The basic understanding for CSTDs is that they should not be used to extend BUD.
However, does this prevent multiple entries into the bag by creating a sealed barrier between the product and the direct compounding area (DCA)? It is interesting to note that the media-fill test procedure for low-risk compounding includes transferring four 5-m L aliquots of TSA into a single 30-m L vial. A CSP prepared under low-risk conditions receives a 48 hour BUD when stored at controlled room temperature.
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At least that’s how things are in California at the moment. Does that still count if one uses a CSTD or other port that prevents re-entry via the stopper?
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 pre-administration storage duration and temperature limits specified apply in the absence of direct sterility testing results that justify different limits for specific CSPs.
The risk levels defined in the apply to the quality of CSPs immediately after the final aseptic mixing or filling or immediately after the final sterilization, unless precluded by the specific characteristics of the preparation.