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| Applications |
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| Pharmaceutical Production and Packaging |
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Manufacturing of pharmaceuticals does include different areas starting with research & development, clinical production, bulk manufacturing, and packaging. Key is the actual recipe that describes how a product is made in a commercial manufacturing or in a contract manufacturing area. PAS-X has a powerful engine to develop and maintain those recipes and to execute the recipes in a paperless production environment. |
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| Biopharmaceutical Production and Packaging |
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Biotech production is a very complex process, as it deals with living cells. The process to manufacture large API molecules is difficult to control, and production runs take some weeks. The manufacturing process needs support for the upstream and downstream processing. Key for the proper process control and implementing the Right First Time approach is the integration to the different automation/DCS/SCADA systems. The operator has to interact with the automation systems as manual and automated production steps interact. PAS-X covers the different requirements with special functions, for handling e.g. the complex order networks, the long lasting fermentation processes and the chromatography and special cleaning / sterilization processes. |
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| Chemical API Production and Packaging |
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Active Pharmaceutical Ingredients (API) means the active substances in a medical product. Typically Active Pharmaceutical Ingredients are formulated in a separate factory, where they are compounded with inert pigments, solvents and excipients, and made into dosage forms. Chemicals manufacture of pharmaceuticals active ingredients needs to conform to the strict Good Manufacturing Practice standards. PAS-X is the backbone for all compliance and manages the process in deep integration with the DCS and process control systems. |
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| Vaccines Production and Packaging |
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Vaccines are manufactured in complex production processes often based on biopharmaceutical APIs. A simple example: the production of viral vaccines in animal cell culture can be accomplished with primary, diploid, or continuous (transformed) cell lines. Each cell line, each virus type, and each vaccine definition requires a specific production and purification process. Media have to be selected as well as the production vessel, production conditions, and type of process. PAS-X is one of the most advanced products to support these requirements. PAS-X also supports all facets of Fill & Finish processes.
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| Blood Plasma |
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Plasma is a very complex mixture of proteins that performs and enables many housekeeping and other specialized bodily
functions. Starting with donations upstream steps are performed, e.g., pooling and fractionation and as the process
moves further downstream, e.g. purification is required. For all steps a Manufacturing Execution System should
monitor and control the entire batch oriented production process. PAS-X offers the best in class product for this
special process industry segment.
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| Fill & Finish |
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Unique for this manufacturing process are unit operations, such as sterilization, filling and lyophilization, etc. associated with aseptic fill and finish operations. PAS-X comes with all relevant functionality for most accurate results.
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Pharmaceutical Production
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