Enzyme indicators (EIs) are the smart biotechnology for advanced validation in aseptic pharmaceutical manufacturing, offering the ability to measure bio-decontamination performance in just 60 seconds per indicator. In contrast, conventional methods require a seven-day incubation period before results are known. When using EIs, each cycle can be analysed straight away – and unlike traditional methods, delivering real-time quantifiable data.
Protak supplies EIs to some of the biggest names in the pharmaceutical industry, including Pfizer, AstraZeneca, Novo Nordisk, Sanofi and many other manufacturers of equipment used during the production of sterile medicinal product and medical devices while providing similar services to other sectors where bio-decontamination is critical to ensure the safety and efficacy of the process is assured.
We consistently seek feedback from our clients to ensure this unique product is evolving to its full capabilities. Our recent upgrade to Protak’s Athena™ software is used to analyse EI data and yield quantifiable results in real time.
How does EI technology enhance your knowledge of decontamination process?
Our Enzyme Indicator technology 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.
EIs emit light after the bio-decontamination cycle which, when measured with a luminometer, provides quantifiable data compared to a simple positive or negative you would yield using conventional methods, like biological indicators. The overall result is a boost to efficiency – our clients have reported gaining two to four weeks of additional production time per region, per year.
Who benefits from using Enzyme Indicator technology?
Protak’s Enzyme Indicator technology will benefit any industry in which gaseous bio-decontamination is necessary
Essentially, in any setting in which you would use traditional methods such as biological or chemical indicators, Enzyme Indicators can yield data with higher accuracy, outperforming conventional methods.
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 acts as an early warning system – it provides highly advanced reporting with enhanced auditing and review features, as well as data archive capabilities during validation cycles.
Enzyme Indicator technology for your organisation
To get started with enzyme indicators, simply speak to a member of the Protak team to arrange a presentation. One of our experts will learn about your challenges and present our advanced Enzyme Indicator technology, explaining the specific advantages it will bring to your organisation.
To arrange a conversation, email us at contact@protakscientific.com
