Quiz for Surface Sampling

What is the primary purpose of surface sampling with contact plates in cleanroom environments?

To test the potency of compounded drugs

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To detect microbial contamination and verify cleaning effectiveness

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To measure air particle counts in controlled areas

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To qualify HVAC system performance

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Which agar medium is most commonly used in contact plates for bacterial growth?

MacConkey Agar

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Tryptic Soy Agar (TSA)

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Sabouraud Dextrose Agar (SDA)

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Blood Agar

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According to USP <797>, how often must surface sampling be performed in classified cleanroom areas?

Daily at the start of operations

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Weekly after cleaning

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At least monthly, and at the end of shifts before cleaning

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Annually during media fill tests

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Which of the following locations must be included in surface sampling?

Office desks and waiting areas

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Restrooms and break rooms

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Pass-through chambers, PECs, and gowning benches

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Pharmacy retail counters

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What is the correct technique for using a contact plate?

Swab the surface with the agar, then leave the lid off for air exposure

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Gently roll the convex agar across the test surface, replace lid, and label

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Dip the contact plate in sterile water before applying to the surface

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Press plate repeatedly on the same surface to maximize recovery

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What are the two stages of incubation for contact plates?

20–25 °C for 14 days only

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30–35 °C for 48 hours, then 20–25 °C for 5 days

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2–8 °C for 7 days only

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37 °C continuously for 10 days

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What is the USP <797> action level for ISO 5 areas?

More than 1 CFU

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More than 3 CFUs

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More than 5 CFUs

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More than 50 CFUs

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If surface sampling results exceed USP action levels, which action is most appropriate?

Disregard the result if it is a single event

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Immediately clean and continue operations

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Investigate, retrain personnel, review cleaning practices, and trend results

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Replace all agar plates and retest immediately

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Which information must be included in documentation of surface sampling?

Location, date/time, operator ID, media lot number, incubation details, and results

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Only the operator’s initials and media brand

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Only the number of CFUs recovered

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The pharmacy license number and FDA registration

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After sampling, what is the correct method for restoring aseptic conditions to the tested area?

Spray bleach solution and air dry

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Wipe with presaturated 70% isopropyl alcohol wipes

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Flame the surface with a Bunsen burner

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Cover with sterile gauze and wait 24 hours

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Competency Testing in Aseptic Manipulation

Video 1 – Introduction

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

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