International Standards (ISO 14644, DIN 2083, EU GMP) describe qualification measurements in clean rooms indifferent areas of pharmaceutical and microelectronic industry, but also in hospitals, pharmacies and at cytostatics work benches.
CRQWin is developed as extension of PASWin to support standards ISO 14644 and DIN 2083. All necessary data will be captured, displayed and storaged as file.
The following qualification measurements are supported:
- Collection of performance data (volume flow rate, air velocity)
- Filter integrity test
- Determining of clean room classes
- Recovery test
- Collection of environmental data (temperature, humidity, pressure)
The structures of clean rooms and flow boxes are clearly represented in tree view and as graphic.
- Direct data transfer to particle counter via cable (RS232/485, USB) or wireless connection (bluetooth, WLAN)
- Simultaneous measurement with 2 or more particle counters
- Realtime measuring data recording, analysis and plotting
- Can be continuously validated beginning from protocol printouts or display of particle counter up to evaluation tables by means of Excel spreadsheet
- In case of using the own protocol printout the data is consistently not modifiable, consistently verifiable.
- Internal calculation of statistical parameters (mean values, confidence interval)
- Free configurable time intervals (stabilisation, sampling/measuring and pause times, repeated measurements)
- Interface for MS Office for automated assembly of entire protocols including possibility of formating/adding of own photos (flow visualisation, problem etc.)