Safety cabinet 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). 

The investigations considered small-scale preparation of capsules, cutaneous preparations, aseptic handling in a safety cabinet with laminar down flow. The inhalation exposure was measured by filtration of the air in the breathing zone, see Fig. 26.5a and b. 

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... 

A safety cabinet is a laminar down flow cabinet, which is constructed specifically for protection of both the sterile product and the operator. It is frequently used in (hospital) pharmacies for aseptic preparation (when products are not fully closed) and for aseptic handling of class 4 or 5 substances (see Sects. 26.5.2 and 26.8). Laminar down flow has the advantage compared to cross flow that the operator does not feel the continuous flow in his direction. Other names for a safety cabinet are biosafety cabinet, biosafety bench, biohazard bench, biohazard cabinet, biological safety cabinet etc. 

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. 

Handling of retrieved implants and tissues may pose safety concerns for laboratory personnel. As a precautionary measure, retrieved implants should be sterilized and disinfected carefully. In cases where implants cannot be sterilized prior to analysis due to protocol requirements, extreme care should be taken to use an aseptic technique. Barrier clothing, gloves and biosafety cabinets should be used. A detailed discussion of precautions to be used in handling of human tissues can be found in ISO 12891-1. 

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