Life Science
Transforming Life Sciences with Advanced Automation
About Customer
The client is a unique global healthcare company, setting up a complex injectable multiproduct greenfield facility at multiple locations. The facility is designed to comply with 21 CFR Part 11 regulatory requirements, ensuring quality, safety, and scalability for manufacturing critical healthcare products.

Business Challenges
The client faced several business and technical challenges while setting up the facility:
Complex injectable multiproduct facility requiring 21 CFR Part 11 compliance
Integration of 70+ equipment under S88 Batch Process Control
Time-to-market pressure without compromising quality
Requirement for scalability to support multiple product lines
High risk of system downtime, impacting productivity
Softcon’s Proposed Solution
Softcon provided an advanced automation and control solution using Rockwell Automation’s PlantPAx DCS and related technologies. The key elements included:
PlantPAx Distributed Control System with Point IO
Plantwide Device Level Ring (DLR) Network ensuring zero downtime
60-unit FactoryTalk Batch Solution for consistent process control
Redundant HMI, Alarm & Data Servers for system reliability
Redundant Historian Server & Interface Nodes for data security
Redundant OPC Server for seamless third-party integration
ThinManager Server with 25 Clients for centralized, scalable operations
Virtualization on VMware, enabling flexibility and future readiness
System Highlights
Speed to Market: Reduced project execution and engineering cycle time
System Network & Interface: High availability with zero downtime using robust DLR
Quality: Enhanced compliance and reduced batch rejection
Plant Visibility: Real-time monitoring and data access across all operations
Decision Making: Faster insights and control through centralized dashboards
Impact & Business Outcomes
Metric
Improvement
Execution Time
Reduced significantly, enabling faster time-to-market
System Downtime
Reduced by 40% through redundant systems
Batch Rejection
Reduced by 35% ensuring higher quality output
Asset Utilization
Improved by 30% with multi-product flexibility
Decision Making
50% faster through real-time insights
Compliance & Readiness
100% 21 CFR Part 11 compliant system
Future Scalability
Virtualization ensures long-term expansion capability
Conclusion
Softcon successfully delivered a 21 CFR Part 11 compliant automation system for the client’s injectable multiproduct greenfield facility. With seamless integration of 70+ systems, robust redundancy, and centralized visibility, the client achieved faster time-to-market, reduced downtime, improved quality, and ensured long-term scalability. This solution empowers the healthcare company to meet global demand, enhance compliance, and strengthen operational excellence.