Stability and sterility testing and dating

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.Greater care is required for aqueous injections that are compounded sterile preparations (CSPs)—the most common CSPs used in therapy.

The 6-hour standard is based on the microbial growth observed in various growth media under conditions specified in USP Chapter 71.

Presence of endotoxins in a compound is evidence of a current or previous contamination.

Removal of endotoxins requires a specialized filtration system, and they are not removed by 0.2um filters used to sterilize compounded medications.

However, studies have demonstrated that the Pha Seal closed-system transfer device (Becton, Dickinson and Company, Durham, NC) maintains sterility of unpreserved, single-use vials for ≤7 days.

In these studies, the Pha Seal system was tested using growth media under simulated conditions.