For organisations working within the pharmaceutical manufacturing industry and intending to supply medicinal products to the USA, compliance with the United States Food and Drug Administration’s (FDA’s) 21 Code of Federal Regulations (CFR) is essential.
The FDA has a responsibility to ensure that all drugs produced within its regulated industries are safe and effective. 21 CFR is made up of 3 chapters, with Chapter I containing the specific requirements for the regulations that apply to Health and human services.
21 CFR Part 11 is contained within Chapter I, subchapter A (General) and provides the regulations for electronic records and electronic signatures. These subparts are designed to help make sure organisations’ digital records are reliable and authentic. Consequently, any electronic records that are used to store FDA-regulated information must comply with 21 CFR Part 11.
How does Enzyme Indicator Technology help?
Protak’s Enzyme Indicators come with our bespoke Athena® 2.0 software, which delivers real-time, quantifiable results for cycle efficacy with 21 CFR Part 11 compliant reporting.
The sophisticated software is used as part of the functioning of the PR2A reader to allow Enzyme Indicators to provide in-depth reporting capability, enhanced audit and review features, and data archive facilities during validation cycles.
Additionally, the results offered by Protak’s technology are quantifiable. Enzyme Indicators will identify a decline in decontamination performance before it reaches a critical set-point, meaning preventative measures can be applied before any significant risk to future processing use of critical equipment can occur.
When handling high-value products, the risk of validation failures is amplified. Failure investigations are lengthy and costly. With Protak’s technology, the conventional ‘run to fail’ approach is replaced by an upfront assessment of the bio-decontamination cycle efficacy, before the product is committed.
A deeper understanding of decontamination
The use of Enzyme Indicator Technology supports increased efficiency and a much more in-depth understanding of the entire decontamination process. Offering significantly more information than conventional methods, Protak’s technology provides numerical values which can be used to generate long-term data.
Detailed, valuable results mean that users can benefit from optimised cycles, based on real-time data across multiple surface types and challenge points. Our Enzyme Indicators significantly reduce the risk of cycle failure and resultant impacts on production and offer safer bio-decontamination.
To find out how Enzyme Indicator Technology can benefit your organisation, reach out today to speak with one of our team and arrange a presentation.