Enzyme Indicator technology is boosting efficiency in pharmaceutical manufacturing. It’s a highly advanced tool for validating bio-decontamination performance, already used by a large number of top organisations worldwide, such as Pfizer, AstraZeneca, Sanofi and Novo Nordisk.
Essentially, any organisation that requires gaseous bio-decontamination can benefit from the new technology, with rapid, quantifiable, real-time validation data.
Businesses that utilise isolators and pass-through chambers, for example, traditionally faced a seven-day wait for results, with an initial validation followed by periodic revalidations to assess effectiveness.
How do Enzyme Indicators help?
The recently updated Annex 1 requirements affect the manufacturing of sterile medicinal products from European member states and products imported from outside Europe.
Aseptic manufacturing poses the highest risk, as the product is not terminally sterilised. The revisions include a number of new points on aseptic manufacturing, with a significant focus on the need to achieve solid contamination controls.
This is where Protak’s Enzyme Indicator technology can help aseptic pharmaceutical manufacturers significantly. Our technology supports efficiency by offering users a far greater understanding of the entire bio-decontamination process.
Enzyme Indicators are a low-risk alternative to conventional validation measures. The technology can routinely assess the process before production commences, removing the need to commit expensive materials to a cycle that might otherwise fail.
Moreover, Enzyme Indicator technology completely eliminates the risk of false positive results, allowing you to have full confidence in your validation data. Ultimately, this is saving aseptic manufacturers time and money, improving quality control and leading to an overall increase in efficiency.
With highly detailed information, organisations can benefit from much more usable data than previous, conventional methods could offer. Enzyme Indicator technology provides linear values, allowing users to view efficiency, rather than only whether or not microbial growth occurred in each challenge location.
To get started with Enzyme Indicator technology for your organisation, simply get in touch with Protak today.
