Using Enzyme Indicators to validate decontamination measurement

The Editor of Cleanroom Technology caught up with Phillip Godden, founder and CEO at Protak about the use of this new technology and its support from the MHRA

Previously the healthcare and pharmaceutical sectors used cold, gaseous processes to decontaminate environments. Likely the most notable of these methods is the hydrogen peroxide decontamination cycle, which offers excellent biological inactivation when delivered correctly. However, this process can be both difficult and dangerous to carry out.

Protak, a supplier of enzymatic indicators (EI) used in decontamination validation, believes that the time is now to embrace a twenty-first century, digital validation tool. According to the company, the EI is everything required to deliver successful decontamination validation quickly, consistently and efficiently.

Recently Cleanroom Technology covered the news that Proktak Scientific had gained support from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). So Murielle Gonzalez, asked the founder of the company to elaborate further on this new technology.

Murielle Gonzalez: Am I right to believe that EI technology has been slowly implemented? If so, what do you think has been the main hurdle?

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 2 years ago. Together Protak and the pharma partner network have stress tested and interrogated the technology. Now with 2 years of data and a growing industry support – Protak is allowing further interested parties to join the process of adoption EI tech for validation.

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 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. Its all he knows. One day a salesman turns up with a brand new shiny tractor! With 800 horse power, 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.

Some people are conservative, especially in the pharmaceutical manufacturing space! Others see the value and immediately see the benefit. We are dealing with people who are all individual. In many ways I feel like the pharmaceutical industry is the worlds largest super tanker moving slowly and not easy to turn. So we stand on the bridge and turn the wheel to make a 180 turn. I feels like nothing is happening to start, in fact it is barely possible to even feel a change. It is only looking back at the wake you can see the boat is turning and as time passes you can see that actually the turn is quicker than it feels and before you even know it, change is affected and the boat is on a new course. It is not that the industry is resistant to change, it just needs to be sure that the change is a good one!

Murielle Gonzalez: At the moment what is the market penetration of EI technology?

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 from Philadelphia for the Americas and in 2019 we will have created a Protak company based from HK 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 3 years will support our aspiration to be the worlds most advanced and preferred decontamination validation company, seeing turnover in excess of £100 million.

Murielle Gonzalez: Gaining the support of the MHRA in the UK is a major win for the EI technology; how will this milestone impact your business?

If terms of support from regulators; worldwide. The support is based on a logical thought process. Regulators do not endorse any technology. Regulators cannot ‘endorse’ anything per say. In our case, the MHRA were kind enough to offer us support, rather than endorsement. 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 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.

In this case specifically, 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 regulators 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 supports the change. Protak have developed a standard model that delivers this information and we support users in this process around the globe.

Murielle Gonzalez: Should EI technology be recognised within a framework?

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 simply brings a digital delivery to an already defined process.

Murielle Gonzalez: Why join Protak and the industry focus group?

Its simple really – 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 road map 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 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!

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