Topas GmbH
Oskar-Röder-Str. 12
D-01237 Dresden
Tel.      +49 (351) 2166 430
Fax:    +49 (351) 2166 4355
E-Mail: office@topas-gmbh.de

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Clean Room Validation Equipment

More and more clean room equipment and facilities are required by an increasing number of industrial applications and research fields. This equipment must be tested and validated on a regular basis (functional test, acceptance test, leak test, protection degree measurement). Apart from technical expertise, testing requires suitable instrumentation, which is itself verified and in compliance with existing standards and guidelines (VDI 2083, VDI 3491, VDI 3867, DIN EN 12469, DIN 12980, ANSI/IEST/ISO 14644-3, ISO 21501).
Topas offers as a leading manufacturer of such devices a high quality and extensive product program for accteptance measurements of clean rooms like cleanroom particle counters, aerosol generators, aerosol dilution systems and rectangular isokinetic sampling probes which have been especially developed to comply with the requirements as specified in current standards and regulations. During the development phase, great emphasis was put on the design of instruments to make them suitable for mobile use. In the context of cleanroom acceptance measurements flow visualization is required with sterile, non-toxic fog, to which nebulizers such as the newly developed Condensation Fog Generator CFG 290 are used.

A reliable detection of filter leaks in clean room environments is only possible if the filter is challenged with a sufficiently high number of particles on its upstream side. In VDI guideline 2083 this concentration is defined as 1 million particles/cf. As clean room particle counters like LAP 340 are limited to a certain concentration range, the challenge aerosol must be diluted in a controlled manner by dilution systems like Topas DIL 554. In this way both upstream and downstream concentrations can be measured with only one particle counter.

With fog generators, such as the CFG 290, flow conditions in clean room areas are made visible and thus also areas are recognized with insufficient air exchange, in which particles can be concentrated. Therefore, before start of operation of a clean room flow visualization measurements are essential. But also if replacements are done in a clean room or maschines are set to new production processes, it must be shown that these measures do not adversely affect the currents.

CRQWin: Software for Clean Room Qualification – Topas developed especially for qualification measurements acc. to  standards ISO 14644, DIN 2083, EU GMP (describing qualification measurements in clean rooms, in different areas of pharmaceutical and microelectronic industry, but also in hospitals, pharmacies and at cytostatics work benches) the software CRQWin to support structured data acquisition, storing, representing, filing and evaluation of all data and parameters necessary for clean room classification.

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