Ohio Pharmacy Law Practice Test

What is the maximum allowable number of particles in a Class 100,000 environment as per ISO standards?

1. 10,000 particles per cubic foot of air

2. 100,000 particles per cubic foot of air

3. 1,000 particles per cubic foot of air

4. 500,000 particles per cubic foot of air

The correct answer is: 100,000 particles per cubic foot of air

The correct answer of 100,000 particles per cubic foot of air in a Class 100,000 environment aligns with ISO standards, which outline specific cleanliness levels for controlled environments such as clean rooms. In a Class 100,000 environment, the maximum allowable particle count specifically indicates that there can be up to 100,000 particles that are 0.5 micrometers or larger in a cubic foot of air. This classification is part of the ISO 14644-1 standard, which categorizes cleanrooms into different classes based on the number of particles allowed per volume of air. Understanding these classifications is crucial for ensuring the appropriate cleanliness necessary for sterile environments, such as those found in pharmaceutical manufacturing and other sensitive operations. Therefore, since the definition of a Class 100,000 environment is clear and well-established, the answer accurately reflects the ISO standards for controlled cleanroom environments.