What is the maximum allowable humidity in a Sterile Product Complex?

The maximum allowable humidity in a Sterile Product Complex is less than 60%. Maintaining humidity levels at or below this threshold is crucial for controlling microbial growth and ensuring the integrity of sterile products. High humidity can encourage the proliferation of bacteria and mold, which poses a significant risk to sterile compounding environments.

Controlling humidity is an essential aspect of maintaining the quality of compounded sterile preparations. If the humidity exceeds this level, it can also lead to complications such as moisture absorption by the products, affecting stability and shelf life. Therefore, keeping the humidity below 60% is a standard practice to ensure a safe and sterile environment in compounding facilities.