Cleanroom Environmental Classification, Controls And Certification; And Sterilization Controls And Monitors

Reviewed by Editorial Team
The ProProfs editorial team is comprised of experienced subject matter experts. They've collectively created over 10,000 quizzes and lessons, serving over 100 million users. Our team includes in-house content moderators and subject matter experts, as well as a global network of rigorously trained contributors. All adhere to our comprehensive editorial guidelines, ensuring the delivery of high-quality content.
Learn about Our Editorial Process
| By Mick Snyder
M
Mick Snyder
Community Contributor
Quizzes Created: 15 | Total Attempts: 9,297
| Attempts: 242
Quiz Flashcard
SettingsSettings
Please wait...
  • 1/5 Questions

    The cleanroom and gowning room are clean zones that are certified per ISO 14644-1 to the requirements of:

    • Class 10
    • Class 2
    • Class 7
    • Class 8
Please wait...
About This Quiz

This quiz assesses knowledge on cleanroom environmental classification and controls, focusing on airborne particle control, ISO certification standards, and microbial monitoring. It also evaluates understanding of sterilization controls and monitors, crucial for maintaining cleanroom integrity.

Cleanroom Environmental Classification, Controls And Certification; And Sterilization Controls And Monitors - Quiz

Quiz Preview

  • 2. 

    Which of the following is not a method included in performing the environmental certification per this procedure?

    • Air Velocity

    • HEPA Filter Challenge

    • Room Dimensions

    • Airborne Particle Counts

    • Temperature and RH

    Correct Answer
    A. Room Dimensions
    Explanation
    This question is asking which method is not included in performing the environmental certification per this procedure. The answer is "Room Dimensions". This means that when performing the environmental certification according to this procedure, room dimensions are not taken into consideration. The other methods listed - Air Velocity, HEPA Filter Challenge, Airborne Particle Counts, and Temperature and RH - are all included in the procedure for performing the environmental certification.

    Rate this question:

  • 3. 

    What is the Action Level for the microbial monitoring of the cleanroom using the fallout plate?

    • 25 CFU

    • 26 CFU

    • 5.0 CFU

    • 76 CFU

    • 10 CFU

    Correct Answer
    A. 26 CFU
    Explanation
    The Action Level for the microbial monitoring of the cleanroom using the fallout plate is 26 CFU. This means that if the number of colony-forming units (CFU) on the fallout plate exceeds 26, it indicates a potential contamination issue in the cleanroom that needs to be addressed. The action level serves as a threshold for taking corrective actions to maintain the cleanliness and sterility of the cleanroom environment.

    Rate this question:

  • 4. 

    A Cleanroom is a defined space in which the concentration if airborne particles are controlled as necessary, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the zone.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    The given statement is false. A cleanroom is a controlled environment where the concentration of airborne particles is kept to a minimum. It is constructed and used in a way that prevents the introduction, generation, and retention of particles inside the area.

    Rate this question:

  • 5. 

    How are sterilization activities controlled (check all that apply)?

    • Quarterly process parameter reviews

    • Sterilization adoptions

    • Validation testing

    • Sterilization run records reviews

    Correct Answer(s)
    A. Validation testing
    A. Sterilization run records reviews
    Explanation
    Sterilization activities are controlled through validation testing and sterilization run records reviews. Validation testing ensures that the sterilization process is effective in eliminating microorganisms and maintaining product sterility. Sterilization run records reviews involve reviewing documentation of the sterilization runs to ensure that the process parameters were met and the sterilization process was properly executed. These control measures help to ensure the effectiveness and reliability of the sterilization activities.

    Rate this question:

Quiz Review Timeline (Updated): Jan 31, 2023 +

Our quizzes are rigorously reviewed, monitored and continuously updated by our expert board to maintain accuracy, relevance, and timeliness.

  • Current Version
  • Jan 31, 2023
    Quiz Edited by
    ProProfs Editorial Team
  • Aug 13, 2018
    Quiz Created by
    Mick Snyder
Back to Top Back to top
Advertisement
×

Wait!
Here's an interesting quiz for you.

We have other quizzes matching your interest.