Quiz for Media Fills – Aseptic Process Simulations

What is the primary purpose of a media fill?

To train operators how to gown properly

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To validate that aseptic processes and personnel can maintain sterility

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To test the stability of a drug formulation

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To measure environmental particle counts

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A media fill must use the exact number of units that are typically prepared in the most challenging production batch.

True

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False

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Which of the following must be included in a properly designed media fill?

Only routine interventions

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Only non-routine interventions

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Both routine and non-routine interventions

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No interventions at all

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Which of the following is a set of challenges that can affect the validity of a media fill test?

Short incubation time, improper aseptic technique, and incorrect media preparation

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Correct gowning, accurate documentation, and validated incubation conditions

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Extended incubation time, double-checking aseptic technique, and redundant quality controls

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Proper environmental monitoring, certified cleanroom, and sterile operator garb

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Match each risk point with its description:

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Correct donning of garb to prevent contamination
Proper sanitization and disinfection procedures
Airflow, temperature, pressure, and other cleanroom controls
Integrity and performance of filling machinery
Ensuring operators maintain aseptic technique and first air practices

Gowning

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Cleaning

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Environmental Controls

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Equipment

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Personnel Practices

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What are the correct incubation conditions for media-filled units?

20–25°C for 7 days, then 30–35°C for 7 days (≥14 days total)

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2–8°C for 14 days

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30–35°C for 14 days only

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20–25°C for 14 days only

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During inspection, a single vial shows turbidity on day 10 of incubation. What does USP <797> require?

Record the finding but consider the test successful if other vials are clear

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Discard the affected vial and continue incubation

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Repeat the media fill; personnel cannot resume compounding until passing

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Ignore the result if environmental monitoring is within limits

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Media fills are primarily a regulatory requirement and provide little benefit for patient safety.

True

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False

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Competency Testing in Aseptic Manipulation

Video 1 – Introduction

Quiz for Media Fills – Aseptic Process Simulations

Seth DePasquale, R.Ph., BCSCP September 4, 2025

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