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Nevertheless, it is prudent to carry out immediate-use compounding in an area that is kept clean and orderly.Additionally, common aseptic techniques should be followed.Single-dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture.Opened single-dose ampuls shall not be stored for any time period.The chapter stratifies the compounding of all sterile products, including irrigations and ophthalmic preparations, into 3 risk levels based on the sterility of the bulk ingredients and the degree of manipulation required to make the final product.The risk levels and requirements for each are summarized in Online Table 1.The content of this chapter applies to health care institutions, pharmacies, physician practice facilities, and other facilities in which CSPs are prepared, stored, and dispensed.

Sterile compounding also requires cleaner facilities; specific training and testing of personnel in principles and practices of aseptic manipulations; air quality evaluation and maintenance; and sound knowledge of sterilization and solution stability principles and practices.The intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs.The quality control and testing for CSPs in this chapter are appropriate and necessary.Greater care is required for aqueous injections that are compounded sterile preparations (CSPs)—the most common CSPs used in therapy.Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are issues of nonsterility and large errors in ingredients.




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