Test methods ISO 14664-3  Performed to determine the air flow

rate in non-unidirectional clean

room
3.2 Airborne Particle measurement 1. Performance Tests B.4 Air flow
 Air velocity distribution in a
tests for two types test unidirectional cleanroom.
Aerosol generator
Particle size…0,
0.05µm, 2µm Non-directional air Main purpose to maintain the
Unidirectional air B.5 Air pressure difference
Air borne particle flow pressure difference b/w
flow
size between 1nm to test installments and surroundings
100µm
Maximum allowable conc.
Occupancy States 3.1.2 Air cleanliness by chemical of chemical substances
concentration… ISO 14664-8
4. Test Procedure 4.2 Principle

Chemical contaminants are included: Methods of

Acid, base, biotoxic, condensable, measurements…Annex C
This test is performed to determine air corrosive, dopant, organic, oxidants
cleanliness and may consist of three parts:

Classification test Microbiological Evaluation of clean Microbial Monitoring

Ultrafine particle test (Optional) rooms and other controlled
Macroparticle test (Optional) Environment…. USP <1116>

Background noise rate

B.1.4 Test Report should be
recorded for classification
/testing of installation
4.1.2 Optional tests
for the DPC
Type of measurement:
Classification/monitoring test
Cleanliness classification of the
installation
Particle size range and count

DPC inlet sampled flow rate and flow rate

 may not be all-inclusive, nor may all
through the sensing chamber volume
of the tests be required for any given
certification project. Sample location(s)
Personnel Training
Sampling protocol for classification or
 Table -2, list for Optional tests. sampling plan for monitoring
occupancy state(s)
 Critical factors involved in the Design and
European Pharmacopoeia
Test methods ISOAnnex 1
14664-3 implementation of a Microbiological Environmental
Control Program

Establishment of Sampling plan

and sites

Air Cleanliness

Microbial Considerations and Actions

Levels for controlled Environment