The NXTbps (Buffer Preparation System) is a transformative approach designed to address the challenges of buffer management in modern biomanufacturing, which is often acknowledged as one of the most resource-intensive activities. As manufacturing capacity increases, facilities face pressure to scale up without expanding their physical footprint or prolonging preparation timelines. Embracing automated, multi-pump inline buffer preparation streamlines the process, leading to substantial savings in facility footprint and optimizing resource utilization. By enabling precise control over buffer composition and reducing manual intervention, the integration of NXTbps enhances overall process efficiency and allows manufacturers to maximize productivity within existing infrastructure.
NXTbps Operational System
The system’s operational success relies on the effective control of buffer pH, which hinges on optimizing buffer capacity and pump flow rate. The design meticulously aligns with the buffer system’s pka, ensuring precise measurement and delivery of individual buffer components by the system pumps.
The system offers three primary operational modes for pH control:
- Flow Control Mode: A basic mode that regulates the flow rate of buffer components.
- Flow + Conductivity Control Mode: An enhanced mode that incorporates conductivity monitoring to supplement flow control, ensuring consistent buffer composition.
- Flow + Conductivity + pH Control Mode: The most advanced mode, integrating pH monitoring and control alongside flow and conductivity regulation for comprehensive pH control capabilities.
How the NXTbps Works (Mechanism)
The NXTbps system utilizes automated, just-in-time (JIT) at point-of-use (POU) solutions to streamline buffer preparation, which optimizes space utilization and enhances operational workflows compared to traditional methods.
It features Buffer Preparation as the core mechanism, which is resilient to components with low solubility, ensuring the final buffer’s integrity and consistency. Dynamic control mechanisms within the system account for the common ion effect, which helps maintain buffer stability and ensures consistent performance.
Application of NXTbps
The NXTbps solution is key to modernizing biomanufacturing practices by supporting:
- Process Intensification: Effective buffer management is integral to initiatives aimed at enhancing production efficiency and throughput.
- Facility Expansion: Strategic buffer management is paramount during facility expansion or the construction of new manufacturing facilities.
- Versatility in Buffer Production: Multiple buffer solutions can be efficiently prepared from the same stock solutions, offering flexibility to diverse bioprocessing requirements.
- Facilitation of Gradient Operations: The system enables the creation of step gradients, linear gradients, and sample conditioning, supporting sophisticated bioprocessing techniques.
NXTbps Performance
To achieve stringent pH specifications, which are typically within ±0.05 pH units, the NXTbps system is required to operate in the pH + Flow + Conductivity Control Mode. This advanced control mode leverages combined pH monitoring, flow rate regulation, and conductivity control to achieve the precise pH control necessary for compliance with exacting quality standards and regulatory requirements.
NXTbps Cleaning and Sterilization
While the NXTbps is designed with features like Low Hold-up to enhance CIP:
- Automated CIP: Is Not Included in the standard configuration, but can be made available with 4 inlet Block Valves.
- SIP (Sterilization-in-Place): Can be made available upon request.
