Wahyong DGU-900 Online Solvent Degassing System
| Brand | Wahyong Instrument |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Direct Manufacturer |
| Region of Origin | Domestic (China) |
| Model | DGU-900 |
| Price Range | USD 7,000 – 14,000 |
Overview
The Wahyong DGU-900 Online Solvent Degassing System is an engineered solution designed specifically for pharmaceutical dissolution testing laboratories requiring consistent, low-oxygen aqueous media. It operates on a combined thermal-vacuum degassing principle—simultaneously heating solvent to reduce gas solubility and applying controlled vacuum to extract dissolved oxygen and other volatile gases. This dual-mode process ensures rapid, reproducible removal of dissolved oxygen to ≤3 ppm, meeting critical method requirements outlined in USP <711>, Ph. Eur. 2.9.43, and FDA guidance for dissolution medium preparation. Unlike batch-style degassers, the DGU-900 integrates seamlessly into automated dissolution workflows by delivering temperature-controlled, deaerated solvent directly to dissolution apparatuses—eliminating manual transfer, secondary handling, and re-aeration risks.
Key Features
- Integrated online operation: Continuous feed-through design enables real-time degassing and delivery without interruption to dissolution testing cycles.
- Precise temperature control: Adjustable setpoint range from ambient to 40 °C with ±1 °C accuracy, ensuring compliance with temperature-sensitive dissolution protocols (e.g., USP Apparatus 2 at 37 °C).
- High-flow capacity: Maximum throughput of 1000 mL/min supports multi-vessel dissolution systems and large-volume media preparation.
- Quantitative dispensing: Volumetric output accuracy of ±1% (minimum volume: 100 mL), traceable and repeatable for method validation and regulatory submissions.
- Modular mobility: Compact footprint; optional trolley configuration allows direct coupling to dissolution vessels—reducing contamination risk and operator intervention.
- Robust software architecture: Built-in role-based access control (RBAC) with three default permission tiers (System Administrator, Supervisor, Operator), supporting up to 1000 user accounts and customizable user groups.
Sample Compatibility & Compliance
The DGU-900 is validated for use with purified water, buffer solutions (e.g., phosphate, acetate), and other aqueous dissolution media commonly employed in USP Apparatus 1–4 testing. It is not intended for organic solvents or high-viscosity formulations. All operational parameters—including temperature setpoints, dispensed volumes, and vacuum dwell times—are fully configurable and logged with timestamped metadata. The system complies with data integrity principles per FDA 21 CFR Part 11 and EU Annex 11, including electronic signature support, audit trail enforcement, and immutable record storage. Audit trails capture all login attempts, parameter changes, start/stop events, and system exceptions—retained for ≥25,000 test batches with tamper-evident encryption.
Software & Data Management
The embedded operating system supports full lifecycle data governance: raw logs, experimental reports, and instrument status histories are stored locally and exportable via USB or network interface to enterprise servers. Reports are generated in PDF format with embedded metadata (user ID, timestamp, version number, checksum) and can be routed to network-connected printers or archived in LIMS environments. Remote firmware updates are supported over secure HTTPS connections, enabling feature enhancements and regulatory-aligned patches without onsite service visits. All software modifications undergo internal verification per ICH Q9/Q10 principles and include version-controlled release notes traceable to change control records.
Applications
- Preparation of deaerated dissolution media for USP <711> and Ph. Eur. 2.9.43-compliant testing.
- Supporting quality control labs performing routine dissolution method transfers and validation studies.
- Enabling continuous media supply in automated dissolution platforms with integrated fluid handling.
- Facilitating GLP- and GMP-regulated environments where ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) data practices are mandatory.
- Reducing inter-operator variability in media preparation through standardized, protocol-driven operation.
FAQ
What types of solvents is the DGU-900 validated for?
It is validated exclusively for aqueous media, including purified water and common buffer solutions used in dissolution testing. Organic solvents, alcohols, or viscous liquids are not supported.
Does the system meet 21 CFR Part 11 requirements?
Yes—audit trail, electronic signatures, role-based access control, and data immutability are implemented in accordance with FDA 21 CFR Part 11 Subpart B for closed systems.
Can the DGU-900 be integrated with third-party LIMS or dissolution apparatuses?
It supports standard Ethernet TCP/IP communication and provides structured CSV/PDF exports compatible with most LIMS platforms. Direct hardware integration requires custom API development under NDA.
What is the warranty and service coverage?
Standard warranty is 24 months from commissioning. On-site engineering support is available across 20+ cities in mainland China; international service partnerships are coordinated through authorized regional distributors.
Is calibration documentation provided?
Yes—factory calibration certificates for temperature sensor and volumetric flow module are included, traceable to NIM (National Institute of Metrology, China) standards. IQ/OQ documentation templates are supplied for customer-led validation.
