Question

Compounding p. 92

The pharmacist intern is reconstituting a 1 gram vial of ceftazidime with 10 ml of sterile water for injection. The reconstituted solution will be added to a bag of normal saline for IV administration. The primary engineering control used to compound this IV admixture should have: (select ALL that apply.)

A. Positive air pressure
B. Unclassified air
C. Unidirectional airflow
D. At least ISO 7 air quality
E. At least ISO 5 air quality

Answer 1

For reconstituting and compounding an IV admixture, the primary engineering control must have positive air pressure, unidirectional airflow, and at least ISO 5 air quality to maintain the necessary sterility of the preparation.

Step-by-step explanation:

The pharmacist intern is reconstituting a 1 gram vial of ceftazidime with 10 ml of sterile water for injection and needs to consider the proper engineering controls during this process. For the compounding of an IV admixture, the primary engineering control should include certain clean air requirements to ensure the sterility and safety of the medication. Specifically, the correct primary engineering controls for compounding sterile preparations, like this IV admixture, should have:

• Positive air pressure to prevent the influx of contaminated air into the sterile area.
• Unidirectional airflow to sweep particles and contaminants out of the critical area where the drug is being compounded.
• At least ISO 5 air quality in the critical area for compounding sterile preparations to ensure a very low particle count in the air.

Unclassified air is not suitable for a sterile compounding environment, and because the ISO refers to the cleanliness level of the air, ISO 5 is required for the critical areas within the primary engineering control (e.g., laminar airflow workbenches), whereas ISO 7 would generally apply to the broader cleanroom environment.