Ohio Pharmacy Law Practice Test

What is the maximum number of airborne particles allowed in a Class 100 environment per cubic foot of air?

1. 50

2. 100

3. 200

4. 500

The correct answer is: 100

In a Class 100 environment, which is a standard for clean rooms commonly referenced in pharmaceutical settings, the maximum allowable number of airborne particles greater than 0.5 micrometers in size is indeed set at 100 particles per cubic foot of air. This classification helps ensure that the area maintains the stringent cleanliness necessary for activities like drug compounding, where even a small amount of contamination can compromise the integrity and safety of pharmaceutical products. The standard is part of the guidelines provided by organizations such as the Federal Standard 209E, which defines clean room classifications based on the number of particulate contaminants. In Class 100 environments, maintaining a low level of airborne particles is crucial for processes that require sterile conditions, such as aseptic processing. The other numbers presented are not accurate for a Class 100 environment, as they refer to higher levels of permissible particles, which would be suitable for less stringent classifications, such as a Class 200 or Class 500 environment, where the tolerance for airborne particles increases significantly, allowing for 200 and 500 particles per cubic foot, respectively. Hence, the standard for Class 100 specifically is set at a maximum of 100 particles.