PTCE PTCE Sterile Preparations

Question 1

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

Accepted Answer

USP 797

Answer

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?

Accepted Answer

ISO Class 5

Answer

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)?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

Cleaning from back to front prevents contaminated particles from flowing back over the clean work surface, and 70% IPA is the standard disinfecting agent.

(PTCE) Pharmacy Technician Certification Exam Practice Test

(PTCE) Pharmacy Technician Certification Exam Practice Test

PTCE PTCE Sterile Preparations