CZGY TT-G03L Insoluble Particle Detection Orbital Shaker

Overview

The CZGY TT-G03L Insoluble Particle Detection Orbital Shaker is an engineered solution designed explicitly to meet the mechanical agitation requirements specified in the Chinese Pharmacopoeia (2025 Edition), Chapter 0903 “Insoluble Particles in Injectable Preparations”, and YY/T 1556–2017 “Test Method for Insoluble Particles in Pharmaceutical Packaging Materials”. It implements standardized orbital motion (13 mm diameter) at precisely controlled speeds (40–310 rpm) to ensure uniform, reproducible suspension of particulate matter in parenteral solutions and extractants used for container-closure system evaluation. Unlike general-purpose shakers, the TT-G03L integrates pharmacopeial timing logic—supporting programmable durations from 1 second to 9999 seconds—with high-resolution speed stability and low acoustic emission (<52 dB(A) at 1 m), making it suitable for ISO Class 5–7 cleanroom-adjacent QC laboratories and GLP-compliant validation environments.

Key Features

• Pharmacopeia-aligned orbital drive: 13 mm orbit diameter ensures consistent fluid dynamics required for particle dispersion per USP , EP 2.9.19, and ChP 0903.
• Brushless DC motor with closed-loop speed control: Maintains ±1 rpm stability across full range (40–310 rpm); eliminates carbon brush wear and electromagnetic interference common in AC induction motors.
• High-resolution LCD interface: Displays real-time speed, elapsed time, and remaining time; supports dual-unit timer input (seconds/minutes/hours) with auto-stop and audible alert.
• Robust 420 × 420 mm stainless steel platform: Precision-machined surface with anti-slip coating; accommodates multiple vials, syringes, or filtration assemblies simultaneously.
• Universal spring clamp system: Secures containers ranging from 2 mL ampoules to 100 mL volumetric flasks; optional track-style clamps available for high-throughput rack-based workflows.
• Thermally optimized chassis design: Integrated heat-dissipating fins and low-noise fan ensure continuous operation at maximum speed without thermal derating.

Sample Compatibility & Compliance

The TT-G03L is validated for use with standard test containers defined in ChP 0903 and YY/T 1556, including glass vials (2–20 mL), polypropylene syringes (1–10 mL), and borosilicate glass bottles (30–100 mL). Its orbital motion profile minimizes foaming and wall adhesion during extraction of leachables from elastomeric closures, plastic stoppers, and polymer-based primary packaging. The device complies with IEC 61000-6-3 (EMC emissions) and IEC 61010-1 (safety for laboratory equipment). While not a regulated medical device itself, its operational parameters are traceable to NIST-traceable tachometers and calibrated timers, supporting audit readiness for FDA 21 CFR Part 11 (when paired with compliant LIMS), ISO/IEC 17025, and EU GMP Annex 11 documentation requirements.

Software & Data Management

The TT-G03L operates as a standalone instrument with embedded firmware (v2.1+), supporting manual protocol execution and repeat-run memory (up to 10 user-defined presets). For integrated data governance, optional RS-232 or USB-to-serial output enables connection to laboratory information management systems (LIMS) or electronic lab notebooks (ELN). Timestamped run logs—including start time, set speed, actual speed (averaged over 5 s intervals), duration, and completion status—can be exported as CSV files. When deployed in regulated environments, the unit may be included in instrument qualification protocols (IQ/OQ/PQ) with documented calibration against metrologically traceable references.

Applications

• Insoluble particle testing of injectable drug products per ChP 0903, USP , and JP 6.07.
• Extractable/leachable studies on pharmaceutical packaging components (e.g., rubber stoppers, plastic cartridges, IV bags) per YY/T 1556 and PQRI guidelines.
• Pre-filtration agitation prior to membrane filtration (10 µm or 25 µm pore size) in particle counting workflows.
• Standardized re-suspension of precipitated proteins or colloidal suspensions in biopharmaceutical stability studies.
• QC release testing of ophthalmic solutions and large-volume parenterals where gentle yet thorough mixing is critical to detection sensitivity.

FAQ

Is the TT-G03L compliant with USP mechanical agitation requirements?
Yes—the 13 mm orbital motion and speed range (40–310 rpm) align with USP Section “Apparatus” for vortex-type shakers, provided the container geometry and fill volume are within validated parameters.
Can the shaker be integrated into a 21 CFR Part 11–compliant workflow?
The unit itself does not provide electronic signature or audit trail functionality, but its serial output enables integration with validated LIMS or ELN platforms that implement Part 11 controls.
What is the maximum load capacity of the platform?
The platform supports up to 5 kg evenly distributed load at 310 rpm, verified per ISO 14644-1 Class 5 cleanroom vibration limits.
Does CZGY offer IQ/OQ documentation support?
Yes—factory-issued IQ/OQ templates, calibration certificates, and performance verification reports (including speed accuracy, timer deviation, and orbit consistency) are available upon request.
Is the universal clamp compatible with ISO-standard microtiter plates?
No—the clamp system is optimized for cylindrical containers; plate adapters are not supplied but can be custom-engineered under NRE agreement.