Enzyme Indicator technology is the advanced alternative to traditional bio-decontamination validation processes. There’s no incubation period or delay, just accurate, quantifiable results within 60 seconds per indicator.
The purpose of the vaporised hydrogen peroxide cycle is to decontaminate the internal surfaces of the isolator, as well as any exposed, external surfaces of any items inside it, such as filling equipment. Ideally, this will create an environment that is appropriate for aseptic production.
Manufacturers cannot challenge the entire internal surface of the isolator, so they must select challenge locations that represent the environment. With traditional decontamination validation methods, this has always been problematic and confusing. Now, Enzyme Indicator technology is providing, quantifiable inactivation results, which means users can explicitly view the performance of every challenge area together as one ‘visual map’.
Enzyme Indicators provide clear insights
For aseptic pharmaceutical manufacturing organisations, a common issue is the way challenge areas are selected during the decontamination validation process.
Traditionally, the approach has been to use past experience and a combination of risk assessments to select challenge areas. Being able to justify your choices is vital and it’s something Enzyme Indicator technology can help with.
With conventional methods, users can only identify areas of microbial growth, or non-growth. The picture is black and white and it involves a seven-day incubation period before you get the result. Conversely, Enzyme Indicators allow you to visualise the difference in efficacy across all of your challenge areas.
Essentially, you can use Enzyme Indicator technology to completely map your enclosure space and begin to investigate areas of interest. The Enzyme Indicators provide real-time data and a rationale on which you can justify your choice of challenge locations.
The task of deciding upon challenge locations is something that many aseptic pharmaceutical manufacturers find confusing. This is also a “hot topic” when regulatory bodies visit an organisation. With Enzyme Indicator technology, you can provide a data-driven answer with confidence.
Getting started with Enzyme Indicator technology
To benefit from Protak’s Enzyme Indicator technology and rapid, quantifiable decontamination validation results, just reach out to us.
A member of our team will listen to you, learn about the requirements of your business and explain the specific ways in which Enzyme Indicator technology can boost your organisation.