What is the minimum number of air changes per hour required in the cleanroom area?

The minimum number of air changes per hour required in the cleanroom area is 30 ACH. This standard is established to ensure that the cleanroom maintains a controlled environment that limits particulate contamination. High air change rates are crucial in a sterile compounding setting to dilute and remove any potential contaminants, including airborne particles and microorganisms that may enter the space.

Implementing 30 ACH helps in maintaining a clean environment by continuously introducing filtered air and removing unfiltered air, thus ensuring the air within the cleanroom remains as clean as possible. The requirement for such a high rate of air changes is pivotal in providing a suitable atmosphere for activities such as sterile compounding, where the safety and efficacy of compounded medications depend on the preservation of sterility free from contaminating agents.