Hydrogen peroxide (H2O2) is a commonly used surface decontamination tool in the aseptic pharmaceutical manufacturing industry. Vaporised H2O2 (vH2O2) is safe, with low toxicity and great material compatibility. Additionally, it’s active at ambient temperatures and is well-documented to have rapid microbial activity.
In aseptic pharmaceutical manufacturing, organisations are required to demonstrate highly efficient decontamination processes. This is a crucial aspect of the contamination control strategy and as with any procedure, this must be understood, verified and validated.
Enzyme Indicator technology is smarter and faster
Enzyme Indicator technology is empowering aseptic pharmaceutical manufacturers by providing accurate quantifiable data that leads to optimised cycle design.
Essentially, Enzyme Indicators are faster and smarter than traditional methods, delivering results in around 60 seconds per indicator, providing a comprehensive view of the bio-decontamination process.
With instant, quantifiable data, Enzyme Indicators are an advanced validation tool that can be positioned in multiple critical locations. They offer compelling advantages where bio-decontamination is performed in complex environments, like cleanrooms, isolators and transfer chambers.
Failure investigations using traditional methods can be both lengthy and costly. With Enzyme Indicators, you can confirm the bio-decontamination process prior to the commitment of any product. So, if it were to fail, there would be no requirement to destroy any product, meaning your organisation saves money and avoids waste.
We’ve also developed Athena® – a bespoke software that delivers results in real-time for cycle efficacy, with FDA CFR 21 part 11 compliant reporting. This is used in partnership with Enzyme Indicators to offer enhanced reporting capabilities, advanced audit and review features, and data archive facilities.
Athena® highlights any decline in decontamination performance before it can reach a critical set point. This means that preventative maintenance can be organised and executed before any risk to batch processing occurs.
How to get Enzyme Indicator technology
To learn more about the smart biotech, simply reach out to us and a member of our team will arrange a presentation.
They’ll learn about your business and its unique needs, before putting together a plan of exactly how Enzyme Indicator technology can support your organisation.