Haosoo DT12 Automated Dissolution Sampling System

Overview

The Haosoo DT12 Automated Dissolution Sampling System is a fully integrated, offline pharmaceutical dissolution testing platform engineered for compliance-driven laboratories requiring precise, reproducible, and auditable solid oral dosage form performance evaluation. Built upon the USP , , and standards—and aligned with ICH Q5A, Q5C, and regulatory expectations for method robustness—the DT12 combines a 12-vessel dissolution apparatus with a dedicated SC12 automated sampling workstation. Its dual-zone (6+6) rotational architecture enables concurrent execution of two independent dissolution protocols—such as comparative bioequivalence studies or stability-indicating method development—without cross-contamination or thermal interference. Each 1000 mL vessel features individual Pt100 temperature sensing with real-time feedback control, ensuring spatial thermal uniformity within ±0.2 °C across the entire bath (40 L capacity), while the water jacket maintains stable thermal inertia from ambient up to 55 °C at 0.01 °C resolution.

Key Features

• Modular, GMP-ready architecture supporting both paddle and basket configurations per USP Apparatus 2 and 1
• Dual-speed zoning: Independent speed control for two groups of six vessels (1–300 rpm), enabling parallel batch testing under differentiated hydrodynamic conditions
• 12 synchronized high-precision syringe pumps delivering automated filtration (0.45 µm or 0.22 µm membrane), timed sampling, medium replenishment, and on-line dilution
• Integrated UV/HPLC-ready sample handling: 192-position 10 mL tube rack + optional 1.5 mL crimp-top vial tray with barcode support
• On-board sterilization: UV-C LED array embedded in recirculating fluid path to suppress microbial proliferation in dissolution medium
• Real-time vessel-level temperature monitoring with NIST-traceable calibration routine and drift compensation
• Comprehensive safety suite: Mechanical emergency stop, liquid level sensors, dual-stage overtemperature cutoff, and collision-detection during probe descent
• Android-based 7-inch capacitive touchscreen UI with intuitive workflow navigation, offline method editing, and one-touch report generation

Sample Compatibility & Compliance

The DT12 accommodates standard USP-compliant dissolution vessels (1000 mL cylindrical glass), including sinker-equipped formulations and extended-release matrices. It supports immediate-release tablets, capsules, orally disintegrating tablets (ODTs), and multiparticulate systems—including pellets, granules, and mini-tablets—provided mechanical stability permits paddle/basket immersion. All firmware and software modules are designed to meet FDA 21 CFR Part 11 requirements for electronic records and signatures, featuring time-stamped audit trails, role-based access control (administrator, analyst, reviewer), and biometric fingerprint authentication. System validation documentation includes IQ/OQ templates compliant with ASTM E2503 and ISO/IEC 17025 laboratory accreditation frameworks. Calibration certificates for temperature sensors and rotational encoders are traceable to national metrology institutes.

Software & Data Management

The embedded dissolution management software provides full lifecycle method control—from protocol definition (dissolution medium, pH, surfactant concentration, sink condition settings) to dynamic event scheduling (e.g., staggered dosing, multi-timepoint sampling, dissolution breakpoint triggers). Data export supports CSV, PDF, and XML formats via USB, RS232, or encrypted Wi-Fi transmission to LIMS or ELN platforms. Over-the-air firmware updates preserve system integrity without local PC dependency. All raw sensor logs (temperature, RPM, pump actuation timestamps, pressure feedback) are retained with SHA-256 hashing for forensic data integrity verification. The built-in thermal printer generates GLP-compliant hardcopy reports containing operator ID, method version, environmental log, and pass/fail status against pre-defined acceptance criteria.

Applications

• Regulatory submission support for ANDA, NDA, and MAA dossiers requiring dissolution profile comparison (f2 similarity testing)
• Formulation development: Excipient screening, coating thickness optimization, and release mechanism modeling (zero-order, Higuchi, Korsmeyer-Peppas)
• Stability studies: Accelerated and real-time dissolution trend analysis across storage conditions
• Quality control release testing per pharmacopoeial monographs (USP, EP, ChP)
• Biopharmaceutics Classification System (BCS) classification support through intrinsic dissolution rate determination
• Reference-standard qualification and compendial method transfer verification

FAQ

Does the DT12 comply with 21 CFR Part 11 for electronic records?
Yes—audit trail logging, electronic signature capture, and user permission tiers are implemented at the firmware level and validated per Annex 11 and ALCOA+ principles.
Can the system perform sequential sampling across multiple timepoints without manual intervention?
Yes—up to 24 programmable sampling events per vessel, with configurable hold times, filter priming cycles, and post-sampling rinse sequences.
Is external HPLC or UV-Vis integration supported?
Yes—via standardized ASCII command protocols over RS232 or TCP/IP; instrument drivers available for Agilent OpenLab, Waters Empower, and Thermo Chromeleon.
What calibration standards are included with shipment?
NIST-traceable PT100 probe calibration certificate, rotational encoder verification sheet, and volumetric pump linearity report (5–100% range).
Can the DT12 be operated in a cleanroom environment (ISO Class 7)?
Yes—optional stainless-steel enclosure upgrade and HEPA-filtered air purge kit are available for controlled environments.