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Sotax - Solutions for Pharmaceutical Testing White Papers

Sotax - Solutions for Pharmaceutical Testing

A New Tool for Fully Automated Dissolution Systems Integrated Video-Monitoring Automated dissolution testing systems have been used extensively in QC environments to increase productivity and reduce testing costs. For these same reasons, it has also become a matter of urgency for these same reasons in the Analytical R&D and formulation laboratories. SOTAX, the market leader in automated solutions for dissolution, content uniformity and assay testing, announces the integration of video-monitoring within our new client/serverWinSOTAX plus Dissolution Software.
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Fully Automated Dissolution System The SOTAX AT 70 BS 60 for consecutive USP 1 and USP 2 tablet dissolution testing.
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Quality By Design: The Automated Pharmaceutical Assay Who can argue against the concept of Quality by Design (QbD) in the pharmaceutical industry? We should always strive to improve our systems and the way tasks are accomplished. The pharmaceutical industry should be no exception. One lofty definition of QbD according to the FDA is “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight.” Coming back down to earth for a moment it is logical to assume that Chemistry, Manufacturing, and Controls (CMC) should be at the core of this initiative. In the pharmaceutical laboratory, QbD challenges our understanding of the product. It requires more robust and rugged methods that can provide more information and be efficiently executed.
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Benefits of Automated Sample Preparation in Pharmaceutical Development and Quality Operations When we think of automation many images come to mind such as large robots bolting on doors on cars in seconds or the mesmerizing packaging machinery most pharmaceutical companies employ. In the pharmaceutical laboratory there are various types of automated instruments. Some automated devices have become ubiquitous. The auto injector on an HPLC is a tool that most consider indispensable. Fully automated sample preparation and dissolution analysis are common however their perceived benefits for purchase justification are primarily confined to labor savings. This article will explore additional ways that laboratory automation can pay off in a big way.
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Automated Sample Preparation for Creams, Gels and Difficult Samples Sample preparation for creams, lotions, gels and ointments is a difficult task. Their high viscosity or unique rheology causes analyte extraction of these sample types to be particularly difficult to disperse. They are most troublesome when the semi-solid base product is not miscible with the preferred solvent required for the assay. This poster will illustrate how automated sample preparation can be utilized to overcome these difficulties. One benefit of automated sample preparation is its ability to eliminate differences in various manual techniques such as sample dispersion.
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Automated Cleaning Swab Validation Testing Using the Zymark® APW3 Assay Workstation Analysis of cleaning swabs provides its own set of challenges to the pharmaceutical laboratory. The large numbers of samples and sporadic requests to the lab make it an ideal candidate for automation. Automated serial processing of swab samples can improve both the analytical quality and laboratory responsiveness.
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