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

1. 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

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.

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.

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

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.

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.

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

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.

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.

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

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.

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.

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

Quarterly process parameter reviews

Sterilization adoptions

Validation testing

Sterilization run records reviews

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.

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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