve developed Athena™ 2.0, our bespoke software that delivers real-time, quantifiable results for cycle efficacy with FDA CFR 21, part 11 compliant 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.
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 email@example.com to get started.