Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

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What defines ISO Class 5 in terms of allowable particles per cubic foot?

100 particles
1,000 particles
10,000 particles
100,000 particles

The correct answer is: 100 particles

ISO Class 5 cleanrooms are defined by stringent standards regarding air cleanliness, specifically in terms of particulate contamination. In an ISO Class 5 environment, there can be no more than 3,520 particles larger than 0.5 micrometers per cubic meter, which translates to approximately 100 particles per cubic foot. This classification is crucial in pharmaceutical settings where sterile compounding occurs, ensuring that the environment is controlled to prevent contamination. This high level of cleanliness is essential for maintaining the integrity of sterile products and protecting patient safety. The specifications outlined by ISO standards are widely recognized and serve as guidelines for maintaining quality in environments that require low levels of contaminants. Understanding these standards is vital for pharmacy professionals, especially those involved in compounding and aseptic technique.