Life Science API Process Control System Solution
Wunderlich-Malec’s Life Science Automation Team routinely designs and implements GMP compliant automation solutions for projects ranging from process upgrades to Greenfield site implementations. Our team works with our customer’s engineering teams and process subject matter experts (SME) to design hardware and software solutions to meet their requirements. Solutions start with GMP design specifications for both OT infrastructure and control system solutions and continue with drawings, programming, testing, commissioning and validation. We worked closely with our customer throughout the process to ensure their success.
Background & Customer Needs
A leading Life Sciences company was looking for an automation partner to help them automate the process for a new API. The company needed support starting with small scale process development all the way through scale up and commercialization. Commercialization required chemical batching from a tank farm, production scale reactors and filter dryers at a Brownfield site. The work required collaboration with MEP engineers, General and Electrical Contractors, OEM vendors and validation engineers in addition to the customer’s team.
Wunderlich-Malec Approach and Solution
Wunderlich-Malec started with a small team to support early process development with customer SMEs. After determining a successful process control strategy in the process development lab, Wunderlich-Malec assembled a multi-office integrated team experienced in Life Science and batch process applications to design and implement the solution at the final manufacturing site. The team designed and implemented the control systems to transfer liquid ingredients from the chemical tank farm to process reactors, run the reactors and perform final drying process. The scope of work included:
- Writing of GMP specifications for hardware and software
- OT network and server design and procurement with Cisco switches and Stratus servers
- S88 based process control strategy
- Rockwell ControlLogix PLCs
- Aveva Wonderware System Platform SCADA
- Aveva InBatch for Batch processing
- Created and implemented control modules, equipment modules, phases and procedures in Rockwell PLCs, SCADA and InBatch
- 25 client stations
- Festo CPX series pneumatic controls
- 3500 plus I/O points
- Site construction management support
- Perform engineering check out
- Complete software Factory Acceptance Test (sFAT)
- Write and execute Site Acceptance Test (SAT)
- Write and execute/support IOQ
- On-going local systems support
Wunderlich-Malec with proven experience to implement control systems to meet the GMP Life Cycle requirements, provided the following benefits:
Solution: Developed automatic batch processing solution
ROI: Optimized process functionality and reduced need for operator interaction
Solution: Created standards for control modules, equipment modules, phases, procedures
ROI: Simplified development effort and reduced validation effort due to class based design.
Solution: Wunderlich-Malec’s Local engineers at plant site.
ROI: Provides customer assurance that service and support are readily available
Solution: Used process tools to implement new process enhancements.
ROI: Reduced effort to implement process improvements and upgrades