The CORONA Dryer and Blender

Transcription

1 Spectral Sensors by Carl Zeiss The CORONA Dryer and Blender Product Information

2 The CORONA Dryer and Blender System description The CORONA Dryer and Blender offers fast online measurements of the powder drying, and blending process, respectively for pharmaceuticals and chemical powders. Accurate non-invasive measurements of moisture, solvents, excipients and active product are possible at high speed. Both use the same technology that incorporates no moving parts and is immune to vibration. The rugged design makes it ideal for process monitoring. All versions of the CORONA use the MMS NIR spectral sensor together with an OMK 500 measuring head which are developed by Zeiss. The MMS NIR is designed as one monolithic body incorporating the imaging grating, photodiode array detector and a fiber cross-section converter. The unit offers permanent wavelength calibration. The CORONA measures the full spectral range from 950 to 1700 nm in milliseconds and with a high measuring frequency. The unique OMK 500 measuring head combined with the spectral sensor, allows the user to average many spectra. Typically 50 scans per second will produce high quality diffuse spectra. The OMK head produces a beam of light with a diameter of 25 mm that is sent through a window of a maximum thickness of 30 mm. The diffuse reflectance is collected by 15 fibers in a circular geometry that is directed towards the spectral sensor. The CORONA Dryer uses an integrated OMK head in the same housing as the MMS NIR. The CORONA Blender has a separate OMK head that connects to the sensor by a fiber of 1.8m or longer. The main advantage of this is that it is possible to mount the OMK to the IBC lid easily, due to its lesser weight compared to the integrated unit. Several versions of the OMK head are available depending on thickness of the dryer or blender window being sampled. Main Benefits CORONA Dryer CORONA Blender Real time measurement reduces lab analysis and increases productivity Increases plant capacity by reducing blending and drying cycle time Measures blend uniformity and reduces waste Get it right first time approach No operator contact and no sampling error Better process understanding Rugged, reliable and reproducible sensor

3 Use a CORONA to reduce blending time by 25 % System configuration Options The CORONA Blender includes the standard CORONA which houses the MMS NIR spectral sensor but is connected to a separate OMK 500 measuring head by 1.8 m NIR fiber. Can be battery operated with wireless communication. The CORONA Blender includes a second light box that houses the battery and one half of the RF modem with a trigger switch. Both are made of IP 65 and mounted to the frame of the IBC blender. A PC with an RF receiver in a remote location collects the data. Wavelength and photometric standards for USP calibration PC with NT 4 On-site verification by a qualified Zeiss engineer ExP, purged enclosure for CORONA Remote to be released soon Blending steps A 4 component blend, includes active, lactose, avicel and magnesium stearate Mg stearate Avicel CORONA Remote with RS 232 OMK 500 with 0/45 geometry for window thickness of 6mm NIR fiber, 1.8m RF converters, trigger and battery with housing White and Dark calibration standards with spacer Addimet process control software IQ/OQ documentation Lactose Saccharin Saccharin increasing absorbance with blending

4 B Step 1 of blending excluding magnesium stearate. Blending is monitored by the increase of absorbance using second derivative. End point can be easily determined from steady signal. C Blend uniformity plotted as a function of moving block standard deviation against time D step 2 blending of magnesium stearate E Moving block standard deviation of magnesium stearate vs sample point Lactose Avicel Mg Stearate decreasing absorbance with blending Saccharin Mg stearate

5 Use a CORONA to reduce drying time by 50 % CORONA Dryer ST CORONA Dryer Exd for hazadous areas when drying with solvents CORONA Dryer IP 65 System configuration CORONA Dryer IP 65 and CORONA Dryer ST for GMP plants The CORONA Dryer is in IP 65 for application development, and in stainless steel housing to meet GMP. OMK 500 with 0/45º geometry for measurement through 6 mm glass. Design and construction of mounting. 12 V power supply, RS 422 PCI card and cable, 15 m as standard, longer lengths up to 80 m are available. White and Dark calibration standards with spacer Addimet process control software IO/OQ documentation PC with Windows NT 4 CORONA Dryer in flame proof housing, Exd. Aluminium construction with 13 mm thick walls, special window of OMK of 12 mm thickness. RS 232 interface included. Exd battery and RF modem for wireless communication White and Dark calibration standards with spacer Addimet process control software IQ/OQ documentation PC with Windows NT 4 Measuring during the drying process Options Standards for wavelength and photometric accuracy conforming to USP. IQ/OQ verification on-site by a qualified Zeiss engineer OMK 500 Measuring Window thickness, Measuring Heads Geometry Max Standard 0/45º 6 mm Optional 0/23º 30 mm

6 Operating Principle Spectrometer Single Beam Diode Array Polychromator MMS NIR 1.7 Sensor Array InGaAs Array, peltier cooled Number of Diodes 128 Wavelength Range nm Wavelength Resolution 6 nm / Diode ( 18 nm / Rayleigh) Wavelength Accuracy < 0.6 nm Photometric Resolution 16 bit Light Source Tungsten lamps, 5V / 9W Life Time of Lamp ca h Measuring Geometry 0 / 45 circular (standard) 0 / 23 circular (optional) Working Distance approx. 13 mm (0/45) Sensing Area approx. 20 mm (0/45) Measuring Rate (max) 100 Measurements/ sec (with RS 422 Interface) 5 Measurements/ sec (with RS 232 Interface) Calibration ( 100 %) On external white standard USP recommended specifications are met for the following tests: Baseline noise < 0.3 x 10-3 for high light flux < 1 x 10 3 for low light flux Photometric accuracy Labsphere RSS All standards +/- 1 %, 5 % standard +/- 0.5 % Wavelength accuracy NIST SRM /- 1 nm Acknowledgements Development of these applications have been in partnership with Pfizer Inc The ExD housing and RF in partnership with Expo-Telektron Safety Systems Ltd, Addimet software developed under GAMP 3 exclusively for Zeiss by PAA Process Analysis and Automation Ltd, Farnborough, England. Carl Zeiss Jena GmbH GF-Spectral Sensors D Jena Phone: Fax: info.spektralsensorik@zeiss.de For further details, please contact: Internet: