South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

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What is the maximum number of particles allowed in an ISO 5 classification?

  1. 3,520 particles

  2. 352,000 particles

  3. 13,520,000 particles

  4. 1,000 particles

The correct answer is: 3,520 particles

The correct answer refers to the classification standard for cleanroom environments specified by ISO (International Organization for Standardization). ISO 5 defines an environment where the maximum allowable number of particles per cubic meter is specified for a given size of particles. Specifically, for particles that are 0.5 micrometers (µm) in diameter, ISO 5 permits up to 3,520 particles. This standard is crucial in settings such as pharmaceutical manufacturing, where maintaining a clean environment is necessary to ensure product safety and efficacy. In maintaining compliance with ISO 5, environments are monitored rigorously to ensure that the number of particles does not exceed this limit. This includes consideration of air filtration and circulation to protect against contamination.

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