GBPI ZF3600N Total Migration & Non-Volatile Residue Analyzer
| Brand | GBPI |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Manufacturer |
| Origin Category | Domestic |
| Model | ZF3600N |
| Pricing | Upon Request |
Overview
The GBPI ZF3600N Total Migration & Non-Volatile Residue Analyzer is an integrated, fully automated laboratory system engineered for precise determination of total migration, non-volatile residue (evaporative residue), and related parameters in regulatory-compliant testing of packaging materials and aqueous/organic extracts. It operates on the gravimetric principle: a defined volume of extract—derived from food contact materials, pharmaceutical packaging, tobacco paper, or chemical reagents—is subjected to sequential, controlled evaporation (in water bath), drying (in heated chamber), cooling (in temperature-stabilized environment), and high-precision weighing until constant mass is achieved. This methodology conforms strictly to pharmacopoeial and national standard protocols—including USP , EP 9.0 WATER, PURIFIED, ChP 2020 Vol. II & IV, GB 31604.8–2016, EN 1186-3:2002 Method A, and GB 8538–2016—ensuring traceable, auditable, and reproducible results under GLP/GMP conditions.
Key Features
- Fully integrated dual-chamber architecture: independent water bath (room temp–100 °C) and drying chamber (room temp–125 °C), both with ±0.5 °C temperature control accuracy via electromagnetic heating regulation.
- Automated sample handling: pneumatic valve-driven liquid dispensing with residual volume <0.1 mL; programmable multi-step cycle (evaporation → drying → cooling → weighing) executed without manual intervention.
- Triple high-accuracy analytical balances (0.01 mg resolution, 0–220 g capacity), each housed in a thermally isolated, water-jacketed enclosure to eliminate thermal drift during weighing.
- 36-position parallel testing capability with individual evaporating dish (50 mL or 100 mL optional) and independent data logging per channel.
- Closed-loop solvent recovery system: integrated recirculating chiller (30 min cooldown to ambient), large-capacity coolant reservoir, and condensate collection bottle achieving >90% solvent recovery efficiency.
- Real-time environmental monitoring: simultaneous display and logging of chamber temperature, humidity, and mass data; all curves saved with timestamped metadata.
Sample Compatibility & Compliance
The ZF3600N accommodates diverse sample matrices: aqueous solutions (e.g., purified water per ChP 2020), organic solvents (n-hexane, ethanol, acetic acid, chloroform), solid dosage forms (for loss on drying or extractables testing), and powdered materials. It supports testing per ISO 10993-12 (biological evaluation of medical devices), FDA 21 CFR Part 170–189 (food contact substances), and Korean MOHW Chapter IV Section 2–8 (utensils and packaging). Its hardware and software architecture are designed to meet requirements for audit readiness under 21 CFR Part 11 (electronic records/signatures), EU Annex 11 (computerized systems), and GMP Annex 11 (data integrity).
Software & Data Management
Running on Windows 10 Pro 64-bit, the proprietary GBPI SmartOS features modular GUI navigation, multilingual support (English/Chinese), role-based user permissions (administrator, operator, reviewer), and full audit trail functionality—including time-stamped log entries for all parameter changes, test initiations, result modifications, and electronic signature events. Test methods are configurable to match specific standard clauses (e.g., “ChP 2020 Vol. II – Purified Water” or “GB/T 9740–2008”). Reports are exportable in PDF, CSV, and XML formats; support for digital signatures and workflow-integrated review/approval ensures compliance with regulated quality systems.
Applications
- Regulatory testing of food contact materials (FCMs) for total migration limits per EU 10/2011 and Chinese GB 31604 series standards.
- Pharmaceutical packaging validation: non-volatile residue assessment of primary containers (glass, plastic, elastomers) per ChP, USP, and EP monographs.
- Quality control of tobacco industry adhesives and tipping papers per GB/T 9740–2008.
- Determination of total dissolved solids (TDS) in drinking water, mineral water, and groundwater per GB 8538–2016 and DZ/T 0064.9–2021.
- Loss on drying (LOD) and extractables profiling of APIs, excipients, and herbal preparations per ChP Vol. IV and USP .
FAQ
What standards does the ZF3600N support out-of-the-box?
Preconfigured test templates align with ChP 2020, USP , EP 9.0, GB 31604.8–2016, EN 1186-3:2002, GB 8538–2016, and GB/T 9740–2008.
Is the system compliant with 21 CFR Part 11?
Yes—the software includes electronic signature capability, audit trail with immutable logs, and role-based access control meeting core Part 11 requirements.
Can it handle organic solvents safely?
Yes—integrated solvent recovery, explosion-proof chamber design, automatic leak detection, and exhaust-compatible venting ensure safe operation with flammable solvents.
What is the minimum detectable mass change for constant weight determination?
The system uses 0.01 mg resolution balances and allows user-defined constancy criteria (default: ≤0.3 mg variation across two consecutive weighings).
Does the instrument support remote diagnostics and data access?
Yes—it integrates with GBPI’s Laboratory IoT Platform for secure web-based access to real-time status, historical datasets, firmware updates, and remote technical support.
