CDI PHARMA - YOUR PARTNER I N QUALITY FOR PHARMACEUTICAL INDUSTRIES CDI Pharma is a manufacturer of instruments for the Pharmaceutical Manufacturing Industry. These instruments can be used for measuring and controlling content uniformity in blending, moisture and solvent content in fluid-bed dryers, thickness of film coating in pan coaters, compact strength and particle size distribution of roller compacted powders. With more than 14 years of experience in manufacturing Near Infra-Red (NIR) spectrometers, we are committed to providing the pharmaceutical industry with the latest, most cost effective solutions offering the highest possible performance. BM-1000 - ON-LINE, IN REAL-TIME MONITORING UNIFORMITY I N BLENDING In response to the FDA'S PAT initiative, CDI Pharma has developed an NIR Sensor system for measuring blend uniformity and end-point in V and bin style blenders. The system is designed for use on-line and provides data in real-time. Incorporating a compact NIR spectrometer with the latest InGaAs diode array technology means fast data acquisition, improved productivity and quality assurance (QA), and reduced scrap materials. Getting it right the first time with low maintenance and minimal operator involvement is our goal. CDI Pharma's blend uniformity monitor, BM-1000, uses wireless communications and features a built-in battery, enabling fast, simple on-line and real-time monitoring of blend homogeneity and end-point determination. The monitor is compact and rugged, ready for use in the laboratory, pilot plant or production environment. CDI Pharma's blend uniformity monitor is also self-referencing, allowing it to perform IQIOQ checks at regular intervals or on demand, and it comes equipped with a built-in line source for automatic wavelength calibration. The sample head contains a white reference, which allows automatic linearity and noise tests. These combine to meet requirements as defined in USP<1119>, "Guidelines for Qualification of NIR Instruments". DM-1000 - ON-LINE, I N REAL-TIME MONITORING MOISTURE AND SOLVENT I N FLUID BED DRYER The PAT initiative encourages the use of new analytical technologies in pharmaceutical manufacturing. The main objective of the initiative is to improve process understanding through implementation of real-time, in-process measurements. CDI Pharma's dryer monitor, DM-1000, is an accurate and precise instrument to monitor and determine moisture and solvent content on-line and in real-time on a fluid-bed dryer. Hence, increasing efficiency and predictability by monitoring process variability. CDI Pharma's dryer monitor includes a NIR spectrometer in a Class I, Div I1 enclosure that covers the spectral region ranges from 900nm to 1700nm or llOOnm to 2200nm using a T.E.-cooled 256-element InGaAs diode array detector. The monitor has a self-referencing probe with two tungsten halogen lamps, an Hg/Ar line source for automatic wavelength calibration, and a spectralon white paddle for acquiring reference, linearity, and noise data. Advantages of using CDI Pharma's Dryer Monitor: ü Direct, non-invasive measurements ü No sample preparation ü Provides both chemical and physical information of all components of the sample ü Improved process understanding by optimizing process equipment ü Obtain process information in real-time ü Increased productivity ü Faster response times to customer demands ü Lower manufacturing costs by eliminating reworklrejects (no OOS reports) ü Total control of production process ü Minimal operator intervention ü Compact, portable DETERMINE COATING THICKNESS I N REAL-TIME CDI Pharma's self-referencing probe for coating thickness is designed such that it can be attached to the spraying arm of any pan coater. The stainless steel housing is Class I, Div II. The Self-Referencing Probe can be connected to any of CDI Pharma's NIR spectrometers via a fiber optic cable and a power cord. The head produces a beam of light approximately 25mm in diameter, projected through a window equipped with an air curtain. The air curtain prevents the sample window from being fouled and allows the probe to be directly in the environment where the coating is applied. Several fibers pick up the diffuse reflectance signals and transmit them to the spectrometer. The probe head has a built-in spectralon disk that is used as a 100% white reference. The spectralon disk can also be used to conduct linearity tests and low/high flux noise measurement as per USP <1119>. Combined with our AutoCal feature, USP <1119> requirements are met by the system. AutoCal uses an internal Hg/Ar lamp to maintain a constant accurate wavelength calibration. All referencing can be done at anytime without having to remove the installed probe. The probe head contains two light bulbs, one as a backup, proving redundancy. Advantages of using CDI Pharma self-referencing probe: ü In-line measurement ü Determine end-point when desired coating thickness is reached ü Probe explosion proof housing with air curtain ü Validated software package ü 21 CFR Part 11 compliant CDI PHARMA DATA ACQUSITION, VALIDATED AND 21 CFR PART 11 SOFTWARE PACKAGE CDI Pharma provides complete solutions that include custom software design, pre-production and validation. CDI blend monitor software allows quantitative and qualitative analysis of blends, using statistical methods, including Classical Least Squares analysis. For validation, software 21 CFR Part 11 compliant that allows basic function like data acquisition, storage of data as per 21 CFR Part 11, system security, and electronic signatures as per 21 CFR Part 11. CDI Pharma offers extensive pre-sale and after-sale customer support. We provide demonstrations of all our products. Further, we will analyze customer samples at our laboratory to determine suitability of our systems for any particular application. | 
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