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Questions and Answers
What sequence should particle counts be taken?
What sequence should particle counts be taken?
From the cleanest area to the dirtiest.
Describe ISO 14644-1.
Describe ISO 14644-1.
Classification of cleanliness.
What is classification?
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?
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?
What is the timeframe for routine monitoring?
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Describe ISO 14644-2.
Describe ISO 14644-2.
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What is the minimum sampling time?
What is the minimum sampling time?
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What is the minimum sampling volume?
What is the minimum sampling volume?
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What is the height in the cleanroom to take particle counts?
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?
What number is used to convert cubic feet per minute to cubic feet per meter?
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Describe ISO 14644-3.
Describe ISO 14644-3.
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What is the abbreviation for micron?
What is the abbreviation for micron?
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What is a discrete particle counter?
What is a discrete particle counter?
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How often should the particle counter be calibrated?
How often should the particle counter be calibrated?
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What is the area required per particle count?
What is the area required per particle count?
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Where must the sampling probe be positioned when taking particle counts?
Where must the sampling probe be positioned when taking particle counts?
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Identify ISO Class 5 particle counts.
Identify ISO Class 5 particle counts.
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Identify ISO Class 7 particle counts.
Identify ISO Class 7 particle counts.
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Identify ISO Class 8 particle counts.
Identify ISO Class 8 particle counts.
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What is the minimum number of sample locations taken for particle counts?
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?
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?
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?
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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Description
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.