The MHRA have agreed to assist Protak Scientific in the formation of a UK focus group to discuss the use of Enzyme Indicators
in the UK. The MHRA have seen the potential of the use of Enzymatic Indicators to measure Decontamination Validation and are open to discuss the regulation process with the group.
Meetings will be via Social media with occasional meetings to be held at the offices of The MHRA in Canary Wharf, London.
Protak Scientific is the exclusive worldwide supplier of Enzymatic Indicators for Decontamination Validation, working with major pharmaceutical companies and
regulatory bodies to improve efficacy, save money and ultimately save lives.
The groupwill discuss issues and opportunities with the UK Decontamination Validation industry.
1. Discussion between innovators and regulators to help allay fears that end users
may have of the MHRA’s approach to regulation
2. Creation of focus groups such as this will aid the industry to navigate the
regulatory processes, allowing for the rapid progression and installation of the
technology across the industry.
3. Encourage movement from the use of 19th century processes such as BIs, to
21st century technologies such as EIs
4. Learn more about the quantitative measure of decontamination efficacy EIs
produce, comparable and correlated to Geobacillus Stearothermophilus
5. Understand the revolutionary nature of the EI and its ability to allow total cycle
mapping to be achieved in minutes.
Rapid microbial methods are advancing the science of validation and regulation, and the group is ready to support such technologies and would-be users.