Within an ISO Class 5 air quality environment, (see ) three sets of four 5-m L aliquots of sterile Soybean Casein Digest Medium are transferred with the same sterile 10-m L syringe and vented needle combination into separate sealed empty sterile 30-m L clear vials (i.e., four 5-m L aliquots into each of three 30-m L vials).Sterile adhesive seals are aseptically affixed to the rubber closures on the three filled vials, then the vials are incubated as described in the This, or an equivalent test, is performed under conditions that closely simulate the most challenging or stressful conditions encountered during compounding.The rigor of in-process quality-control checks and of postcompounding quality inspection and testing increases corresponding to the potential hazard of the route of administration.For example, nonsterility, excessive bacterial endotoxin contamination, large errors in strength of correct ingredients, and incorrect ingredients in CSPs are potentially more dangerous to patients when the CSPs are administered into the vascular and central nervous systems than when administered by most other routes.
Greater care is required for aqueous injections that are compounded sterile preparations (CSPs)the most common CSPs used in therapy.
Qualified licensed health care professionals who supervise compounding and dispensing of CSPs shall ensure that the following objectives are achieved.
This chapter emphasizes the need to maintain high standards for the quality and control of processes, components, and environments; and for the skill and knowledge of personnel who prepare CSPs.
Compounding supervisors shall ensure through either direct measurement or appropriate information sources that specific CSPs maintain their labeled strength within monograph limits for USP articles, or within 10% if not specified, until their beyond-use dates.
All CSPs are prepared in a manner that maintains sterility and minimizes the introduction of particulate matter.