Cleanroom Standards Practice Questions and Answers
Question 1: Which of the following is the primary function of an ISO Class 5 cleanroom in a pharmaceutical setting?
A) To store raw materials for compounding
B) To maintain sterility during compounding
C) To provide ventilation for hazardous drugs
D) To serve as a transition area between non-sterile and sterile zones
Answer: B) To maintain sterility during compounding
Explanation:
ISO Class 5 cleanrooms are designed to maintain an environment with very low particulate matter to ensure sterility during the preparation of sterile pharmaceutical products. These cleanrooms provide a critical aseptic environment for compounding.
Explanation:
ISO Class 5 cleanrooms are designed to maintain an environment with very low particulate matter to ensure sterility during the preparation of sterile pharmaceutical products. These cleanrooms provide a critical aseptic environment for compounding.
Question 2: What is the maximum allowed particle count per cubic meter for ISO Class 7 cleanrooms?
A) 10,000 particles
B) 350,000 particles
C) 350,000 particles (0.5 micron)
D) 3,520 particles (0.5 micron)
Answer: C) 350,000 particles (0.5 micron)
Explanation:
ISO Class 7 cleanrooms are designed to limit the number of airborne particles to 350,000 particles per cubic meter for particles 0.5 microns or larger. This is suitable for environments requiring high levels of cleanliness but not as stringent as ISO Class 5.
Explanation:
ISO Class 7 cleanrooms are designed to limit the number of airborne particles to 350,000 particles per cubic meter for particles 0.5 microns or larger. This is suitable for environments requiring high levels of cleanliness but not as stringent as ISO Class 5.
Question 3: In which ISO class cleanroom should sterile pharmaceutical compounding activities primarily take place?
A) ISO Class 8
B) ISO Class 7
C) ISO Class 5
D) ISO Class 6
Answer: C) ISO Class 5
Explanation:
Sterile pharmaceutical compounding is performed in ISO Class 5 cleanrooms, where the environment is controlled to ensure the highest sterility by limiting the number of airborne particles to 3,520 per cubic meter.
Explanation:
Sterile pharmaceutical compounding is performed in ISO Class 5 cleanrooms, where the environment is controlled to ensure the highest sterility by limiting the number of airborne particles to 3,520 per cubic meter.
Question 4: Which of the following ISO class cleanrooms would be appropriate for an ante-room to prepare and gown for entering sterile compounding areas?
A) ISO Class 5
B) ISO Class 8
C) ISO Class 7
D) ISO Class 6
Answer: B) ISO Class 8
Explanation:
ISO Class 8 cleanrooms are often used as ante-rooms for sterile compounding, where personnel prepare and gown before entering the ISO Class 5 sterile environment. These rooms have less stringent particle limits than ISO Class 5 and are meant for transition.
Explanation:
ISO Class 8 cleanrooms are often used as ante-rooms for sterile compounding, where personnel prepare and gown before entering the ISO Class 5 sterile environment. These rooms have less stringent particle limits than ISO Class 5 and are meant for transition.
Question 5: When considering the design of an ISO Class 5 cleanroom, which of the following is essential for maintaining sterility during pharmaceutical compounding?
A) Use of biological safety cabinets and laminar flow hoods
B) Regular floor cleaning and air quality monitoring
C) Constant temperature control
D) High-efficiency particulate air (HEPA) filtration and positive air pressure
Answer: D) High-efficiency particulate air (HEPA) filtration and positive air pressure
Explanation:
ISO Class 5 cleanrooms maintain sterility through HEPA filtration and positive pressure. The HEPA filters clean the air, and positive pressure prevents contamination from entering the cleanroom environment, ensuring that the sterile compounding process remains uncontaminated.
Explanation:
ISO Class 5 cleanrooms maintain sterility through HEPA filtration and positive pressure. The HEPA filters clean the air, and positive pressure prevents contamination from entering the cleanroom environment, ensuring that the sterile compounding process remains uncontaminated.
Question 6: Which of the following is true regarding the air quality in an ISO Class 7 cleanroom?
A) The air contains no more than 3,520 particles per cubic meter (0.5 microns)
B) The air contains no more than 350,000 particles per cubic meter (0.5 microns)
C) The air must be free of microorganisms
D) The air contains no more than 35,000 particles per cubic meter (0.5 microns)
Answer: B) The air contains no more than 350,000 particles per cubic meter (0.5 microns)
Explanation:
ISO Class 7 cleanrooms have a particle limit of 350,000 particles per cubic meter for particles 0.5 microns and larger. This level of cleanliness is appropriate for areas where controlled environments are necessary but not as strict as ISO Class 5.
Explanation:
ISO Class 7 cleanrooms have a particle limit of 350,000 particles per cubic meter for particles 0.5 microns and larger. This level of cleanliness is appropriate for areas where controlled environments are necessary but not as strict as ISO Class 5.
Question 7: In which scenario would an ISO Class 8 cleanroom be most appropriate?
