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US 9,008,815 B2Granted
Apparatus for monitoring pharmaceutical manufacturing processes
AssigneeSMP Logic Systems LLC
InventorShane M. Popp
Life of this patent
Estimating the term…
Abstract
An apparatus for monitoring data generated by a device adapted for use in a pharmaceutical manufacturing environment are described and disclosed herein. The method creates a historic record of the pharmaceutical manufacturing process and provides it to an end user or a plurality of end users. Consequently, the methods provide a means to track the frequency of hazards associated with said device and thereby perform quality control on an integrated level whereby a pharmaceutical manufacturer can ensure data and product integrity and minimize cost.
Claims17
An apparatus comprising,
- a) a non-transitory computer memory having computer executable instructions adapted for use in a pharmaceutical manufacturing process wherein an active pharmaceutical ingredient but not an inactive pharmaceutical ingredient is produced, and wherein said non-transitory computer memory having computer executable instructions is used in monitoring data compiled during said pharmaceutical manufacturing process, wherein said monitoring occurs at a critical control point, and wherein said critical control point relates to a function in said pharmaceutical manufacturing process that has an adverse affect on the quality of said active pharmaceutical ingredient;
- b) a controller;
- c) a database, wherein said database stores said data over time to provide a historic record of said pharmaceutical manufacturing process;
- d) a plurality of devices adapted for use in a pharmaceutical manufacturing process wherein an active pharmaceutical ingredient but not an inactive pharmaceutical ingredient is produced and wherein said devices are integrated with said non-transitory computer memory having computer executable instructions on a device by device basis.
1 more element
Dependencies are inferred from the claim text.