DuoFill Single-Use Bulk Liquid Dispensing System
| Brand | DUONING |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Domestic |
| Model | DuoFill |
| Pricing | Available Upon Request |
Overview
The DuoFill Single-Use Bulk Liquid Dispensing System is an integrated, GMP-compliant automation platform engineered for precise, aseptic dispensing of biopharmaceutical bulk drug substances—including drug substance (DS), intermediates, cell culture media, and buffer solutions—within ISO Class 5 (Grade A) environments such as laminar flow hoods or biosafety cabinets. Built upon a closed, single-use fluid path architecture with zero mechanical valves, the system eliminates cross-contamination risk and minimizes hold-up volume through seamless tubing-based fluid handling. It operates on dual dispensing modalities: gravimetric mode (real-time mass feedback via external high-accuracy load cells) and volumetric mode (flow-controlled dispensing using calibrated peristaltic pumps and inline flow meters). This dual-mode architecture ensures ≤±1% dispensing accuracy across batch sizes ranging from pilot-scale (1–10 L) to commercial manufacturing (up to 200 L), while maintaining full data integrity per FDA 21 CFR Part 11 and EU Annex 11 requirements.
Key Features
- True single-use design: Entire fluid path—including tubing, filters, sensors, and connectors—is pre-sterilized and disposable; no cleaning-in-place (CIP) or sterilization-in-place (SIP) required.
- Zero-valve architecture: Eliminates dead-legs, reduces residual volume to <0.5 mL per channel, and avoids particulate generation associated with valve actuation.
- Dual dispensing modes: Automatically detects and configures gravimetric (weight-loss/weight-gain) or volumetric (constant-flow/constant-pressure) protocols based on user-defined recipe parameters.
- Integrated process monitoring: Real-time pressure sensing (0–60 PSI, ±5% accuracy), flow rate measurement (0–15 L/min, ±3% accuracy), and weight signal acquisition (via RS-232/485 or analog 4–20 mA interface).
- Modular expandability: 12 configurable I/O ports support seamless integration with external agitators, balance systems, peristaltic pumps, and PLC-controlled utilities.
- Rapid deployment: Fully operational within ≤60 seconds after power-on; compact footprint (545 × 420 × 500 mm) enables desktop placement inside standard ISO Class 5 hoods.
Sample Compatibility & Compliance
The DuoFill accommodates a broad range of container formats—including single-use bags (e.g., freeze-thaw, storage, and mixing bags), rigid bottles (glass or polymer), and custom trays—via adjustable, tool-free mounting fixtures. All wetted materials comply with USP Class VI and ISO 10993-5 biological safety standards. The system meets ISO 13485:2016 for medical device quality management and supports full audit trail generation per ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Its control architecture conforms to IEC 62304 (Software Lifecycle) and IEC 61508 (Functional Safety), and it is validated for use in environments compliant with EU GMP Annex 1, WHO TRS 961, and USP <1058> Analytical Instrument Qualification.
Software & Data Management
Powered by a Siemens S7-1500 PLC and a 13-inch multi-touch industrial HMI, the DuoFill’s embedded software provides role-based access control with nine hierarchical user levels, domain controller integration, electronic signatures, and configurable audit trails. All operational data—including timestamps, parameter sets, sensor readings, alarms, and user actions—are stored in an encrypted SQLite database with ≥10 years retention capacity. Backup options include scheduled local export (USB), network-based redundancy (Rsync over TCP/IP), and OPC UA/Modbus TCP gateway connectivity for SCADA or MES integration. Batch reports are auto-generated in PDF format with digital signatures and may be exported with full metadata traceability.
Applications
- Final drug substance (DS) dispensing into vials or bags prior to lyophilization or liquid formulation.
- Aseptic transfer and aliquoting of cell culture harvests during upstream processing.
- Precision dispensing of formulation buffers and diluents into mixing vessels under controlled flow conditions.
- Intermediate product dispensing between purification steps (e.g., post-protein A, post-virus filtration).
- Media and feed solution preparation for bioreactor inoculation and feeding strategies.
- Support for QbD-driven process development, tech transfer, and commercial validation studies.
FAQ
Does the DuoFill require compressed air or purified water to operate?
No. The system is self-contained and requires only AC power (90–260 V, 50/60 Hz); no utility gases or process liquids are needed.
Can the DuoFill be validated for GMP manufacturing use?
Yes. The system is supplied with IQ/OQ documentation templates, calibration certificates for all critical sensors, and a comprehensive risk assessment (FMEA) report aligned with ICH Q9.
Is remote operation supported?
Yes. VNC-based remote desktop access is enabled by default; secure TLS-encrypted connections are configurable via enterprise IT policies.
What level of regulatory compliance does the software support?
Full 21 CFR Part 11 and EU Annex 11 compliance—including electronic signatures, audit trail immutability, and role-based permission enforcement—is natively implemented and factory-verified.
How is calibration managed for gravimetric dispensing?
The system supports on-site calibration verification using NIST-traceable weights and provides guided workflows for routine performance qualification (PQ) of connected weighing modules.
