Protak Scientific with the support of the MHRA form an Enzymatic Indicator and Rapid Decontamination Validation Industry focus group
The MHRA have agreed to support 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 have offered to support industry and provide a regulator's perspective and assistance to interested parties.
As a first step the MHRA have offered to meet with Pharmaceutical manufacturers and interested parties at the MHRA offices in London to discuss and advise on regulatory perspective.
One of the misconceptions from interested parties is that regulators will not embrace new technology or advances in the scientific understanding of process validation. Put simply this is not the case. Rapid microbial methods are advancing the science of validation and regulatory are ready to be supportive of such technologies and would be users.
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 group will discuss issues and opportunities with the UK Decontamination Validation industry.Including:
1.Discussion between innovators and regulators to help allay fears that end users may have of the MHRA’s approach to new validation technologies and techniques.
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 RMM 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.
Notes to Editor:
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