Transforming the H₂O₂ bio-decontamination process in multiple sectors across the world.

Who We Are

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.

Enzyme Indicators

We manufacture ‘Enzyme Indicators’ – an advanced validation tool for measuring bio-decontamination performance that is transforming global validation processes. Enzyme Indicators are rapidly becoming an essential component in understanding cycle efficacy. Bio-decontamination processes are critical to many sectors using H₂O₂, including Pharmaceuticals, Contract Manufacturing, Original Equipment Manufacturers (OEMs), Medical Device, Engineering, Hospital Pharmacy and Compounding, Universities and Research Organisations, and other sectors where sterile environments and contamination control are required. One of our largest sectors is pharmaceutical manufacturing.

Our Real-Time Digital Data and Validation Software

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.

Enzyme Indicator Focus Group 

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:

  • Produce a consistent approach and Points to Consider Guide to industry application of H₂O₂ bio-decontamination
  • Improve understanding and reduce complexity of factors impacting H₂O₂ efficacy 
  • Improve benchmarking of H₂O₂ bio-decontamination equipment
  • Harmonise EI/BI correlation methodology
  • Evaluate routine process verification using EIs

Resources

Enzyme Indicators

Read about the advantages and benefits of using our Enzyme Indicators for your H₂O₂ bio-decontamination validation processes.

BI vs EI

Biological Indicators vs Enzyme Indicators at a glance.

Case Studies

Presentations, white papers, webinars, shared articles, project summaries and product analysis.