Protak Scientific

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

Who We Are

Protak Scientific manufacture Enzyme Indicator technology (EIs), a rapid validation tool for gaseous bio-decontamination. EIs were originally developed in collaboration with Public Health England (now the UK Health Security Agency). One of Protak Scientific’s largest sectors is Pharmaceutical Manufacturing, where they partner with over 80% of the largest global companies. 

They also provide validation consultancy to multiple sectors where bio-decontamination is critical to ensure safety and efficacy. Part of the technology is a specially developed software, ATHENA™, that delivers real-time quantifiable results for cycle efficacy. This offers enhanced reporting and review features that support compliance requirements.

The technology can help companies in various sectors design manufacturing facilities, build bespoke equipment or manage quality assurance of pharmaceutical production, providing customers with the most effective method of bio-decontamination validation.

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 H₂O₂bio-decontamination
Improve understanding and reduce complexity of factors impacting H₂O₂efficacy
Improve benchmarking of H₂O₂bio-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.

Protak Scientific

Who We Are

Enzyme Indicators

Our Real-Time Digital Data and Validation Software

Enzyme Indicator Focus Group

Resources

Enzyme Indicators

BI vs EI

Case Studies

PROTAK SCIENTIFIC LTD