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Quizzes > Quizzes for Business > Manufacturing

Pharmaceutical Cleanroom Technician Competency Test Quiz

Assess Your Cleanroom Procedures and Protocols

Difficulty: Moderate
Questions: 20
Learning OutcomesStudy Material
Colorful paper art representing a quiz on Pharmaceutical Cleanroom Technician Competency Test

Welcome to the Pharmaceutical Cleanroom Technician Competency Test, designed to assess mastery of aseptic techniques and contamination control. Ideal for aspiring cleanroom operators, quality assurance staff, or pharmaceutical professionals, this quiz challenges your understanding of critical cleanroom protocols. With 15 multiple-choice questions, participants can sharpen their skills and identify areas for targeted improvement. This fully editable quiz can be tailored in our editor to match your training objectives. For further practice, try the Pharmaceutical Knowledge Assessment Quiz, explore the Technician Safety Knowledge Test , or check out all quizzes.

Which ISO cleanroom class has the strictest limit on airborne particles?
ISO 5
ISO 7
ISO 8
ISO 9
ISO classes use lower numbers to indicate fewer particles per cubic meter. ISO 5 allows the lowest particle count, making it the strictest.
What is the first step in the correct cleanroom gowning procedure?
Remove jewelry and personal items
Put on gloves
Don coverall
Sanitize hands
Removing jewelry and personal items prevents loose items from becoming sources of contamination before donning PPE.
Which of the following is standard personal protective equipment in a cleanroom?
Face mask
Steel-toe boots
Wool gloves
Personal stethoscope
Face masks are part of PPE to limit microbial and particle shedding from personnel into the cleanroom environment.
What is the primary function of a HEPA filter in cleanroom operation?
Remove particles ≥0.3 μm at 99.97% efficiency
Kill all bacteria passing through
Regulate humidity levels
Measure differential pressure
HEPA filters are designed to capture at least 99.97% of airborne particles 0.3 micrometers or larger, ensuring air purity.
Through which controlled entry point should materials be passed into a cleanroom?
Airlock or pass-through chamber
Main personnel door
Open window
Through gowning bench
Airlocks or pass-through chambers maintain pressure differentials and prevent direct contamination when transferring materials.
FS209E Class 100 is roughly equivalent to which ISO cleanroom classification?
ISO 5
ISO 6
ISO 7
ISO 8
Under Federal Standard 209E, Class 100 corresponds to ISO 5, reflecting a maximum of 100 particles ≥0.5 μm per cubic foot.
In the gowning sequence, which item should be put on immediately after donning the coverall?
Boot covers
Gloves
Face mask
Hair cover
After the coverall, boot covers are applied next to ensure footwear is enclosed before moving on to head and hand protection.
Which practice best demonstrates proper aseptic technique to minimize contamination risk?
Keeping hands above waist level after gloving
Crossing arms over the chest
Talking over the sterile field
Touching face shield before touching product
Keeping hands in the visual field and above waist level reduces risk of inadvertent contact with unclean surfaces or below-field contamination.
Sticky mats at cleanroom entrances are primarily used to remove what?
Particulate contamination from shoe soles
Microbial endotoxins
Chemical residues
Odors from outside
Sticky mats capture and remove particles and dust from footwear, reducing particulate load carried into the cleanroom.
What is the main purpose of using settle plates in environmental monitoring?
Detect viable microbial fallout over time
Measure airflow velocity
Count nonviable particles
Assess surface chemical residues
Settle plates collect airborne microorganisms settling out of the air, providing data on viable contamination over a set exposure period.
Which instrument measures real-time nonviable particle counts in a cleanroom?
Laser particle counter
Impaction air sampler
Settle plate
pH meter
A laser particle counter provides instantaneous readings of nonviable particle concentrations at various particle sizes.
What distinguishes sterilisation from disinfection in cleanroom decontamination?
Sterilisation kills all microorganisms including spores
Disinfection removes 100% of particles
Disinfection is always physical rather than chemical
Sterilisation only reduces microbial load
Sterilisation aims to destroy all forms of microbial life, including resistant spores, whereas disinfection reduces viable microorganisms to acceptable levels.
Which parameter is critical when validating an autoclave sterilisation cycle?
Biological indicator D-value
Air exchange rate
pH of wash water
Relative humidity of room
The D-value from biological indicators shows the time needed at a given temperature to achieve a one-log reduction in microorganisms, validating cycle efficacy.
When a chemical disinfectant spill occurs in a cleanroom, what is the first action?
Evacuate area and follow spill protocol
Wipe up with a dry cloth
Dilute with water and rinse
Ignore and continue work
Immediate evacuation and adherence to spill response procedures protect personnel from exposure and maintain environmental safety.
How often should personnel perform hand hygiene when working in an ISO 7 cleanroom?
Before gowning and periodically as needed
Only at start of shift
Every two hours regardless of activity
After every minor task
Hand hygiene is required before gowning and whenever contamination risk is detected to minimize microbial introduction into the clean environment.
You count 12 CFU on a 90 mm petri settle plate after a 4-hour exposure in an ISO 7 area. If the ISO 7 limit is 25 CFU per 4 hours, what does this indicate?
The environment is within acceptable microbial limits
The environment exceeds microbial limits
The settle plate method is invalid
Repeat monitoring immediately
A count of 12 CFU is below the ISO 7 threshold of 25 CFU per 4 hours, indicating compliance with the viable fallout limit.
Which value describes the time required to reduce a microbial population by 90% at a given disinfectant concentration?
D-value
Z-value
F0-value
CFU index
The D-value represents the decimal reduction time, or the time needed to achieve a one-log (90%) reduction in viable organisms at a set condition.
In designing an environmental monitoring program, which location is highest risk and should be monitored most frequently?
Adjacent to critical aseptic manipulations
Near the cleanroom entrance
In the hallway outside
Inside the gowning area
Areas where sterile products are actively manipulated pose the greatest contamination risk and require the most frequent monitoring.
Which sterilisation parameter combination is most effective for eliminating bacterial spores in a vaporised hydrogen peroxide system?
Low humidity, 6-log sporicidal dose, controlled dwell time
High humidity, short exposure time, low concentration
Ambient temperature, no dwell time, moderate dose
High humidity, low dose, uncontrolled dwell
Vaporised hydrogen peroxide sterilisation requires low humidity, a validated 6-log sporicidal concentration, and sufficient dwell time for spore inactivation.
During a trend analysis of particle counts, counts in ISO 6 areas are steadily rising but still below limits. What is the best corrective action?
Investigate HVAC performance and filter integrity
Ignore until limits are exceeded
Increase sampling frequency only
Disinfect surfaces more often
A gradual increase in particle counts suggests potential HVAC or filter degradation; investigating and maintaining airflow systems prevents future excursions.
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Learning Outcomes

