Enzyme Indicators – New technology for decontamination validation

Posted: 18 May 2017 | | No comments yet

Enzyme Indicators (EI’s) are an industry-changing advance in measuring decontamination performance. No longer will the pharmaceutical industry suffer financial losses, wasted man hours, and the burden of high risks associated with BI’s.

Enzyme Indicators

The conventional 7 day wait for Biological Indicator (BI) decontamination results is over. There is an alternative way to really measure and validate decontamination performance instantly.

Enzyme Indicators (EI’s) are an industry-changing advance in measuring decontamination performance. No longer will the pharmaceutical industry suffer financial losses, wasted man hours, and the burden of high risks associated with BI’s. EI’s offer a fast, cost effective, accurate, and risk-free alternative to biological indicators.

Technical details about EI’s

ADENYLATE KINASE : Adenylate kinase is an enzyme – its presence and activity can be measured using a rapid and sensitive luminescence assay. The technology originated from the isolation of thermostable Adenylate Kinase (tAK) from thermophilic bacteria found in hot springs (Sulpholobus acidocaldarius).

tAK: tAK is a remarkably stable enzyme that has a high tolerance to processes that would quickly inactivate most other proteins such as high temperature and oxidising agents. The enzyme has a predictable inactivation profile which can be measured across a wide dynamic range.  These characteristics make tAK ideal as a surrogate marker for monitoring decontamination processes.

The real value of using enzyme indicators for decontamination validation

Using an Enzyme Indicator as a supporting tool for cycle development immediately maps performance to a data scale. This effectively enables isolators, equipment or pretty much anything that uses H₂O₂ as a decontamination tool to be fully mapped on the first cycle. The data is collected immediately, taking just 3 seconds per test to collate. From the first cycle, typically within less than an hour in total, the GCD process is clearly mapped out, least penetrative spots are located and positive action can be taken.

This is verses a BI model where at this point you would still be putting the BI’s into broth and preparing to incubate.  You would then wait days – up to seven to collate assured data. Even when you have that data all you would know is that you did or didn’t achieve a >Log⁶ reduction. You would have no real idea about how close of far from this goal you really are.

IQ/ PQ / FAT / SAT just became a lot quicker and easier. Using EI’s gives confidence in cycle. This ensures that when processing with end users and developing a cycle, as a manufacturer you already know the outcome of your cycle and can then easily demonstrate the performance of your system to customers with complete confidence. Using EI’s alongside a BI also gives immediate assurance that you are not suffering Rogue syndrome too. EI’s offer a direct correlation to the performance of BI Geobacillus Stearothermophilus using a developed standard curve and you can “test the test” at any time, with positive and negative control built into the EI reader.

Enzyme Indicators take away all the frustration and wasted time associated with Gassing Cycle Development. Enzyme Indicators are never fully denatured so are always able to provide a true measure of cycle performance. That alone is a massive boost to the process but the fact that data is captured immediately and enables multiple cycles per day and immediate action – that is where the true value lies.

Why EI’s are simply better

If you are not already nodding your head, then here is a summary of the reasons why Enzyme Indicators is simply better than conventional practices.

Instant results – This is THE most important factor in why this new science will change the world. Instant results mean instant action. And instant action is what’s needed to reduce waste, improve productivity and to, in the end contribute to save lives.

Accurate data capture – EI READERS provide quantifiable, linear readings that provide users with substantially more information than the current BI’s. Enzyme Indicators can act as early warning systems – allowing performance monitoring, threshold release and automatic data capture.

Simple & easy to use – EI Tests are simple and easy to use and so can be used regularly by medical and pharmaceutical users and technicians alike. A simple test strip is used alongside a bespoke luminometer, which reads and delivers results instantly.

Life-changing implications – From being faster to bring operating theatres back into service to ongoing surgical equipment validation and immediate medical batch release of medicines, the benefits are tangible – this revolutionary science may save lives.

Satisfies audit process – EI’s and tAK validation provide the information needed to satisfy the audit process quickly and easily – and satisfy the regulator’s scrutiny.

Performance assurance – EI’s are manufactured to eliminate rogue results and include an optional onsite self-validation process. The Enzyme Indicator Readers offer more accurate quantifiable data than traditional Biological Indicator tests.

Reasonably priced – The EI technology, readers and test strips are reasonably priced and the results far outweigh the cost. They also have a long and stable shelf life compared with traditional BI’s.

Developed and Extensively tested by Public Health England (PHE) – PHE, a part of the UK Department of Health has been researching and testing this technology for 15 years with significant investment and over sixty patents granted.

It’s clear this technology is worth investigating and putting head to head with current biological indicator validation processes to truly see the results. 

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