Methods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processes
First Claim
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1. A method for monitoring a pharmaceutical manufacturing process using at least a dry heat sterilizer, said method comprising:
- a) deriving an algorithm implemented in computer executable instructions that performs data analysis on said pharmaceutical manufacturing process using at least a dry heat sterilizer;
b) performing “
logic analysis”
on said algorithm;
c) performing “
software safety code analysis”
on said algorithm;
d) performing “
software safety design analysis”
on said algorithm;
e) performing “
software safety requirements analysis”
on said algorithm;
f) performing “
software safety test analysis”
on said algorithm;
g) integrating the said algorithm into a pharmaceutical manufacturing process whereby actual monitoring of the manufacturing process is attained.
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Abstract
Methods, systems, and software program for validation of pharmaceutical manufacturing processes and quality assurance process are described and disclosed herein. Consequently, the methods provide a means to perform validation on an integrated level whereby the quality control unit can ensure data and product integrity and minimize cost.
333 Citations
6 Claims
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1. A method for monitoring a pharmaceutical manufacturing process using at least a dry heat sterilizer, said method comprising:
-
a) deriving an algorithm implemented in computer executable instructions that performs data analysis on said pharmaceutical manufacturing process using at least a dry heat sterilizer; b) performing “
logic analysis”
on said algorithm;c) performing “
software safety code analysis”
on said algorithm;d) performing “
software safety design analysis”
on said algorithm;e) performing “
software safety requirements analysis”
on said algorithm;f) performing “
software safety test analysis”
on said algorithm;g) integrating the said algorithm into a pharmaceutical manufacturing process whereby actual monitoring of the manufacturing process is attained. - View Dependent Claims (2, 3, 4, 5, 6)
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Specification
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- Resources
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Current AssigneeSMP Logic Systems LLC
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Original AssigneeSMP Logic Systems LLC
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InventorsPopp, Shane M.
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Primary Examiner(s)Cottingham, John R.
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Assistant Examiner(s)GARLAND, STEVEN R
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Application NumberUS12/313,804Time in Patent Office1,330 DaysField of Search700/110, 700/109, 700/26, 700/207, 700/208, 700/211, 705 1- 3, 705/1.1US Class Current700/110CPC Class CodesG05B 2219/11 Plc I-O input outputG05B 2219/1112 Bit addressing, handlingG05B 2223/02 Indirect monitoring, e.g. m...G05B 23/0224 Process history based detec...G05B 23/0235 based on a comparison with ...G06Q 10/06 Resources, workflows, human...
