DESIGN ENGINEERING

Custom bioreactor and process equipment design tailored to your specific pharmaceutical manufacturing needs.

• CGMP-Compliant Design – Ensuring all equipment and layouts meet global regulatory standards.
• Modular & Scalable Architecture – Design systems that grow with your process and production demands.
• Custom-Built Process Equipment – Tailor-made solutions for bioreactors, fermenters, filtration, and CIP/SIP systems.
• Automation-Ready Systems – Designed for seamless integration with DCS, PLC, SCADA, and MES platforms.
• Ergonomic & Maintenance-Friendly Layouts – Optimized for operator efficiency and easy service access.
• Material Selection for Cleanroom & Sterile Environments – SS316L, PTFE, and other biopharma-grade materials.
• Validation-Ready Design Documentation – Complete support for DQ, IQ, OQ, and PQ documentation.
• Compliance with ASME BPE, ISPE, and GAMP Guidelines – Meeting the highest bioprocessing design standards.
• Energy-Efficient & Sustainable Designs – Focus on reduced utility consumption and environmental impact.
• Integrated Safety & Containment Features – Design incorporating risk mitigation and contamination control.

QUALIFICATION & VALIDATION

EQUIPMENT QUALIFICATION APPROACH STRICTLY ADHERES TO:

• GAMP
• ISPE
• ASTM E2500 industry standards

KEY FOCUSES:

• Rigorous validation of critical aspects affecting end-product quality
• Tailored activities and documentation aligned with customer specifications
• Consideration of risk levels and process complexity

OBJECTIVES & OUTCOMES:

• Ensures comprehensive regulatory compliance
• Optimizes resource efficiency
• Prioritizes high-risk areas
• Maintains robust documentation throughout the validation process
• Guarantees reliability and integrity of pharmaceutical and biopharmaceutical manufacturing processes
• Fosters confidence in the quality and safety of end products within the highly regulated healthcare industry

INDUSTRIAL AUTOMATION

Expert guidance on bioprocess optimization, scale-up strategies, and regulatory compliance for pharmaceutical operations.

EXPERTISE INCLUDES:

• Designing and programming PLCs
• Implementing DCS for centralized control
• Developing user-friendly HMIs
• Creating SCADA for remote monitoring
• Optimizing batch processing
• Ensuring safety compliance
• Integrating robotics
• Configuring efficient drive systems
• Implementing MES for production management
• Analyzing real-time data with MII
• Seamlessly integrating automation with ERP systems

AUTOMATION

Advanced automation solutions for pharmaceutical manufacturing processes, including SCADA systems and process control.

• PLC
• Robotics
• DCS
• Drives
• HMI
• MES
• SCADA
• MII
• Batch
• ERP
• Data Integration
• Safety

SYSTEM ENGINEERING

Extensive pharmaceutical industry expertise integrating advanced technology with engineering principles to deliver customized, reliable, and compliant solutions.

OFFER CORE SERVICES SUCH AS:

• Thorough requirements analysis to define project goals
• Detailed system architecture design for optimized performance and reliability
• Seamless integration of hardware and software components
• Rigorous verification and validation to ensure compliance with specifications
• Proven expertise across industries including pharma
• Full lifecycle support including maintenance, upgrades, and optimization
• Maximizing system efficiency, performance, and longevity

TRAINING

Comprehensive training programs in the pharma industry for students and professionals, offering hands-on experience in equipment design, automation, and qualification.

• Hands-on training in equipment design, construction, automation, and qualification
• Practical sessions covering the full process from conceptualization to implementation
• Focus on equipment qualification, validation protocols, regulatory compliance, and testing methodologies
• Led by industry experts with real-world applications and mentorship
• Certification upon completion to boost expertise and career opportunities

Digitization

Innovative digitization strategies to streamline complexities in large-scale active ingredient production.

• Enhances transparency, sustainable planning, and complete traceability using digital process data
• Integrates digital technologies into workflows to reduce operational complexity and boost efficiency
• Promotes sustainability by optimizing resource usage and adhering to environmental standards
• Enables real-time data access for informed, data-driven decision-making
• Supports high standards of quality assurance and continuous improvement in production processes