Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

Clean rooms must be classified at which ISO level?

1. Class 5

2. Class 6

3. Class 7

4. Class 8

The correct answer is: Class 7

The correct classification for clean rooms in a pharmaceutical context is Class 7 according to ISO 14644-1 standards. Clean rooms are essential for controlling contamination during the manufacturing and handling processes of sterile products. Class 7 indicates that the clean room environment allows for a maximum allowable number of particles of size 0.5 micrometers per cubic meter, which is critical for areas where products requiring high sterility and cleanliness are produced. This classification ensures that the air cleanliness is maintained at a level that reduces the risk of contamination in pharmaceutical environments, especially when preparing injectable drugs or compounding sterile preparations. Maintaining such a classification helps to comply with regulatory requirements and provides a controlled environment necessary for operations that cannot tolerate any level of microbial contamination. While other classes, such as Class 5 or Class 6, have stricter particle limits suitable for more sensitive processes, Class 7 is typically the standard for general compounded sterile preparations and is therefore the most relevant choice in this context.