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News Kaiser Announces the RAMAN WORKSTATION™ Raman AnalyzerANN ARBOR, MI - Kaiser is pleased to announce the release of a new generation RAMAN WORKSTATION™ Raman analyzer. Formulation development remains a critical step in the development of a new drug product. Each step represents a risk to product quality as each step exposes the active pharmaceutical ingredient to potential change and / or dilution. In order to evaluate process induced transformations in situ, Kaiser developed PhAT technology in 2005. In addition to in situ testing it is also possible to use Raman for unit doseage confirmation by using transmission Raman approaches to evaluate content uniformity. While transmission Raman has the potential to provide whole tablet quantitation it cannot provide detailed information on the product surface or indications of clumping of the active pharmaceutical ingredient. In order to obtain this type of information a Raman microscope is typically used. Thus in order to obtain detailed information on the formulation process it has been necessary for a company to invest in and use two different types of Raman analyzers. The RAMAN WORKSTATION™ Raman analyzer addresses both these needs in a single analyzer. Raman images from the surface and the bulk can be provided at either low or high spatial resolution without removing the tablet. In transmission modes the RAMAN WORKSTATION™ Raman analyzer can be used to evaluate tablet’s or capsule’s content uniformity. Utilizing a RAMAN WORKSTATION™ Raman analyzer a formulation's critical quality attributes during the formulation development phase can be determined. This information can be fed back to the manufacturing team to ensure an optimized deployment of an in situ RAMAN WORKSTATION™ PhAT-capable analyzer in order to monitor and control critical parameters, thus ensuring optimized product quality while meeting the goals of the Quality by Design (QbD) initiative. The RAMAN WORKSTATION™ Raman analyzer meets the needs of the pharmaceutical and solids catalyst markets where solids formulations development is critical. The combination of the capabilities of a wide area Raman analyzer and a Raman microscope make the analyzer attractive in term of both analyzer ROI and analyst time. About Kaiser Optical Systems For Immediate Release For Kaiser |
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