Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

A cleanroom must have either Laminar airflow hood or Barrier Isolation System within what type of environment?

1. ISO Class 5 room

2. ISO Class 7 room

3. Positive pressure room

4. Negative pressure room

The correct answer is: ISO Class 7 room

The requirement for a cleanroom to have either a Laminar Airflow Hood or a Barrier Isolation System is most appropriately aligned with an ISO Class 7 room. ISO Class 7 is designed to control the level of airborne particulate contamination to a maximum allowable count while also maintaining specific conditions regarding airflow and pressure. In such environments, laminar airflow or barrier systems are crucial to achieve the necessary cleanliness levels and to protect both the compounding materials and the final products from contamination. ISO Class 5, while it may also use these systems, has stricter particulate limits and is specifically for more sensitive processes, therefore, it is not the environment chosen for this particular question. Meanwhile, positive and negative pressure rooms serve different purposes related to air pressure rather than the specific cleanliness requirements of ISO Class ratings. Positive pressure rooms are typically employed to prevent contaminants from entering, while negative pressure rooms help contain contaminants, primarily in isolation settings, which does not directly relate to the cleanliness class required for pharmaceutical compounding like in an ISO Class 7 cleanroom. Thus, the assumption about the necessity for laminar airflow or barrier isolation in this context is accurately justified for an ISO Class 7 environment.