Abstract: A method and system for simulating, modeling and scheduling equipment preparation procedures in the biopharmaceutical production process is described herein. The use of process vessels in batch process manufacturing is optimized through the use of peak load scheduling frames. The system and method includes the steps of identifying soiled process components and their associated equipment preparation procedures. After the soiled process components are identified, a master list of soiled process components and their associated equipment preparation procedures is generated. After the soiled process components and the equipment preparation procedures are identified, the equipment preparation procedures are scheduled out based on preparation equipment protocols to generate a equipment preparation load summary table. Next, the size and capacity of the preparation equipment is determined based on the information in the load summary table.

Abstract: A system and method for the modeling of biopharmaceutical batch process manufacturing facilities uses process time lines. The system employs an eleven-field delimited string code which specifies the unit identifier code and the iteration value for each of the ten levels of nested scheduling cycles of the biopharmaceutical drug production process being modeled. The method includes generating a process time line using operational parameters, a block flow diagram, and a set of scheduling cycles for each of a sequence of unit operations. The process time line is used as a tool for batch processing and facility design.

Abstract: A system and method for the modeling of biopharmaceutical batch process manufacturing facilities uses process time lines. The system employs an eleven-field delimited string code which specifies the unit identifier code and the iteration value for each of the ten levels of nested scheduling cycles of the biopharmaceutical drug production process being modeled. The method includes generating a process time line using operational parameters, a block flow diagram, and a set of scheduling cycles for each of a sequence of unit operations. The process time line is used as a tool for batch processing and facility design.

Abstract: A method and system for simulating, modeling and scheduling equipment preparation procedures in the biopharmaceutical production process is described herein. The use of process vessels in batch process manufacturing is optimized through the use of peak load scheduling frames. The system and method includes the steps of identifying soiled process components and their associated equipment preparation procedures. After the soiled process components are identified, a master list of soiled process components and their associated equipment preparation procedures is generated. After the soiled process components and the equipment preparation procedures are identified, the equipment preparation procedures are scheduled out based on preparation equipment protocols to generate a equipment preparation load summary table. Next, the size and capacity of the preparation equipment is determined based on the information in the load summary table.

Abstract: A system and method for the modeling of biopharmaceutical batch process manufacturing facilities uses process time lines. The system employs an eleven-field delimited string code which specifies the unit identifier code and the iteration value for each of the ten levels of nested scheduling cycles of the biopharmaceutical drug production process being modeled. The method includes generating a process time line using operational parameters, a block flow diagram, and a set of scheduling cycles for each of a sequence of unit operations. The process time line is used as a tool for batch processing and facility design.

Abstract: A system and method for the modeling of biopharmaceutical batch process manufacturing facilities uses process time lines. The system employs an eleven-field delimited string code which specifies the unit identifier code and the iteration value for each of the ten levels of nested scheduling cycles of the biopharmaceutical drug production process being modeled. The method includes generating a process time line using operational parameters, a block flow diagram, and a set of scheduling cycles for each of a sequence of unit operations. The process time line is used as a tool for batch processing and facility design.

Abstract: A system and method for the simulation and modeling of biopharmaceutical batch process manufacturing facilities using process time lines is described herein. The system employs an eleven-field delimited string code which specifies the unit identifier code and the iteration value for each of the ten levels of nested scheduling cycles of the biopharmaceutical drug production process being modeled. The method includes generating a process time line using operational parameters, a block flow diagram, and a set of scheduling cycles for each of a sequence of unit operations. The process time line is used as a tool for batch processing and facility design.

Abstract: A system and method for the simulation and modeling of biopharmaceutical batch process manufacturing facilities using process time lines is described herein. The system employs an eleven-field delimited string code which specifies the unit identifier code and the iteration value for each of the ten levels of nested scheduling cycles of the biopharmaceutical drug production process being modeled. The method includes generating a process time line using operational parameters, a block flow diagram, and a set of scheduling cycles for each of a sequence of unit operations. The process time line is used as a tool for batch processing and facility design.

Abstract: A method and system for simulating, modeling and scheduling equipment preparation procedures in the biopharmaceutical production process is described herein. The use of process vessels in batch process manufacturing is optimized through the use of peak load scheduling frames. The system and method includes the steps of identifying soiled process components and their associated equipment preparation procedures. After the soiled process components are identified, a master list of soiled process components and their associated equipment preparation procedures is generated. After the soiled process components and the equipment preparation procedures are identified, the equipment preparation procedures are scheduled out based on preparation equipment protocols to generate a equipment preparation load summary table. Next, the size and capacity of the preparation equipment is determined based on the information in the load summary table.

Abstract: A method and computer program product for simulating, modeling and scheduling solution preparation in the biopharmaceutical production process is described herein. The computer program product and method includes the steps of identifying a solution for preparation and its associated volume. After the solution for preparation is identified, a predetermined start date and one successive start date for solution preparation for the solution are identified. After the solution, start and successive start dates are identified, the solution is assigned to a preparation vessel. After the solution has been assigned to a preparation vessel, the duration of the solution preparation procedure is determined and assigned to the solution preparation vessel.

Abstract: In an effort to achieve the lowest cost of goods (COG) possible, a key objective in batch manufacturing is to maximize equipment utilization so that the capacity and size of equipment per batch cycle is the smallest possible for a given batch production capacity. This optimization of equipment utilization minimizes equipment and direct utility costs per batch, as well as reduces the physical space and the associated utilities required to support manufacturing operations. The present invention provides a process of: (1) determining the optimal number of batch cycles per year for a required annual production capacity; and (2) determining the optimal number of equipment cycle iterations per batch cycle in a manner that: (a) creates the smallest batch sizes possible; and (b) achieves higher equipment utilization per batch cycle, thereby reducing the capacity and size of equipment required to produce a given batch quantity of product.

