Protak Scientific celebrate landmark development that is transforming the H202 bio-decontamination and validation process in pharmaceutical aseptic manufacturing
The UK based manufacturer supply ‘Enzyme Indicators’ – the unique, advanced rapid validation tool for measuring H2O2 gaseous bio-decontamination performance to many of the largest pharmaceutical names including AstraZeneca, Pfizer, Novo Nordisk, Roche, Bayer, Baxter and Sanofi and manufacturers of equipment used during the production of sterile medicinal product and medical devices.
Following extensive feedback from existing pharmaceutical industry users Protak have introduced a significant performance upgrade to Athena™ – their bespoke software that delivers real-time, quantifiable results for cycle efficacy with full 21 CFR Part 11 compliance features.
The pharmaceutical development process is a painstakingly lengthy one. From initial concept to the formation, approval and manufacturing of a product can easily take ten to fifteen years. It’s just eight years since Protak first commercialised their unique technology for rapid gaseous bio-decontamination. And after over two challenging years of pandemic they’re celebrating another ground-breaking development.
Protak Scientific’s Enzyme Indicators are fast becoming an essential component of the pharmaceutical manufacturing validation process in understanding cycle efficacy that’s outperforming 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 7 day incubation period, generating ‘challenge area’ specific data reducing cost, saving time and improving efficiency.
The Athena software is used alongside Enzyme Indicators to deliver advanced reporting capability, enhanced audit and review features along with data archive facilities during validation cycles. It can act as an early warning system allowing proactive execution and planning to occur.
Protak’s advanced Enzyme Indicator technology can be effectively applied in any industry sector where gaseous bio-decontamination is used as it remains one of the most effective methods of neutralising contaminants in clean room settings and sterile environments where high levels of sterility are required.
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.
Data analysis
They’ll explain the advantages and significant benefits of using Enzyme Indicators throughout your bio-decontamination and validation processes, creating a programme that allows accurate testing, analysis and proof of concept through an initial trial study and data analysis.
Get in touch at: contact@protakscientific.com to arrange a conversation.
