Pharma-test PTWS 1220 Dissolution Tester

Overview

The Pharma-test PTWS 1220 is a CE-marked, 12-vessel dissolution testing system engineered for pharmaceutical quality control laboratories requiring strict adherence to global pharmacopoeial standards. Designed in accordance with the hydrodynamic principles defined in USP Chapter (Dissolution) and (Drug Release), as well as European Pharmacopoeia monographs 2.9.3 (Dissolution Test for Solid Dosage Forms) and 2.9.4 (Apparatus for Drug Release Testing), the PTWS 1220 implements a single-drive mechanical architecture with independent vessel positioning and synchronized paddle or basket rotation. Its temperature-controlled water bath maintains thermal equilibrium across all 12 vessels within ±0.2 °C of setpoint (typically 37.0 °C), verified via integrated platinum resistance thermometer (PT100) sensors and logged automatically at each sampling interval. The system operates under laminar flow conditions compliant with USP-specified fluid dynamics for sink condition validation, supporting both immediate-release and modified-release solid oral dosage forms.

Key Features

• Single-motor, 12-position drive mechanism with individual vessel encoding—ensures traceability and eliminates cross-vessel calibration drift
• Motorized lift column with programmable vertical travel for precise immersion depth control per USP requirements
• Real-time temperature monitoring and logging at every sampling event—data stamped with date, time, and vessel ID
• Traffic-light status display (green = ready, yellow = warming/stabilizing, red = fault or deviation beyond tolerance)
• Optical and acoustic sampling alerts synchronized with pre-defined test protocols—reducing operator dependency and timing errors
• SD card-based method storage supporting hundreds of user-defined dissolution protocols—including variable rpm profiles, multi-stage temperature ramps, and staggered sampling schedules
• Onboard power-up self-diagnostic routine verifying motor function, temperature sensor integrity, lift position accuracy, and communication bus health
• Low-volatility vessel lids minimizing solvent evaporation during extended tests (e.g., 24–72 h extended-release studies)
• Quick-release water bath assembly—designed for tool-free removal, enabling full access for cleaning, decontamination, and verification of thermal uniformity per ASTM E2503
• Role-based user authentication with configurable permissions for method editing, result export, system configuration, and audit trail review

Sample Compatibility & Compliance

The PTWS 1220 accommodates standard USP Apparatus 1 (basket) and Apparatus 2 (paddle) configurations with optional accessories for Apparatus 3 (reciprocating cylinder) and Apparatus 4 (flow-through cell) when integrated with external pumping modules. It supports dissolution media volumes from 500 mL to 1000 mL per vessel and accepts tablets, capsules, granules, and orally disintegrating films. All operational parameters—including rotation speed (25–200 rpm), temperature setpoint (25–45 °C), and sampling intervals—are fully programmable and auditable. The system meets regulatory expectations for data integrity under FDA 21 CFR Part 11 (when paired with validated third-party LIMS or electronic lab notebook systems), supports GLP/GMP-aligned documentation practices, and includes built-in prompts for Operational Qualification (OQ) and Performance Qualification (PQ) execution per ICH Q5C and USP .

Software & Data Management

While the PTWS 1220 operates as a standalone instrument with embedded firmware, its SD card interface enables seamless transfer of raw time-stamped temperature logs, method metadata, and event timestamps (e.g., lift activation, sampling trigger, fault occurrence). Exported CSV files are structured for direct import into statistical process control (SPC) platforms or validated chromatography data systems (CDS). Audit trails—comprising user login/logout events, method modifications, and critical parameter changes—are retained on-device and exportable. Firmware supports firmware versioning and update logging, ensuring traceability during regulatory inspections. No proprietary software installation is required for basic operation; however, Pharma-test’s optional PT-Soft suite (v4.x+) provides enhanced visualization, trend analysis, and PQ report generation compatible with ISO/IEC 17025-accredited environments.

Applications

• Release testing of generic and innovator solid oral dosage forms per ANDA and NDA submission requirements
• Stability-indicating dissolution profiling during accelerated and long-term stability studies (ICH Q1A–Q1E)
• In vitro–in vivo correlation (IVIVC) model development using multi-timepoint sampling datasets
• Excipient compatibility assessment and formulation robustness evaluation under varying pH and surfactant conditions
• Support for biowaiver justification packages under WHO and EMA guidance for BCS Class I and III compounds
• Method transfer between QC labs and contract manufacturing organizations (CMOs) using standardized protocol templates

FAQ

Does the PTWS 1220 include factory calibration certificates?

No—this is a pre-owned unit; original calibration documentation is not included. Users must perform initial IQ/OQ/PQ per internal SOPs and applicable regulatory guidelines prior to first use.
Is the system compatible with automated sampling systems?

The PTWS 1220 does not integrate natively with auto-samplers; it is designed for manual sampling with timed visual/audible cues. However, its RS232 port allows synchronization signals to be sent to external robotic samplers via custom TTL-triggered interfaces.
What firmware version is installed?

Firmware version varies by unit history; typical field units operate on v3.2x or higher. Upgrades require authorized Pharma-test service support and valid license keys.
Can vessel temperature uniformity be verified per ASTM E2503?

Yes—the removable bath design and accessible sensor layout permit insertion of calibrated reference thermometers at designated positions (e.g., center, corner, mid-depth) to validate thermal homogeneity across all 12 vessels.
Is user training available for this used instrument?

Third-party technical training—covering operation, preventive maintenance, and PQ execution—is available through certified Pharma-test service partners upon request and subject to regional availability.