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

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| By Mick Snyder

Mick Snyder

Community Contributor

Quizzes Created: 15 | Total Attempts: 8,775

Questions: 5 | Attempts: 240 | Updated: Jan 31, 2023

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Questions and Answers

1.

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.
- A.
  
  True
- B.
  
  False
Correct Answer
B. 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.

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2.

The cleanroom and gowning room are clean zones that are certified per ISO 14644-1 to the requirements of:
- A.
  
  Class 10
- B.
  
  Class 2
- C.
  
  Class 7
- D.
  
  Class 8
Correct Answer
D. Class 8

Explanation
The cleanroom and gowning room are certified to the requirements of Class 8 according to ISO 14644-1. This means that the clean zones have a maximum allowable particle count of 3,520,000 particles per cubic meter of air with a size greater than or equal to 0.5 micrometers. Class 8 classification indicates a controlled environment with moderately low levels of airborne particles, suitable for industries such as electronics, pharmaceuticals, and medical devices.

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3.

Which of the following is not a method included in performing the environmental certification per this procedure?
- A.
  
  Air Velocity
- B.
  
  HEPA Filter Challenge
- C.
  
  Room Dimensions
- D.
  
  Airborne Particle Counts
- E.
  
  Temperature and RH
Correct Answer
C. 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.

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4.

What is the Action Level for the microbial monitoring of the cleanroom using the fallout plate?
- A.
  
  25 CFU
- B.
  
  26 CFU
- C.
  
  5.0 CFU
- D.
  
  76 CFU
- E.
  
  10 CFU
Correct Answer
B. 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.

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5.

How are sterilization activities controlled (check all that apply)?
- A.
  
  Quarterly process parameter reviews
- B.
  
  Sterilization adoptions
- C.
  
  Validation testing
- D.
  
  Sterilization run records reviews
Correct Answer(s)
C. Validation testing
D. 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.

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Current Version
Jan 31, 2023

Quiz Edited by
ProProfs Editorial Team
Aug 13, 2018

Quiz Created by
Mick Snyder

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

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.

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

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

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

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