Transforming the H₂O₂ bio -decontamination and validation process in pharmaceutical aseptic manufacturing.
Protak Scientific is a UK based organisation and the manufacturers of a unique rapid validation technology for gaseous decontamination using ‘Enzyme Indicators’ developed in collaboration with Public Health England before being replaced by the UK Health Security Agency and Office for Health Improvement and Disparities. We already supply, project manage and support over 50% of the top twenty largest pharmaceutical names and manufacturers of equipment used during the production of sterile medicinal product and medical devices while providing similar services to other sectors where bio-decontamination is critical to ensure the safety and efficacy of the process is assured.
Protak Athena™, our bespoke software delivers real-time quantifiable results for cycle efficacy with FDA CFR part 21, part 11 compliance reporting.
Athena 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.
Whether designing manufacturing facilities, building bespoke equipment or managing quality assurance of pharmaceutical production our product is the most effective method of bio-decontamination efficacy in clean room settings and sterile environments where high levels of sterility are required.
Protak Scientific’s validation process delivers accurate, quantifiable data in seconds, compared to the traditional validation tool with 7 day incubation, highlighting differences in location of any challenge areas, reducing cost, saving time and improving efficiency.
We’re working alongside many of the biggest pharmaceutical names creating a standardised approach to H₂O₂ and other gaseous bio-decontamination validation. Our groups’ membership includes AstraZeneca, Baxter, Bayer, Novo Nordisk, Sanofi, Pfizer and Roche.
In light of the need of a more standardised validation process and following the announced changes of the EU GMP Annex 1: Manufacture of Sterile Medicinal Products, we brought together an industry working group to discuss the challenges the industry is facing.
The group aims to share knowledge and deliver the following objectives:
Read about the advantages and benefits of using our Enzyme Indicators for your H₂O₂ bio-decontamination validation processes.
Biological Indicators vs Enzyme Indicators at a glance.
Presentations, white papers, webinars, shared articles, project summaries and product analysis.
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