Life Sciences & Pharmaceuticals
DSI Innovations delivers highly specialized automation systems to the Life Sciences and Pharmaceuticals industry, ensuring precision, compliance, and data integrity. In a nutshell, we simplify the complex, so you don’t have to! From cleanroom environment control to batch record automation (EBR), we work hand in hand with manufacturers to streamline production while meeting stringent regulatory standards, including FDA 21 CFR Part 11 compliance.
Our expertise in Process Analytical Technology (PAT) and precision dosing and filling control ensures consistent quality and efficiency. Additionally, our data integrity and traceability solutions provide full visibility across the supply chain, safeguarding the safety and effectiveness of your products…so you can sleep much better at night!
Our Life Sciences & Pharmaceuticals Capabilities
Process & Control Automation
- PLC/HMI/SCADA Programming: Customizing control logic, interfaces, and alarm management to maintain strict quality standards.
- Batch & Continuous Process Control: Designing systems for recipe management, batch sequencing (ISA S88), and real-time monitoring.
- CIP (Clean-in-Place) & SIP (Sterilize-in-Place) Automation: Ensuring validated cleaning and sterilization protocols to minimize contamination risks.
- Advanced Process Control (APC): Deploying predictive models and real-time optimization for consistent product quality and reduced cycle times.
- Real-Time Data Acquisition & Historian: Capturing process data for trend analysis, quality review, and regulatory reporting.
- Redundancy & High Availability: Implementing fault-tolerant architectures for critical systems to minimize downtime.
cGMP & Regulatory Compliance
- 21 CFR Part 11 Expertise: Designing systems with secure electronic records, electronic signatures, and robust audit trails.
- GAMP 5 Methodologies: Aligning with Good Automated Manufacturing Practice guidelines for compliant automation solutions.
- Validation & Qualification Support: Providing IQ/OQ/PQ protocols, execution, and documentation to meet FDA and EMA requirements.
- Change Control & Traceability: Managing revisions to software/hardware with comprehensive documentation and approvals.
- Data Integrity & Security: Ensuring authenticity, reliability, and accuracy of electronic records throughout the process lifecycle.
Validation & Documentation
- Risk-Based Validation Strategies: Conducting FMEA, HAZOP, or other risk assessments to focus on critical process parameters.
- Commissioning & Qualification: Creating and executing test scripts for Installation (IQ), Operational (OQ), and Performance (PQ) qualifications.
- Software Validation: Verifying control system functionality under simulated and real operating conditions.
- Documentation & Reporting: Providing thorough validation documentation that meets regulatory standards, including test results and change logs.
- Continuous Validation Maintenance: Updating validation materials when systems are upgraded or modified.
SCADA, Data Integrity & 21 CFR Part 11
- SCADA System Implementation: Developing real-time monitoring and control interfaces with user-friendly graphics and alarm management.
- Audit Trail & Electronic Signatures: Ensuring secure, traceable user actions that meet Part 11 requirements for accountability.
- Role-Based Access Control: Implementing tiered user permissions to protect critical functions and data.
- Data Archiving & Disaster Recovery: Storing process and batch records securely off-site with robust backup strategies.
- Alarm Rationalization: Minimizing nuisance alarms while maintaining regulatory compliance and operator awareness.
Batch Management & MES Integration
- ISA S88-Compliant Batch Control: Standardizing recipe structures, phasing, and equipment modules for consistent production.
- Seamless MES/ERP Connectivity: Integrating plant-floor systems with higher-level enterprise software for production scheduling and inventory tracking.
- Electronic Batch Records (EBR): Automating data capture and documentation of each batch for faster review and release.
- Real-Time Production Tracking: Monitoring throughput, yields, and quality parameters across multiple lines or facilities.
- Recipe Version Control: Enforcing strict version management and approval workflows for regulated changes.
Clean Utilities & Environmental Monitoring
- HVAC & Cleanroom Control: Integrating temperature, humidity, and pressure controls to maintain critical environments.
- Environmental Monitoring Systems: Implementing particle counters, microbial sampling, and other sensor networks for GMP compliance.
- Water Purification Systems: Automating WFI (Water for Injection), RO/DI, and other high-purity water processes.
