Protak’s Enzyme Indicator technology is being used by over half of the top pharmaceutical manufacturing organisations worldwide to increase efficiency throughout the bio-decontamination validation cycle.
Simultaneously, Enzyme Indicator technology is helping businesses adhere to industry standards in both Europe and the United States of America.
EU GMP Annex 1 compliance
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.
Pharmaceutical manufacturers will be well aware of recent revisions to Annex 1 that require compliance provisions to be completed by August 2023. These changes directly affect products imported from outside of Europe, as well as those manufactured within European member states.
For aseptic manufacturers, the revisions to Annex 1 increase the need for solid contamination controls. Section 4.22 states: “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 also suggests that irregular surfaces, like gloves, should be “appropriately extended with fingers separated to ensure contact with the agent” and that cleaning methods should “render the interior surfaces and critical zone of the isolator free from viable micro-organisms.”
Manufacturers that use Enzyme Indicator technology will benefit from rapid, quantifiable results and greater performance assurance.
Traditional bio-decontamination validation methods required a seven-day incubation period. With Enzyme Indicators technology, data is available after just 60 seconds. This exponentially faster process leads to a higher level of confidence in quality assurance and a more comprehensive understanding of the enclosure space, ensuring compliance with Annex 1.
FDA 21 CFR Part 11 compliance
Any pharmaceutical manufacturers intending to sell medicinal products to companies in the USA must comply with the FDA’s 21 Code of Federal Regulations (CFR). These rules are designed to ensure organisations’ digital records are authentic and reliable.
Protak’s bespoke Athena® software delivers real-time, quantifiable results for cycle efficacy and is used alongside Enzyme Indicators to deliver rapid, quantifiable results in real-time, with advanced audit capabilities, in-depth review features and data archive facilities all improving cycle efficacy with 21 CFR Part 11 compliant reporting.
To learn more about Enzyme Indicator technology, or get started with your business, get in touch with Protak today.