Pharmaceutical Manufacturers will be very aware of the European Medicines Agency revisions to “Annex 1 Manufacturing of Sterile Medicinal Products” of the EU Guidelines to Good Manufacturing Process that requires compliance provisions to be fulfilled by August 2023.
The EU Annex 1 Good Manufacturing Process (GMP) updated 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 revision of Annex 1 includes a number of new aspects on aseptic manufacturing and focuses on the need to achieve good contamination controls.
Section 4.22 of Annex 1 specifies that “the bio-decontamination process of the interior should be automated, validated and controlled within defined cycle parameters and should include a sporicidal agent in a suitable form (e.g. gaseous or vaporised form).
It recommends that irregular and challenging surfaces such as gloves “should be appropriately extended with fingers separated to ensure contact with the agent” and that “methods used (cleaning and sporicidal bio-decontamination) should render the interior surfaces and critical zone of the isolator free from viable micro-organisms”.
Section 4.36 of the Annex 1 updated requirements recommends process changes where fumigation or vapour disinfection (e.g. Vapour-phase Hydrogen Peroxide) of cleanrooms and associated surfaces are used and highlights that “the effectiveness of any fumigation agent and dispersion system should be understood and validated”.
How does Enzyme Indicator Technology help meet Annex 1 requirements?
Traditionally, any process that uses hydrogen peroxide (H2O2) for decontamination, such as isolators and pass-through chambers, relied on initial validation and periodic revalidation to assess efficacy.
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 a rapid 60 seconds per indicator.
Unlike conventional tools, Enzyme Indicators offer rapid, quantitative feedback in around 60 seconds, per indicator. Due to the speed and quality of data collection, the technology provides a stronger level of confidence in quality assurance and, consequently, a greater data-driven and consistent approach to ensure compliance with Annex 1, unlike traditional methods.
Enzyme Indicators provide increased or enhanced performance assurance enabling optimised cycle design, reducing the risk of routine failures, improving production performance and providing safer bio-decontamination.
Protak’s validation process delivers quantifiable results in seconds, compared to the traditional validation tool with a seven-day incubation period.
Getting started with Enzyme Indicator technology
To start using Enzyme Indicator technology for your business, simply get in touch with us to arrange a presentation.
The Protak team will first understand your challenges, then give a detailed presentation of our technology, equipment and capabilities while establishing the most effective usage of Enzyme Indicators for your bio-decontamination validation processes.