The area having controlled airborne particle concentration is considered as the clean zone or clean room. These areas are constructed to minimize the introduction, generation, and retention of airborne particles in the area.
The concentration of particles depends on their diameter; hence the bigger particles will be less in number than the smaller particles in any cleanroom environment.
The airborne particles play a considerable role in aseptic processing because the viable particles i.e. bacteria, fungus etc. are associated with non-viable particles and may cause contamination in pharmaceutical sterile preparations.
Classification of these areas are given in many guidelines but the base of all other guidelines is ISO i.e. ISO-14644-1. A proper classification is given in ISO with the formula which gives the concentration of airborne non-viable particles in any class.
Table 1 shows the different classes of cleanrooms.
There are 9 classes of cleanrooms in ISO but only ISO Class 5 to ISO Class 8 for 0.5 µm and 5.0 µm are applicable in pharmaceuticals.
These numbers of particles are calculated for every class and for all particle sizes by the formula given below-
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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