Enzyme Indicators are the latest biotechnology for advanced validation in aseptic manufacturing, providing the ability to measure bio-decontamination performance in just 60 seconds per indicator. Traditional methods have always involved a seven-day incubation period before any results can be known. With Enzyme Indicator technology, every cycle can be analysed immediately, using an on-site reader and with real-time, quantifiable data.
At Protak, we supply Enzyme Indicator technology to some of the largest organisations in the pharmaceutical industry, including AstraZeneca, Sanofi, Pfizer and many other manufacturers involved in the production of sterile medicinal products and medical devices. Enzyme Indicators are used during processes that utilise hydrogen peroxide for bio-decontamination, including isolators, pass-through chambers and cleanrooms.
We also offer consultancy services to many organisations that require bio-decontamination validation of equipment, processes or facilities. These include Annex 1 compliance, End 2 End validation lifecycle testing and load optimisation, to name just a few.
Which sectors can use Enzyme Indicator technology?
Our Enzyme Indicator technology can be effectively applied in any industry 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 cleanroom settings and sterile environments where high levels of sterility are required.
Essentially, in any setting in which you would use traditional methods, such as biological indicators, Enzyme Indicators can provide quantifiable results with higher accuracy, outperforming conventional techniques.
Decontamination processes are integral within the pharmaceutical industry and Protak is working with many of the top 20 organisations in the sector. For manufacturers, our Athena® software provides highly advanced reporting with enhanced auditing and review features, as well as data archive capabilities during validation cycles
Getting started with Enzyme Indicator Technology
To start using Enzyme Indicator technology for your business, simply get in touch with us to arrange a presentation. Our team will discuss your challenges and establish the most effective usage of Enzyme Indicators for your bio-decontamination processes.
To make an enquiry, arrange a presentation or even ask a question, get in touch now.