Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

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ISO Class 7 permits how many particles per cubic foot?

  1. 1,000

  2. 10,000

  3. 100,000

  4. 10,000,000

The correct answer is: 10,000,000

ISO Class 7 cleanrooms are defined by specific particle limits to maintain suitable conditions for processes such as compounding sterile preparations. A Class 7 environment permits up to 10,000 particles per cubic foot for particles of size 0.5 micrometers and larger. Classifications of cleanroom environments like ISO Class 7 are critical in pharmacy settings as they ensure that controlled environments minimize the risk of contamination in sterile compounding. Knowing the particle limits helps pharmacy professionals construct and maintain spaces that meet regulatory requirements for patient safety. In the context of the question, indicating that ISO Class 7 allows for 10,000,000 particles would be incorrect, as it exceeds the predetermined threshold for this classification. Understanding the particle limits of various ISO classes is vital for maintaining compliance and ensuring safety in pharmacy operations.