South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What ISO classification is required for a Primary Engineering Control (PEC)?

1. ISO 3

2. ISO 5

3. ISO 7

4. ISO 8

The correct answer is: ISO 5

A Primary Engineering Control (PEC) is required to maintain an environment that minimizes contamination risk during the preparation of sterile products. The standard for such environments is defined by the International Organization for Standardization (ISO), specifically focusing on the cleanliness of the air in terms of the number of particles per cubic meter. ISO 5 classification indicates that the area must have no more than 3,520 particles per cubic meter that are 0.5 micrometers or larger, which is essential for ensuring that the sterile products are not compromised during their preparation. This classification allows for a controlled environment where sterile compounding can take place safely, providing the necessary protection against airborne contaminants. In contrast, other ISO classifications, such as ISO 3 or ISO 7, have different specifications that are not suitable for the stringent conditions required for sterile compounding. ISO 3, for instance, is much cleaner than what is necessary for standard PEC operations and is typically reserved for very specialized applications like clean rooms for specific medical procedures. ISO 7 and ISO 8 are less clean and are more applicable to other areas in the compounding process, such as buffer areas or where less stringent control is adequate. Thus, maintaining an ISO 5 environment is crucial for the efficacy and