GM80 Fully Automatic Melting Point Apparatus with Temperature Range RT-400℃ Meeting 21CFR Part 11

Overview

The GM80 Fully Automatic Melting Point Apparatus redefines thermal analysis with its wide temperature range (Room Temperature to 400°C) and strict compliance with 21CFR Part 11, making it ideal for precise melting point determination in regulated industries. Combining rapid heating rates with nanoscale temperature control, this instrument provides reliable data for solid-state characterization, from pharmaceuticals to polymers.

The GM80 features a high-definition optical sensor that monitors sample transparency in real-time, eliminating subjective manual observations. Its intuitive touchscreen interface guides users through method setup, while the modular design allows easy calibration and maintenance. With built-in safety features like overheat protection and fume extraction compatibility, the GM80 balances performance with operational security.

Features

1. Extended Temperature Range & Precision Control

Capable of heating from 20°C to 400°C at programmable rates (0.1–20°C/min), the GM80 uses a ceramic heating block with ±0.1°C uniformity, ensuring accurate determination of both low-melting organics and high-temperature inorganic compounds. The adaptive PID algorithm compensates for ambient temperature fluctuations, maintaining setpoint stability within ±0.05°C.

2. 21CFR Part 11 Compliance

Designed for regulated environments, the apparatus includes role-based user access, electronic signature capture, and tamper-evident data storage. Audit trails log all system changes and sample analyses, while the encrypted database prevents unauthorized data modification.

3. Automatic Sample Loading & Analysis

The motorized sample stage holds up to 6 capillary tubes, enabling sequential analysis without operator intervention. The optical detection system identifies both initial melting (onset) and complete melting (endset) with sub-micron resolution, eliminating human error in endpoint detection.

4. Multilingual Software & Connectivity

The user interface supports 8 languages, including English, Chinese, and Japanese, with customizable method templates for USP, EP, and JP pharmacopoeia requirements. Wireless connectivity allows remote monitoring via tablet or PC, while the built-in cloud server enables secure data backup and real-time trend analysis.

Applications

Pharmaceutical Formulation

In drug development, the GM80 verifies the polymorphic purity of active ingredients, ensuring batch consistency by detecting even minor melting point deviations (±0.2°C). Its compliance with 21CFR Part 11 makes it suitable for submitting regulatory dossiers to agencies like the FDA and EMA.

Polymer Science

For polymer characterization, the apparatus measures the melting behavior of thermoplastics and elastomers, providing critical data for quality control in manufacturing. Researchers use it to analyze crystallinity changes induced by processing conditions, such as injection molding or extrusion.

Petrochemical Analysis

In petroleum labs, the GM80 determines the melting points of waxes and asphalt fractions, aiding in the assessment of product specifications. The high-temperature capability (400°C) allows analysis of heavy hydrocarbons without compromising precision.

Academic Research

University labs utilize the GM80 for teaching organic chemistry and material science, as its automatic functions simplify complex experiments for students. The instrument’s data export options (CSV, PDF, Excel) facilitate easy integration with research papers and lab reports.

Common Faults and Troubleshooting

1. Electrode shows no response or drifts

  Possible cause: Electrode membrane contamination, dry up of the internal filling solution, or blockage of the salt bridge.

  Solution: Soak and clean the electrode with 0.1mol/L HCl, replace the internal filling solution (such as 3mol/L KCl), and unclog the salt bridge. If the electrode is aged, replace it with an imported micro electrode.

2. Inaccurate determination of the titration end point

  Possible cause: Improper setting of the potential jump value, uneven stirring.

  Solution: Re optimize the end point parameters (such as setting ΔE≥50mV), and adjust the stirring speed until there are no swirls in the solution. If the electrode performance declines, calibrate or replace it.

3. The turntable of the automatic sampler gets stuck

  Possible cause: Displacement of the sample bottle or motor failure.

  Solution: Manually reset the turntable and check the positioning groove. If the motor is abnormal, contact the after sales service to replace the drive module.

4. Error or loss of data recording

  Possible cause: Malfunction of the storage device or software conflict.

  Solution: Check the connection of the hard disk or memory card, and try to reinstall the data processing software. Enable the audit trail function to trace operation records.