除病毒过滤系统

Virus Filtration System

The Virus Filtration System is a user-friendly, automated benchtop device. It features an integrated piping system with various sensors and预留 TC (Tri-Clamp) interfaces compatible with most filter capsules. This makes it widely applicable for small-scale virus filtration process development, especially ideal for handling high-value products or smaller volume virus filtration. In the field of biopharmaceutical R&D, the Virus Filtration System, with its high efficiency, serves as an ideal "lab partner" for daily small-scale virus removal operations.

Advantages

• Extremely low hold-up volume for maximum product recovery

• Two-stage filtration for high efficiency

• Automated operation ensuring high repeatability

• Reliable performance with easy scalability

• User-friendly human-machine interface (HMI)

• Advanced data management

• Standard international OPC protocol for data exchange and integration with upstream/downstream processes

• Compact, mobile design with minimal footprint

• Hygienic design, easy to clean, supports CIP (Clean-in-Place) and SIP (Sterilize-in-Place)

• Quick-connect interfaces for fast connection to other equipment and filter capsules

• Available in different specifications for customer selection

Applications

• Monoclonal Antibodies (mAbs)

• Vaccines

• Plasma

• Blood

Device Functions

• Filtration: The integrated system combines pre-filtration and virus filtration devices in series, with a standard operating flow rate of 1.5 L/min.

• Integrity Test: The system can perform automatic integrity testing on the virus filter capsule with one-button operation, determining pass/fail status.

• CIP: The system can perform independent CIP cleaning on the fluid path, automatically determining the cleaning endpoint.

System Features

• Easy-to-Use Operator Interface: The system is equipped with a Siemens industrial PC that boots automatically upon power-up. The touchscreen allows easy management and access to system control information. Operators can conveniently monitor flow rate, temperature, and pressure, view system status, warnings, and alarm indicators, and input commands via the control panel.

• Warnings and Alarms: The system can run automatically at a set constant pump speed or constant pressure differential (ΔP). Alarm setpoints (High/Low and High-High/Low-Low) can be configured for the feed-to-retentate pressure differential (ΔP). Upon reaching a High/Low alarm, the system triggers a warning without stopping operation, allowing adjustment to bring the process back within control limits. Upon reaching a High-High/Low-Low alarm, the system automatically shuts down to prevent permanent damage, accompanied by an alarm. An emergency stop button is also provided for immediate system halt if necessary.

• Process Monitoring via P&ID: A P&ID (Piping & Instrumentation Diagram) display monitors and shows all online parameters, including pump speed, feed flow rate, inlet pressure, outlet pressure, feed temperature, pressure differential (ΔP), and conductivity, facilitating real-time process monitoring. Parameter trend graphs provide quick visualization of key parameter changes during operation, offering strong data support for process development.

• Automatic Data Logging and Export: The system automatically logs all operational parameters (inlet pressure, outlet pressure, ΔP, pump speed, temperature) along with alarm and event history, all time-stamped for easy traceability and analysis. Logged data can be saved as SQL database files on a computer and used to directly generate batch report files.

• Linear Scalability & Production-Condition Simulation: The system uses components standard in industrial production, such as diaphragm pumps and 316L stainless steel fluid paths. This design allows simulation of production conditions in the lab, ensuring smooth process scale-up. For small-scale production, an optional data logger compliant with CFR 21 Part 11 standards is available.

  

Technical Specifications