Pharmacy Practice MCQ » PHARMACAREERS

Pharmacy Practice MCQ, in this article we will solve, Practice MCQ under subject Microbiology. Read following article for your reference.

Clean Area Classification » PHARMACAREERS

What is the primary purpose of clean area classification?
- a) To regulate the temperature of the area
- b) To control contamination levels
- c) To enhance the aesthetic appeal
- d) To reduce noise pollution
Which of the following is a key factor in clean area classification?
- a) Airflow pattern
- b) Lighting intensity
- c) Color of walls
- d) Floor material
What is the classification standard for clean areas known as in the United States?
- a) ISO
- b) EU GMP
- c) FDA
- d) USP
What does ISO stand for in the context of clean area classification?
- a) International Sterility Organization
- b) International Standards Organization
- c) International Safety Organization
- d) International Sanitation Organization
Which ISO class represents the highest level of cleanliness?
- a) ISO Class 1
- b) ISO Class 5
- c) ISO Class 7
- d) ISO Class 9
What is the maximum allowable number of particles (≥0.5 µm) per cubic meter in an ISO Class 5 clean room?
- a) 100
- b) 1,000
- c) 10,000
- d) 100,000
Which organization provides the EU GMP classification for clean areas?
- a) World Health Organization (WHO)
- b) United States Pharmacopeia (USP)
- c) European Medicines Agency (EMA)
- d) International Organization for Standardization (ISO)
What is the EU GMP classification for the cleanest area in pharmaceutical production?
- a) Grade A
- b) Grade B
- c) Grade C
- d) Grade D
Which of the following is a characteristic of Grade A clean areas according to EU GMP?
- a) Turbulent airflow
- b) Laminar airflow
- c) Circular airflow
- d) Random airflow
What is the main focus of clean area classification?
- a) Controlling contamination levels
- b) Regulating lighting intensity
- c) Enhancing aesthetic appeal
- d) Reducing noise pollution
What type of filtration system is commonly used in clean areas to remove particles from the air?
- a) HEPA filters
- b) Carbon filters
- c) UV filters
- d) Ceramic filters
Which clean area classification is typically required for aseptic processing?
- a) ISO Class 3
- b) ISO Class 5
- c) ISO Class 7
- d) ISO Class 9
Which of the following is an essential element of clean area design?
- a) Smooth, non-porous surfaces
- b) Bright, colorful walls
- c) Soft, comfortable flooring
- d) Decorative lighting
What is the purpose of laminar airflow in clean areas?
- a) To regulate temperature
- b) To control contamination
- c) To enhance aesthetic appeal
- d) To reduce noise
Which classification system is used globally to standardize clean area requirements?
- a) ISO
- b) EU GMP
- c) FDA
- d) USP
Which grade in EU GMP classification is considered the least stringent?
- a) Grade A
- b) Grade B
- c) Grade C
- d) Grade D
What is the maximum allowable number of particles (≥0.5 µm) per cubic meter in an ISO Class 7 clean room?
- a) 10,000
- b) 100,000
- c) 1,000,000
- d) 10,000,000
What is the primary goal of clean area classification in pharmaceutical manufacturing?
- a) To ensure product quality and safety
- b) To reduce energy consumption
- c) To improve worker comfort
- d) To enhance product packaging
Which clean area classification requires the highest level of control and monitoring?
- a) ISO Class 1
- b) ISO Class 5
- c) ISO Class 7
- d) ISO Class 9
Which of the following is a common feature of clean rooms?
- a) High-efficiency particulate air (HEPA) filtration
- b) Bright, decorative lighting
- c) Comfortable furniture
- d) Open windows
What is the significance of particle count in clean area classification?
- a) It determines the cleanliness level of the area
- b) It measures the temperature of the area
- c) It assesses the lighting intensity
- d) It evaluates the noise level
Which clean area classification is typically required for filling and sealing sterile products?
- a) ISO Class 3
- b) ISO Class 5
- c) ISO Class 7
- d) ISO Class 9
What is the role of airlocks in clean area design?
- a) To provide ventilation
- b) To prevent contamination during entry and exit
- c) To store equipment
- d) To regulate temperature
Which organization provides guidelines for clean area classification in the United States?
- a) FDA
- b) ISO
- c) USP
- d) EMA
What is the primary purpose of clean room garments?
- a) To provide comfort to personnel
- b) To prevent contamination from personnel
- c) To enhance the aesthetic appeal
- d) To regulate body temperature
Which grade in EU GMP classification is used for background environments where less critical operations are performed?
- a) Grade A
- b) Grade B
- c) Grade C
- d) Grade D
What is the maximum allowable number of particles (≥0.5 µm) per cubic meter in a Grade A clean area according to EU GMP?
- a) 100
- b) 1,000
- c) 10,000
- d) 100,000
What is the role of environmental monitoring in clean areas?
- a) To enhance lighting
- b) To maintain temperature
- c) To ensure compliance with cleanliness standards
- d) To reduce noise levels
Which clean area classification is most suitable for storing raw materials?
- a) ISO Class 1
- b) ISO Class 5
- c) ISO Class 7
- d) ISO Class 9
What is the primary focus of clean area classification in the context of pharmaceutical manufacturing?
- a) Ensuring product quality and safety
- b) Reducing energy consumption
- c) Improving worker comfort
- d) Enhancing product packaging

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