A) Sterile pharmaceutical compounding
B) Packing hazardous drugs in sealed containers
C) Prepping non-sterile medications and supplies
D) Performing microbiological testing for sterility
Answer: C) Prepping non-sterile medications and supplies
Explanation:
ISO Class 8 cleanrooms are typically used for less critical areas, such as preparing non-sterile medications and supplies. These rooms have less stringent particle limits and are often used for activities like packaging or preparing materials before they are brought into more sterile areas.
Explanation:
ISO Class 8 cleanrooms are typically used for less critical areas, such as preparing non-sterile medications and supplies. These rooms have less stringent particle limits and are often used for activities like packaging or preparing materials before they are brought into more sterile areas.
Question 8: What does the "positive pressure" in an ISO Class 5 cleanroom help prevent?
A) Temperature fluctuations
B) Cross-contamination from outside the cleanroom
C) Excessive humidity
D) Airborne particulate matter
Answer: B) Cross-contamination from outside the cleanroom
Explanation:
Positive pressure in an ISO Class 5 cleanroom ensures that the air flows outward from the cleanroom, preventing contaminants from entering from outside areas. This helps maintain the sterility of the room, which is essential for compounding sterile medications.
Explanation:
Positive pressure in an ISO Class 5 cleanroom ensures that the air flows outward from the cleanroom, preventing contaminants from entering from outside areas. This helps maintain the sterility of the room, which is essential for compounding sterile medications.
Question 9: Which of the following activities should be performed in an ISO Class 5 cleanroom?
A) Compounding hazardous drugs
B) Washing and sterilizing equipment
C) Performing sterility testing on compounded drugs
D) Compounding sterile medications
Answer: D) Compounding sterile medications
Explanation:
ISO Class 5 cleanrooms provide the sterile environment necessary for compounding sterile medications. These rooms maintain a low particle count and are equipped with HEPA filtration and positive pressure to ensure that the sterility of medications is not compromised.
Explanation:
ISO Class 5 cleanrooms provide the sterile environment necessary for compounding sterile medications. These rooms maintain a low particle count and are equipped with HEPA filtration and positive pressure to ensure that the sterility of medications is not compromised.
Question 10: Which of the following best describes the airflow system required in ISO Class 7 and ISO Class 5 cleanrooms?
A) Air should be circulated in a circular motion to ensure even distribution.
B) Air must flow from clean areas (ISO 5) to less clean areas (ISO 7 and 8) to prevent contamination.
C) Air should flow in a zig-zag pattern to reduce airborne contaminants.
D) Air should be filtered but not necessarily directed in a specific flow pattern.
Answer: B) Air must flow from clean areas (ISO 5) to less clean areas (ISO 7 and 8) to prevent contamination.
Explanation:
In cleanroom environments, air flows from cleaner to less clean areas to prevent contamination. In an ISO Class 5 cleanroom, air is filtered and flows into the ISO Class 7 and ISO Class 8 areas, maintaining sterility and ensuring that contamination does not enter the more controlled areas.
Explanation:
In cleanroom environments, air flows from cleaner to less clean areas to prevent contamination. In an ISO Class 5 cleanroom, air is filtered and flows into the ISO Class 7 and ISO Class 8 areas, maintaining sterility and ensuring that contamination does not enter the more controlled areas.
Question 11: Where should hazardous pharmaceutical products be stored in a cleanroom environment?
A) ISO Class 8 cleanroom
B) ISO Class 5 cleanroom with laminar flow hood
C) Designated hazardous drug storage area with negative pressure and HEPA filtration
D) ISO Class 7 cleanroom with general storage bins
Answer: C) Designated hazardous drug storage area with negative pressure and HEPA filtration
Explanation:
Hazardous pharmaceutical products should be stored in designated areas within cleanrooms that have negative pressure and HEPA filtration to ensure containment and prevent the spread of hazardous substances. Negative pressure rooms ensure that air does not escape to other areas, protecting personnel from exposure.
Explanation:
Hazardous pharmaceutical products should be stored in designated areas within cleanrooms that have negative pressure and HEPA filtration to ensure containment and prevent the spread of hazardous substances. Negative pressure rooms ensure that air does not escape to other areas, protecting personnel from exposure.
Question 12: Which of the following is the correct order for the gowning process before entering a cleanroom for handling hazardous materials?
A) Wash hands, put on gloves, wear face mask, gown, shoe covers, and hair cover
B) Wash hands, put on gown, shoe covers, hair cover, face mask, and gloves
C) Wear gloves, hair cover, face mask, gown, shoe covers, wash hands
D) Wash hands, wear face mask, gown, shoe covers, gloves, and hair cover
Answer: B) Wash hands, put on gown, shoe covers, hair cover, face mask, and gloves
Explanation:
The correct gowning order involves first washing hands, then putting on the gown to prevent contaminants from clothing, followed by shoe covers, hair cover, face mask, and finally gloves. This ensures that contaminants from outside the cleanroom do not enter and that the gowning process is performed in the proper order to maintain sterility.
Explanation:
The correct gowning order involves first washing hands, then putting on the gown to prevent contaminants from clothing, followed by shoe covers, hair cover, face mask, and finally gloves. This ensures that contaminants from outside the cleanroom do not enter and that the gowning process is performed in the proper order to maintain sterility.
