GBPI ZF3600Y Total Migration and Non-Volatile Residue Analyzer
| Brand | GBPI |
|---|---|
| Origin | Guangdong, China |
| Manufacturer | GBPI Packaging Instruments Co., Ltd. |
| Model | ZF3600Y |
| Measurement Range | 0–80 g |
| Balance Resolution | 0.01 mg |
| Balance Capacity | 0–220 g |
| Constant-Weight Tolerance | ±0.3 mg (user-configurable) |
| Water Bath Temp Range | RT to 100 °C |
| Drying Chamber Temp Range | RT to 125 °C |
| Temp Control Accuracy | ±0.5 °C |
| Sample Positions | 36 |
| Evaporating Dish Volume | 50 mL or 100 mL (optional) |
| Pneumatic Interface | Φ8 mm |
| Dimensions (L×W×H) | 1200 × 850 × 1335 mm |
| Power Supply | 220 V, 50 Hz |
| Rated Power | 7000 W |
| OS | Windows 10 Pro 64-bit |
Overview
The GBPI ZF3600Y Total Migration and Non-Volatile Residue Analyzer is an integrated, fully automated laboratory system engineered for precise determination of non-volatile residue (NVR), total migration, evaporable residue, and total dissolved solids (TDS) in aqueous and organic extracts. It operates on the gravimetric principle: a defined volume of test solution is dispensed into pre-tared evaporating dishes; residual solvent is removed under controlled water-bath evaporation below the boiling point of the extraction medium, followed by drying at 105 °C in a thermally stable chamber, cooling in a humidity- and temperature-stabilized environment, and high-precision weighing until constant mass is achieved. This sequential, closed-loop process eliminates operator intervention, environmental drift, and manual handling errors—ensuring compliance with pharmacopeial and regulatory gravimetric endpoints.
Key Features
- Integrated Dual-Zone Thermal Architecture: Combines a liquid-level-sensing water bath (RT–100 °C) and a forced-air drying chamber (RT–125 °C) within a single sealed enclosure, enabling seamless transition between evaporation, drying, cooling, and weighing phases without sample transfer.
- Automated Fluid Handling: Pneumatically actuated dispensing system with ≤0.1 mL residual volume per cycle; supports aqueous solutions (e.g., purified water per ChP 2020 Vol. II), organic solvents (n-hexane, ethanol, chloroform), and extractants compliant with ISO 10993-12, EN 1186-3:2002 Method A, and USP .
- Triple High-Precision Balance System: Three imported analytical balances (0.01 mg resolution, 220 g capacity), each housed in a vibration-damped, water-jacketed isolation chamber with independent thermal stabilization—ensuring measurement integrity during active heating/cooling cycles.
- Constant-Weight Validation Protocol: Programmable convergence criteria (default ±0.3 mg over two consecutive weighings); automatic termination upon achievement of gravimetric endpoint per ChP 2020, EP 9.0 WATER, PURIFIED, and USP WATER DETERMINATION.
- Solvent Recovery & Environmental Control: Integrated recirculating chiller (30 min cooldown to ambient), large-capacity condensate collection, and >90% solvent recovery efficiency—reducing hazardous waste generation and operational cost.
- Ergonomic & Audit-Ready Design: 1.2 m working height, transparent observation window, real-time display of mass, temperature, and humidity curves, and GMP-aligned software architecture with role-based access control.
Sample Compatibility & Compliance
The ZF3600Y accommodates diverse sample matrices including purified water (ChP 2020, EP 9.0), pharmaceutical packaging materials (YBB standards), food contact articles (GB 31604.8–2016, EN 1186 series), cigarette tipping paper (GB/T 9740–2008), chemical reagents, and solid dosage forms (ChP 2020 Vol. IV “Extractables” and “Loss on Drying”). All test sequences adhere to internationally recognized gravimetric validation requirements—including ASTM D5907 (total suspended solids), ISO 2566-1 (moisture content), and FDA 21 CFR Part 11-compliant electronic record integrity via time-stamped audit trails, user authentication, and immutable data logging.
Software & Data Management
Running on Windows 10 Pro 64-bit, the proprietary GBPI SmartLab OS implements modular, icon-driven workflow configuration. Users define method parameters—including evaporation temperature, drying duration, cooling delay, and convergence tolerance—in alignment with pharmacopeial monographs or internal SOPs. The system enforces ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. Full audit trail captures all user actions, parameter changes, instrument events, and calibration logs. Reports are exportable in PDF, CSV, and XML formats; support electronic signatures (e-Sign), multi-level review workflows, and integration with LIMS via secure API. Language switching (English/Chinese) is configurable without software reinstallation.
Applications
- Pharmaceutical Quality Control: Purified water testing per ChP/EP/USP; extractables assessment of primary packaging (glass, polymer, elastomer).
- Food Safety Laboratories: Migration testing of food-contact plastics, coatings, and adhesives per GB 31604.x series and EU Regulation 10/2011.
- Tobacco Product Compliance: Non-volatile residue quantification in cigarette filter papers per GB/T 9740–2008.
- Environmental & Geochemical Analysis: Total dissolved solids (TDS) in groundwater per GB 8538–2016 and DZ/T 0064.9–2021.
- Chemical Manufacturing: Residue analysis of solvents, catalysts, and intermediates per GB/T 14415–2007 and ISO 6353-1.
- Academic & Regulatory Research: Standardized loss-on-drying (LOD) studies for APIs and excipients per USP and ChP Vol. IV General Chapters.
FAQ
What regulatory standards does the ZF3600Y support out-of-the-box?
The system includes preloaded method templates aligned with ChP 2020, EP 9.0, USP , GB 31604.8–2016, EN 1186-3:2002, and GB/T 9740–2008—each validated for instrument-specific repeatability and endpoint accuracy.
Can the ZF3600Y handle volatile organic solvents safely?
Yes. The sealed chamber design, integrated condensation coil, solvent recovery bottle, and exhaust-compatible pneumatic interface meet IEC 61000-6-4 EMI and local VOC containment requirements when connected to facility fume extraction.
Is the balance system calibrated traceable to national metrology institutes?
All three balances are factory-calibrated using NIST-traceable weights (Class E2); optional on-site verification and recalibration services are available with ISO/IEC 17025-accredited certificates.
How does the system ensure data integrity for FDA or EMA inspections?
Through 21 CFR Part 11-compliant features: electronic signatures, biometric or token-based login, immutable audit trails, automatic backup to network storage, and password-protected method locking.
What maintenance is required for long-term reliability?
Scheduled tasks include quarterly water bath descaling, annual balance sensitivity verification, biannual chiller coolant replacement, and semi-annual inspection of pneumatic valves and dish positioning actuators—all documented in the built-in maintenance log.
