Cleanroom Basics – Could You Be Contaminating Your Cleanroom?

  1. What is the most commonly used cleanroom classification standard globally?

    • a) ISO 9001
    • b) ISO 14644-1 ✅ Explanation: ISO 14644-1 is the current international standard for cleanroom classification.
    • c) FS209E
    • d) GMP Annex 1
  2. Which of the following is not a primary source of contamination in a cleanroom?

    • a) People
    • b) Equipment
    • c) Airflow
    • d) Windows ✅Explanation: Windows may contribute, but they are not among the primary sources of contamination.
  3. An ISO Class 5 cleanroom allows how many particles ≥0.5µm per cubic meter?

    • a) 100
    • b) 3,520 ✅Explanation: ISO 5 allows 3,520 particles per m³ at ≥0.5µm.
    • c) 35,200
    • d) 100,000
  4. Which cleanroom garment is most effective at reducing particle shedding?

    • a) Cotton scrubs
    • b) Polyester lab coat
    • c) Cleanroom coverall ✅ Explanation: Specialized coveralls are engineered for low particle release.
    • d) Street clothes under a smock
  5. What does “HEPA” stand for?

    • a) High Efficiency Particle Absorber ✅ Explanation: HEPA filters remove 99.97% of particles ≥0.3µm.
    • b) High Energy Particle Analyzer
    • c) Heat Exchange Process Agent
    • d) Hazard Elimination Particle Array