PULUODY TQ-01A Fully Automatic Membrane Degasser for Purified Water

Overview

The PULUODY TQ-01A Fully Automatic Membrane Degasser for Purified Water is an engineered solution for the precise, reproducible removal of dissolved gases—primarily oxygen and carbon dioxide—from aqueous dissolution media prior to use in pharmaceutical dissolution testing. Utilizing hydrophobic microporous membrane technology, the system achieves gas–liquid phase separation under controlled vacuum and temperature conditions, enabling consistent deaeration without introducing contamination, foaming, or volatile loss. Unlike vacuum-based boiling or sonication methods, membrane degassing operates at ambient or mildly elevated temperatures, preserving the chemical integrity of sensitive media and eliminating thermal degradation risks. The TQ-01A is purpose-built for compliance-driven laboratories performing routine USP dissolution method validation, where residual dissolved oxygen levels directly impact drug release kinetics and assay reproducibility.

Key Features

• Integrated pre-heating module: Solvent is heated to user-defined setpoints (35–42 °C) prior to membrane contact, enhancing gas solubility reduction and improving degassing efficiency by up to 35% compared to ambient-temperature operation.
• High-accuracy volumetric dispensing: Programmable delivery with ±1% volume accuracy for setpoints ≥2 L; no fixed reservoir limit—enables continuous, on-demand supply to dissolution vessels or automated sampling systems.
• Modular stainless-steel inlet filtration: Interchangeable 40 µm / 25 µm / 20 µm woven mesh filters protect the membrane stack from particulate fouling and extend service intervals.
• Intuitive HMI interface: 7-inch high-resolution capacitive touchscreen with multilingual support (English, Chinese, Spanish), real-time status monitoring (flow rate, temperature, vacuum level, cumulative volume), and password-protected method storage.
• Robust thermal management: PID-controlled heating circuit with ±2 °C stability; optional low-ambient adaptation kit available for installations in cold-climate facilities (e.g., unheated QC labs).
• Service-oriented architecture: All wetted components—including membrane cartridges, filters, and flow sensors—are tool-free replaceable; full maintenance log accessible via USB export.

Sample Compatibility & Compliance

The TQ-01A is validated for use with deionized water, distilled water, and buffered aqueous solutions within pH 1–14, excluding formulations containing surfactants (e.g., SDS, polysorbates), which may compromise membrane wettability and long-term flux stability. It meets functional requirements outlined in USP General Chapter “The Dissolution Procedure: Development and Validation” and supports alignment with FDA’s “Dissolution Testing of Immediate-Release Solid Oral Dosage Forms” guidance. While not a GMP-certified instrument per se, its audit-ready operational logs, parameter locking, and electronic signature support (via optional software upgrade) facilitate 21 CFR Part 11 compliance when integrated into validated dissolution workflows. Routine IQ/OQ documentation templates are provided for laboratory qualification.

Software & Data Management

The embedded firmware records timestamped operational data—including start/stop times, total dispensed volume, average flow rate, inlet/outlet temperature, and vacuum pressure—for each batch. Data exports as CSV via USB port; no cloud connectivity or proprietary drivers required. Optional PULUODY LabLink™ software (sold separately) enables remote monitoring, multi-unit fleet management, trend analysis of dissolved oxygen residuals over time, and automatic report generation compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate). Audit trail functionality captures all user actions, parameter changes, and calibration events with operator ID and timestamp.

Applications

• Preparation of degassed dissolution media for USP Apparatus I (basket) and II (paddle) systems.
• Supply of low-dissolved-oxygen water to flow-through (Apparatus IV) and reciprocating holder (Apparatus V) configurations.
• Supporting forced degradation studies requiring oxygen-sensitive conditions (e.g., oxidative stability testing).
• QC lab integration with automated dissolution testers (e.g., SOTAX AT7, Hanson SR8-Plus) via dry-contact relay or Modbus RTU interface.
• Research applications involving controlled deaeration of calibration standards for DO sensors or electrochemical cell preparation.

FAQ

What is the minimum operating temperature for the TQ-01A?
The unit requires inlet medium temperature ≥18 °C to ensure stable membrane performance and avoid condensation-induced vacuum fluctuations.
Can the TQ-01A be used with organic solvents like ethanol or isopropanol?
No. The hydrophobic PVDF membrane and internal seals are rated exclusively for aqueous media (pH 1–14); organic solvents will irreversibly swell or degrade system components.
How often must the membrane cartridge be replaced?
Under typical QC lab usage (8 h/day, 5 days/week), replacement is recommended every 6–9 months—or sooner if flow rate drops >15% at nominal vacuum or dissolved oxygen residuals exceed specification limits after recalibration.
Is calibration traceable to national standards?
Yes. Temperature and flow sensors are factory-calibrated against NIST-traceable references; certificate of conformance and as-found/as-left reports are included with each unit.
Does the system support external PLC integration?
Yes. Digital I/O terminals (24 VDC) and RS-485 Modbus RTU port enable seamless coordination with dissolution apparatus controllers, SCADA systems, or MES platforms.