Enzyme Indicator technology is transforming the bio-decontamination validation process for pharmaceutical manufacturers of aseptic products. The innovative technology offers quantifiable results in as little as 60 seconds, helping to boost the efficiency of organisations across the globe.
Because Enzyme Indicator technology yields quantitative results, what manufacturers are seeing is helping them to understand aspects beyond microbial growth or non-growth and seeing that variation in challenge locations can occur for a range of different reasons.
Enzyme Indicators are a signpost for load configuration
Variance in challenge locations has always occurred and until now has not always been detectable. Challenge location variation can not only be caused by the setup of the chamber from a gas distribution perspective but also by the load items exposed to the process, especially when they are made of materials that are permeable to hydrogen peroxide.
This use of Enzyme Indicator technology allows for the optimum load configuration to be set and protects against the risk of microbial growth.
An additional use and benefit can be found when changes to the load configuration are required in the future. The use of EIs to map the load and selected challenge locations allows for rapid assessment of any change and impact on the previous validation. This would previously have resulted in a complete re-validation of the load and lengthy downtime for the process under test. With EIs, one cycle is all that is required to justify that there has been no change to the previously validated gas distribution profile.
Getting started with Enzyme Indicator technology
To start benefiting from the smart new biotechnology, simply reach out to Protak and one of our experts will be happy to get to know your business and identify the specific ways our product can help you reach your goals.