Abstract
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 limited data relating to the particle generation from wipes when they are used in practical conditions. This paper outlines a study of the particles generated as three different cleanroom 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 those areas, but that wipes which are not certified for use in higher grade cleanrooms should not be used in such areas due to the high level of particles generated. © 2013 Pharmaceutical and Healthcare Sciences Society.
| Original language | English |
|---|---|
| Pages (from-to) | 5-10 |
| Number of pages | 5 |
| Journal | European Journal of Parenteral and Pharmaceutical Sciences |
| Volume | 18 |
| Issue number | 1 |
| Publication status | Published - Dec 2013 |
Keywords
- Cleanrooms
- Contamination control
- Particle counts
- Pharmaceutical manufacturing
- Wipes