What is considered a critical factor in maintaining the quality of sterile preparations?

Temperature control during storage and handling is crucial for maintaining the quality of sterile preparations. This is because certain sterile products are highly sensitive to temperature variations, which can compromise their stability, efficacy, and safety. For example, many medications need to be stored at specific temperature ranges to prevent degradation or loss of potency. If the temperature is not controlled properly, it can lead to chemical reactions or microbial growth that can render the preparation ineffective or harmful.

Additionally, effective temperature control helps ensure that the integrity of the sterile environment is maintained throughout the entire process, from compounding to storage. This is especially important in environments designed to limit exposure to potential contaminants and ensure that the end product is safe for patient use. Therefore, careful attention to temperature is an integral aspect of sterile compounding practices as defined by USP 797 standards.