Why is it critical to maintain a temperature of 20C or cooler in a sterile compounding environment?

Maintaining a temperature of 20°C or cooler in a sterile compounding environment is critical for upholding product integrity and stability. Many sterile compounding products, including certain medications and biologics, are sensitive to temperature fluctuations. Elevated temperatures can lead to degradation, alter the chemical composition of the substances, or decrease their efficacy. By ensuring that the temperature remains at or below this threshold, the potency and safety of the compounded sterile preparations can be preserved, ultimately ensuring that patients receive medications that are both effective and safe for use.

While adequate refrigeration is important in specific scenarios, the broader focus on maintaining a specific temperature is primarily about the stability of compounded products. Additionally, while preventing contamination is essential in a sterile environment, temperature control alone is not a primary method for preventing contamination. Finally, compliance with local health codes, although important for overall operations, is secondary to the fundamental need for product integrity in sterile compounding.