Abstract: The present invention relates to an improved method to process, purify and/or produce biopharmaceuticals or other products involving automated blending of pH buffered solutions from water and common stocks of concentrated acids and bases, and other components. This approach reduces the cost and complexity of the solution preparation systems required for producing these solutions under aseptic or sterile conditions, and reduces the material costs of the solutions themselves. This approach is particularly beneficial to use with continuously-produced feedstocks and with continuous separation operations.

Abstract: A system and method for the simulation and modeling of biopharmaceutical batch process manufacturing facilities using process time lines is described herein. The system employs a four-field delimited string code which specifies the unit identifier code and the iteration value for each of the three levels of scheduling cycle “Unit Operation Cycles,” “Unit Operation Cluster Cycles,” and “Batch Cycles”—of the biopharmaceutical drug production process being modeled. The method includes the step of selecting a sequence of unit operations wherein each of the sequence of unit operations has an identifier code. Next, a set of scheduling cycles is selected for each of the sequence of unit operations. A master table is then referenced, using the identifier code, to obtain operational parameters for each of the sequence of unit operations. A block flow diagram is then generated using the sequence of unit operations and the operational parameters.

Abstract: A system and method for the simulation and modeling of biopharmaceutical batch process manufacturing facilities using process time lines is described herein. The system employs a four-field delimited string code which specifies the unit identifier code and the iteration value for each of the three levels of scheduling cycle—“Unit Operation Cycles,” “Unit Operation Cluster Cycles,” and “Batch Cycles”—of the biopharmaceutical drug production process being modeled. The method includes the step of selecting a sequence of unit operations wherein each of the sequence of unit operations has an identifier code. Next, a set of scheduling cycles is selected for each of the sequence of unit operations. A master table is then referenced, using the identifier code, to obtain operational parameters for each of the sequence of unit operations. A block flow diagram is then generated using the sequence of unit operations and the operational parameters.

Abstract: In an effort to achieve the lowest cost of goods (COG) possible, a key objective in batch manufacturing is to maximize equipment utilization so that the capacity and size of equipment per batch cycle is the smallest possible for a given batch production capacity. This optimization of equipment utilization minimizes equipment and direct utility costs per batch, as well as reduces the physical space and the associated utilities required to support manufacturing operations. The present invention provides a means of: (1) determining the optimal number of batch cycles per year for a required annual production capacity; and (2) determining the optimal number of equipment cycle iterations per batch cycle in a manner that: (a) creates the smallest batch sizes possible; and (b) achieves higher equipment utilization per batch cycle, thereby reducing the capacity and size of equipment required to produce a given batch quantity of product.

Abstract: A method and system for simulating, modeling and scheduling equipment preparation procedures in the biopharmaceutical production process is described herein. The use of process vessels in batch process manufacturing is optimized through the use of peak load scheduling frames. The system and method includes the steps of identifying soiled process components and their associated equipment preparation procedures. After the soiled process components are identified, a master list of soiled process components and their associated equipment preparation procedures is generated. After the soiled process components and the equipment preparation procedures are identified, the equipment preparation procedures are scheduled out based on preparation equipment protocols to generate a equipment preparation load summary table. Next, the size and capacity of the preparation equipment is determined based on the information in the load summary table.

Abstract: A method and system for simulating, modeling and scheduling equipment preparation procedures in the biopharmaceutical production process is described herein. The system and method includes the steps of identifying soiled process components and their associated equipment preparation procedures. After the soiled process components are identified, a master list of soiled process components and their associated equipment preparation procedures is generated. After the soiled process components and the equipment preparation procedures are identified, the equipment preparation procedures are scheduled out based on preparation equipment protocols to generate a equipment preparation load summary table. Next, the size and capacity of the preparation equipment is determined based on the information in the load summary table. After the size and capacity of the preparation equipment is determined, an equipment preparation time line is generated.

Abstract: A system and method for the simulation and modeling of biopharmaceutical batch process manufacturing facilities is described herein. The system and method includes the steps of identifying a production process sequence, the production process sequence including a plurality of zsubprocesses. At least one of the plurality of subprocesses includes a plurality of batch cycles, each of which includes a plurality of unit operations. Each of the unit operations are identified by unit operation identifiers. Next, the system and method retrieves the process parameter information from a master list for each of the unit operation identifiers in the process sequence. The process parameter information includes information on discrete tasks associated with each unit operation. After the steps of identifying and retrieving, the system and method generates a process schedule that identifies initiation and completion times for each of the discrete tasks in the process sequence.

Abstract: A method and computer program product for simulating, modeling and scheduling equipment maintenance and calibration procedures in a biopharmaceutical production facility is described herein. The method and computer program product includes the steps of identifying maintenance, and maintenance and calibration data associated with biopharmaceutical production process equipment. After the maintenance and calibration data are identified, biopharmaceutical production process equipment is used to generate a table of equipment and maintenance and calibration data. After the table of equipment and data is generated, the table is compared with a procedure time line to determine the schedule of calibration and maintenance for the equipment in the biopharmaceutical production process.

Abstract: A protective antenna guard is intended for use with portable cellular telephones of the type with a retractable antenna, and further intended to be attached to the user's belt or clothing, being provided with clips for that purpose. The antenna guard provides support for the antenna in the retracted position, and also provides a smooth surface at the upper part of the phone, so that the phone, with the protective antenna guard attached, will not snag or become entangled in the user's clothing. The antenna guard is formed into two side tabs, a raised antenna support, a back, and sides, the whole guard being molded in one piece from a compliant, light-weight plastic or the like.