Automation + Instrumentation Controls

This expertise takes the process discrete operations and integrates all of the critical operational steps into an interface that operators, supervisors and senior business managers can use to control the manufacturing steps. Activities include:

  • Daily production and distribution planning, including all nodes in the
    supply chain, supporting the JIT of critical, pre-sterilized medias, supplies and materials
  • Production scheduling for each batch run in the supply chain (minute by minute), including critical in-process operator interrogation, sign-off
    and approvals
  • The monitoring of each production step, including the consumption of materials, QC testing, batch release, in processing holds, WHIPs and flow of final product ship out. Integration of environmental monitoring of all critical classified room environments, incubation chambers, freezers, media storage cold rooms, refrigerators and discrete incubators
  • Forward planning and forecasting of production demand, coordinating the demand forecast of all current and growth customers
  • Source planning, including current inventory and forecast demand, in collaboration with all certified vendors
  • Control of inbound operations, including transportation from suppliers and the receiving, guaranteeing and release, batch specific of the inventory
  • Outbound operations, including all fulfillment activities, final product storage and transportation to customers
  • Accounting for all constraints in the supply chain, including all certified vendors, the integrated manufacturing platform and key final product shipping telemetry
  • From production level to supply level accounting all transit of rejected materials, in process batch losses, loss of final product in packaging / shipment, damage of final shippers to customer. Strategic network optimization, monitoring strategic suppliers, distributors, and customers, creating communication channels for critical information flow and operational improvements
  • Product life cycle management, so that new and existing products can
    be optimally integrated into the supply chain and capacity management activities