Quality Control and Assurance Flashcards

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?

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

The USP 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.

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

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

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.

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?

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

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.

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

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

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.

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

Answer: Zero CFUs on both hands.

For the initial competency evaluation in garbing and hand hygiene, USP 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.

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?

Answer: Gas sterilization (e.g., ethylene oxide)

Autoclaving (steam) and dry heat sterilization are both high-temperature methods that would degrade a heat-sensitive (labile) substance. Filtration is only suitable for liquids, not powders. Gas sterilization, using agents like ethylene oxide, operates at much lower temperatures and is an effective method for sterilizing heat-sensitive and moisture-sensitive items, including powders.