What category of sterile compounding utilizes nonsterile starting ingredients prepared in an ISO class 5 cleanroom?

• A. Category 1
• B. Category 2
• C. Category 3
• D. Category 4

Answer: (C)

In sterile compounding, the category that utilizes nonsterile starting ingredients prepared in an ISO Class 5 cleanroom is Category 2. This category is designated for preparations that require the use of nonsterile components but then must be compounded in a controlled environment to achieve sterility.

Category 2 compounding addresses the requirement to manage the sterility of products prior to their use, ensuring that they are prepared in a sufficient environment to mitigate risks associated with contamination. The ISO Class 5 environment ensures that the air quality is controlled to minimize airborne particles, which is critical for maintaining the sterility of the compounded product.