The most critical component in preparation of CSPs is maintenance of sterility—in the compound itself and in the area where it is mixed. This pertains to both the physical plant and facilities and the personnel themselves. USP standards include the following in the office of a physician who prepares and mixes allergy vials:
Explore this issue:November 2007
- An anteroom where personnel wash their hands in a prescribed manner and don sterile garb. It is also a transition room that provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas and that reduces the need for heating, ventilating, and air conditioning.
- Attention to the beyond-use date (a certain number of days after the preparation was compounded), at which time it must be discarded.
- A ventilated biological safety cabinet for personnel and products, having an open front with inward airflow for personnel protection and filtered laminar airflow for product protection.
- A buffer area or room where preparation and staging of components take place.
- A clean room in which the compounds are mixed.
- Disinfectant, a chemical agent that destroys disease-causing pathogens.
- Appropriate labeling on all containers used to mix the compounds, as well as those that contain the compounds themselves, with name, ingredients, date mixed —and by whom they were prepared.
- Terminal sterilization for sealed containers to achieve a predetermined sterility level. This is usually accomplished by steam under pressure or autoclave.
Compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed, and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed. These performance responsibilities include maintaining appropriate cleanliness and conditions and providing labeling and supplementary instructions for the proper clinical administration of CSPs.
Compounding supervisors must ensure, through either direct measurement or appropriate information sources, that specific CSPs maintain their labeled strength within USP-designated limits, or within 10% if not specified, until their beyond-use dates. All CSPs should be prepared in a manner that maintains sterility and minimizes introduction of particulate matter.
A written quality assurance procedure includes the following in-process checks that are applied, as appropriate, to specific CSPs: accuracy and precision of measuring and weighing; the requirement for sterility; methods of sterilization and purification; safe limits and ranges for strength of ingredients, bacterial endotoxins, particulate matter, and pH; labeling accuracy and completeness; beyond-use date assignment; and packaging and storage requirements. When appropriate and practical, the dispenser must obtain and evaluate results of testing for identity, strength, purity, and sterility before a CSP is dispensed. Qualified, licensed health care professionals who supervise compounding and dispensing of CSPs are required to ensure that certain objectives are achieved.