Accelerated MBR development
The "PAS-X Process Libraries" Content Packages support all major industry segments, such as API biotech, solid dosage and packaging. The packages accelerate the development of MBRs and help to assure high quality MBR design based on the industry best practices.
"PAS-X Process Libraries" Content Packages are available for:
- API biotech
- API chemical
- Solid dosage
- Fill & finish incl. sterile
Biopharmaceutical production is an extremely complex process since it involves the use of living cells. As a result, the manufacturing process of large active pharmaceutical ingredient (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 interaction 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, long-lasting fermentation processes, 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 mixed 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.
PAS-X supports the pharmaceutical and biopharmaceutical industries by managing all necessary steps in order to produce solids efficiently, GMP-compliant and fast. The manufacturing of pharmaceutical solids involves mixing active pharmaceutical ingredients (APIs) with excipients to create solid dosage forms such as powder, granules, tablets, capsules and pellets. Typical manufacturing processes comprise weighing, mixing, granulating, sieving, compressing and coating.
Fill & finish incl. sterile
The sterile fill and finish process comprises typically process steps such as formulation preparation, filling, inspection and finishing. Most of these manufacturing processes are done under aseptic conditions. The aseptic production process has to be used, if the product may not be sterilized in its final form due to temperature sensitivity. Thoroughly monitoring of environmental conditions is a must within the production process. Due to its flexible user interface and integration capabilities to monitoring systems PAS-X supports all kinds of sterile manufacturing processes.
The packaging of pharmaceutical bulk products is driven by highly automated packaging lines to achieve high throughputs at utmost flexibility under GMP compliant regulations. PAS-X supports all kinds of pharmaceutical packaging processes for bulk material in its different dosage forms as solids, powders, liquids or ointments. Specific GMP compliant regulations such as material reconciliations, sampling or in-process controls are also covered by its comprehensive functionality.