Case Study

Pharmaceutical Company Begins Manufacturing New Generic Therapeutic Drug with The Help of Advanced Process Automation System


A pharmaceutical manufacturer needed to finalize production of a new generic therapeutic drug. As part of their initiative, they wanted to include a state-of-the-art, robust, expandable, and supportable automation system to control, data archive and report on their world-class process. Malisko was asked to assist with specifying, designing, procuring, documenting, programming, testing, commissioning, and validating their new system for process control, data, and reporting.


  • Taking a Research and Development product of a small, manual process and expanding it into a large scale world-class automated batch process of a generic injectable drug
  • Manufacturing process for the powdered polymer was designed differently than methods used by the original manufacturer
  • Scale up the drug manufacturing process, automation system, data capture and reporting from an “R & D” small batch process unit to a fully validated production-sized batch process
  • To produce saleable batches meeting all quality and performance specifications for the therapeutic drug
  • Address factor-causing process variability challenges by developing new and innovative automation programming methods
  • Address factor-causing process variability challenges by developing new and innovative automation programming methods
  • Specify, design and implement a robust, validated automation system from conceptual stage through design, engineering testing and validation project phases
  • Meet project budget and schedule milestones within a dynamically evolving work scope environment


  • At the onset, the process design was in a “preliminary phase” at best thus making it very difficult to focus on details of the automation system.
  • Process design saw frequent changes affecting the automation system design – it was like “trying to hit a moving target”.
  • Manufacturing process is intricate, sensitive and can be unstable from a quality standpoint.
  • Sterilization process is crucial to the product performance and the corresponding programming was complex.
  • Sterility monitoring and tracking was very complex.
  • Process, CIP, and SIP sequences are comparatively complicated to maintain sterility and the desired product quality.
  • Process and automation design took eighteen (18) months.
  • 2000+ pages of functional and configuration specifications.
  • Numerous programming additions and scope changes were vital to verifying the correct and repeatable drug production process.


  • FEED [Front-End Engineering and Design], Drawings and documentation.
  • Process optimization via the automation system.
  • Specify components for Controls / Network / Security / SCADA / Servers / Historian / Reporting for a robust system:
  • A variety of interfaces and network types:
  • ASi bus
  • EtherCAT
  • EtherNet/IP
  • CIP (Common Industrial Protocol) Safety
  • DLR Ethernet system on device plant level
  • Communication redundancy
  • Spec’d entire control system for UPS backup
  • Designed and created new monitoring systems in PLC program
  • CIP/SIP cycle and effectiveness studies
  • Multiple meetings with process design team + engineers to specify all project details and scope each area for system programming requirements
  • Programming included
  • State machines
  • Specialized device monitoring visualization AOI’s
  • Utilized Rockwell Automation’s PhaseManager and SequenceManager, and PlantPAX
  • Data archiving and reporting
  • Modern UX/UI design following ISA-101 guidelines with focus on Unit Management organization
  • Hardware and Software Specifications and Procurement including all industrial automation control system hardware and software, system simulation software, control panels, and communications devices
  • Project Management, and Contractor Oversight
  • Design, Functional, Configuration, and SOP Documentation
  • Design Reviews, FAT, and SAT
  • On-Site Commissioning
  • Engineering Testing – water batch support
  • Training, Production Support


  • Successfully passed FAT/SAT execution
  • Successfully executed and tested water batch trials
  • Running additional water trials and optimizing CIP and SIP runs/cycles
  • Making batches without active ingredients and with some inert chemicals to replicate product in testing environment (placebo batches)
  • Monitoring across the control and process manufacturing system has met client expectations
  • Client’s project budget and schedule were met
  • Client is happy with the level of success and project execution to date

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