Enzyme Indicator technology is an advanced rapid validation tool for measuring hydrogen peroxide (H2O2) gaseous bio-decontamination performance.
Already used by the majority of the top ten pharmaceutical companies, such as Pfizer, Sanofi, GSK and AstraZeneca, Protak’s Enzyme Indicators are bringing tangible benefits to any manufacturer of equipment used during the production of sterile medicinal products and medical devices.
Enzyme Indicators facilitate quality control
Enzyme Indicators are a low-risk alternative to conventional bio-decontamination validation measures. Users can quickly assess the enclosure space before production commences, removing the need to commit expensive materials to a process that could fail.
Furthermore, Enzyme Indicator technology completely eliminates the risk of false positive results, allowing you to be fully confident in your data. This means aseptic manufacturers using Protak’s Enzyme Indicators are saving time and money, with improved quality control and higher efficiency.
Annex 1 compliance
Traditionally, any process that uses H2O2 for decontamination, such as isolators and pass-through chambers, relied on initial validation followed by periodic revalidation to assess efficacy.
With Enzyme Indicators, there’s no long incubation period or delay. Instead, a short 60-second wait per indicator is all that’s needed for quantifiable validation results.
Due to the speed and integrity of data collection, the technology provides a stronger level of confidence in quality assurance and, consequently, a more data-driven and consistent approach to ensure compliance with Annex 1, which traditional validation tools are unable to offer.
Consequently, Enzyme Indicator technology also facilitates optimised cycle design, reducing the risk of routine failures, improving production performance and providing safer bio-decontamination.
Protak’s validation process delivers quantifiable results in seconds, compared to the traditional validation tool with a seven-day incubation period.
Why do aseptic manufacturers choose Enzyme Indicators?
There are several key benefits of using Enzyme Indicator technology rather than traditional validation methods. Protak’s Enzyme Indicators are faster, delivering immediate results and a comprehensive view of the efficacy of bio-decontamination processes – but that’s not all.
Linear results
Conventional methods provide binary results, whilst Enzyme Indicator technology offers numerical values to quantify and detect changes to repeat cycles which can generate long-term statistical data.
No false positives
Aseptic manufacturers risk heavy financial and time-related losses from false positive results, leading to lengthy and expensive failure investigations. Enzyme Indicator technology removes the risk entirely to provide a total view of the validation process.
A proactive warning system – real-time data
We’ve developed Athena® 2.0, Protak’s bespoke software that delivers real-time, quantifiable results for cycle efficacy with FDA CFR 21, part 11 compliant reporting.
Athena® is used in collaboration with Enzyme Indicators to deliver advanced auditing and review features, enhanced reporting capabilities and data archive facilities. The technology acts as an early warning system and allows for proactive planning and execution.
To find out more about Enzyme Indicators, or get started with technology at your organisation, just reach out to us.
