Whitepapers - Pharmaceutical Technology

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Whitepapers

  • Final Bulk Inspection of Solid-Dose Pharmaceuticals


    Final bulk inspection of solid-dose OTC and regulated pharmaceuticals must deliver consistently high product quality. Customers scrutinize products closely, and processes are increasingly coming under the review of regulatory agencies. Advanced technology addresses these challenges, as new automated continuous inspection systems are more effective and commercially viable than ever before.

    Containment of Basket Filtration Centrifuges


    Basket filtration centrifuges are commonly used as a means of filtering potent compounds, and are an effective way to separate and purify solid products. As the demands to minimize operator exposure to the products increase, and as the exposure limits to solvent vapors decrease, the challenge with basket filtration centrifuges is to maintain contained transfer of the caked solids during discharge into downstream processing equipment.

    Wireless Environmental Monitoring Solutions


    This paper describes the advantages of using a wireless environmental monitoring system for measuring humidity and temperature parameters in manufacturing and process industries. It explains the ease of installation procedure and answers the safety and data security concerns that often influence a purchase decision.

    Scale-up of Liquid / Liquid Centrifuges


    Centrifugal contactors are one of the technologies employed for liquid / liquid separation and liquid / liquid extraction processes. Every liquid / liquid system has its own specific characteristics and in order to successfully predict behavior, testing must be performed with small scale equipment to predict industrial performance. Process intensification studies can be performed using laboratory scale centrifugal contactors to evaluate these parameters. Pilot scale testing is performed with larger equipment to perform more thorough and specific testing.

    In Situ Monitoring of CHO Cell Culture Medium Using NIR Spectroscopy


    NIR spectroscopy using specialized transmission probes and fiber optics allows real-time in situ analysis of bioreactor feed stocks and product. With continuous NIR analysis, metabolic parameters and culture media constituents can be better monitored and controlled, which increases CHO cell life and lengthens the production phase.

    A Guide to Near-Infrared Spectroscopic Analysis of Industrial Manufacturing Processes


    Near-infrared (NIR) spectroscopy is a simple, quick (<10 second analysis time), non-destructive technique that provides multi-constituent analysis on virtually any matrix with levels of accuracy and precision that are comparable to primary reference methods. NIR analyses require no sample preparation or manipulation and no reagents. This guide provides a practical overview of the critical factors that are useful and necessary when developing and implementing NIR spectroscopic methods of analysis in pharmaceutical and chemical manufacturing operations.

    Near-Infrared Assay and Content Uniformity of Tablets


    Near-Infrared (NIR) technique for the determination of content uniformity of tablets provides a fast and accurate means of monitoring tablet production that is in step with the FDA Process Analytical Technology (PAT) initiatives. The FOSS XDS MasterLab™ was used to determine the content uniformity of tablets, instrument precision and accuracy. The data showed promising results that could relieve laboratory workload from HPLC analysis and bring analysis closer to "real-time" for process monitoring.

    In-line Process Analysis of Residual Moisture in a Fluid Bed Granulator–Dryer Using NIR Spectroscopy


    The authors describe the in-line moisture measurement of a pharmaceutical granulation of lactose, microcrystalline cellulose and crospovidone in a fluid bed granulator-dryer using top sprayed granulating liquid. A Near-Infrared (NIR) prediction model was developed for moisture on spectra collected during a calibration run. Subsequent granulations were analyzed for moisture content real-time throughout the granulation and drying process using the FOSS NIR process instrument.

    Monitoring Granulation Drying using Near-Infrared Spectroscopy


    In situ analysis of residual moisture and methanol using Near-Infrared (NIR) Spectroscopy. A novel probe design can reduce the powder-sample density variance such that moisture and solvent levels can be accurately modeled and predicted in process. NIR can monitor low levels of residual moisture, alcohol and other process constituents to yield better process control and quality management.

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