Aseptic handling working area

In pharmacies a laminar flow unit is used to protect the product against microbiological contamination from the operator. With a cross flow LAF cabinet the HEPA filtered air is directed over the working area to the operator. This type of LAF bench thus cannot be used for operations with hazardous substances (hazardous being defined as any substance with a H statement, so with a hazard class higher than one, see Sect. 26.3.1). It can be used for aseptic preparation processes with closed systems, such as aseptic handling, see Chap. 31. 

The working area is the immediate environment in which the aseptic handling is performed. It is the working surface (EU Grade A zone) of the LAF or safety cabinet or isolator. 

The presence of containers and materials liable to generate fibres should be minimized in dean areas and avoided completely when aseptic work is in progress. Components, bulk-product containers, and equipment should be handled after the final deaning process in such a way that they are not recontaminated. The stage of processing of components, bulk-product containers, and equipment should be properly identified. 

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