Pharmacy Law Practice Exam

What is identified as the primary engineering control in 797?

1. ISO 6

2. ISO 7

3. ISO 8

4. ISO 5 or better

The correct answer is: ISO 5 or better

In the context of USP Chapter 797, which outlines guidelines for compounding sterile preparations, the primary engineering control refers specifically to the environment that is required to minimize contamination. This is primarily achieved through the use of a Laminar Flow Hood or a Biological Safety Cabinet, which must maintain a clean environment during the compounding process. ISO classifications indicate the cleanliness levels of an environment based on the number of allowable particles per cubic meter of air. ISO 5 represents a very clean environment with a maximum of 3,520 particles per cubic meter for particles equal to or greater than 0.5 micrometers. This level is critical for preventing contamination in the preparation of sterile products. The requirement for "ISO 5 or better" ensures that the environment used for compounding sterile medications is adequately controlled and minimizes the possibility of microbial contamination. The other classifications — ISO 6, ISO 7, and ISO 8 — denote progressively less clean environments and are not specific to the primary engineering control for sterile compounding. As a result, although these classifications may serve other purposes within the pharmacy setting, they do not meet the stringent requirements set forth in USP 797 for the primary engineering control. Thus, "ISO 5 or better" is clearly established