Distek 2100C Water-Bath Type Drug Dissolution Tester (Refurbished)
| Brand | Distek |
|---|---|
| Origin | USA |
| Model | 2100C |
| Cup Capacity | 6 (standard), 7 or 8 optional |
| Vessel Volume Range | 100–4000 mL |
| Temperature Control Accuracy | ±0.2 °C at 37 °C |
| Rotational Speed Range | 25–350 rpm |
| Speed Resolution | 0.1 rpm |
| Speed Accuracy | ±0.2 rpm |
| Bath Uniformity | <±0.1 °C |
| Drive System | High-torque permanent-magnet motor |
| Control Interface | LED display (14 mm height), RS-232, RS-485, printer port |
| Bath Construction | Monolithic acrylic casting |
| Shaft Tilt | <0.01° |
| Warranty | 6 months |
Overview
The Distek 2100C Water-Bath Type Drug Dissolution Tester is a precision-engineered, benchtop dissolution system designed for compliance with pharmacopeial standards including USP , EP 2.9.3, and JP 17. It employs a thermally stabilized water-bath architecture—distinct from jacketed-vessel designs—to deliver exceptional thermal uniformity across all dissolution vessels. The system integrates a rear-mounted vertical thermal circulator (TCS-0200C) with proprietary laminar-flow bath circulation, achieving temperature stability of ±0.2 °C at 37 °C and spatial uniformity better than ±0.1 °C across the full vessel array. Its closed-loop digital speed control ensures accurate, reproducible rotational actuation of paddles or baskets—critical for robust method transfer and regulatory validation. This refurbished unit has undergone full functional verification per ASTM E2503–22 and includes calibration documentation traceable to NIST standards.
Key Features
- Monolithic acrylic water bath construction eliminates seam-related leakage and minimizes evaporation; integrated vessel cover reduces ambient contamination and thermal drift.
- Digital closed-loop motor control with high-torque permanent-magnet drive enables precise speed regulation from 25 to 350 rpm (0.1 rpm resolution, ±0.2 rpm accuracy).
- “QuickChange” universal shaft assembly supports rapid interchange of paddles, baskets, and sinker devices without tools; built-in height adjustment ensures repeatable vessel-to-shaft centering (<0.01° tilt tolerance).
- Modular cup configuration: standard 6-vessel layout; optionally configurable for 7 or 8 vessels; vessel volumes selectable from 100 mL to 4000 mL in transparent or amber glass.
- Integrated SystemLink™ communications architecture enables bidirectional data exchange via RS-232 and RS-485 ports; supports direct connection to LIMS, chromatography data systems (CDS), and automated sampling platforms.
- Front-accessible service panel and tool-free vessel tray removal simplify routine maintenance, cleaning, and GLP-compliant instrument qualification (IQ/OQ/PQ).
Sample Compatibility & Compliance
The 2100C accommodates standard USP Apparatus I (basket) and II (paddle) configurations, as well as extended geometries including reciprocating cylinder (Apparatus III), flow-through cell (Apparatus IV), and intrinsic dissolution cells. Vessel options include 1 L, 2 L, and 4 L capacities in borosilicate glass; basket mesh sizes range from 20 to 80 mesh per USP requirements. All mechanical and thermal performance criteria meet or exceed USP and ISO 10993-12 specifications for dissolution apparatus qualification. The system supports 21 CFR Part 11–compliant audit trails when paired with validated third-party software (e.g., Empower™ or Analyst™), and its hardware design conforms to IEC 61010-1 safety standards for laboratory equipment.
Software & Data Management
While the 2100C operates as a standalone instrument with local LED interface, its embedded RS-232/RS-485 ports enable seamless integration into regulated laboratory environments. When connected to validated PC-based control software, the system logs timestamped parameters—including actual bath temperature, setpoint deviation, shaft RPM, runtime, and error flags—with automatic export to CSV or XML formats. Audit trail functionality captures user identity, parameter changes, and calibration events—fully supporting ALCOA+ data integrity principles. Instrument firmware is field-upgradable and retains version history for GMP traceability.
Applications
This system is routinely deployed in pharmaceutical QC/QA laboratories for routine release testing of immediate- and extended-release solid oral dosage forms (tablets, capsules, pellets). It supports formulation development studies requiring precise discrimination between product variants, dissolution profile comparison per FDA Guidance for Industry (2015), and stability-indicating method validation. Academic and contract research organizations utilize the 2100C for biorelevant dissolution modeling (e.g., FaSSIF/FeSSIF media), excipient interaction screening, and in vitro–in vivo correlation (IVIVC) model generation. Its thermal stability and mechanical repeatability make it suitable for long-duration dissolution runs (>24 h) under GLP conditions.
FAQ
Is this unit certified for GMP use?
Yes—this refurbished 2100C includes full operational verification, documented calibration against NIST-traceable references, and a 6-month limited warranty covering parts and labor. IQ/OQ documentation templates are available upon request.
What validation support is provided?
Spectralab supplies a Certificate of Conformance, as-found/as-left test reports, and a summary of mechanical and thermal qualification per ASTM E2503–22. Full PQ support requires site-specific protocol development.
Can the system be integrated with automated samplers?
Yes—the RS-232 and RS-485 interfaces are compatible with leading autosamplers (e.g., Gilson FC204, Agilent 7693) using standard Modbus RTU or custom ASCII command sets.
Are spare parts and consumables available?
All original Distek replacement components—including TCS-0200C thermal modules, QuickChange shafts, baskets, paddles, and vessel gaskets—are stocked and ship globally within 48 hours.
Does the unit include software?
No—the 2100C is hardware-only. Third-party dissolution control software (e.g., WinDiss, Dissolution Pro) must be licensed separately and validated per your internal SOPs.
