Pharmacy Study Material

Free pharmacy material When designing a facility for pharmaceutical manufacturing, a foremost consideration is preventing product contamination. International GMP standards talk about contamination in terms of contamination of the product itself and cross contamination between   different products and batches. In production areas, especially where the product is exposed, the environment needs to be tightly controlled and clean. A significant aspect of this cleanliness is control of particulate by way of room air filtration. This technology is well known and codified in several widely used standards, primarily International Organization for Standardization (ISO) 14644-1 (1) and, for the manufacturing of sterile pharmaceuticals,  Eudralex , Volume 4, Annex 1 (2). Other factors besides air classification impact the potential for product contamination and production area cleanliness, and these are embodied within the concept of clean zones, which is defined in general term...