Monday, 20 May 2013

Cleanroom wipes: a source of particle counts?

A new paper of interest, in relation to cleanrooms, particles and contamination control has been published. The paper looks at particles generated from cleanroom wipes.

The abstract reads:

“Cleanroom wipes, saturated with disinfectant, are commonly used within pharmaceutical grade cleanrooms as part of contamination control programmes. Whilst standards are in place for the testing of wipes for particle shedding, there is a limited data relating to the particle generation from wipes when they are used in practical conditions. This paper outlines a study that was undertaken of three different cleanroom wipes of the particles generated as the wipes were used. The study was undertaken within an isolator in order to minimise the background particle levels. The study showed that cleanroom wipes designed for ISO class 5 / EU GMP Grade A use are suitable for the those areas, but that wipes which are not certified for use in higher grade cleanrooms should not be used in those areas due to the high level of particles generated.”

The reference is:

Sandle, T. (2013). In situ study of particles generated from the use of pharmaceutical grade cleanroom wipes, European Journal of Parenteral and PharmaceuticalSciences, Vol. 18, No.1, pp5-11

Posted by Tim Sandle

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