Aseptic processing clean environment

The purpose of open unidirectional airflow benches is to protect products from particulate contaminants by creating a controlled environment. These benches are used, for example, in electronic, biological, pharmaceutical, and food industries. It should be mentioned that within pharmaceutical production, aseptic sterile processes must be carried out in a Class 100 environment (U.S. Federal Standard 209 E, Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones). To avoid particle contamination in the bench, horizontal or vertical airflow with high-efficiency particulate air (HEPA)-filtered air is used. The air velocity is normally 0.4-0.5 ra s". Some examples of typical arrangements of open unidirectional airflow benches are shown in Fig. 10.51. 

Buildings and Facilities Contamination/Cross Contamination, Water SystemAVater Quality, Aseptic/SterUe Processing Equipment Multipurpose Equipment, Equipment Cleaning and Use Log, Equipment Located Outdoors, Protected Environment, Cleaning of Product Contact Surfaces Raw Materials... 

A natural extension from the simple handling of potent compounds is to use barrier technology to provide highly secure mechanisms for processing and more complex manipulation of powders. Isolators of this type and configuration have the objectives of operator and environmental protection as well as the provision of a secure clean and aseptic environment around the process. 

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