Pharma-test DFC1220SP Semi-Automatic Dissolution Testing System (Refurbished)

Overview

The Pharma-test DFC1220SP Semi-Automatic Dissolution Testing System is a rigorously refurbished, CE-certified dissolution apparatus engineered for pharmaceutical quality control laboratories requiring full compliance with international pharmacopoeial standards. Designed and manufactured in Germany, the DFC1220SP implements the paddle (USP Apparatus 2) and basket (USP Apparatus 1) dissolution methodologies under precisely controlled hydrodynamic and thermal conditions. Its core architecture centers on the PTWS 1220 water bath — a thermostatically regulated stainless-steel dissolution vessel housing eight independently aligned vessels — coupled with either an in-situ sampling probe or the EPE-1220 automated sampling module. This offline configuration enables discrete, time-resolved collection of dissolution media into vials or tubes housed in the PTFC-16 fraction collector. Unlike fully integrated online systems, the DFC1220SP prioritizes operational flexibility, mechanical robustness, and method traceability — making it particularly suited for routine QC testing, formulation development, and regulatory batch release in GLP- and GMP-aligned environments.

Key Features

• Eight-position dissolution bath (PTWS 1220) with precise ±0.2 °C temperature stability and independent vessel centering for reproducible hydrodynamics
• Dual PT-SP8 precision syringe pumps (2 × 10 mL capacity) for programmable, low-shear aspiration; compatible with alternative fluid handling options including Ismatec peristaltic and CAT piston pumps
• PTFC-16 fraction collector with refrigerated sample storage (4–10 °C), barcode-readable vial positions, and configurable tube rack geometry
• Two distinct sampling architectures: continuous in-situ probe immersion (for real-time monitoring applications) or intermittent EPE-1220 probe insertion/retraction (minimizing thermal disturbance and vessel contamination)
• Optional in-line temperature monitoring (ITM-1220) providing continuous media temperature logging at the sampling point, critical for USP validation
• Integrated media replenishment function to compensate for volume loss during sampling — essential for extended dissolution profiles (>60 min) and sink condition maintenance
• Modular expansion support for tablet drop testing (TM-1220/TMA-1220), hardness correlation studies, and thermal mapping verification

Sample Compatibility & Compliance

The DFC1220SP accommodates standard USP-compliant dissolution vessels (1000 mL, 900 mL, and custom geometries), baskets, paddles, and sinker devices. It supports immediate-release, modified-release, and extended-release solid oral dosage forms — including tablets, capsules, pellets, and mini-tablets — across pH 1.2 to 7.4 dissolution media. The system meets all mechanical calibration requirements outlined in USP (Dissolution) and (Drug Release), as well as European Pharmacopoeia monographs 2.9.3 (Dissolution Test for Solid Dosage Forms) and 2.9.4 (Dissolution Test for Transdermal Systems). All refurbished units undergo full mechanical verification, temperature uniformity mapping (per USP Annex), and pump flow-rate calibration against NIST-traceable standards. Documentation includes a comprehensive refurbishment report, IQ/OQ summary, and certificate of conformance to ISO 9001 and ISO/IEC 17025 principles.

Software & Data Management

While the DFC1220SP operates via dedicated front-panel controls and hardware timers, its data acquisition and reporting are fully compatible with third-party LIMS and chromatography data systems (CDS) via RS-232 or USB-to-serial interfaces. All sampling events, pump actuation timestamps, temperature logs (when ITM-1220 is installed), and media replenishment cycles are recorded with millisecond resolution and stored in CSV or ASCII format. When paired with the PT-RP80 thermal printer, the system generates audit-ready hardcopy reports containing test parameters, vessel IDs, sampling times, volumes aspirated, and operator signatures — satisfying FDA 21 CFR Part 11 requirements for electronic records when used within validated workflows. Audit trails, user access levels, and electronic signature capture are managed externally through validated laboratory software platforms.

Applications

• Routine QC dissolution testing for batch release in accordance with ICH Q5A and Q5C guidelines
• Comparative dissolution profiling (f1/f2 analysis) during generic product development and bioequivalence studies
• Stability-indicating method development for detecting degradation products in dissolution media
• Excipient interaction screening via pH-shifted or surfactant-enhanced dissolution protocols
• Validation of dissolution apparatus performance per USP mechanical calibration and hydrodynamic qualification
• Supporting regulatory submissions to EMA, PMDA, Health Canada, and ANVISA with fully documented instrument history and calibration lineage

FAQ

Is this unit supplied with full documentation and calibration records?
Yes — each refurbished DFC1220SP includes a complete refurbishment dossier, mechanical verification report, temperature uniformity map, pump calibration certificates, and a Certificate of Conformance compliant with ISO 9001 and ISO/IEC 17025.
Can the system be upgraded to full automation or connected to HPLC autosamplers?
The DFC1220SP’s modular architecture supports integration with external autosamplers via TTL-triggered I/O ports and analog output signals; however, native HPLC coupling requires custom interface engineering and is not included in the base configuration.
What is the typical lead time for installation and qualification support?
Standard delivery includes pre-shipment functional testing; on-site IQ/OQ support is available globally through certified Pharma-test service partners, with typical turnaround of 5–10 business days post-installation.
Does the system support dissolution testing of transdermal patches or implants?
Yes — with appropriate vessel modifications (e.g., flow-through cells or paddle-over-disk assemblies), the DFC1220SP has been successfully deployed for EP 2.9.4-compliant transdermal system testing and implant erosion studies under static or dynamic media exchange modes.
Are spare parts and consumables readily available?
All critical components — including PT-SP8 pump syringes, PTFE tubing, fraction collector racks, and vessel gaskets — are stocked by authorized Pharma-test distributors in North America, EU, and APAC regions, with average lead time of 3–5 business days.