Development and production of automated robotic systems for filter testing in cleanrooms according to DIN EN ISO 14644-3.
Smart Cleanroom Solutions GmbH
New on Amplifa
About Smart Cleanroom Solutions
Smart Cleanroom Solutions GmbH is a company of InfraSolution AG and develops and produces automated robotic systems for quality assurance of HEPA/ULPA filters in cleanroom applications. The AutomaticParticleScanSystems (APSS) product family automates filter integrity testing according to DIN EN ISO 14644-3 during ongoing operation. With RobotScanFlex (RSF), vertical and horizontal laminar-flow systems as well as terminal filters are tested, LinearTwinScan (LTS) is designed for filter testing in hot-air sterilization tunnels, and integratedRobotScanFlex (iRSF) is used for the qualification of open and closed RABS, isolators and safety workbenches. The measurement process delivers a real-time 2D heatmap of the filter status, an integral assessment and an automatic leak verification; the test reports are provided as read-only PDF in accordance with FDA 21 CFR Part 11 and EU GMP Annex 11. Cleanroom measurements are additionally offered as a service by the sister company IBD Ingenieur-Büro Dorfner GmbH. Target industries are the pharmaceutical industry, medical technology, laboratories and hospitals.
- Processes
- Filter integrity testing in hot-air sterilization tunnels (LinearTwinScan, LTS), Visualization of airflow in cleanrooms using special methods (IBD), Development and production of automated robotic systems for quality testing of HEPA/ULPA filters, Automatic filter leak testing according to DIN EN ISO 14644-3, Real-time 2D heatmap filter status, integral assessment, automatic leak verification, Test reports as read-only PDF in accordance with FDA 21 CFR Part 11 and EU GMP Annex 11, Cleanroom measurements as a service (via sister company IBD Ingenieur-Büro Dorfner GmbH)
- Certificates
- DIN EN ISO 9001:2015, ISO 9001
- Industries
- Pharmaceutical industry, Cleanroom technology, Medical technology, Laboratories, Hospitals, Cleanroom technology
- 01
Development of the robotic systems
- 02
Production of the APSS systems
- 03
Filter leak testing according to DIN EN ISO 14644-3
- 04
Evaluation: 2D heatmap, integral assessment, leak verification
- 05
Read-only test report in accordance with FDA 21 CFR Part 11 and EU GMP Annex 11
- 06
Cleanroom measurements as a service (via IBD Ingenieur-Büro Dorfner GmbH)
Systems
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Testing | – | – | – | – | – |
| Testing | – | – | – | – | – |
| Filter integrity testing in hot-air sterilization tunnels (LinearTwinScan, LTS)Testing | – | – | – | – | – |
| Testing | – | – | – | – | – |
| Testing | – | – | – | – | – |
| Visualization of airflow in cleanrooms using special methods (IBD)Testing | – | – | – | – | – |
3 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| – | Smart Cleanroom Solutions GmbH RobotScanFlex (RSF) | – | – | – | – |
| Linear robotic system for filter testing in hot-air sterilization tunnels | Smart Cleanroom Solutions GmbH LinearTwinScan (LTS) | – | – | – | – |
| Integrated robotic system for qualification of RABS, isolators and safety workbenches | Smart Cleanroom Solutions GmbH integratedRobotScanFlex (iRSF) | – | – | – | – |
Additional services
Reference customers
Quality
Smart Cleanroom Solutions is certified according to DIN EN ISO 9001:2015 (register no. Q1 0114605-06). The systems generate test reports as read-only PDF in accordance with FDA 21 CFR Part 11 and EU GMP Annex 11.
| Evidence | Company |
|---|---|
| ISO 9001 |