CSPT - Compounded Sterile Preparation Technician Quality Control and Assurance Questions and Answers

Question 1

Routine surface sampling in an ISO Class 5 Primary Engineering Control (PEC) yields a result of 5 Colony-Forming Units (CFUs).
According to USP guidelines, what is the required response to this finding?

Accepted Answer

Investigate the potential cause, identify the microorganisms, and implement corrective actions.

Answer

Document the result as it is within the acceptable limit.

Answer

Immediately re-clean the PEC, resample, and proceed with compounding.

Answer

Discard all compounded sterile preparations made in the PEC since the last compliant sample.

Question 2

What is the primary purpose of conducting a media-fill test (process simulation) in a sterile compounding facility?

Accepted Answer

To qualify a technician's aseptic technique and validate the compounding processes.

Answer

To sterilize the compounding equipment before use.

Answer

To determine the chemical stability and beyond-use date of a new formulation.

Answer

To verify that the cleanroom's air quality meets its ISO classification.

Question 3

While performing the final visual inspection of a Total Parenteral Nutrition (TPN) admixture, a technician observes a white, crystalline precipitate. What is the most appropriate immediate action?

Accepted Answer

Segregate the preparation, label it as quarantined, and notify the pharmacist for investigation.

Answer

Gently warm the bag to see if the precipitate dissolves.

Answer

Filter the TPN using a 0.22-micron filter before dispensing.

Answer

Document the observation in the compounding record and dispense the bag.

Question 4

Which of the following elements is required to be documented on a Master Formulation Record (MFR)?

Accepted Answer

The assigned beyond-use date (BUD) and storage requirements.

Answer

The lot numbers of the specific ingredients used for a batch.

Answer

The date and time the preparation was compounded.

Answer

The name of the technician who performed the compounding.

Question 5

To achieve initial qualification for aseptic compounding, a technician must successfully pass a gloved fingertip and thumb sampling test. According to USP <797>, what is the maximum acceptable Colony-Forming Unit (CFU) count for this initial competency evaluation?

Accepted Answer

Zero CFUs on both hands.

Answer

Less than or equal to 3 CFUs on one hand.

Answer

A total of 5 CFUs for both hands combined.

Answer

Less than or equal to 1 CFU on each hand.

Question 6

A pharmacy needs to sterilize a bulk quantity of a heat-sensitive powder that will be used for compounding. Which sterilization method is most appropriate for this component?

Accepted Answer

Gas sterilization (e.g., ethylene oxide)

Answer

Autoclaving (steam sterilization)

Answer

Dry heat sterilization

Answer

Filtration using a 0.22-micron filter

Routine surface sampling in an ISO Class 5 Primary Engineering Control (PEC) yields a result of 5 Colony-Forming Units (CFUs).According to USP guidelines, what is the required response to this finding?

Routine surface sampling in an ISO Class 5 Primary Engineering Control (PEC) yields a result of 5 Colony-Forming Units (CFUs).
According to USP guidelines, what is the required response to this finding?