PreFluid WF350 Multi-Channel Peristaltic Filling System

Overview

The PreFluid WF350 Multi-Channel Peristaltic Filling System is an engineered solution for high-precision, multi-needle liquid dispensing in regulated laboratory and pilot-scale production settings. Built upon a closed-loop brushless DC servo motor architecture, the system delivers deterministic angular positioning and repeatable volumetric output via peristaltic pumping—eliminating fluid contact with mechanical components and ensuring contamination-free handling of sensitive biologics, diagnostics, and sterile formulations. Unlike pressure-driven or piston-based systems, the WF350 relies on controlled occlusion of elastomeric tubing to displace fluid, making it inherently compatible with shear-sensitive media such as live vaccines, cell suspensions, and protein-rich reagents. Its modular design supports 3-, 4-, 5-, and 6-needle configurations, scalable up to 20 channels through synchronized controller expansion—enabling parallel processing without cross-channel drift or timing skew. The system is intended for use in laboratories requiring traceable, reproducible dispensing across variable viscosity ranges (1–50,000 cP), with operational validation aligned to ISO 8655-3 (volumetric dispensers) and USP (performance verification of automated liquid handlers).

Key Features

• Precision step-angle dispensing with 1° resolution and ≤±0.5% volumetric accuracy for fill volumes ≥1 mL, verified per ISO 8655 calibration protocols
• 10 programmable acceleration/deceleration curves to minimize pulsation and tube fatigue during start/stop cycles
• Integrated retract function (0°–360°) for post-dispense drip control and meniscus stabilization
• Auto-empty mode for pre-fill priming and post-cycle tubing evacuation—critical for cross-product changeover and cleaning-in-place (CIP) workflows
• Real-time parameter monitoring via dual-display interface: 4.3″ TFT LCD showing global system status, plus LED numeric panels for individual channel feedback
• No-bottle detection input to halt dispensing automatically—reducing reagent waste and preventing dry-run damage to tubing
• Power-loss memory retention: restores last-used configuration, angle position, and runtime state after unexpected shutdown
• RS485 Modbus RTU interface for integration into SCADA, LIMS, or MES platforms with full command-and-control capability
• IP61-rated enclosure with corrosion-resistant coated chassis—designed for frequent wipe-downs in GMP-adjacent cleanroom-adjacent labs
• Support for multiple pump head types (PF246, YZ35, KZ35, etc.) enabling optimization of flow rate vs. pressure capability across viscosity gradients

Sample Compatibility & Compliance

The WF350 accommodates a broad spectrum of aqueous and non-aqueous liquids—from low-viscosity buffers (e.g., PBS, Tris-HCl) to viscous bioprocess intermediates (e.g., adjuvanted vaccines, hydrogel precursors). Its tubing-based fluid path avoids metal contact, preserving integrity of metal-sensitive compounds (e.g., chelated therapeutics, oligonucleotides). All standard configurations comply with IEC 61000-6-2 (immunity) and IEC 61000-6-4 (emissions). When operated with validated tubing (e.g., PharMed® BPT, Norprene® LFT), the system supports sterilization via gamma irradiation (25 kGy) or autoclaving (121°C, 20 min)—enabling reuse in aseptic filling applications. Documentation packages include IQ/OQ templates aligned with ASTM E2500-13 and EU Annex 11 principles, facilitating qualification under GLP, GMP, or ISO 13485 quality systems.

Software & Data Management

The embedded controller firmware provides local execution of all dispensing logic—no external PC required for basic operation. For advanced data governance, optional PreFluid Control Suite (v3.2+) enables remote configuration, batch logging, electronic signature capture, and 21 CFR Part 11-compliant audit trails—including user action timestamps, parameter change history, and error event logs. Export formats include CSV and PDF reports with digital signatures. Modbus RTU integration allows bidirectional data exchange with third-party lab automation software (e.g., Thermo Fisher SampleManager, LabVantage), supporting automated lot tracking and material consumption reconciliation.

Applications

• Primary packaging of diagnostic reagents into microtiter plates, vials, and syringes
• Fill-finish operations for clinical trial materials—especially where low-volume, high-potency dosing is required
• Automated buffer preparation in chromatography workflow support
• Cell therapy manufacturing: dispensing of cryopreservation media into cryovials with minimal shear exposure
• QC/QA laboratories performing method transfer studies requiring inter-laboratory precision matching
• Veterinary biologics production—as demonstrated in validated 100 mL live porcine vaccine filling at ≤±0.75 mL tolerance

FAQ

What tubing sizes are supported for optimal accuracy at 250 mL fills?
For 250 mL dispensing, use 9.6 × 2.4 mm ID/OD silicone or PharMed BPT tubing with KZ35 or PF246 pump heads—calibrated at 150–250 rpm for ≤±0.5% repeatability.
Can the WF350 be validated for GMP manufacturing use?
Yes—when paired with documented IQ/OQ protocols, qualified tubing, and Part 11-compliant software, the system meets baseline requirements for Stage 1–2 manufacturing support per ICH Q5C and WHO TRS 961 Annex 2.
Is sterilization of the pump head assembly possible?
Pump heads themselves are not autoclavable; however, removable tubing paths and front-panel components tolerate VHP (vaporized hydrogen peroxide) decontamination cycles.
How does the system handle high-viscosity fluids (>10,000 cP)?
Reduced rotational speed (≤100 rpm), larger-bore tubing (e.g., 3.1 × 2.4 mm), and extended acceleration curves mitigate backpressure-induced slip—verified using glycerol/water reference standards per ISO 2556.
Does the controller support recipe import/export via USB?
No—configuration is managed exclusively via RS485 or front-panel keypad; USB connectivity is not implemented to maintain electromagnetic compatibility and regulatory boundary integrity.