A number of different areas are involved in the manufacture of pharmaceutical drugs, including research & development, clinical trial manufacturing, bulk manufacturing, and packaging. The manufacturing process itself is based on the recipe that describes how the product is to be made - either through commercial or through contract manufacturing. The powerful authoring engine included in PAS-X makes sure that these recipes can be easily developed and maintained and that they can be executed in a paperless production environment.
Biopharmaceutical production is an extremely complex process since it involves the use of living cells. As a result, the manufacturing process of large API molecules is hard to control and one production run may take several weeks. It is therefore necessary to provide adequate support systems for upstream and downstream production processes. To ensure flawless process control and to facilitate a proper implementation of the "right-first-time" approach, where the best results are achieved at the very first attempt, PAS-X has to be fully integrated with existing DCS, SCADA and automation systems. The operator has to be able to interact with the automation systems, whenever there is an interplay between manual and automated production steps. PAS-X meets these diverse requirements by providing numerous specific functions. For example, specialized PAS-X functionality facilitates handling of complex order networks, of long-lasting fermentation processes, and of chromatography, special cleaning and sterilization processes.
An active pharmaceutical ingredient (API) is the substance in a drug or other medical product that is pharmaceutically active. In general, an API is formulated in a specific plant, where it is mixed with inert pigments, solvents, and excipients, and then made into the desired dosage form. The manufacturer must consistently and strictly follow the stringent standards of Good Manufacturing Practice (GMP) in the chemical manufacturing process for active ingredients. When it comes to compliance, i. e., meeting all regulatory requirements, PAS-X forms the backbone of the entire system. It manages all the system processes in close integration with the DCS and process control systems.
The manufacturing of vaccines involves complex production processes, which are often based on biopharmaceutical APIs. Here is a simple example: Viral vaccines are made in animal cell cultures by using either primary, diploid, or continuous (transformed) cell lines. Each cell line, virus type, and vaccine definition requires its own specific production and purification process. This entails a careful selection of the media to be used, the production vessel, production conditions, and the type of manufacturing process itself. PAS-X is one of the most technically advanced software products and completely meets all of these requirements. PAS-X also supports all aspects relating to Fill & Finish processes.
Blood plasma contains a mixture of dissolved proteins, glucose, clotting factors, mineral ions, hormones and carbon dioxide. It plays a critical role in the overall functioning of the body and controls or enables many specialized body functions. Producing pharmaceutical products by extracting proteins from blood plasma is a very complex process. Once the blood was donated, a number of upstream steps ensue. For example, the plasma is pooled and fractioned. Additional downstream activities include purification steps. For all of these steps, a Manufacturing Execution System ought to monitor and control the entire batch-oriented manufacturing process. PAS-X is the best-in-class MES product for this specific sector of the process industry.
This manufacturing process features some key operations, which are specific to aseptic fill & finish processes, such as sterilization, filling, and freeze-drying. PAS-X provides all the functionality required to achieve the most precise results as is required in this field.
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Pharmaceutical Production
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