A cleanroom is a contained space in which provisions are made to manage the entry of particulates and contaminants, as well as prevent microorganisms from settling in controlled environments where they could cause a threat to health and safety.
For aseptic pharmaceutical manufacturing organisations, cleanrooms are vital. Microbes, in particular, can significantly alter the chemistry and pharmacology of a product. In real terms, this could lead to higher toxicity and, ultimately, negative effects on end users.
The EU Good Manufacturing Practice (GMP) Annex 1 is a document that stipulates the necessary control measures for the manufacturing of sterile medicinal products from European Union Member States and products imported from outside of Europe.
What makes Enzyme Indicator technology so useful?
A recent revision of Annex 1 has placed a heavy emphasis on organisations developing a robust Contamination Control Strategy (CCS). Quality assurance is key to aseptic manufacturing and the cleanroom is an integral component of that.
This is where Enzyme Indicator technology can bring about significant benefits to aseptic pharmaceutical manufacturers, with higher levels of performance assurance and real-time, quantifiable data on the bio-decontamination process.
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).
“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”.
Enzyme Indicator technology facilitates efficiency and provides a far greater understanding of the whole bio-decontamination process. With highly detailed information, organisations can benefit from much more useful data than previous, conventional methods could yield.
Our Enzyme Indicator technology gives linear, numerical values which you can use to generate long-term statistical data. Additionally, aseptic pharmaceutical manufacturers can be fully confident in their validation results, as the technology eliminates the possibility of false positives.
High-quality information leads to optimised cycles, informed by real-time quantifiable data, across a wide array of challenge locations and surface types. Users also profit from a severely reduced risk of cycle failure and, consequently, unwanted impacts on production.
How to get Enzyme Indicator technology
To learn more about Enzyme Indicators, or to get started with the technology for your organisation, simply reach out to Protak to book a presentation.
Our experts will get to know your business, discuss your unique challenges and identify the most effective application of Enzyme Indicator technology for your bio-decontamination validation process.
