Solution

Validex - Pioneering a Global Standard


Disinfectant efficacy testing can be a daunting task as there are numerous factors to consider.

There are a number of standardised test methods available that can be used to demonstrate disinfectant efficacy. However, there are currently differences between the methods generally used in the EU and the US and all existing standards have individual pitfalls and unique challenges. Currently there is very little detail around explicit regulatory expectations for disinfectant efficacy testing, but there are guidance documents available which should be considered when embarking on this task.

It is important to note that the existing standards are not specifically for cleanroom disinfectants and so adaptations to the standard to reflect a cleanroom environment should be considered with the support of guidance documents such as (USP) 40-NF35 Chapter <1072>.

All these factors have been taken into consideration and resulted in the Validex harmonised method developed by Ecolab to support efficacy studies conducted by end users. Further supporting data is also available on the performance of Ecolab disinfectants on a range of different surfaces and isolates relevant to the cleanroom environment.

This additional supporting information will enable end users to use this data as an extension of their own validation data, therefore minimising the cost and resources required for their own efficacy studies. This harmonised ‘One Method’ can give companies a transferable platform to achieve replicable results between laboratories and between countries.

Solution

Speak to your Ecolab Account Manager today about Validex and how our Global Technical Consultants can help you reduce complexity and gain greater efficiency in your disinfectant efficacy validation processes.

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