ANDISSO D1200 PRO 12-Position Automated Dissolution Sampling System
| Brand | ANDISSO |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Authorized Distributor |
| Regional Classification | Domestic (China) |
| Model | D1200 PRO |
| Instrument Type | Online Sampling Dissolution System |
| Vessels | 12 |
| Temperature Range | Ambient to 50 °C |
| Temperature Accuracy | ±0.2 °C |
| Water Bath Volume | 46 L |
Overview
The ANDISSO D1200 PRO is a fully automated, online dissolution sampling system engineered for pharmaceutical quality control and formulation development laboratories requiring high-throughput, regulatory-compliant dissolution testing. It operates on the principle of standardized USP Apparatus 1 (basket), Apparatus 2 (paddle), Apparatus 3 (reciprocating cylinder), Apparatus 4 (flow-through cell), and Apparatus 5/6 (rotating disk and paddle-over-disk) — all enabled via interchangeable mechanical adapters. Designed in strict alignment with the 2020 Chinese Pharmacopoeia (ChP) Chapter “Dissolution and Release Testing”, the system supports method transfer across global pharmacopoeial standards including USP, EP, and JP. Its robust architecture ensures stable hydrodynamic conditions, precise temperature maintenance, and minimal sample handling variability—critical for generating data suitable for regulatory submissions under ICH Q5C and Q6A guidelines.
Key Features
- 12-vessel parallel configuration with independent temperature control per station, enabling concurrent multi-formulation or multi-timepoint studies
- Integrated online sampling module with programmable timing, volume selection (1–10 mL), and automated filtration (0.45 µm or 0.22 µm membrane compatibility)
- High-stability water bath with 46 L capacity and PID-controlled heating; maintains ±0.2 °C accuracy across the full 20–50 °C operational range
- Modular adapter platform supporting USP Apparatus 1–6 configurations without hardware reconfiguration—reducing method validation effort
- Corrosion-resistant stainless-steel frame, PTFE-coated sampling probes, and sealed drive mechanisms for long-term reliability in aqueous and organic solvent environments
- Compliance-ready design featuring audit trail logging, user access levels, and electronic signature support aligned with FDA 21 CFR Part 11 requirements
Sample Compatibility & Compliance
The D1200 PRO accommodates a broad spectrum of solid oral dosage forms—including immediate-release tablets, extended-release capsules, matrix-based pellets, transdermal patches, and buccal films—as well as specialized dosage forms requiring non-standard dissolution geometries. Optional accessories include static dialysis baskets, immersion cells, intrinsic dissolution apparatuses, and sedimentation baskets, each validated for use under ChP Annexes and USP . All vessel assemblies meet ISO 9001-certified dimensional tolerances and surface finish specifications (Ra ≤ 0.8 µm). The system’s mechanical calibration protocol conforms to USP and ChP mechanical verification criteria, including rotational speed accuracy (±1 rpm), centering tolerance (<1.0 mm), and wobble measurement (<0.2 mm).
Software & Data Management
Controlled via ANDISSO Dissolution Suite v3.2, the system delivers full lifecycle data management—from method creation and instrument calibration to real-time monitoring and report generation. Software features include GLP-compliant electronic notebooks, automatic metadata tagging (operator ID, timestamp, environmental log), and export-ready output in CSV, PDF, and XML formats compliant with CDISC SDTM standards. Audit trails record all parameter modifications, sampling events, and user actions with immutable timestamps. Integration with LIMS platforms (e.g., Thermo Fisher SampleManager, LabVantage) is supported via ASTM E1384-compliant API interfaces. Data integrity safeguards include dual-password authentication, role-based permissions, and encrypted local database storage.
Applications
- Comparative dissolution profiling of generic and reference listed drugs (RLDs) per FDA Guidance for Industry (2013)
- Stability-indicating release testing during accelerated and long-term stability programs (ICH Q1A–Q1E)
- In vitro–in vivo correlation (IVIVC) model development for modified-release products
- Excipient screening and formulation optimization using discriminatory dissolution media (e.g., pH-shift, surfactant-containing, biorelevant fluids)
- Quality-by-Design (QbD) studies supporting Design Space definition per ICH Q8(R2)
- Regulatory batch release testing in GMP environments compliant with Annex 15 and EU GMP Chapter 6
FAQ
Does the D1200 PRO support USP Apparatus 4 (flow-through cell)?
Yes—via optional flow-through cell adapter kits with calibrated peristaltic pumps and reservoir modules meeting USP volumetric accuracy requirements (±2% at 8 mL/min).
Can the system be validated for 21 CFR Part 11 compliance?
Yes—the software includes configurable electronic signatures, audit trail review tools, and documented IQ/OQ/PQ protocols available upon request.
What is the maximum allowable sampling volume per timepoint?
Up to 10 mL per vessel per sampling event, with programmable replacement volume compensation to maintain sink conditions.
Is remote monitoring supported?
Yes—via secure HTTPS web interface with real-time status dashboard, alarm notifications, and historical trend visualization.
Are calibration certificates traceable to NIM (National Institute of Metrology, China)?
All temperature and rotational sensors are supplied with NIM-traceable calibration reports valid for 12 months.
