·         Highest resolution - 0.8nm with 1024 element array! ·         Fast - non-scanning device, acquire full spectrum in a millisecond! ·         Wireless and battery operated! ·         Self-referencing and self-calibrating!

In September of 2004, the FDA published a guidance document, “ PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance.”  PAT is “ a system for designing, analyzing, and controlling manufacturing through timely measurement (i.e. during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality”.

Crystallization or the presence of adsorbed liquids (organic solvent or binder solution or water) in solid pharmaceutical substances can significantly influence properties like chemical decay rate, crystal size, solubility and compaction power.  Current direct techniques for moisture determination in dryers are off-line (Karl Fischer, LOD) and require stopping the drying process to remove samples, which significantly increase cycle times.  Manually collected samples are susceptible to changes in physical conditions like humidity and segregation, which will lead to inaccurate moisture analysis.  Physical handling of highly potent samples can raise safety and hygiene issues.  The other approach is to monitor instrument parameters like airflow, inlet/outlet air or product temperature.  This method is not the most accurate as these parameters do not always reflect the critical product properties, i.e. moisture and solvent levels, which can again lead to long cycle times and product degradation (like over drying), or even result in total batch loss.  NIRS provides the opportunity to monitor and determine moisture and solvent content on-line and in real time in a fluid bed dryer.

Benefits of measuring moisture in-situ during the drying process

• Eliminate off-line bench top testing on Gravimetric Analyzers
• Reduce drying time by eliminating re-dries
• Reduce drying time by factor of ~2X by using higher inlet temperature
• Improve Yield, control output moisture to tighter limits
• Monitor average particle size using full spectrum NIR spectrometers
  
• Get it right every time
• Reduce scrap and improve yield
• Improved product quality
• Fast analysis at point of manufacture speeds time to market and reduces inventory
• Measurements are non-invasive and allow measurements of hazardous materials
• Minimal operator involvement

Product Specifications

Spectrometer
Optics	f/2 or f/3
Detector Options and Resolution
Type	Standard InGaAs Single Stage T.E. Cooled			Extended InGaAs Dual Stage T.E. Cooled
Wavelength Range	900nm to 1700nm			1100nm to 2200nm
Number of elements	256	512	1024	256	512
Resolution (nm/pixel)	3.25	1.6	0.8	4.4	2.2
Data Acquisition
Electronics	16 Bit A/D, 330 Khz
Read out speed	0.7 ms per spectrum for 256 element array
Probe Head
Working Distance	Up to 25 mm from window
Sensing Area	25 mm
Light Source	Dual Tungsten Halogen Lamps, 5.4 watts each
Lifetime of Lamps	~9,000.00 hours each
Communications
Protocol	802.11 G Wireless Ethernet
Battery
Type	Li-Ion
Life	~3.5 hrs.
Changer	Built in
Auto Calibration
Wavelength Reference	Mercury-Argon line source
White Reference	Spectralon
USP <1119> Specifications (Sensor meets or exceeds the following)
Baseline Noise	<0.3 X 10-3 for high light flux <1 X 10-3 for low light flux
Photometric Accuracy	+/- 1% for all levels
Wavelength Accuracy NIST SRM 1920 or equivalent	+/- 1nm
Physical
Dimensions	14.95"L X 7.90"W X 6.75"H  379.731. mm X 200.66W mm X 171.45H mm
Weight	19.19 Ibs, 8.7 Kg
Housing	Class I,Div 11, EP available
Documentation	I/Q and O/Q documentation Included
Software BlendSpekTM PharmaSpekTM Spec32TM
Warranty and Support
Warranty	1 year
Extended Warranty	Available
Support	Several support packages available
Telephone	CDI Pharma Help Desk

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Part Numer:  DM-1000

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