Manufacturing Projects and Systems Engineering

Pharmaceutical Manufacturing and Lab Facility

Project Description
A global pharmaceutical company needed a engineering study and impact gap assessment for a new facility. Partnered with Enterprise Partners assessing gaps with scheduling, planning, engineering designs, specifications, vendors and physical systems with readiness to install, commission, and validate (IQ, OQ, PQ) the new $168 M facility. Assessed gaps and alignments between corporate, applications, and the new facility with IT, operations and process owners against schedule, resources, and cost with the manufacturing, lab, warehouse, packaging and serialization.
Process Equipment
Formulation, Spray Drying, Vacuum Drying, Formulation Hydration, Sterile Filtration, Component Prep Wash (Autoclaves), Vial Filling Line, Freeze Drying, Vial Inspection, EMS Monitoring, Building Management (HVAC/AHU), Solid Dose Packaging, Vial Packaging Line, Dispensing and Sampling, Process Utilities (Air, Water, Gas, Solvents), Server Rooms, Networking, and Lab Systems (Autoclaves, Dryers, PLC's, Incubators, HPLC, Chambers, Ovens).
Solution
Study included meetings with multiple groups and teams (VP's, sr. managers, directors, and team leads). Analyzed scheduling, operations, business processes, specifications, equipment, IT, electrical, networking designs, and roadmaps. Systems included IT networking, server room (30 server virtuals), Oracle EBS, Maximo, Labwatch, Rockwell FactoryTalk & View, OSI-PI, iFix, BMS, Labwatch, LDAS, LES/LEN, Log Books, OBIEE, SysTech, Belimed, GEA, NNE, and Ulhmann Packaging.
Results
Delivered results with report-out, gap assessment presentation, opportunity savings, application road maps and commission and testing readiness to the executive steering committee.

Food Plant ISA-88 Recipe Batch and Control Management

Project Description
Automated two food plants with dressing and ingredient products to increase productivity and profitability while maintain quality control to meet FDA title 21 and ISO-9001 compliance. The goal was to optimize batch processes, eliminate unplanned and reduce cycle times minimizing change over times, and remove capacity bottlenecks in the batch and packaging processes while reducing cycle/down time and operations and maintenance costs.
Process Equipment
Process equipment consisted of two batch production lines merged with different routes fed from 8 raw material storage tanks, mixing units, blenders, batching unit tanks with transfer pumping with VFD controls, weigh scales, postion control valves, closed loop cooling exchangers, surge tanks, filling and capping, labeling, case packaging and robotic palletizers.
Solution
The solution provided a ISA-95/88 architecture with a plant netowrk, Wonderware SCADA distributed 8 operation stations in batch process cells. Engineering and configuration included two EWS stations, batch server and Rockwell Allen Bradley Control Logix and PAC controllers with PID loops, and I/O System with 10K points managing 750+ Recipes, recipe process simulation, 95 phases and over 255 devices. System connected to a AS-400 Business System and MES system tracking production orders, material consumption, reporting, work-instructions, metrics, ingredients, mixing, lab sampling and product yields.
Results
The solutions increased production capacity by 50% resulting (100 batches/day - 65.5M lbs./year) with an estimated $9 millions cost savings over 2 years. Cost savings resulted in reducing formulation costs, batch cycle times and conversion costs. The solution was easy to use for operations producing consistent product quality deferring capital investment through increased customer orders and plant capacity.

Food Plant Products, Materials and Operations Traceability

Project Description
A food company with several plants in the mid west to southern states specializing in broths, fats and protein ingredients partnered to find a better solution to improve its process, operations and technology to support increasing demand with its customers and value chain. One plant lacked visibility and automation across it's processes to track lot product and compliance while another plant automated with Rockwell Factory Talk needed MES capability with lots, traceability, OEE and downtime with its processes and equipment. Product specifications, lab inspections, and cooking processes needed to be integrated into the lab with product pack out providing a smart manufacturing informational model to support product runs, FDA compliance, BRC standards and traceability.
Process Equipment
Process equipment consisted Griders, Separators (Weight), Box Dryers, Dehydrated Dryers, Frozen Broth Freezers, Fluid Bed Dryers, Cooking Broth Room (8 Broth Cookers), and Packout (Dry Meat, Broths).
Solution
The solution provided a ISA-95 manufacturing enterprise architecture with a plant network, budgets for controls and plant wide network to their PLC's tracking the customer order, product Sku, materials and process conversion steps and parameters with genealogy and traceability through cooking processes and product specifications through pack out giving visibility of resources, scheduling, allocations and assets.
Results
The prject savings estimated was $3.5 million using the plants labor rates with multiple benefits increasing product, metrics and operations visibility with OEE, SPC, product specs and lab quality traceability. Over a $1 M in savings could be achieved eliminating manual processes, data entry, accuracy, downtime, and scheduling resources. Additional $882 K in savings could be realized with 45% more capacity throughput recovering $1.92 M lbs. in lost product managing equipment constraints and resource scheduling with CIP and equipment asset downtime.