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VALIDATION AND ACCEPTANCE OF CLEANROOMS

Standard series ISO 14644 requires various proofs that your cleanroom or your cleanroom facility meets the corresponding specifications. Various test routines are described in the standard, with the classification test being mandatory. This confirms cleanroom status. A particle counter determines the number concentration of particles by taking several measurements at different positions. Afterwards, the nominal cleanroom status can be confirmed or withheld in accordance with the specifications of ISO 14644-1. The appropriate technology solution is the particle counter CPA 341 and the CRQWin device control and data acquisition & evaluation software developed by Topas. Trust our experts.

 

Turbulent or laminar – Topas visualizes everything.”

In consultation with the operator, the following tests can be also carried out:

Cleanroom classes according to ISO 14644-1, GMP, and VDI Guideline 2083 are necessary in order to correctly describe the purpose of the cleanroom and ensure that its requirements are met. During the classification test, the particle concentration is measured at various points in a cleanroom, depending on the room area. The different measuring points are sampled with ambient air over a certain period of time. Finally, the measured values obtained are compared with the limit values of ISO 14644-1 to verify the cleanroom class. We recommend the CPA 341 Cleanroom Particle Analyzer as a measuring device: lightweight, robust, easy to use, and intuitive to operate.

With this test, also called filter leakage test or leakage test, the leak-tightness of the installed filter is checked by testing it with a reference aerosol (e.g. DEHS, Emery). The filter test in the installed state is carried out in the cleanroom using the same methods (aerosol generation, dilution and measurement) and basic principles as during filter production.

A reference aerosol (ATM 228) is applied in a sufficiently high concentration on the filter upstream side. The aerosol concentration is measured using a particle counter (CPA 341). First, a defined reduction in concentration is necessary using a dilution system (DIL 554/DIL 544 - soon available) to the working range of the particle counter. On the downstream side, the filter surface is systematically scanned for possible defects using a sampling probe (SYS 529) and a particle counter.

The measurement technology set for the acceptance of cleanroom systems with the components ATM 228 aerosol generator, DIL 554 dilution system, CPA 341 particle counter (soon available), SYS 529 sampling probe, and the CRQWin cleanroom qualification software is ideally suited for the filter integrity test. With the new Cleanroom Particle Analyzer CPA 341 (cooperation product), the cleanroom set is now state-of-the-art. We recommend this lightweight yet robust measuring device to anyone who values ease of use and intuitive operation in their daily work.

In order to remove potential particle contamination quickly, the air exchange rate in cleanrooms must always be sufficiently high. During recovery time measurement, test aerosols are introduced into the room. The decay curve of the particle concentration and thus the recovery time of the room to the original concentration level is then measured. With this Topas technology, you will be successful in your recovery time measurements: ATM 228 aerosol generator, CPA 341 cleanroom particle analyzer, CRQWin cleanroom qualification software.

 

Flow visualization

Devices for visualizing airflows, such as the CFG 291 fog generator, make laminar or turbulent flow conditions in cleanroom areas visible. Measurement objectives in practical applications include:

  • Flow type
  • Locating flow dead spots
  • Visualization of pressure cascades in the clean room

If you are interested in learning more, we recommend our information on testing operating rooms.

 

 

The following standards and guidelines were taken into account when designing the cleanroom measurement technology set:

Our software for the guided evaluation of cleanrooms

Our central software systems CRQWin (ISO 14644) and OPQWin (DIN 1946-4) combine the full range of validation hardware in use and are capable to communicate with a wide variety of available particle counters. Call us for an exact specification of which models we support.

Our technology solution

CFG 291

Condensation Fog Generator CFG 291 for fog generation to visualise air flows according to ISO 14644-3

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Condensation Fog Generator CFG 291 for cleanroom validation, frontside
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ATM 226

ATM 226 Atomizer Aerosol Generator for aerosol generation from liquids for mobile use (e.g. cleanroom acceptance measurement), integrated compressor

Atomizer Aerosol Generator ATM 226, front view
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ATM 228

Atomizer Aerosol Generator ATM 228 for aerosol generation from liquids for mobile use, integrated compressor, pneumitic-controlled, remote controllable

Atomizer Aerosol Generator ATM 228 for cleanroom validation, frontside
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CRQWin

CRQWin software for acceptance testing of clean rooms according to ISO 14644-3

Cleanroom Qualification Software CRQWin, measurement result at the monitor display
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DIL 554

DIL 554 Dilution System for static dilution (1:100) of aerosols at static air flow rate (28,3 L/min) for mobile operation

Dilution System for Aerosols DIL 554, front view
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DIL 554/H

DIL 554/H Dilution System for static dilution (1:100) of aerosols at static air flow rate (56,6 L/min) for mobile operation

Dilution System for Aerosols DIL 554/H, front view
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DIL 554/T

DIL 554/T Dilution System for static dilution (1:100) of aerosols at static air flow rate (28,3 L/min) for mobile operation, 1/4'' hose connector

Dilution System for Aerosols DIL 554/T, front view
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DIL 554/Z

DIL 554/Z Dilution System for static dilution (1:10) of aerosols at static air flow rate (28,3 L/min) for mobile operation

Dilution System for Aerosols DIL 554/Z, front view
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LAP 340

Optical Particle Counter LAP 340 for analysis of particle size distributions and particle concentrations in aerosols, best for cleanroom applications

Laser Aerosol Particle Counter LAP 340, front view
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SYS 529

Rectangular Sampling Probe SYS 529 for leakage and integrity testing according ISO 14644-3 for a sample flow rate of 28,3 l/min

Rectangular Sampling Probe SYS 529
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TopFog

Fog fluid TopFog for operation of the Condensation Fog Generator CFG 290

Fog Fluid for Fog Generator TopFog in bottle a 250ml
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TopFog Light

Fog fluid TopFog Light for operation of the Condensation Fog Generator CFG 291

Fog fluid TopFog Light for use with Condensation Fog Generator CFG 291, front
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TopFog Regular

Fog fluid TopFog for operation of the Condensation Fog Generator CFG 291

Fog fluid TopFog Regular for use with Condensation Fog Generator CFG 291, front
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