May 25 2017
Enzyme Indicators (EI’s) have been proven as a revolutionary viable alternative to biological indicators (BI’s) for Hydrogen Peroxide decontamination validation. A white paper published today by the Parenteral Drug Association (PDA) Journal of Pharmaceutical Science & Technology, and written by Public Health England (PHE), states that Enzyme Indicators are a “potentially valuable tool for rapid VPHP bio-decontamination cycle development and subsequent re-qualification.”
The paper entitled “Evaluation of novel process indicators for rapid monitoring of hydrogen peroxide decontamination processes” explains the process of comparing Enzyme Indicator performance against the current industry standard approach of using biological indicators (BI’s). Given ongoing concerns about the reliability and response time of BI's, PHE explored the potential for an enzyme-based approach decontamination process evaluation.
The Enzyme Indicator is based on thermostable Adenylate Kinase, an enzyme whose presence and activity can be rapidly measured by luminescence assays. This enzyme, unlike many proteins, is very thermostable and resistant to oxidizing agents. It has a very predictable biphasic inactivation profile. These characteristics make it suitable for monitoring and quantification of oxidation decontamination processes such as VH2O2. Indicators with thermostable Adenylate Kinase (tAK), once processed, are used to catalyse a biochemical reaction with Luciferin / Luciferase. Such a reaction produces bioluminescence instantaneously. The individual photons of light produced by this reaction are recorded with a special Lunometer and an accurate measure of the degree of inactivation of the tAK indicator is achieved.
Protak Scientific are the globally exclusive licensee of this technology for gaseous decontamination validation with PHE and are working hard to educate pharmaceutical manufacturing companies about how Enzyme Indicators can benefit them from the Bio-technician to the CFO.
Phillip Godden, CEO, Protak Scientific explains:
The Enzyme Indicator is a surrogate of the Biological Indicator (Geobacillus Stearothermophilus). In order to check their reliability, they can initially be combined with Biological Indicators, both for cycle development and for validation. Once validation is concluded and its reliability verified, this new technology offers three great advantages. It gives quantitative results, one test offering a scale of <2.5log to >9log, for example a degree of reduction i.e. Log 6.55 reduction. It is instantaneous – amazingly in less than 3 seconds - and Enzyme Indicators do not suffer rogue syndrome. No false positives - in fact EI technology offers positive and negative controls! The Enzyme Indicators provide immediate and quantitative proof that the decontamination cycle has achieved the expected results. And this is a game-changing revolution that radically transforms decontamination validation as we know it. The Net result? This could potentially save pharmaceutical manufacturers millions of dollars per year, thousands of hours, reduce risk, remove a run to fail process and increase process understanding instantly.