CSPT Quality Assurance Protocols 5

Question 1

Which environmental monitoring method uses settle plates exposed to room air to assess viable microbial contamination?

Accepted Answer

Passive air sampling

Answer

Settle plates (passive air sampling) are petri dishes with agar left open for a set time to allow airborne microorganisms to settle and grow, providing a qualitative measure of bioburden.

Question 2

A sterile compounding facility finds mold on a surface sample taken inside the ISO 7 buffer area. According to USP <797>, what is the MOST appropriate immediate response?

Accepted Answer

Cease compounding, perform thorough disinfection with a sporicidal agent, and re-sample before resuming

Answer

Mold (fungal contamination) in the buffer area requires immediate cessation of compounding, sporicidal disinfection (since IPA is not sporicidal), and verification re-sampling before resuming.

Question 3

In sterile compounding QA, what is the purpose of a 'lot-specific certificate of analysis' (COA) for a bulk active pharmaceutical ingredient?

Accepted Answer

To verify that the specific lot meets identity, potency, purity, and quality specifications

Answer

A lot-specific COA provides analytical test results (identity, assay, impurities, microbial limits) for that exact lot, confirming it meets specifications before use in compounding.

Question 4

What is the significance of establishing action levels (vs. alert levels) in environmental monitoring programs?

Accepted Answer

Action levels require mandatory investigation and corrective action, while alert levels signal a trend requiring increased vigilance

Answer

Alert levels indicate a potential drift from normal conditions and prompt review, whereas action levels mandate immediate investigation, corrective action, and documentation to prevent patient harm.

Question 5

Which sterility testing method exposes the entire sample volume to culture media by filtering it through a membrane?

Accepted Answer

Membrane filtration method

Answer

The membrane filtration method passes the entire preparation through a 0.45 µm membrane that retains microorganisms, which are then incubated in culture media, making it suitable for large-volume preparations.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Quality Assurance Protocols 5