- Compressed Air & Gases: Monitoring and controlling compressed air and gas distribution systems within strict quality specifications.
- Critical Alarm Management: Providing immediate alerts for deviations in environmental conditions or utility parameters.
Control Panel & Instrumentation Services
- Custom Panel Design & Fabrication: Building GMP-compliant enclosures with proper documentation and labeling.
- Component Specification & Sourcing: Selecting hardware that meets pharmaceutical-grade standards (stainless steel, IP/NEMA ratings).
- Instrumentation Selection & Calibration: Specifying and calibrating sensors for pH, conductivity, temperature, flow, and pressure.
- Traceable Calibration Procedures: Using NIST-traceable references and generating comprehensive calibration certificates.
- Factory & Site Acceptance Testing: Conducting FAT and SAT to verify functionality and compliance before full production.
Project Management & Consulting
- Front-End Engineering Design (FEED): Evaluating feasibility, scoping, and budget planning with a compliance-focused mindset.
- Regulatory Guidance: Advising on FDA, EMA, GMP, and other global requirements throughout project execution.
- Timeline & Resource Management: Coordinating multiple stakeholders, including engineering teams, vendors, and validation experts.
- Risk Assessment & Mitigation: Identifying project risks early (technical, regulatory, schedule) and implementing contingency plans.
- Training & Knowledge Transfer: Providing hands-on operator and maintenance training to ensure proper system use and upkeep.
Upgrades, Retrofits & Migration
- Legacy Migrations & Obsolescence: Removal of end-of-life hardware and unsupported systems to prevent downtime risks, ensure replacement parts availability, and secure long-term reliability through modern, vendor-supported solutions.
- Hardware & Software Upgrades: Incorporating new controllers, drives, sensors, or automation software to boost system reliability, integrate modern features, and future-proof operations.
- Retrofits & Expansions: Enhancing or reconfiguring existing equipment and systems to meet evolving production demands, address obsolescence, and capitalize on new market opportunities—all while managing costs and downtime through planned rollouts.
- Parallel Testing & Commissioning: Running new solutions in tandem with existing setups to minimize operational interruptions and verify functionality before full cutover.
- Hardware & Software Standardization: Unifying multiple control platforms, operating versions, and communication protocols to simplify maintenance, reduce training overhead, and streamline spare parts management.
- Phased Implementation Strategies: Scheduling major updates—mechanical, electrical, or software-related—over planned outages or staggered deployments, ensuring production continuity and optimized resource usage.
- Post-Upgrade Support & Optimization: Providing ongoing support after modernization, including system tuning, operator training, and performance reviews to ensure a smooth transition and long-term success.
Maintenance & Support Services
- Preventive Maintenance Programs
Regularly scheduled inspections and servicing to minimize downtime and extend equipment lifespan.
- 24/7 Technical Support & Emergency Response (with Support Contract)
Round-the-clock assistance to address urgent issues, available to clients who opt for a support contract.
- Post-Project Support
Included with every project to ensure a seamless handover and immediate troubleshooting once the system goes live.
- Field Services
Rapid dispatch of technicians to diagnose equipment issues, perform repairs, and restore functionality—minimizing disruption and downtime.
- Remote Monitoring & Troubleshooting
Real-time tracking of system performance to detect and resolve potential issues before they escalate.
- Staff Augmentation
Access to skilled professionals to fill short-term or specialized staffing needs for ongoing or complex projects.
- Software & System Upgrades
Regular updates to maintain optimal performance, ensure compatibility, and address emerging security concerns.
- Employee Training & Knowledge Transfer
Comprehensive support for in-house teams, covering best practices and hands-on training.
- Compliance & Safety Support
Guidance on meeting regulatory requirements and maintaining best practices for safe operation.
- Lifecycle & Asset Management
Proactive planning for equipment upgrades and replacements to optimize total cost of ownership.
Featured Projects
Case Study
SCALING RELIABILITY: HVAC Integration for a Pharmaceutical Leader
Case Study
OPTIMIZING PHARMA OPERATIONS: Modernizing Process Control Systems
Case Study
SEAMLESS AMMONIA UPGRADE: Improving Reliability & Control
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