Monday, 9 March 2020

Call for a global disinfectant standard


The time has come for industry and disinfectant manufacturers to set out guidelines for evaluating products appropriate for pharmaceutical cleanrooms.

Maintaining environmental control in a pharmaceutical manufacturing environment is dependent on the facility’s cleaning and disinfection programme, which requires the selection of the appropriate disinfectants, their proper application, and an assessment of their capability to inactivate or kill bacteria and fungi.

Disinfectants have a variety of properties that include spectrum of activity, mode of action, and effectiveness. Equally, the chemicals are often categorised into groups based on their chemical nature, spectrum of activity, or mode of action. Effectiveness is assessed through disinfectant efficacy testing.

A problem faced by users, is the array of different (and often contradictory) standards together with differing and often unrealistic, acceptance criteria. For those working in pharmaceuticals and healthcare, a global approach applicable to these sectors is required. Ecolab have developed such an approach.

Tim Sandle outlines such an approach in a new article:


Sandle, T. (2019) Call for a global disinfectant standard, Cleanroom Technology, 27 (11): 36-38

The article concludes:

With Ecolab having set out some clear, sensible and reproducible criteria for the evaluation of disinfectants for use in pharmaceutical facility cleanrooms, it is now time for industry and manufacturers of disinfectants to come together to ensure that such an approach becomes the de facto approach for the industry.

This can happen through users developing protocols along the lines recommended; having supplier recommending the revised criteria; and, most importantly, engaging with regulators to present the scientific arguments behind the approach and seeking universal acceptance of what needs to become a global standard for disinfectant efficacy testing as applied to pharmaceuticals.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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