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Overview: Monitoring and controlling residual moisture in powders, lyophilized solids, foods, etc can be a critical factor in achieving and maintaining quality products throughout their expected shelf life. Improper levels of moisture in products can result in poor powder flow properties, spoilage, polymorph changes, changes in compaction properties, microorganism growth promotion, higher degradation kinetics, and in the case of freeze-dried products, loss of physical structure and changes in reconstitution properties. There are several methods typically employed to determine residual moisture, and the choice of method will be based on the sample tested, the level of residual moisture present, and the accuracy and precision required for testing. Additionally, many of these methods require a skill and knowledge in preparing and testing the samples if accurate results are to be achieved. In fact, in many cases, samples containing very low residual moisture, as in the case with freeze-dried products, accurate results for residual moisture are not achieved simply due to improper sample preparation and handling. Additionally, inaccurate and or imprecise results will be obtained if the correct method for testing residual moisture is not chosen. In addition to covering the various techniques employed for residual moisture testing, this seminar will pay particular attention to choosing the correct technique for a specific application, specific details of sample preparation, sample handling, and data analysis, all of which can affect the final result. In addition, a high throughput, non-destructive technique will be discussed, which can be used, if applied correctly, for very rapid and accurate testing with 100% sample recovery. Areas Covered in the Session: Thermal properties of formulated products How and where residual moisture is trapped in products Effects of residual moisture on dried products Gravimetric methods for residual moisture testing Near infrared spectroscopy method for residual moisture testing Volumetric Karl Fischer titration Coulometric Kark Fischer titration Specialized methods of residual moisture testing Proper handling techniques for external extraction in sealed vials Learning objectives: Choosing the correct residual moisture test for your applications Understanding the advantages and disadvantages of the different techniques covered Understanding (via a step by step method) the proper technique for conducting a coulometric Karl Fischer external extraction (including equations) Who Will Benefit: Quality Control Scientists Development Scientists Production Management Quality Assurance Jeff Schwegman, Ph.D. is currently the founder and chief executive officer of AB BioTechnologies (www.ab-biotech.com) where he develops formulations, lyophilization cycles, determines residual moisture by Karl Fischer, and provides thermal characterization studies including freeze-dry microscopy and DSC. Additionally, Dr. Schwegman specializes in speaking and consulting in parenteral pre-formulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules. He also holds patents and develops new technologies within the lyophilization field. Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process development. In 1999 he began graduate study in the Department of Industrial and Physical Pharmacy at Purdue University under the direction of Dr. Steve Nail, where his focus of research involved studying changes in the physical structure of biological molecules during lyophilization. Dr. Schwegman received his PhD from Purdue University in 2003, and returned to Bloomington where he worked at Baxter Pharmaceutical Solutions as a Research Scientist in the Pharmaceutical Development group. In November 2005, he left Baxter and formed BioConvergence LLC with 3 other founders which specialized in developing new formulations and manufacturing processes for parenteral products. In February 2008, he left BioConvergence, which has become a successful company, to form AB BioTechnologies. He is currently the course Director for a 3-day course called Lyophilization Technology which he teaches through the Center for Professional Innovation and Education. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products. AMAZINES.COM
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Online Training, Proven Techniques, Residual Moisture Testing, RAC, RAPS, powders, foods,
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