Cleanroom Particle Count Flashcards

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?

Designated particle sizes shall be considered and the occupancy state of that particular room. Signup and view all the answers

What is the timeframe for routine monitoring?

Every 6 months. Signup and view all the answers

Describe ISO 14644-2.

Specification for testing and monitoring to prove continued compliance with ISO 14644-1. Signup and view all the answers

What is the minimum sampling time?

1 minute. Signup and view all the answers

What is the minimum sampling volume?

2 liters. Signup and view all the answers

What is the height in the cleanroom to take particle counts?

Cleanroom work height of 42 inches. Signup and view all the answers

What number is used to convert cubic feet per minute to cubic feet per meter?

0.093. Signup and view all the answers

Describe ISO 14644-3.

Test methods. Signup and view all the answers

What is the abbreviation for micron?

µm. Signup and view all the answers

What is a discrete particle counter?

Per ISO 14644-1, (DPC), a discrete-particle-counting, light-scattering instrument is a device/method used to determine the concentration of airborne particles, equal to and larger than the specified sizes at designated sampling locations. The particle sizes for determining airborne concentrations are from 0.5 microns. Signup and view all the answers

How often should the particle counter be calibrated?

Within one year to a recognized organization such as an NIST. Signup and view all the answers

What is the area required per particle count?

Signup and view all the answers

Where must the sampling probe be positioned when taking particle counts?

Sampling probe shall be positioned pointing into the airflow. Signup and view all the answers

Identify ISO Class 5 particle counts.

Max of 3,520 particles 0.5 µm and larger per cubic meter of air sampled. Signup and view all the answers

Identify ISO Class 7 particle counts.

Max of 352,000 particles 0.5 µm and larger per cubic meter of air sampled. Signup and view all the answers

Identify ISO Class 8 particle counts.

Max of 3,520,000 particles 0.5 µm and larger per cubic meter of air sampled. Signup and view all the answers

What is the minimum number of sample locations taken for particle counts?

Sample locations shall be no less than the square roots of the clean space area in square meters. Signup and view all the answers

For BSC's typically used in sterile compounding, what is a reasonable plan as to the locations used for taking particle counts?

Locations are in each of the four corners 6 inches from the interior walls and one at the geometric center of the work area. A minimum of one sample location should be positioned 6 to 12 inches directly upstream of the critical site. Signup and view all the answers

What are the two sets of criteria that laminar flow devices are certified to?

Physical tests and particle count for cleanliness classification. Signup and view all the answers

What shall be included in the designation of airborne particulate cleanliness for clean rooms and clean zones?

The classification number expressed as ISO class, the occupancy state and the considered particle size and its related concentration. Signup and view all the answers

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.