Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What is the required ISO classification for hoods inside clean rooms?

1. ISO Class 4

2. ISO Class 5

3. ISO Class 6

4. ISO Class 8

The correct answer is: ISO Class 5

The required ISO classification for hoods inside clean rooms is ISO Class 5. This classification indicates that the environment provides a controlled level of cleanliness necessary for the compounding of sterile pharmaceuticals. In ISO Class 5, the air cleanliness is specified to maintain a maximum of 3,520 particles of 0.5 micrometers or larger per cubic meter of air, which is essential for preventing contamination of sterile products. Hoods designed to operate in this environment are crucial for activities like sterile compounding, where any particulate matter could compromise the safety and efficacy of the pharmaceuticals being prepared. Other classifications, such as ISO Class 4, 6, and 8, have varying levels of allowable particulate matter and are not as stringent as Class 5. For example, ISO Class 4 allows for fewer particles than Class 5 but is not typically required for most pharmacy operations concerning sterile compounding, where Class 5 is the standard. Class 6 has a higher allowable particulate count, making it unsuitable for the same applications. In summary, ISO Class 5 strikes the right balance of cleanliness required for the sterile compounding environment, which is why it is mandated for hoods inside clean rooms.