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All publications from STZ EURO Steinbeis-Transferzentrum

Test 1 – Visualization of the basic flow / Figure 2: Visualization of the basic flow with Nebula Fluid Extra Clean in the left image and via CFD simulation in the middle image. On the right, the visualization with water mist.

Test 1 – Visualization of the basic flow / Figure 2: Visualization of the basic flow with Extra Clean fog fluid in the left image and via CFD simulation in the middle image. On the right, the visualization with water mist.

Test 2 – Visualization of vortex regions / Figure 3: Visualization of the vortex region with Extra Clean fog fluid in the left image, using CFD simulation in the middle image, and with water mist in the right image.

Test 2 – Visualization of vortex regions / Figure 3: Visualization of the vortex region with Nebelfluid Extra Clean in the left image, using CFD simulation in the middle image, and with water mist in the right image.

Test 2 – Visualization of Vortex Regions / Figure 3: Visualization of the vortex region with Nebula Fluid Extra Clean in the left image, via CFD simulation in the middle image, and with water mist in the right image.

Test 3 – Visualization of the Fog Ascent Height / Figure 4: Visualization of the fog ascent height with Fog Fluid Extra Clean with low impulse in the left image. The middle image shows the visualization with water vapor with low impulse. The right image also shows water vapor but with high impulse

Test 3 – Visualization of the Fog Rise Height / Figure 4: Visualization of the fog rise height with Fog Fluid Extra Clean with low momentum in the left image. The middle image shows the visualization with water vapor with low momentum. The right image also shows water vapor but with high momentum.

Table 2: Evaluation of the fog ascent height (see Figure 4)

Test 4 – Visualization of cloud dispersion in vortex areas / Figure 5: Visualization of cloud dispersion with Nebelfluid Extra Clean with low momentum in the left image. The middle image shows a CFD simulation, and the right image displays water mist with low momentum

Test 4 – Visualization of cloud dispersion in vortex areas / Figure 5: Visualization of cloud dispersion with Nebelfluid Extra Clean with low impulse in the left image. In the middle image via CFD simulation and in the right image with water mist with low impulse

Test 4 – Visualization of fog dispersion in vortex areas / Figure 5: Visualization of fog dispersion with fog fluid Extra Clean with low momentum in the left image. In the middle image via CFD simulation and in the right image with water fog with low momentum

Figure 1: Sinking of the water fog with increasing distance from the fog outlet at three different fog densities (1.1, 1.2, 1.3) and initial horizontal velocity of 0.5 m/s in the horizontal flow area (Source: Diploma thesis)6

Table 1: Requirements of VDI 2083 Sheet 3 for test substances and test equipment for flow visualization.

19.11.2023
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Visualisation

Which fog fluid is suitable for flow visualization according to GMP Annex 1?

The perfect fog fluid still does not exist. Pharmaceutical companies that perform or have performed airflow visualizations in critical cleanroom areas will find in this white paper comprehensive information to select the appropriate fog fluid for the specific application. A comparison between fog an…

Figure 1: Disruption of a filling needle by primary air in an isolator. The left image shows the detection within the framework of a CFD simulation (design), and the right image shows the detection during flow visualization on the real system as part of qualification.

Figure 2: Example of a flow visualization in a turbulently ventilated cleanroom of class B. The inspection and evaluation were carried out here based on VDI 2083 Sheet 34.

Figure 3: Visualization of the TAV flow in a closed isolator with a current filament lance.

Figure 4: Glove intervention on an RTP (Rapid Transfer Port) of an isolator with flow visualization and fog application above the glove. Additionally, fog is introduced below the glove later in the process.

Figure 5: Visualization of the overpressure at the mousehole of an open isolator. Additionally, in the further course of the flow visualization, fog should be omitted on the downstream side of the mousehole and checked whether fog penetrates into the isolator.

Figure 6: Visualization of a personnel intervention with an open door at a RABS. Fog task on the operator's clothing.

05.10.2023
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ANNEX 1

The new Annex 1 and the requirements for airflow and their visualization

In August 2022, the new and completely revised Annex 1 to the EU GMP Guide was published, featuring many new requirements for airflow and airflow visualization. These are discussed individually in this white paper.

The Annex 1 to the GMP Guide1 (hereinafter referred to as the new Annex 1) was publish…

Figure 2: Flow visualization to depict the air dispersion and to check whether a short circuit is visually detectable. Air is drawn in at the bottom of this device and blown out at the top.

Figure 3: Course of particle concentration (≥ 0.5 µm) during the recovery time measurement. Additionally, the measurement values for air exchange rate, sound pressure level, and electrical active power consumption are provided (figure only available in web resolution).

Dipl.-Ing. (FH) Michael Kuhn, Head of the Steinbeis Transfer Center for Energy, Environmental, and Cleanroom Technology, Lecturer in Cleanroom Technology, and Chairman of VDI 2083-19.

28.03.2021
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Buildings & Rooms

STZ EURO: Testing of air purifiers

Effective protection against coronavirus transmission in enclosed spaces

The company F. Hoffmann-La Roche AG planned to purchase air purification devices for office and meeting rooms that lack mechanical ventilation in order to potentially reduce viruses present in the indoor air. The Steinbeis Transfer Center STZ EURO conducted a preliminary measurement analysis on five…

Figure 2: Testing of an electrical installation box on the STZ EURO test stand.

