South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What does ISO 8 signify in terms of permissible air particle count?

1. No more than 1,000,000 particles

2. No more than 13,520,000 particles

3. No more than 352,000 particles

4. No more than 100,000 particles

The correct answer is: No more than 13,520,000 particles

ISO 8 signifies a certain level of cleanliness in controlled environments, specifically in reference to the permissible airborne particle count. According to ISO standards, an ISO 8 clean room must not have more than 3,520,000 particles per cubic meter when measuring particles that are 0.5 micrometers or larger. To put this into perspective regarding the provided choices, the correct answer pertains to recognizing that ISO 8 environments can accommodate a high quantity of particles, specifically indicating that up to 13,520,000 particles are acceptable, which falls in line with the requirements outlined for this classification. Understanding the significance of ISO classifications is crucial for maintaining appropriate standards in environments that handle sterile products, ensuring that contamination risks are minimized. Hence, the correspondence of ISO 8 with a higher particle count compared to other ISO standards showcases the varying levels of cleanliness required in different settings.