A comprehensive contamination and control strategy (CCS) is vital for aseptic pharmaceutical manufacturers. This document considers elements of the process, from sterility assurance and facility design to disinfection and contamination.
Annex 1 of the European Good Manufacturing Practice (GMP) for sterile products stipulates that organisations must design an effective CCS, based on scientific assessment, to understand and apply risk management principles.
In the latest Cleanroom Technology Conference (24th and 25th May) presenters will discuss how to design an effective CCS in an aseptic clean room environment to meet regulatory requirements for facility assessment.
Kate Marshall, Protak’s Technical Director will be presenting at the conference and explaining how Enzyme Indicator technology helps to meet the challenges of Annex 1 and the Contamination Control Strategy
What is Protak’s Enzyme Indicator technology?
Enzyme Indicators are an advanced validation method for measuring bio-decontamination performance.
Whether designing manufacturing facilities, building bespoke equipment or managing quality assurance of pharmaceutical production our product is an effective measure of bio-decontamination efficacy in clean room settings and sterile environments where high levels of sterility are required.
This technology can be used in any industry setting that uses gaseous bio-decontamination and we are already supplying our product to some of the largest names in the pharmaceutical sector, including Pfizer, AstraZeneca, Roche, Novo Nordisk and Sanofi
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.
The Annex 1 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 sterilized. The revision of Annex 1 includes a number of new aspects on aseptic manufacturing and focuses on the need to achieve good contamination controls.
Heavy focus has been placed upon organisations to have a robust Contamination Control Strategy (CCS) in place, the importance of quality assurance is paramount.
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 vaporized form). Gloves should be appropriately extended with fingers separated to ensure contact with the agent. Methods used (cleaning and sporicidal bio-decontamination) should render the interior surfaces and critical zone of the isolator free from viable micro-organisms.”
This is where Enzyme Indicator technology can significantly benefit pharmaceutical manufacturers by providing greater performance assurance and real-time quantifiable results and data
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.
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. Our team will discuss your challenges and establish the most effective usage of Enzyme Indicators for your bio-decontamination processes.
To make an enquiry, arrange a presentation or even ask a question, get in touch now.
