Finished pharmaceutical product testing required to assign the maximum allowable beyond use dates (BUD) requires a final preparation sterility test to be performed. The shelf-life of compounded pharmaceutical preparations is typically 30-60 days but is commonly less. Without an adequate sterility test (e.g., per USP <797>), room temperature stored sterile compounded drug preparations would have a labeled BUD of 4 to 6 days.
Cytometry systems may be used to detect very small quantities of contaminant such as bacterium, mold, fungi, etc. A cytometry system may be capable of detecting contamination as small as a single living cell, and the ability of the cell to multiply is not required for testing (as would be for a culture-based test). However, current cytometry systems require that the tested composition be in an aqueous preparation. Therefore oil-based preparations cannot be tested.
What is needed is a system and method for addressing the above, and related, problems.
USPTO Backgrounds
USPTO Backgrounds