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Life Science System Integration Project Profiles
Fill Finish Facility
Filling and inspection Equipment Specification, Automation Engineering, Software Development and IOQ was performed for a major California based Biotech company.
The following equipment was included in the scope of work:
- Three (3) Eisai vial inspection machines
- One (1) Seidenader vial inspection machine
- Two (2) PennTech trayloaders
- One (1) IMA tray loader
- Garvey conveyors
- Inova fillers and Cappers
- Cognex Vision Systems
- PLC / SCADA systems included: AB ControlLogix, AB CompactLogix, Siemens S7, PanelView, Wonderware, and RSView32.
The following services were performed:
- Specification of Equipment
- Coordination of Equipment Vendors
- Development of Requirements Specifications
- PLC/SCADA Programming
- Test Plan Development
- Write and run Factory Acceptance Test (FAT)
- Machine Troubleshooting and Integration
- Startup
- Write and run Site Acceptance Test (SAT)
- Write and run IOQ
RO/DI WFI Expansion and Control System Upgrade
Automation Engineering, System Integration and Process Engineering was performed to integrate Siemens BMS, RO/DI skid, WFI still and WFI distribution system.
Eichleay Engineers Inc. was contracted by a San Francisco Bay Area pharmaceutical company to expand and upgrade their clean utilities control system to an Allen Bradley SLC 5/04 platform and to implement the following process controls improvements:
- Improve WFI loop temperature control
- Improve loop sanitization process
- Integrate WFI still functionality with central PLC
- Implement point of use temperature controls
- Add Siemens BMS monitoring of system
To deliver a turnkey and validated system the following services were performed:
- Pressure Safety Valve sizing and specification
- Define GAMP software requirements documentation
- PLC programmingPanelView ProgrammingDevelop test plan
- Write and run Factory Acceptance Test (FAT)
- Provide construction support services for installation of new hardware
- Perform Startup
- Write and run Site Acceptance Test (SAT)
- Write and run stream-lined IOQ by leveraging FAT and SAT test forms
COP Washer Integration
Automation Engineering, System Integration and Process Engineering was performed to integrate a WFI System, PW System, DI System, CIP skid and three Sani-Matic COP washers.
Eichleay Engineers Inc. was contracted by a major California based Biotech company to integrate three new Sani-Matic COP washers with their existing supervisory PLC system. The following functionality was included in the final control system software:
- Coordination, hand shaking and utility supply arbitration of WFI, DI, CIP and Pure Water supply to each of the COP skids.
- Point Of Use (POU) controls for WFI, DI, and Pure Water including “Sample Flush”, “Normal Draw” and “Sanitization” steps.
- POU temperature controls
- SIP of the three washers
To deliver a turnkey system software implementation the following services were performed:
- Specify and sizing of POU heat exchangers
- Specification and sizing of temperature control valves, pressure safety valves and pressure regulators.
- Develop GAMP software requirements documentation
- Review Sani-Matic’s COP engineering submittals and TOPs
- Perform Allen Bradley ControlLogix and PLC5 PLC programming
- Perform Allen Bradley PanelView programming
- Develop test plan
- Write and run Factory Acceptance Test (FAT)
- Perform Startup
- Write and run Site Acceptance Test (SAT)
- Support Controls Qualification (CQ) effort
Lyophilizer Integration
Automation Engineering and System Integration to integrate PLC5 EMS, new Lyophilizer, Loaders, and Stopper Washer in existing manufacturing facility.
Eichleay Engineers Inc. was contracted by a major California based Biotech company to integrate a new Lyophilizer and loader units with their existing supervisory PLC system and Environmental Monitoring System (EMS). The following functionality was included in the final control system software:
- Coordination and arbitration of WFI/Utilities supply to the Lyophilizer, Vial Washer, Stopper Processor, Ultrasonic Parts Washer, and CIP skid.
- Integration of Stopper Washer “In Cycle” status with Supervisory PLC
- Integration of new equipment with the existing EMS
To deliver a turnkey system software implementation the following services were performed:
- Revise GAMP software requirements documentation
- Perform Allen Bradley PLC5 PLC programming
- Perform Fix32 SCADA programming
- Develop test plan
- Write and run Factory Acceptance Test (FAT)
- Perform Startup
- Write and run Site Acceptance Test (SAT)
- Support Controls Qualification (CQ) effort
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