Which temperature is considered acceptable for storing low-risk CSPs when frozen?

For low-risk compounding sterile preparations (CSPs) that are intended to be stored in a frozen state, the most suitable temperature range is -25 to -10 degrees Celsius. This temperature range helps maintain the integrity and stability of the compounded sterile preparations, ensuring that they remain within their specified shelf-life and do not degrade or lose potency due to improper storage conditions.

Low-risk CSPs are only produced under specific conditions, typically with minimal exposure to microbial contamination, and proper storage is crucial in preserving their quality. The designated freezing temperature minimizes the risk of ice crystal formation, which can compromise the physical properties of some formulations. Therefore, adhering to the -25 to -10 degrees Celsius range ensures optimal preservation of the defined attributes of the preparation until it is ready to be used.

Additionally, this range aligns with guidelines that suggest freezing CSPs at lower temperatures to protect their stability. Other ranges listed may not provide the optimal protection needed for these formulations, potentially leading to risks related to potency and safety.