Pharma-test DFC1220 12-Position Automated Sampling Dissolution System

Overview

The Pharma-test DFC1220 12-Position Automated Sampling Dissolution System is a pre-owned, fully functional dissolution testing platform engineered for pharmaceutical quality control and formulation development laboratories operating under regulated environments. Designed in accordance with the core principles of USP , Ph. Eur. 2.9.3, and JP 17 dissolution methodologies, this system implements a standardized paddle or basket apparatus coupled with real-time, automated sampling and UV-Vis quantification. The DFC1220 integrates a precision-engineered 12-vessel dissolution bath with temperature-controlled water circulation (±0.2 °C), programmable rotation speed (25–250 rpm), and synchronized sampling logic. Its modular architecture allows seamless integration with any Pharma-test dissolution tester (e.g., PT-DT series), transforming standalone units into fully compliant online dissolution systems without hardware retrofitting.

Key Features

• 12-position dissolution vessel array with independent temperature monitoring and digital PID-controlled heating/circulation
• Automated sampling module featuring dual-stage filtration (0.45 µm syringe filter + optional 0.22 µm inline filter) to prevent line clogging and ensure particulate-free aliquots
• IPC8 or IPC16 multi-channel peristaltic pump delivering high reproducibility across all channels (flow rate stability ±1.5% CV over 24 h)
• UV-Vis detection module supporting 8- or 16-cell carousels; compatible with standard quartz or UV-grade fused silica cuvettes (pathlengths 0.1 mm to 20 mm)
• Win DISS 32 software platform validated for 21 CFR Part 11 compliance—supporting electronic signatures, audit trails, user role-based access control, and secure data archiving
• Open architecture enabling bidirectional communication with third-party UV-Vis spectrophotometers (e.g., Agilent Cary, Shimadzu UV-1900, Thermo Scientific Evolution series) via RS-232 or Ethernet

Sample Compatibility & Compliance

The DFC1220 accommodates solid oral dosage forms including immediate-release tablets, extended-release capsules, orally disintegrating tablets (ODTs), and multiparticulate systems. Sample handling adheres to GLP and GMP requirements for dissolution method transfer and validation. All wetted components—including tubing, filters, and sample loops—are chemically resistant (PharMed® BPT or Santoprene®) and compatible with common dissolution media (0.1 N HCl, pH 4.5 acetate buffer, pH 6.8 phosphate buffer, simulated gastric/intestinal fluids). The system meets ASTM E2503–21 (Standard Practice for Performance Verification of Dissolution Apparatus) and supports IQ/OQ documentation packages for laboratory qualification. Full traceability is maintained through time-stamped sampling events, temperature logs, and raw absorbance spectra stored in secure .diss binary format.

Software & Data Management

Win DISS 32 serves as the central control and analytical engine. It provides method-driven workflow automation: defining dissolution profiles (e.g., multi-timepoint sampling at 5, 10, 15, 30, 45, 60 min), auto-calibration routines (blank subtraction, wavelength verification), and real-time concentration calculation using Beer-Lambert law with optional multi-point calibration curves. All data—including raw UV scans, calculated % dissolved, and system event logs—are stored in an encrypted SQL Server database. Reports are exportable in PDF, CSV, and XML formats, with configurable templates aligned to internal SOPs or regulatory submission standards (e.g., CTD Module 3). Audit trail records capture operator ID, timestamp, parameter changes, and result modifications—fully compliant with FDA and EMA expectations for electronic records integrity.

Applications

• Comparative dissolution profiling for generic drug development and bioequivalence studies
• Stability-indicating dissolution testing during accelerated and long-term stability programs
• In-process control (IPC) of tablet coating uniformity and release kinetics
• Excipient interaction screening during preformulation
• Method validation and robustness assessment per ICH Q2(R2)
• Support of ANDA, NDA, and MAA regulatory submissions requiring dissolution data traceability

FAQ

Is this unit supplied with original calibration certificates and maintenance history?
Yes—this pre-owned DFC1220 includes full service records from prior operational use, factory calibration reports for temperature, rotation speed, and sampling volume accuracy, and a recent operational verification test report.
Can Win DISS 32 be installed on modern Windows OS platforms?
Win DISS 32 v3.2.1 and later support Windows 10 (64-bit) and Windows 11; virtualization options (VMware Workstation) are available for legacy method continuity.
What validation documentation is included?
A complete IQ/OQ protocol package is provided, aligned with ASTM E2503 and USP , including instrument specifications, test procedures, acceptance criteria, and executed worksheets.
Does the system support sink condition monitoring or pH-stat functionality?
No—the DFC1220 does not include integrated pH sensing or automatic media replenishment; it operates as a fixed-volume, non-sink dissolution system per standard USP protocols.
Are spare parts and technical support available post-purchase?
Pharma-test continues to supply consumables (tubing kits, filters, cuvette trays) and offers remote diagnostics and on-site service contracts through authorized EU-based partners.