Isolators aseptic handling

Controlled environments also regard to aseptic handling in pharmacies, where they are achieved using laminar flow cabinets, biological safety cabinets or isolators (see Sect. 28.4). 

Aseptic handling of solutions with class 5 substances in a safety cabinet or an isolator is safe for inhalation exposure. 

For aseptic handling in closed systems a cabinet with unidirectional airflow (LAF or safety cabinet) or an isolator can be used (see Sect. 28.3). The requirements for the background room depend on national guidelines and on the types of containment in the cabinets. Adjustments are allowed but must be based on a risk assessment. 

Aseptic handling and preparation must be executed under class A conditions, usually a LAP (Laminar Air Flow) cabinet, a LDF (Laminar Down Flow) cabinet, a safety cabinet or an isolator see Sect 28.3. The background room for stock preparations in a LAP, or LDF... 

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. 

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. 

Isolators are now used in industrial scale aseptic processing for both formulation and filling. Fig. 5 shows an example of a rigid interconnected network of isolators providing a complete component handling and aseptic filling capability in an integrated line. The internal... 

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