AGC Instruments has developed an AGC NovaCHROM GC System to monitor N2 Pharmacopeia as per the European Medicines Agency standards.
Satisfying the key requirements for the Quality Control of Nitrogen (N2) for Medicinal Use, the NovaCHROM 4000 GC System ensures that the Nitrogen contains not less than 99.5 per cent V/V of N2 as directed by the European Medicines Agency (EMA). It closely adheres to all other elements required by the EMA to ensure compliance with the strict regulatory protocols.
There are a number of Quality Control Protocols built into the system to adhere to these strict conditions of medicinal nitrogen. The column performance is substantiated by injecting air and this shows that oxygen (O2) has been separated from Nitrogen (N2). Furthermore, the Auto-Calibration function is used with a certified N2 calibration gas to show what results should be expected. This is in addition to alarms based on the peak sizes of the chromatograms which, in turn, verifies the detector response.
The status fail safes are supported by alarms for the Carrier Gas and Air Supply pressure rates and the Oven Temperatures. If any of these parameters change, then the results will fall outside the preset thresholds which will also trigger the Detector Response and Column Function alarms. This interlinked alarm system is also complimented by a locked cabinet door on the system which prevents unauthorised changes to the calibration settings.
As with all GC systems from AGC Instruments, the System Sequencing and methods are pre-programmed to allow a quick transition from installation through to operation. All system parameters can be changed by the end-user to suit their requirements with full support from AGC technicians and trained distributors. The stability of the GC System has a stated value of 0.5% but typically records results within 0.1% of the value required for this application. Using the AGC TrendVision Chromatography Software, the results are aptly displayed as Digital Panel Meters (DPM), Chromatograms and Trends. The results can then be transferred from the GC to the Control Room or DCS via the 4-20 mA outputs which are included as standard.
To discuss any applications you may have, please contact AGC Instruments directly where our highly trained engineers can guide you through the whole process to achieve a system suited to your needs.