RYAN BERTRAM


“Nothing in this world can take the place of persistence. Talent will not: nothing is more common than unsuccessful men with talent. Genius will not; unrewarded genius is almost a proverb. Education will not: the world is full of educated derelicts. Persistence and determination alone are omnipotent." -Calvin Coolidge

After a 12 year-old Ryan visited the Corvette factory in Bowling Green, Kentucky, he knew he wanted to part of how America makes things. With continued interest in the art and science of manufacturing, Ryan pursued his Bachelors in International Business at Calvin College. After graduating, he realized his dream of working with manufacturing by holding client relations positions throughout the manufacturing industry. At Malisko, Ryan enjoys bringing together the right people for the right job to tackle complex projects, and helping to bring the total solution to the client's plant floor.

Personal Passion
He likes spending time with his family and helping his children to blaze their own trail.

Dream Job
Build houses for Habitat for Humanity

Interesting Fact
He secretly likes the handy-man "fix-it" list his wife gives him every weekend. (Shhh! don't tell her that though!)

CARRIE LEINICKE


"Do not worry about your difficulties in mathematics; I can assure you that mine are still greater" - Albert Einstein

Numbers have always come easy for Carrie. With her natural ability and interest in numbers, Carrie achieved her Master of Science in Accounting from Fontbonne University and then her Master of Business Administration from Webster University. Joining the Malisko Team in 2019, Carrie is very customer service focused and being committed to finding answers for clients. She's passionate about providing accurate financials and forecasting to support high-level business decisions and strategy.

Personal Passion
Being outdoors as often as her schedule allows.

Hobbies
Camping/Traveling with her Siberian Husky, Sailing at Carlyle Lake, and antiquing mid-century/art-deco items.

DAN HARDER




TBD

Personal Passion
TBD

Hobbies
TBD

CASE STUDY

PHARMACEUTICAL COMPANY BEGINS MANUFACTURING NEW GENERIC THERAPEUTIC DRUG WITH THE HELP OF ADVANCED PROCESS AUTOMATION SYSTEM

Background

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.

Objectives

  • 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

CHALLENGES

  • 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.

SERVICES

  • 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

RESULTS

  • 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

LEARN MORE

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