PTCE PTCE Sterile Preparations

Question 1

What USP chapter governs the compounding of sterile preparations in US pharmacies?

Accepted Answer

USP 797

Answer

USP 795

Answer

USP 800

Answer

USP 825

Question 2

What is the ISO classification required for the primary engineering control (PEC) where sterile preparations are made?

Accepted Answer

ISO Class 5

Answer

ISO Class 4

Answer

ISO Class 7

Answer

ISO Class 8

Question 3

What is the primary purpose of a laminar airflow workbench (LAFW)?

Accepted Answer

To provide a sterile ISO Class 5 environment by passing air through a HEPA filter

Answer

To sterilize equipment using UV light

Answer

To control room temperature during compounding

Answer

To store sterile IV bags at proper temperature

Question 4

What is a beyond-use date (BUD) in sterile compounding?

Accepted Answer

The date after which a compounded sterile preparation should not be used

Answer

The manufacturer's expiration date printed on the vial

Answer

The date a prior authorization expires

Answer

The date the laminar flow hood was last certified

Question 5

What is the correct direction for cleaning the laminar flow hood interior?

Accepted Answer

Back to front in overlapping side-to-side strokes using sterile 70% IPA

Answer

Front to back in overlapping side-to-side strokes

Answer

Top to bottom in circular motions

Answer

Side to side starting from the center outward

Question 6

What is aseptic technique in sterile compounding?

Accepted Answer

A set of practices designed to prevent microbial contamination during preparation of sterile products

Answer

Using antibiotics to sterilize IV solutions

Answer

Filtering all IV bags through a 0.2 micron membrane

Answer

Autoclaving all equipment before use