El control total de la contaminación en Salas Blancas y Estériles

Cleaning of Compounding Aseptic Isolators (CAIs) and Class II Biological Safety Cabinets (BSCs)

Compounding Aseptic Isolators and Class II biological safety cabinets are used in hospital pharmacies and other dispensing facilities to formulate (i.e. “compound”) individual prescriptions for patient care.

Overview

Compounding Aseptic Isolators and Class II biological safety cabinets are used in hospital pharmacies and other dispensing facilities to formulate (i.e. “compound”) individual prescriptions for patient care. A typical hospital pharmacy utilizing a CAI for contamination control and sterility, will make individual pharmaceutical preparations that are transferred aseptically into vials, intravenous (IV) bags, syringes, infusion devices, etc.
These are termed compound sterile preparations (CSPs) in the industry. By contrast, a licensed compounding facility, utilizing a Class II biological safety cabinet for containment, contamination control and sterility, might produce cancer treatment drugs in batches of perhaps tens or a few hundred.

Both CAIs and Class II BSCs are used to physically isolate manufactured products from contamination from the background environment — the room outside the isolator. Class II BSCs provide containment capability not found in CAIs. This is necessary when working with hazardous drugs such as cytoxics, hormones and radiopharmaceuticals. Both are rated as ISO Class 5 devices in terms of air particle cleanliness and are maintained as sterile environments to a Sterility Assurance Level (SAL) of 10-3.

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