CSPT - Compounded Sterile Preparation Technician Quality Control and Assurance Questions and Answers 1

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 <797> guidelines, what is the required response to this finding?

Accepted Answer

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

Answer

The USP <797> action level for microbial surface sampling in an ISO Class 5 environment is >3 CFUs. A result of 5 CFUs exceeds this limit and triggers a required investigation. This investigation includes identifying the microorganisms to understand the potential risk and source, determining the root cause (e.g., improper cleaning, break in technique), and implementing a corrective and preventive action (CAPA) plan, which would include re-cleaning and resampling.

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

A media-fill test uses a sterile microbiological growth medium (like Tryptic Soy Broth) in place of actual drug components to simulate the entire compounding process. Its main purpose is to serve as a performance-based test to ensure that personnel can compound sterile preparations aseptically and that the facility's processes prevent microbial contamination.

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

The presence of a precipitate in a TPN is a critical sign of a potential chemical incompatibility, most dangerously between calcium and phosphate, which can form emboli if infused. Such a preparation is unsafe for patient administration and must be immediately removed from the workflow, quarantined, and brought to the pharmacist's attention for a full investigation. Attempting to filter or dispense the product would be a serious safety risk.

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

A Master Formulation Record is the detailed "recipe" or set of instructions for a specific compounded preparation. It includes elements like ingredient names, quantities, equipment, step-by-step procedures, quality control steps, and the assigned BUD with storage instructions. Information specific to a single compounding event, such as lot numbers, the date of compounding, and technician names, is recorded on the Compounding Record.

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

For the initial competency evaluation in garbing and hand hygiene, USP <797> requires a result of zero CFUs across three separate, successful sampling events. The action level of >3 CFUs applies to subsequent, routine sampling that occurs after a media-fill test, not the initial qualification.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Quality Control and Assurance Questions and Answers 1