Who We AreProtak 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.
Enzyme IndicatorsWe manufacture ‘Enzyme Indicators’ – the unique, advanced validation tool for measuring bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research. Enzyme Indicators are fast becoming an essential component of the pharmaceutical manufacturing validation process in understanding cycle efficacy that’s outperforming traditional methods. Decontamination processes are critical to the pharmaceutical sector, Contract Development and Manufacturing Companies (CDMOs), Original Equipment Manufacturers (OEMs) and other sectors where clinical sterile environments and infection control are required. One of our largest sectors is pharmaceutical manufacturing.
Our Real-Time Digital Data and Validation Software
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.
An Essential Component of any H₂O₂ Validation Process
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.
Enzyme Indicator Focus Group
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:
- Harmonise EI/BI correlation methodology;
- Evaluate continuous process verification using EIs;
- Improve benchmarking of H₂O₂ decontamination equipment and;
- Produce a consistent approach and good practice guide to industry application of H₂O₂ decontamination.