Questions and Answers
What sequence should particle counts be taken?
From the cleanest area to the dirtiest.
Describe ISO 14644-1.
Classification of cleanliness.
What is classification?
When you prove a room's ISO class.
What must be defined in order to prove compliance to a certain ISO class?
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What is the timeframe for routine monitoring?
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Describe ISO 14644-2.
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What is the minimum sampling time?
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What is the minimum sampling volume?
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What is the height in the cleanroom to take particle counts?
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What number is used to convert cubic feet per minute to cubic feet per meter?
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Describe ISO 14644-3.
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What is the abbreviation for micron?
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What is a discrete particle counter?
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How often should the particle counter be calibrated?
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What is the area required per particle count?
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Where must the sampling probe be positioned when taking particle counts?
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Identify ISO Class 5 particle counts.
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Identify ISO Class 7 particle counts.
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Identify ISO Class 8 particle counts.
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What is the minimum number of sample locations taken for particle counts?
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For BSC's typically used in sterile compounding, what is a reasonable plan as to the locations used for taking particle counts?
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What are the two sets of criteria that laminar flow devices are certified to?
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What shall be included in the designation of airborne particulate cleanliness for clean rooms and clean zones?
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Study Notes
Particle Counts in Cleanrooms
- Particle counts should be taken from the cleanest area to the dirtiest to ensure thorough monitoring of air quality.
- ISO 14644-1 addresses the classification of cleanliness in controlled environments.
- Classification confirms a room's compliance with a specific ISO class through testing.
- Compliance to an ISO class requires consideration of designated particle sizes and the room's occupancy state.
- Routine monitoring of particle counts is required every 6 months to maintain compliance.
- ISO 14644-2 specifies testing and monitoring methods to prove ongoing compliance with ISO 14644-1 standards.
- Minimum sampling time for particle counts is set at 1 minute to obtain accurate data.
- The minimum required sampling volume is 2 liters to ensure reliability of results.
- Particle counts should be taken at a clean room work height of 42 inches for standardization.
- To convert cubic feet per minute to cubic feet per meter, the factor of 0.093 is used.
- ISO 14644-3 outlines the test methods applicable for cleanliness classification.
- The abbreviation for micron is represented as µm.
- A discrete particle counter (DPC) is used to assess airborne particle concentration starting from sizes of 0.5 microns.
- Calibration of the particle counter should occur within one year at an organization recognized by NIST.
- The area required for each particle count is dictated by specific standards not detailed in the notes.
- The sampling probe must be positioned to point directly into the airflow when taking particle counts for accuracy.
- ISO Class 5 allows a maximum of 3,520 particles per cubic meter for particles measuring 0.5 µm and larger.
- ISO Class 7 permits up to 352,000 particles per cubic meter for 0.5 µm and larger particles.
- ISO Class 8 has a threshold of 3,520,000 particles 0.5 µm and larger per cubic meter of air.
- The minimum number of sample locations for particle counts is calculated as the square root of the clean space area in square meters.
- In Biological Safety Cabinets (BSCs) used for sterile compounding, sample locations should be at the corners and center of the work area, with one near critical sites.
- Laminar flow devices must be certified based on physical tests and particle counts to meet cleanliness standards.
- Airborne particulate cleanliness designations must include the ISO classification number, occupancy state, and relevant particle sizes with their concentrations.
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Test your knowledge of particle counts and cleanroom standards with these flashcards. Focused on the principles of cleanliness classification, ISO 14644-1, and compliance verification. Perfect for those preparing for cleanroom certifications or audits.