Unlike drug manufacturers that produce mass quantities of a standardized drug for widespread distribution, pharmaceutical compounding centers produce small batches of highly customized medications based on a particular patient’s dosage or formulation needs – even their flavor preferences. Compounding pharmacies can also create drugs that have been discontinued by drug manufacturers, as well as provide replacement drugs when a patient’s normal medication is in short supply. One area where compounding is common is in chemotherapy, where treatment decisions depend on highly individual factors such as the type of cancer being treated and a patient’s unique characteristics such as height, weight, and tolerance of side effects.
During the compounding process, it is critical to maintain a clean environment to avoid contamination of the medication. This video from the Dana Farber Cancer Institute talks about the many types of precautions that are typically taken during sterile compounding, including personal protective equipment, containment technology and procedural controls.
Pharmaceutical compounding often takes place in a clean room inside a biological safety cabinet or clean bench. A Class II biosafety cabinet protects the medication from particulates in the air outside the cabinet, and protects the compounding pharmacist from any aerosols produced during the compounding process. A laminar flow clean bench protects the compounded product only, and is most appropriate for processes that will not create harmful aerosols, such as in the preparation of some IV fluids.
For facilities that do not have a clean room or that need to save space, a compounding aseptic isolator (CAI or glovebox) is used to provide the air cleanliness needed for the compounding process. Sometimes, a CAI is just more convenient to use than a clean room. For example, James Wagner, President of Controlled Environment Consulting, pointed out in a recent article that “the garbing and gowning process required for access to a cleanroom might actually take longer than the average time needed for the compounding procedure itself.”
Chemotherapy and other cytotoxic drugs should be produced in a compounding aseptic containment isolator (CACI). CACIs perform the same functions and provide the same conveniences as CAIs, but they operate at a negative pressure to the room, protecting personnel from hazardous compounds in the event of a leak.