Stability and sterility testing and dating


20-Apr-2017 17:34

The chapter is divided into the following main sections: 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 conditions and providing labeling and supplementary instructions for the proper clinical administration of CSPs.The quality control and testing for CSPs in this chapter are appropriate and necessary.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.A written quality assurance procedure includes the following in-process checks that are applied, as is 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 p H; labeling accuracy and completeness; beyond-use date assignment; and packaging and storage requirements.The dispenser shall, when appropriate and practicable, obtain and evaluate results of testing for identity, strength, purity, and sterility before a CSP is dispensed.

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 appropriate risk level—low, medium, or high—is assigned according to the corresponding probability of contaminating a CSP with (1) microbial contamination (microbial organisms, spores, and endotoxins) and (2) chemical and physical contamination (foreign chemicals and physical matter).Potential sources of contamination include, but are not limited to, solid and liquid matter from compounding personnel and objects; nonsterile components employed and incorporated before terminal sterilization; inappropriate conditions within the restricted compounding environment; prolonged presterilization procedures with aqueous preparations; and nonsterile dosage forms used to compound CSPs.For a summary of the criteria according to risk levels, please see the This, or an equivalent test, is performed at least annually by each person authorized to compound in a low-risk level under conditions that closely simulate the most challenging or stressful conditions encountered during compounding of low-risk level CSPs.

Once begun, this test is completed without interruption.This test is completed without interruption within an ISO Class 5 air quality environment (see ).Six 100-m L aliquots of sterile Soybean– Casein Digest Medium are aseptically transferred by gravity through separate tubing sets into separate evacuated sterile containers.The six containers are then arranged as three pairs, and a sterile 10-m L syringe and 18-gauge needle combination is used to exchange two 5-m L aliquots of medium from one container to the other container in the pair.



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