Companies have been invited to join a focus group to discuss the use of Enzyme Indicator (EI) technology for bio-decontamination validation. The initiative follows on from the support Protak Scientific, the exclusive worldwide EI supplier, received from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). Could this be a game-changer in the industry?
The healthcare and pharmaceutical sectors use cold, gaseous processes to decontaminate environments. The most notable of these methods is the hydrogen peroxide decontamination cycle, which offers excellent biological inactivation when delivered correctly. The MHRA has already made public its concern about the "fragility" of the process.
What is the market penetration of the technology? Why should players in the market consider EI technology? Phillip Godden, Protak Scientific CEO, answers these and other relevant questions.
Why do you think EI technology has been slowly implemented?
Phillip Godden: Adoption of EI technology throughout the industry has started in a controlled and measured way. Protak selected two multinational pharmaceutical partners to work with, approximately two years ago. Together Protak and the pharma partner network have stress tested and interrogated the technology. Now with two years of data, and growing industry support, Protak is allowing further interested parties to join the process of adoption EI tech for validation.
What do you think has been the main hurdle in this process?
PG: Some people are conservative, especially in the pharmaceutical manufacturing space! Others see the value and immediately see the benefit.
I like this analogy; consider that for the last 30 years a farmer has ploughed his field successfully with a horse and plough. Its hard work, the horse has a variable performance from month to month: some days the environment makes the work harder and so on. The farmer, however, knows his horse and feels comfortable. It's all he knows. One day a salesman turns up with a brand new shiny tractor! With 800 horsepower, GPS and a promise to improve and speed up the process. Imagine it takes the farmer a week (that’s 604,800 seconds) to plough his field and the tractor can do it in a mere fraction of that time, and deliver more consistent results etc.
In many ways, I feel like the pharmaceutical industry is the world's largest supertanker moving slowly and not easy to turn. It is not that the industry is resistant to change, it just needs to be sure that the change is a good one!
tAK enzyme indicator strip
What is the market penetration of EI technology?
PG: The Protak strategy has always been to deliver EI technology into the market in a measured way so that we can grow and meet customer expectation in terms of support and product delivery. Currently, our HQ based in the UK supports EMEA. We have our Protak US operation based in Philadelphia for the Americas, and in 2019 we will have created a Protak company based in Hong Kong to support our growth in Asia. These three hubs will then support local territory distributors who can then serve local markets at a local level.
Our top 10 customers have a combined turnover of more than a trillion dollars and we are working with more than 50% of our target already. Our current partners projected revenue in the next three years will support our aspiration to be the worlds most advanced and preferred decontamination validation company, seeing turnover in excess of £100 million.
Gaining the support of the MHRA in the UK is a major win for the EI technology; how will this milestone impact your business?
PG: In terms of support from regulators [the impact is] worldwide. The support is based on a logical thought process. The MHRA has offered to host an industry focus group at their offices in Canary Wharf so that they and would-be partners can have a conversation on the topic. I think that perhaps the regulators are frustrated that people have a perception that they are closed to new technology when in fact they of all people in industry welcome new horizons and opportunities to improve the process of validation.
The MHRA have voiced strong concerns about hydrogen peroxide decontamination processes and the fragility of the cycle. Now our technology can be used to ensure that every cycle is effective and deliver the information immediately. As the regulators said when we met a couple of months ago: "Why would anyone think that regulators wouldn’t want users to embrace this technology?"
I have to also say at this point, one thing that is clear from a regulatory perspective: it is up to the user to satisfy themselves that our technology is as a minimum equal to the current challenge and to be able to show themselves and regulators the data to support the change. Protak has developed a standard model that delivers this information and we support users in this process around the globe.
Should EI technology be recognised within a framework?
PG: Actually, the biological challenge that is an enzyme indicator is already clearly defined as a biological indicator. The requirement to challenge cycles specified Geobacillus stearothermophilus as a hardy thermophile – the enzyme within the enzymatic biological indicator is from Sulfolobus acidocaldarius, another 'hardier' and 'robust' thermophile with considerably more resistance to cold process oxidisation processes. Thus, the framework exists already; our technology brings a digital delivery to an already defined process.
Why join Protak and the industry focus group?
PG: This is a one-time offer from Protak and the MHRA in the UK to join a group of interested parties to create a uniform and clearly understood roadmap for the adoption and use of a rapid decontamination validation process (RDVP) that will save time, money and ultimately have the potential to save lives.
On every count, EI technology is a good thing for business and society. It is not expensive, it carries a low risk for adoption and will very quickly repay the investment and will continue to do so while improving quality control and validation, which in turn advances decontamination validation and that is an improvement that removes 'run to fail' from a process!
Phillip Godden further explains the EI technology, its uses and benefit in an article that is featured in the October issue of Cleanroom Technology.
