Protak Scientific is a UK based organisation that manufactures a rapid validation technology for gaseous bio-decontamination using ‘Enzyme Indicators’, developed in collaboration with Public Health England (now the UK Health Security Agency). We supply, project manage and provide validation consultancy to multiple sectors where bio-decontamination is critical to ensure safety and efficacy.
ATHENA™, our bespoke software, delivers real-time quantifiable results for cycle efficacy with FDA 21 CFR 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.
We are working alongside many of the largest pharmaceutical companies, creating a standardised approach to H₂O₂ bio-decontamination validation. This groups includes AstraZeneca, Baxter, Bayer, Novo Nordisk, Sanofi, Pfizer and Roche.
Following the changes of EU GMP Annex 1: Manufacture of Sterile Medicinal Products, we brought together an industry working group to discuss the new requirements.
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.