Sterile Compounding Basics for the PTCB Exam

USP 797 Standards

Sterile compounding prepares medications that must be free from microbial contamination, primarily injectable and ophthalmic preparations. USP Chapter 797 establishes standards for sterile compounding including personnel training, environmental controls, and beyond-use dating.

Compounded sterile preparations (CSPs) are categorized by risk level. Low-risk preparations involve simple transfers using closed systems. Medium-risk involves multiple transfers or pooling. High-risk includes nonsterile starting ingredients that must be sterilized.

Aseptic Technique

Aseptic technique is the foundation of sterile compounding. This includes proper hand washing, garbing in sterile attire (gown, gloves, mask, hair cover, shoe covers), and working within a laminar airflow workbench (LAFW) or compounding aseptic isolator (CAI).

The critical site of a needle, syringe, or vial must never be touched or obstructed from first air. Items should be placed at least 6 inches inside the LAFW to ensure proper airflow protection.

Study Sterile Compounding

Sterile compounding is a significant PTCB exam topic. Master the concepts with our flashcards and test your knowledge with mini exams.