  1. Identify cleanroom classifications and standards
  2. Demonstrate correct gowning and aseptic techniques
  3. Apply contamination control measures effectively
  4. Evaluate environmental monitoring and test results
  5. Analyse decontamination and sterilisation protocols
  6. Master cleanroom safety and hygiene best practices

Cheat Sheet

  1. Understand Cleanroom Classifications - Dive into the world of ISO 14644 and learn how cleanrooms are ranked by particle counts. Knowing that an ISO Class 5 room only allows about 3,520 particles of 0.5 microns per cubic meter helps you visualize just how dust-free it must be! This knowledge is the secret sauce for designing and maintaining a spotless workspace. Read more
    2. en.wikipedia.org
  2. Master Proper Gowning Procedures - Suit up like a contamination detective! Follow the step-by-step gowning order - shoes, coveralls, mask, gloves - to block any stray particles from hitching a ride. A quick hand wash before you gear up makes you the ultimate cleanroom superhero. Read more
    3. blog.gotopac.com
  3. Implement Effective Aseptic Techniques - Think of 70% isopropyl alcohol as your trusty sidekick for sanitizing equipment. Move slowly and deliberately to keep particle generation to a minimum - no sudden dance moves allowed! These habits turn you into a contamination-busting ninja. Read more
    4. news-medical.net
  4. Apply Contamination Control Measures - Arm yourself with hydrogen peroxide sprays and specialized wipes to scrub surfaces spotless. Regular cleaning schedules ensure no sneaky microbes set up camp on your workstation. Think of it as your daily sparkle ritual. Read more
    5. news-medical.net
  5. Evaluate Environmental Monitoring Results - Become an air and surface sampling detective by analyzing monitoring data. Spot any rising particle trends or microbial counts early, and swoop in with corrective actions. This proactivity keeps your cleanroom in top-notch shape. Read more
    6. pmc.ncbi.nlm.nih.gov
  6. Understand Decontamination Protocols - Get cozy with sterilization methods like autoclaving and chemical disinfectants. Knowing when to zap equipment with heat or hit it with a bleach solution is key to total germ eradication. It's like having a Swiss Army knife of sanitization at your fingertips. Read more
    7. cfpie.com
  7. Maintain Cleanroom Hygiene Best Practices - Follow the golden rules: wash hands often, dispose of waste properly, and clean up spills right away. A little vigilance goes a long way in keeping contamination baddies at bay. Plus, a tidy workspace always feels more inspiring! Read more
    8. news-medical.net
  8. Control Environmental Conditions - Monitor temperature, humidity, and air pressure like a climate maestro. Slight changes can invite unwanted particles or compromise product stability, so stay on top of your gauges. It's all about striking that perfect environmental harmony. Read more
    9. cfpie.com
  9. Understand Airflow Dynamics - Explore how unidirectional (laminar) airflow systems sweep away airborne contaminants like a giant gentle breeze. Mastering airflow design ensures particles don't park themselves where they shouldn't. It's the wind beneath your cleanroom's wings. Read more
    10. ispe.org
  10. Stay Updated on Cleanroom Standards - Keep your toolkit fresh by tracking ISO 14644 updates and industry best practices. Regularly refreshing your knowledge ensures your cleanroom always meets the latest cleanliness benchmarks. Learning never stops when you're aiming for sterile success! Read more
    11. ispe.org
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