PTCE PTCE Sterile Preparations 1 — Questions and Answers
Question 1: What USP chapter governs the compounding of sterile preparations in US pharmacies?
- USP 795
- USP 797 (Correct answer)
- USP 800
- USP 825
Correct answer: USP 797
USP 797 sets standards for sterile compounding including environmental controls, personnel training, and beyond-use dating to prevent contamination and patient harm.
Question 2: What is the ISO classification required for the primary engineering control (PEC) where sterile preparations are made?
- ISO Class 4
- ISO Class 5 (Correct answer)
- ISO Class 7
- ISO Class 8
Correct answer: ISO Class 5
ISO Class 5 is the cleanest required environment, maintained by the laminar airflow workbench (LAFW) or biological safety cabinet used during sterile compounding.
Question 3: What is the primary purpose of a laminar airflow workbench (LAFW)?
- To sterilize equipment using UV light
- To provide a sterile ISO Class 5 environment by passing air through a HEPA filter (Correct answer)
- To control room temperature during compounding
- To store sterile IV bags at proper temperature
Correct answer: To provide a sterile ISO Class 5 environment by passing air through a HEPA filter
The LAFW uses a HEPA filter to remove particles from air and direct it over the work surface in a unidirectional flow, creating a sterile compounding zone.
Question 4: What is a beyond-use date (BUD) in sterile compounding?
- The manufacturer's expiration date printed on the vial
- The date after which a compounded sterile preparation should not be used (Correct answer)
- The date a prior authorization expires
- The date the laminar flow hood was last certified
Correct answer: The date after which a compounded sterile preparation should not be used
The BUD is assigned by the compounder and indicates the latest date/time the preparation should be administered, based on risk level and storage conditions per USP 797.
Question 5: What is the correct direction for cleaning the laminar flow hood interior?
- Front to back in overlapping side-to-side strokes
- Back to front in overlapping side-to-side strokes using sterile 70% IPA (Correct answer)
- Top to bottom in circular motions
- Side to side starting from the center outward
Correct answer: Back to front in overlapping side-to-side strokes using sterile 70% IPA
Cleaning from back to front prevents contaminated particles from flowing back over the clean work surface, and 70% IPA is the standard disinfecting agent.
Question 6: What is aseptic technique in sterile compounding?
- Using antibiotics to sterilize IV solutions
- A set of practices designed to prevent microbial contamination during preparation of sterile products (Correct answer)
- Filtering all IV bags through a 0.2 micron membrane
- Autoclaving all equipment before use
Correct answer: A set of practices designed to prevent microbial contamination during preparation of sterile products
Aseptic technique includes proper garbing, hand washing, LAFW cleaning, and handling critical sites without contamination to ensure sterile product integrity.
PTCE PTCE Sterile Preparations 1
What USP chapter governs the compounding of sterile preparations in US pharmacies?