South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is the required ISO classification for the area where hand hygiene and garbing occurs?

1. ISO 5

2. ISO 7

3. ISO 8

4. ISO 9

The correct answer is: ISO 8

The correct classification for the area where hand hygiene and garbing occurs is ISO 8. This area is typically considered to be a transition zone between the general environment and the sterile compounding area where critical processes take place. In such transition areas, it’s essential to maintain some level of particulate control to prevent contamination when individuals prepare to enter a more controlled environment for compounding sterile products. ISO 8 classification allows for a higher level of permissible particles compared to ISO 5, which is required in the actual cleanroom where sterile preparations are made. ISO 7 is required for areas that may require a higher control of airborne contamination than ISO 8, typically closer to the compounding area but not for the hand hygiene and garbing areas. ISO 9 is not suitable, as it allows for even higher levels of contamination, which would be unacceptable in a pharmaceutical setting where hand hygiene and garbing are critical to maintaining aseptic conditions.