Enzyme Indicator technology is the smart alternative to conventional bio-decontamination validation methods. With quantifiable and highly accurate data, aseptic manufacturing processes can benefit from optimised cycle design and faster results, with each indicator taking just 60 seconds to yield validation information
Protak’s Enzyme Indicator technology is already being used by a large working group of industry leaders such as Pfizer, Baxter, AstraZeneca and many more. Any organisation that uses gaseous bio-decontamination can become more efficient with Enzyme Indicator technology.
How does Enzyme Indicator technology boost efficiency?
One of the key advantages of using Enzyme Indicators is that your results are quantitative, as opposed to binary data that you’d receive from conventional validation methods.
Essentially, this means that manufacturers are measuring challenge locations, as opposed to just looking at whether there has been microbial growth or not. You can then start to map different levels of enzyme inactivation and therefore efficacy of the process across your entire enclosure space.
With Enzyme Indicator technology, aseptic manufacturers can identify areas where the bio-decontamination process isn’t as effective in just 60 seconds per indicator used. This then allows for a full view of what is needed to improve the process and bring these locations back up to standard.
Conversely, traditional methods can only show if there has been a failure or not and there’s after a seven-day incubation period before finding out the results.
The bio-decontamination processes used have also traditionally run at risk. Bio-decontamination validation is initially conducted and then not re-qualified until six to 12 months later, at which point there may be failures.
This leaves manufacturers in a tough position, as they then need to justify that those failures haven’t impacted any of their products. The risk companies are taking is that they take their product to market, just to be forced to recall it.
How does Enzyme Indicator technology help?
The non-viable, low-risk nature of Enzyme Indicator technology means that manufacturers can assess the bio-decontamination process on a routine basis before production begins. Consequently, no materials are committed and if the bio-decontamination process were to fail, there’s no requirement to risk rejection of any material produced.
Moreover, Enzyme Indicator technology completely alleviates the risk of false positive results, allowing you to be fully confident in your bio-decontamination validation. Ultimately, this smart technology is saving aseptic manufacturers time and money, leading to an overall increase in efficiency.
To get started with Enzyme Indicator technology for your business, simply get in touch with Protak today.
