PTCE Pharmacy Quality Assurance 3

Question 1

Which USP chapter governs sterile compounding environmental quality standards, including ISO classifications?

Accepted Answer

USP <797>

Answer

USP <797> sets environmental monitoring requirements and ISO classification standards for sterile compounding facilities.

Question 2

An ISO Class 5 environment is required for which compounding activity?

Accepted Answer

Direct compounding of sterile preparations

Answer

ISO Class 5 (also called the Primary Engineering Control) is required for the actual preparation of CSPs to limit microbial and particulate contamination.

Question 3

Which action is the most appropriate response when a compounding technician discovers a significant calculation error after the CSP has been dispensed?

Accepted Answer

Notify the pharmacist immediately and initiate a recall if needed

Answer

Immediate pharmacist notification and potential product recall is the correct response to protect patient safety after a dispensing error.

Question 4

What is the primary purpose of media-fill testing in a sterile compounding environment?

Accepted Answer

To evaluate the aseptic technique of compounding personnel

Answer

Media-fill testing uses microbiological growth media to simulate CSP preparation and assess whether personnel aseptic technique can prevent contamination.

Question 5

Environmental surface sampling in a sterile compounding area is performed primarily to:

Accepted Answer

Monitor for microbial contamination on work surfaces

Answer

Surface sampling detects microbial bioburden on compounding surfaces to ensure the environment remains within acceptable contamination limits.

(PTCE) Pharmacy Technician Certification Exam Practice Test

(PTCE) Pharmacy Technician Certification Exam Practice Test

PTCE Pharmacy Quality Assurance 3