Life Sciences

With a deep understanding of the stringent regulations and complex processes inherent in the Life Sciences industry, we offer:

• Pharmaceutical Manufacturing Automation: Implementing systems that ensure consistent product quality and regulatory compliance in pharmaceutical manufacturing. Our solutions automate various stages of production to maintain high standards and meet regulatory requirements.
• Biotechnology Process Control: Designing and integrating advanced control systems for specialized bioprocessing applications, including the Production of Biopharmaceuticals, Single-Use Bioprocessing Systems, and Continuous Bioprocessing.
• Medical Device Assembly Automation: Developing automated solutions for the precision assembly and testing of medical devices.
• Regulatory Compliance Support: Providing validation and documentation services to meet FDA and international standards.

Our expertise spans leading hardware and software platforms, including Rockwell Automation, Emerson DeltaV™, Siemens, and many others. Most importantly, we listen to our clients first and apply technology that best fits their specific needs.

We offer comprehensive and collaborative services:

• Specification and Documentation
  User Requirement Specs (URS), Functional and Detailed Design Specs (FRS, DDS, SDDS), and validation documentation (IQ, OQ, PQ) —all available in digital format with e-approvals.
• Independent Professional Services
  Expert reviews of system design, cybersecurity, and best practices for integration and deployment.
• Quality and Traceability
  All documentation and processes are audit-ready and developed in close alignment with FDA and global regulatory expectations.

• System Design and Integration: Comprehensive system design, including instrumentation, system networks, and mechanical, piping, and skid design.
• Process Controls and Automation: Design, implementation, and integration of DCS, PLC, HMI, SCADA systems, and MES.
• Data Management: SCADA and MES integration, EBR (electronic batch record) deployment, data acquisition, analysis, and historians for process analytics.
• Digital Transformation: Services to modernize and optimize operations through the integration of advanced digital technologies.
• Validation and Compliance: Documentation services to meet regulatory standards, including electronic validation and UL certifications (UL508A, UL698A, UL NNNY).
• Predictive Maintenance: Implementation of systems to forecast equipment failures and optimize maintenance schedules.
• Cybersecurity: Measures to protect industrial control systems from cyber threats.
• Panel and Skid Design: In-house UL-certified panel shops across North America and Asia deliver turnkey skid systems, robot cells, and full mechanical designs.
• Advanced Testing Facilities: State-of-the-art facilities for system testing and validation.

Single Use Fermentor Upgrade

This project focused on upgrading an integral Single Use Fermentor (S.U.F.) to reduce reliance on proprietary software and enhance process efficiency. Key aspects included:

• Controller Replacement: Replaced the pre-existing proprietary controller and  DeltaV interface,with a newAllen Bradley PLC and connected to the plant supervisory PLC and iFix SCADA interface.
• Enhanced Process Control: Added functionality for improved control of fermentation loops in the Single Use Fermentor (S.U.F)
• Additional Equipment: Installed additional peristaltic dosing pumps for pH control and new I/P pressure regulator valves for dissolved oxygen (DO) control.
• Temperature Control: Converted the S.U.F. to use a dual loop heat exchanger for precise temperature control.

Plant Utilities Upgrade

This project involved a comprehensive update of the Water for Injection (WFI), steam, chilled water, clean steam, and condensate systems across the entire plant. Key aspects included:

• Controller Migration: Transitioned from GE Fanuc PAC controllers to Allen Bradley controllers.
• Integration: Integrated multiple vendor skids with the new plant supervisory controller and SCADA system (iFix).
• Logic Update: Recontrolled outdated logic using S88 standards to ensure modern, efficient operations.
• Supervisory Control: Implemented supervisory control for new plant steam and WFI skids, enabling load balancing and redundancy.
• Validation Support: Provided validation support for over four separate Installation and Operational Qualification (IOQ) processes.

Clean in Place (CIP) Skid Upgrade

This project involved upgrading the Clean in Place (CIP) system for a Contract Development and Manufacturing Organization (CDMO) from an end-of-life controller and PanelView interface to a modern Allen Bradley PLC with iFix. Key aspects included:

• System Upgrade: Transitioned the CIP system to a modern Allen Bradley PLC with iFix.
• Phased Validation Approach: Developed and implemented a phased validation approach due to the CIP skid’s impact on every process in the plant.
• Validation: Validated hardware, software, and functionality in separate phases (IQ/OQ/PQ).

Waste Neutralization System

This project involved implementing a new plant waste neutralization system to process purification and fermentation waste before release to the city. Key aspects included:

• System Implementation: Installed a dual sump and tank system to enable “semi-continuous batch” neutralization.
• Automated Sampling: Implemented automated pH sampling with 2oo3 voting for quality data.
• Data Historization: Established data historization for city reporting purposes.

With locations and resources across North America and East Asia, LSI can support your Life Sciences operations wherever you’re located, ensuring continuity, expertise, and compliance across your projects.

What are your unique requirements? What are your largest challenges?

Let’s start a conversation about how LSI can help move your project forward, with the experience, resources, and dedication to make it a success.

Contact LSI Today