Method and system for monitoring batch product manufacturing
A system and method for monitoring product through a batch manufacturing plant is provided. The system includes, a parallel flow mode when product flows concurrently from at least two units to a single unit; and a serial flow mode where product flows from one unit to another at a given time, wherein the batch manufacturing plant is modeled based on the parallel and serial flow modes. A lot association is built based on product flow and a parent/child record is created for lot association. The system also includes a data collection system that collects phase information for every unit and a procedure identifier is used to create a batch identifier, where a batch identifier is associated with each lot on each unit through which product is flowing to and/or from at a given time.
1. A system for monitoring a product through a batch manufacturing plant in order to trace contamination, comprising:
a plurality of holding units configured to store a product, wherein at least some of the units can be individually decontaminated;
a plurality of logical representations of the units, wherein a new logical representation of a unit is created upon decontamination of the unit;
a plurality of records that identify when a first unit started and stopped feeding into a second unit; and
at least one contamination tracing component configured to identify one or more source units that could have fed into a target unit based at least in part on start and stop times of feedings stored in the plurality of records, wherein the determination is iteratively applied so as to identify both direct source units that could have directly fed into the target unit and indirect source units that could have fed into the direct source units.
2. A contamination tracking system comprising:
a plurality of units configured to hold and transport a product;
a plurality of components configured to detect potential flows from and to source units and target units;
a database configured to store information about potential flows, including at least a start time and an end time that each potential flow occurred from each source unit to each target unit; and
a software component configured to select a contaminated target unit and to determine, based at least in part on the potential flow information, at least one source unit that could have made a contribution to the selected target unit and thus could have contributed to the contamination of the contaminated target unit.
3. The system of claim 2 , wherein the software component is further configured to recursively determine potential sources of contribution to each source unit so as to determine a plurality of source units that could have contributed to the contamination of the contaminated target unit.
4. The system of claim 3 , wherein the software component is further configured to determine, based at least in part on the potential flow information, other target units that could also be contaminated.
5. The system of claim 2 , wherein the potential flow database represents each unit logically and a new logical representation for a unit is created upon occurrence of an event that ensures that the unit is free from contamination.