·         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”.

The current practice of blending for a pre-determined amount of time does not take into account physical differences in raw materials (e.g. excipients) like particle shape, size distribution, inter- and intra-particulate bonding, or humidity in the environment.  CDI Pharma’s Blend Analyzer provides information related to both physical (e.g. particle size, morphic form, moisture content) and chemical attributes.  It addresses limitations of time defined end points.  The end point can now be determined based on the desired attributes of the materials necessary for the next unit operation, i.e. blend is homogenous and uniform.

Benefits of Real-Time Control

• Get it right every time
• Reduced scrap and improved 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
• Low maintenance

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
WavelengthRange	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

About CDI Pharma

CDI Pharma is a division of Control Development, Inc.  The division was formed to serve the unique needs of the pharmaceutical industry.  Control Development, Inc., an instrument and sensor maker has a 15-year history of innovation in dynamic process analysis.  We are one of the largest producers of NIR-diode array-based spectrometers today, with over 1,000 systems in place globally.

“All our sensors are diode array-based, and we pride ourselves as the premier manufacturer of such systems.”

CDI Pharma products include a battery-powered and wireless-transmitting NIR blend uniformity analyzer designed for PAT applications.  The monitor is contaminant-resistant and has a very high optical efficiency.  Our product is already in use at several pharmaceutical sites.  The division’s software suite includes PharmaSpek™ and BlendSpek™, with their 21CFCR11 ready cores tailored for specific blender, granulator, coater and dryer interface requirements.

CDI Pharma has trained its staff to professional pharmaceutical standards, instituted GMP-compatible qualification packages, and has instituted audit-ready software support programs.

Our Technology

Self-calibrating probe head and sampling system

We have patents pending (worldwide) on our sampling and illumination system.  Our unique design enhances performance, while increasing ruggedness at the same time.

• Sample is illuminated by dual tungsten halogen lamps
• Large 25 mm diameter sample area
• Working distance up to 25mm from window
• Sapphire double meniscus window reduces back reflection
• Spectralon white reference plate
• Hg-Ar wavelength calibration source
• Fiber optic pickup

Click here for a large view 

All our NIR spectrometer sensor systems use T. E. cooled InGaAs diode arrays.  InGaAs array performance and packaging has improved over the last 10 years to meet the stringent requirements of the telecommunications industry and are now available to the pharmaceutical industry.

These devices feature:

·        Wide dynamic range ·        Low noise and low dark current ·     Selectable gain ·        Anti-saturation circuitry ·        Correlated double sampling circuitry (greatly reduces reset noise) ·        Offset compensation circuit ·        Low cross talk ·      High resolution ·        Thermo-electric cooling, single stage for standard InGaAs detectors and dual stage for extended InGaAs detectors

Click here to download a PDF file of this product
Part Number:  BM-1000

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