Execution system for the monitoring and execution of insulin manufacture
First Claim
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1. ) An execution system (“
- ES”
) for use in an insulin manufacturing by a process comprising,a) contacting the ES to a plurality of devices used in the insulin manufacturing process;
b) monitoring data generated by the ES during said insulin manufacturing process;
c) analyzing the data to provide a risk-based assessment in case of failure;
d) taking corrective action to obviate the failure wherein said corrective action comprises modifying said insulin manufacturing process.
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Abstract
Execution systems and methods thereof used to monitor and execute an insulin manufacturing process are disclosed herein. Consequently, the methods and systems provide a means to perform validation and quality manufacturing on an integrated level whereby insulin manufacturers can achieve data and product integrity and ultimately minimize cost.
101 Citations
19 Claims
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1. ) An execution system (“
- ES”
) for use in an insulin manufacturing by a process comprising,a) contacting the ES to a plurality of devices used in the insulin manufacturing process; b) monitoring data generated by the ES during said insulin manufacturing process; c) analyzing the data to provide a risk-based assessment in case of failure; d) taking corrective action to obviate the failure wherein said corrective action comprises modifying said insulin manufacturing process. - View Dependent Claims (2, 3, 4)
- ES”
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5. ) A method of monitoring an insulin manufacturing process said method comprising,
a) deriving an algorithm implemented in computer-readable instructions that performs data analysis on an insulin manufacturing process; -
b) contacting said algorithm to a device used in insulin manufacture; c) analyzing the data to provide a risk-based assessment in case of failure; d) taking corrective action to obviate the failure. - View Dependent Claims (7, 8, 9, 10, 11)
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6. ) The method of clam 5, further comprising maintaining a historical record of the data analysis.
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12. ) A method of monitoring an acceptance criteria of an insulin manufacturing system, said method comprising,
a) monitoring data generated by an insulin manufacturing system during insulin manufacture; -
b) maintaining the data over time to provide a historic record; c) analyzing the historic record to provide a comparative analysis against an acceptance criteria; d) taking corrective during insulin manufacture to obviate a rejection against an acceptance criteria. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19)
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Specification