Seamless Scalability and Consistency: From Lab to Production
Ensure seamless scalability and consistent quality from lab to full-scale production with our advanced technology. Discover how we help streamline development, reduce costs, and meet regulatory standards efficiently.
Efficient Development and Production
Our technology guarantees a smooth transition from laboratory to production, maintaining consistency and reliability across all stages. Avoid common scale-up errors by using the same technology throughout.
Consistent Product Quality
Using the same validated technology from lab to production ensures stable product quality, with parameters directly transferable to larger systems for uniformity and reliability.
Time and Cost Savings
- Accelerated Development: Streamline processes and reduce time spent on adjustments by using consistent technology from the start.
- Reduced Investment: Lower costs by avoiding the need for new technology at different stages of production.
GMP Compliance and Standardization
- Regulatory Assurance: Our technology adheres to GMP standards from development to production, reducing risks and speeding up approvals.
- Enhanced Process Safety: Standardized technology simplifies validation and documentation, crucial for GMP compliance.
Optimized Process Control
- Automated Monitoring: Consistent monitoring of critical quality attributes (CQAs) enhances precision across all stages.
- Improved Development: Early issue detection in lab-scale tests prevents problems during mass production.
Flexibility and Adaptability
- Market Responsiveness: Adjust production capacity easily to meet market demands without major investments.
- Product Innovation: A versatile platform supports rapid product development and faster market entry.
Enhanced Reproducibility and Traceability
- Uniform Data: Consistent technology use ensures continuous data for seamless traceability and regulatory compliance.
- Reproducible Results: Minimize batch variability to maintain high manufacturing standards.
Lyophilization Cycle Transfer with Tempris
Freeze-dryer A
Example: Transfer of lyophilization cycle from
freeze-dryer A (24 m² / 258 sqft)
to freeze-dryer B (33 m² / 355 sqft)
Freeze-dryer B
Lyophilization cycle temperature profiles from different runs on both freeze-dryers are superimposed to demonstrate that the lyophilization cycles are equivalent.
Overlay Freeze-dryer A+B
No further assessment of upper and lower temperature limits is required.
