Case Study
Blending Hall Upgrade
Project:
Boehringer Ingelheim Blending Hall Upgrade
Client: Boehringer Ingelheim Animal Health located in Pirbright
History: Boehringer Ingelheim Animal Health manufactures foot-and-mouth vaccines. The facility has eight stainless steel formulation vessels used in the production of two main vaccine products. The existing cleaning regime between batches involved rinsing the vessels with Hot WFI and a more rigorous alkaline clean during a yearly shutdown. However, the client was not in compliance with the cleaning validation requirements defined in EudraLex Volume 4, Annex 15, Item 10. This project aimed to address this compliance gap by implementing a new Cleaning In Place (CIP) system.

Design Intent
The current plant was to be modified to integrate the new CIP system and upgrade the existing formulation process control system. The modifications included:
- Central PLC System and Operator HMIs: Replacing the existing operator control push buttons, switches, lamps, and discrete instruments with a central Siemens S7-1500 PLC system with Remote ET200 IO, Burkert AirLINE SP valve island and operator WinCC Comfort 1500 HMIs.
- PROFINET Protocol: Connecting networked devices using the Siemens PROFINET protocol.
- Manual Operation via HMIs: Allowing manual operation by process hall staff using the new HMIs.
- Future Process Automation: Designing the system to allow further process automation in the future.
Design Specifications
The system design was provided to GAMP 5 Standard in the form of the following documents:
- Functional Specification (FS): Document defining in detail the proposed design solution and describing how the design requirements will be met.
- Hardware Design Specification (HDS): Document defining the system hardware design.
- Software Design Specification (SDS): Document defining the system software design.
- Requirement Trace Matrix (RTM): Document tracing the addressing of the design requirements by design documents and test phases. This document was continually updated as the project progressed.
The user facilities, and the engineering characteristics in terms of functionality, system operation, and performance, are specified in these documents. The documents are approved by the client or client’s representative before detailed works commenced.
Scope of Supply
The scope of supply for the Electrical Control & Instrumentation (EC&I) element included the following:
- Survey Existing Panels: Correct existing drawings and re-create any missing drawings.
- Survey Existing Equipment: Confirm motor sizes, types, etc.
- Lead Investigation: Propose design solution for Emergency Stop and Manway switch safety circuits for approval.
- Interface with CIP Skid Vendor: Ensure proper interface between the systems.
- Document the New Design: Create FS, HDS, and SDS document sets and issue for approval.
- Document Detailed Design: Create new and revised drawing packs and issue for approval.
- Remove Redundant Panels: Remove X11 Operator Control Panel, Vessel 8 Operator Control Panel, and V2/V5/V6 Additional Panel from the process hall.
- Design/Build/Test/Install New Panels: Including PLC panel, X11 operator panel with 2 HMIs, Remote I/O and Valve Panel, and HMI panel for CIP Skid.
- Re-design/Modify/Test Existing Panels: Including X19 Motor Control Panel, Vessel 1 Silverson Softstart Panel, Vessel 2 Silverson Softstart Panel, and Vessels 2/5/6 Motor Control Panel.
- Install Required Field Wiring and Valve Air Pipework: Including Stainless Steel containment for process system and CIP return pumps.
- Create New PLC Software and HMI Configurations: To meet the requirements of the approved FS/HDS/SDS.
- Create and Maintain RTM: Ensure traceability of requirements.
- Create and Execute DQ: Design Qualification.
- Create Validation Protocol Documents: Including FAT, IQ, OQ for approval.
- Execute Validation Protocols: FAT, IQ, and OQ tests using approved protocol documents.
- Provide Support for Site PQ Validation Works: Performance Qualification.
- Provide ‘As Installed’ Design Document Sets and O&M Manuals: All documents were issued in native format (Word, Excel, AutoCAD, etc.).
Solution
The project involved several key upgrades and installations to ensure compliance and improve operational efficiency:
- Installation of a New PLC Process Control System: A Siemens S7-1500PLC was installed to control the operating logic and WinCC Comfort HMIs for operator interface.
- Upgrading Existing MCC Panels: The existing Motor Control Centers (MCCs) were revised to suit PLC control and upgrade obsolete Danfoss Variable Speed Drives (VSDs).
- Safety Circuit Revisions: Vessel manway safety circuits were revised to ensure safe plant operation.
- New Operator Control Panel: A new control panel with operator interface via WinCC Comfort HMIs was installed.
- Process Data Logging: A new electronic Eurotherm chart recorder was installed for process data logging.
- Automated Valve Controls: New Burkert AirLINE SP valve controls were installed for all existing and new CIP routing valves.
- Automated CIP Functions: Automated control of routes for the CIP functions and interaction between process and CIP functions were implemented.
Results
The implementation of the new CIP system and associated upgrades resulted in several significant improvements:
- Compliance with Cleaning Validation Requirements: The facility now meets the cleaning validation requirements as defined in EudraLex Volume 4, Annex 15, Item 10.
- Enhanced Operational Efficiency: The automated control system and new operator interfaces improved the efficiency and reliability of the cleaning processes.
- Improved Safety: The revised safety circuits and automated controls enhanced the overall safety of the plant operations.
- Data Integrity and Logging: The new electronic chart recorder ensured accurate process data logging, meeting the requirements for data integrity as per 21 CFR Part 11 regulations.
"The successful implementation of the new CIP system and control upgrades has significantly improved our compliance and operational efficiency. The automated controls and enhanced safety measures have made a substantial difference in our daily operations."
- Graham Nelson, Project Engineer, Boehringer Ingelheim
Silchester Control Systems
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