PreFluid WF350 Combined Multi-Channel Peristaltic Pump System

Overview

The PreFluid WF350 Combined Multi-Channel Peristaltic Pump System is an engineered solution for precision liquid handling in regulated pharmaceutical, biotechnology, and diagnostic manufacturing environments. Designed around the fundamental principle of peristaltic pumping—where rollers compress flexible tubing to generate positive displacement—the WF350 delivers repeatable, contamination-free fluid transfer without pump head contact with the process fluid. Its modular architecture supports up to multiple pump heads mounted on a single compact chassis, enabling synchronized multi-channel dispensing while maintaining footprint efficiency. The system integrates a brushless DC servo motor with closed-loop speed and position feedback, ensuring stable rotational output across the full 1–350 rpm range. Constructed entirely from electropolished stainless steel (AISI 304), the enclosure meets hygienic design standards for cleanroom-compatible operation and complies with core GMP requirements for equipment qualification, surface finish, and cleanability.

Key Features

• Modular multi-pump-head configuration: Supports simultaneous installation and centralized control of multiple peristaltic pump modules, reducing spatial footprint and simplifying system integration.
• GMP-compliant stainless steel housing: Seamless, crevice-free enclosure with smooth internal surfaces facilitates CIP/SIP compatibility and routine sanitization.
• Closed-loop servo-driven actuation: High-torque brushless DC motor with real-time encoder feedback ensures consistent speed stability and torque response under variable load conditions.
• Advanced dispensing logic: Programmable parameters include target volume, dispensing time, retraction angle (to eliminate post-dispense drip), acceleration/deceleration profiles (to suppress splashing and foam generation), and batch counter with audit-ready logging.
• Intelligent operational safeguards: No-bottle detection prevents overfilling; power-fail memory retains all setpoints and production history; automatic tube emptying and calibration verification routines support routine maintenance and qualification.
• Bilingual HMI interface: Touch-enabled display with switchable English/Chinese language mode, intuitive menu navigation, and real-time status visualization including direction, speed, and micro-adjustment angle.

Sample Compatibility & Compliance

The WF350 is compatible with a broad range of certified peristaltic tubing materials—including silicone, Viton®, and Pharmed® BPT—enabling safe handling of aqueous buffers, viscous formulations, organic solvents, and mildly aggressive reagents. Tubing selection directly influences volumetric accuracy and cycle time; validated performance data (±0.5% to ±3%) is referenced against ISO 8536-4 (infusion devices) and aligned with USP Analytical Instrument Qualification principles. The system’s mechanical design and software architecture support IQ/OQ documentation packages required for GMP-regulated environments. While not inherently 21 CFR Part 11 compliant out-of-the-box, its event-logged operations (including user actions, parameter changes, and dispensing records) provide foundational traceability that can be extended via external LIMS or MES integration.

Software & Data Management

The embedded firmware enables local storage of up to 100 dispensing programs, each configurable with volume, timing, retraction, and ramp profiles. All dispensing events—including start/stop timestamps, actual volume dispensed (via calibrated flow-rate integration), operator ID, and error codes—are timestamped and retained in non-volatile memory. Exportable logs (CSV format via USB port) support retrospective analysis and deviation investigation. Optional RS-485 or Modbus RTU communication allows integration into SCADA or PLC-based supervisory control systems for line-level coordination. Audit trail functionality includes immutable records of parameter modifications, program execution, and system resets—critical for GLP/GMP traceability and regulatory inspection readiness.

Applications

• Aseptic filling of sterile water-for-injection (WFI) and saline solutions in vial and ampoule formats.
• Accurate metering of lyophilized powder reconstitution buffers and final formulation excipients in freeze-dried product lines.
• High-throughput dispensing of ELISA, lateral flow, and molecular diagnostic reagents into assay strips, microplates, and cartridge reservoirs.
• Controlled delivery of polymer-based coating suspensions during tablet film-coating or medical device surface functionalization processes.
• Process-scale buffer and media transfer in upstream and downstream bioprocessing skids where sterility and material compatibility are critical.

FAQ

What tubing sizes and materials are validated for use with the WF350?
The system is validated with PreFluid-certified tubing sets (e.g., part numbers 204020058–204020055), including silicone and pharma-grade thermoplastic elastomers. Material compatibility must be confirmed per application-specific chemical resistance and extractables/leachables requirements.
Does the WF350 support electronic signature and audit trail for FDA submissions?
It provides timestamped, user-attributed event logs suitable for Part 11 extension; however, full compliance requires implementation of external authentication, digital signature, and secure archive layers via integrated LIMS or validated software platforms.
Can the pump be integrated into a fully automated fill-finish line?
Yes—through standard industrial protocols (Modbus RTU, RS-485), the WF350 accepts external start/stop commands and reports status signals, enabling synchronization with conveyor indexing, capping, and vision inspection subsystems.
How is volumetric accuracy verified and maintained over time?
Accuracy is verified using gravimetric calibration per USP , with periodic recalibration recommended after tubing replacement or mechanical adjustment. The built-in “volume check” function compares dispensed mass against programmed setpoint and adjusts compensation factors accordingly.
Is cleaning validation data available for the stainless steel housing?
Surface roughness (Ra ≤ 0.8 µm), weld integrity, and passivation test reports are provided upon request as part of the Equipment Qualification Package (EQP).