What is the preferred method for terminally sterilizing aqueous CSPs?

Thermal sterilization is the preferred method for terminally sterilizing aqueous compounded sterile preparations (CSPs) because it effectively eliminates a wide range of microorganisms, including bacteria, viruses, and spores. This method typically involves the use of steam under pressure, such as in autoclaving, which raises the temperature and pressure to a point where microbial life is effectively destroyed.

Aqueous CSPs are particularly sensitive to heat, and thermal sterilization is capable of achieving the high temperatures necessary to ensure sterility without compromising the integrity of the solution. The moist heat penetrates the solution and container more effectively than dry heat, making it particularly suited for liquid formulations. This approach also has the advantage of being a well-established standard that provides reliable and consistent results when applied correctly.

While other methods like dry heat sterilization, chemical sterilization, and radiation sterilization can be employed under specific circumstances, they are generally not the first choice for aqueous CSPs. Dry heat may not be as effective for moisture-laden products, chemical sterilization may leave residues or require significant handling precautions, and radiation is more suited for solid dosage forms or materials that can be irradiated without damage. Thus, thermal sterilization stands out as the most effective and suitable method for ensuring