Pharmacy · PTCB

PTCB: Sterile and Non-Sterile Compounding

Aseptic technique, USP compounding standards, and beyond-use dating concepts tested on the PTCB exam.

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What does USP General Chapter <795> cover?
Standards for non-sterile compounding.
What does USP General Chapter <797> cover?
Standards for sterile compounding.
What does USP General Chapter <800> cover?
Handling of hazardous drugs in healthcare settings.
What is aseptic technique?
Practices used to prevent contamination of a sterile preparation by microorganisms.
What ISO air classification must a primary engineering control (PEC) provide?
ISO Class 5.
What ISO air classification is required for the buffer area surrounding a PEC?
ISO Class 7.
What ISO air classification is required for the ante area leading into the buffer area?
ISO Class 8.
What type of air pressure is maintained in a room used to compound non-hazardous sterile preparations?
Positive pressure.
What type of air pressure is maintained in a room used to compound hazardous sterile preparations?
Negative pressure.
In a horizontal laminar airflow workbench, which direction does HEPA-filtered air flow?
From the back of the cabinet across the work surface toward the opening.
What engineering control uses vertical airflow to protect both the preparation and the operator during hazardous sterile compounding?
A biological safety cabinet (BSC).
What sealed, glove-box-style device is used to compound hazardous sterile preparations?
A compounding aseptic containment isolator (CACI).
In standard garbing order, which item is put on first?
Dedicated shoes or shoe covers.
In standard garbing order, which item is put on last, immediately before compounding?
Sterile gloves.
What should a technician do with their hands before donning sterile garb?
Wash them thoroughly with soap and water.

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