Le SentroPAT BU II est le système NIR de référence pour le blending de poudres en pharmacie : surveillance temps réel de l’uniformité, point final process par qualité produit, transfert seamless labo-pilote-prod, batterie hot-swap, conformité GmP, validation intégrée et montage rapide sur tout mélangeur.
Sécurité, précision et flexibilité sans compromis.
Points clés
- Système NIR dédié au mélange/blending de poudres pharmaceutiques
- Détermination process endpoint par propriété produit, pas temps fixe
- Surveillance temps réel, gestion variabilité process, release rapide
- Calibrations transférables labo → pilote → production
- Mise en conformité GmP, surfaces lisses, validation IQ/OQ intégrée
- 2 batteries hotswap pour plus de 5h, aucune perte de données, OPC/connectivité SiPAT
- Montage rapide sur mélangeur (flange 4″), triggers logiciels & NIR automatiques
- Logiciel SentroSuite 21CFR part 11, validation USP/EP intégrée
Et plus...
| Technical Data | SentroPAT Blend Uniformity TL |
|---|---|
| Wavelength range | 1350 – 1800nm |
| Spectral resolution | >= 0.3nm (configurable), specification at 2nm |
| Wavelength accuracy | < 1nm |
| Wavelength reproducibility | < 0.1nm |
| Photometric linearity | Fulfilling USP <1119> requirements |
| Noise – High flux | < 0.3 x 10-³ AU according to USP<1119> |
| Noise – Low flux | < 1 x 10-³ AU according to USP<1119> |
| Data acquisition time | 400msec |
| Sampling interface | Non contact, through sapphire window |
| Measurement spot size | 25mm uniform beam shape for homogeneous sample illumination effective detection area 12mm diameter |
| Working distance | Depending of sapphire window (27mm at 8.5mm sapphire thickness) |
| Power supply | 2 hot swappable batteries with in total > 5hours operation External power supply for lab operation and recharging |
| Enclosure | IP65 / NEMA4, cGMP conform |
| Dimensions | 220 x 210 x 150mm (W x D x H) Width: add 80mm for handle Height: add 50mm for flange |
| Weight | 6.5Kg / 14.5lb |
| Measurement trigger | Internal software controlled 3D position measurement |
| Communications | Wireless LAN (802.11 b/g/n) |
| Software | SentroSuite GmP |
| Validation | Software integrated validation routines according USP<1119>, EP2.2.40 |
| Service port | Connections for DVI-D monitor and 3x USB |
| Mounting | 4″ hygienic flange |
Main features
- High performance spectrometer engine, easy to mount
- accurate and reliable NIR technology
- Seamless method transfer between instruments
- GmP friendly with smooth surfaces
- Superior spectroscopic performance
- Low cost of ownership
- Hot swappable battery
- No data loss at communication failure
- OPC connectivity
- SiPAT interface
