Regulations Concerning Airborne Particle Counting

82 Pages·2013·1.74 MB·English

Regulations Concerning
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Particle Counting
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Two types of activities performed
with an airborne particle counter:
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Classification focuses primarily on
the environment
Monitoring focuses on process,
people and the environment
Process People
People as a Contamination Source
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2000 to 5000 microorganisms/cm2 on skin
Filter efficiency of clothing or garment varies greatly
2
Classification:
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ISO 14644-1 FED STD 209E Classification is the process of qualifying the
cleanroom environment by the number of
ISO Class English Metric
particles using a standard method
1
2
DDetermiine cllassiiffiicatiion off room accorddiing to
standards
3 1 M1.5
“ISO Class 5” or “Class 100”
4 10 M2.5
Performed on a regular basis but not frequently
6 months, yearly or ???
5 100 M3.5
Standards define minimum number of sample points
Usually based on area of cleanroom or clean zone
6 1,000 M4.5
Standards define minimum amount of air to be
sampled
7 10,000 M5.5
Minimum volumes for statistically valid samples
8 100,000 M6.5
9 Classification is a standardized method
3
Environmental Monitoring
Determine stability of room or zone over time; develop trend data
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Minimum number of sample points defined
by QA
– Area of cleanroom or clean zone
– Activity
– Risk to product
Frequency and volume of sample points
defined by QA
– Frequent enough to show control
– Frequent enough to provide
meaningful trend information
Not controlled by regulation…but need for trend information
4
Process Monitoring
Determine readiness of room to carry out designated task
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Minimum number of sample points
defined by QA
AArea off clleanroom or cllean zone
Activity
Risk to product
Frequency and volume of sample
points defined by QA
FFrequentt enoughh tto shhow conttroll
Frequent enough to manage
financial risk of product
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NNot ddetermiinedd bby regullatiion…bbut bby riiskk!!
5
Differences
Classification Monitoring
Frequency 6 months or annual Daily, weekly, monthly
or continuous
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Sample volume By formula By need for data
Pass/Fail criteria By table By need for trend info
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Reporting format By standard In form needed for
rapid understanding
6
Differences
Classification Monitoring
Distribution of counts Uniform or Unique at each
in a room or zone homogenous sample position
7
Classification
8
Classification Standards for Airborne Particles
General Air Monitoring Standards – before 1999
9
Classification Standards for Airborne Particles
General Air Monitoring Standards
– ISO 14644-1
• Classification of air cleanliness
– ISO 14644-2
• Specifications for testing and
monitoring to prove continued
compliance with ISO 14644-1
– IISSOO 1144664444-33
• Guidance on instrumentation to
be used for testing for
1999
compliance with ISO 14644-1
ISO 14644
10