Figure 3: Hollow wall boxes O-range ECONÂ® by Kaiser for airtight and cleanroom-compatible electrical installation.

Figure 1: Example of a test certificate.

Figure 4: Dipl.-Ing. (FH) Michael Kuhn, Head of the Steinbeis Transfer Center for Energy, Environmental, and Cleanroom Technology, Lecturer in Cleanroom Technology, and Chairman of VDI 2083-19.

22.02.2021
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Buildings & Rooms

STZ EURO tested the tightness of electrical installation boxes on behalf of the company KAISER based on VDI 2083-19.

Electrical installation boxes with tightness class 6

Finally, the possibility exists to access tested and proven airtight components already during the planning of cleanrooms and containments.

The company Kaiser GmbH & Co. KG, market leader for electrical installation boxes, tested the newly developed test stand of STZ EURO with different fittings in v…

Table 1: Comparison of airflow requirements with/without lowering and energy-saving potential in lowering operation for heating/cooling/dehumidification and humidification (excluding electrical energy for fans).

Figure 1: Example of a leak-tight, conservatively designed cleanroom area operated without depressurization.

Figure 2: Example of a leaky, conservatively designed cleanroom area with improved energy efficiency, operated using the standard lowering method.

Figure 3: Example of an innovatively designed and precisely defined cleanroom area, with the most efficient lowering method.

Dipl.-Ing. (FH) Michael Kuhn, Head of the Steinbeis Transfer Center for Energy, Environmental, and Cleanroom Technology, Lecturer for Cleanroom Technology, and Chairman of VDI 2083-19.

11.11.2020
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Buildings & Rooms

STZ EURO: Future-proof resource conservation based on VDI 2083-19

Visions for climate-friendly cleanroom operation

For many cleanroom applications, a defined airtightness is not required, especially if compliance with product protection or environmental protection does not demand it. Nevertheless, it can make sense to achieve a airtightness as defined by VDI 2083 Sheet 19 in order to specifically and economicall…

The wall covering had to be removed to locate the leak behind it (inappropriate electrical cable entry, see arrow).

Measurement setup in the crawl space under the S3 laboratory, approximately 1 meter high.

Leak detection at the construction site on a faulty installed smoke detector.

23.09.2020
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Buildings & Rooms

STZ EURO: Manufacturer-independent testing within the framework of VDI 2083-19

Leakage test S3 laboratory under extreme conditions

The VDI Guideline 2083-19, concerning the airtightness of cleanrooms, already considers all relevant aspects of room airtightness during the planning phase and can thus prevent laboratory and cleanroom operators from unpleasant surprises. Retrofitting existing laboratories and cleanrooms is often as…

The STZ EURO has recently introduced a sample specification text for leak tests of cleanrooms and laboratories according to VDI 2083-19.

09.09.2020
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Buildings & Rooms

STZ EURO offers sample template text for the specification list

Optimize tenders for leak testing of cleanrooms and laboratories

Cleanroom technology is and remains a specialized field that requires particular expertise. This is especially evident in the context of tenders. Specification documents are not always complete or effective. Therefore, STZ EURO has recently made an example available on its own website: a sample spec…

Employees of the STZ EURO conducting requalification measurements on-site at the customer's location.

Employees of the STZ EURO during maintenance work on-site at the customer's location.

Benjamin Pfändler. Head of the Steinbeis Transfer Center for Energy, Environmental, and Cleanroom Technology.

26.08.2020
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Buildings & Rooms

(Re-)Qualifications and Modernizations in Cleanroom Technology – Despite Short Maintenance Windows

Minimize production downtime in the cleanroom

(Re-)Qualifications and maintenance in cleanroom technology often take days or even weeks. Production or cost pressures are making long maintenance intervals increasingly difficult to accommodate. The STZ EURO responds with preparatory planning, digital technologies, and experienced measurement team…

Smoke studies within the framework of VDI 2083-3 also include detailed analyses using test smoke during personnel interventions.

03.06.2020
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Buildings & Rooms

STZ EURO offers insights and training on VDI 2083, Sheet 3

Methodology for flow visualization clearly defined

GMP and FDA inspectors have been demanding proof of airflow visualization in cleanrooms for years, also known as Smoke Studies. The extent of flow visualization, the respective reporting, and the key data for qualification were not specifically regulated. With the newly revised VDI Guideline 2083 Pa…

The data of the volume flow and room pressure controllers in the customer's production room were also transferred into the virtual model.

Compare measurement data with the simulation.

04.03.2020
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Buildings & Rooms

STZ EURO offers fast and realistic simulations for cleanroom planning, construction, commissioning, and optimization.

New: Print optimization of cleanrooms during ongoing operation

The digital age is transforming our daily lives. Planning, construction, optimization, and qualification of cleanrooms require in-depth engineering knowledge. These complex relationships can now be represented with the help of STZ EURO through simulation calculations. This promises faster, cost-opti…

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