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 formally the executive agency of the Department of Health and Social Care before being replaced by the UK Health Security Agency and Office for Health Improvement and Disparities.
Enzyme Indicators (EIs) are fast becoming an essential component of the validation process in understanding decontamination validation lifecycle efficacy.
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. We’re working with many of the top 20 pharmaceutical brands.
INDUSTRY WORKING GROUP
Protak Scientific works alongside top Pharma companies to create a standardised approach to Gaseous decontamination Validation
Protak Scientific is the manufacturer of a rapid validation technology for gaseous decontamination (Predominately H2O2) with diverse application globally. Founded 8 years ago, Enzyme Indicators (EIs) enable faster, smarter and safer results in decontamination validation.
Protak Scientific largest customer base is pharmaceutical manufacturing companies where H2O2 decontamination processes are critical to the manufacture of Sterile products. Working with over 50% of the top 20 Pharmaceutical manufacturers including Pfizer, AstraZeneca, Roche, and Novo Nordisk to create standardised validation decontamination ways of working including the use of EIs.
Along with 7 leading pharma companies including AstraZeneca, Baxter, Bayer, Novo Nordisk, Pfizer and Roche, Protak Scientific aims to demonstrate that Is are fast becoming an essential component of the validation process in understanding the cycle efficacy of the applications to ensure they remain robust, repeatable and ultimately effective. In light of the need of a more standardised validation process and following the announced changes of EU GMP Annex 1: Manufacture of Sterile Medicinal Products, Protak Scientific sought to bring together an industry working group to discuss the challenges the industry is facing. The group aims to share knowledge and deliver the following objectives:
The group aims to share knowledge and deliver the following objectives:
- Harmonise EI/BI correlation methodology.
- Produce a consistent approach and good practice guide to industry application of H2O2 decontamination.
- Evaluate continuous process verification using EIs.
- Improve benchmarking of H2O2 decontamination equipment.
Thanks to the collective data and knowledge shared among these leading pharmaceutical companies the last eighteen months have been ground-breaking and have served to highlight Protak’s Enzyme Indicators as a robust, repeatable and wholly effective decontamination validation process.
Faster; Optimised Cycles, Smarter; Quantitative Data, Safer; Bio Decontamination
To find out more please contact Kate Marshall, Technical Director at Protak Scientific
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