Logan UDT-870DLA 15-Vessel Dissolution Collection System
The Logan UDT-818-15 / SYSTEM 870DLA 15-Channel Fully Automated Injection Pump Dissolution Sampling System is specifically designed for high-throughput pharmaceutical quality control (QC), formulation development (R&D), and bioequivalence/bioequivalence (BE) testing. The system features a compact 15-channel matrix arrangement and supports independent speed control for 2 or 3 channels. A single unit can perfectly perform parallel execution of "standard statistical analysis of 12 samples (n=12) + dual-channel blank control/replacement" or "parallel comparison of two complete and independent formulations." In a high-precision flow field and ultra-low temperature bath environment, it significantly shortens the development cycle and eliminates batch-to-batch operational errors.
I. Fully compliant with ICH M9, USP <711/724> (Apparatus 1, 2, 5, 6), EP, BP, JP and ChP specifications; features 2-zone or 3-zone independent speed control (up to 300 RPM), giving formulation screening a high degree of freedom.
II. The integrated anti-evaporation water bath and double-layer insulated cup lid design (15-vessel measured internal temperature difference < 0.2°C), combined with dual high-torque optically encoded feedback injection pumps (SYP-8L-10 × 2), enables 15-channel synchronous precise sampling (accuracy up to ±0.05 mL).
III. Built-in automatic pipeline pre-lubrication (Flushing/Rinsing), media replacement (media replacement at equal volume and temperature/room temperature), filter membrane back-flushing, and automatic pipeline emptying and cleaning after testing (Auto Cleaning) to completely eliminate cross-contamination.
IV. The system fully complies with FDA 21 CFR Part 11 and ALCOA+ data integrity standards; it supports password-level protection or fingerprint recognition, 3-view camera monitoring and remote monitoring via mobile devices, ensuring data authenticity and preventing tampering.
Equipment Introduction
Regulatory Compliance & High-Throughput Parallel Testing
Fully compliant with ICH M9, USP, EP, JP and ChP standards. The 15-vessel configuration perfectly supports the evaluation of the dissolution uniformity of 12 tablets (n=12) in a single batch, with reserved standard tanks, blank tanks or solvent replenishment tanks; it can also perform parallel screening of multiple prescriptions to eliminate systematic errors across days and between different instruments.
2 or 3 Speed Zones Independent Control
Supports independent speed settings for 2 or 3 zones (up to 300 RPM), allowing simultaneous examination of the effects of different stirring shear forces (such as 50 RPM vs 75 RPM vs 100 RPM) on drug release rate under the same water bath conditions.
High-Precision Dual Syringe Pump System
It is equipped with two SYP-8L-10 (SYP-8L2B-10ml) high-precision syringe pump modules, which are integrated into the DSC-800 system controller to maximize desktop space saving.
It employs a high-torque motor paired with an optical encoder closed-loop feedback control, achieving a transmission accuracy better than ±0.05 mL when the sampling volume is greater than 1 mL (up to 10 mL per stroke).
Multi-specification secondary in-line filtration system
The sampling flow path supports secondary filtration technology and is compatible with standard 13 mm, 25 mm, and 38 mm syringe filters (small disc, 0.22 µm or 0.45 µm) from various brands. It can be directly filtered and injected into sample vials for seamless integration with HPLC/UPLC instruments.
Fully automated flow path self-cleaning and solvent replenishment functions.
Pre-sampling flushing/rinsing : The media is automatically extracted to flush the pipeline before sampling to prevent adsorption and dilution errors.
Media Replacement : After sampling, fresh medium is automatically replenished at the same volume to precisely maintain the sink condition.
Back-flushing & Auto-Cleaning : The filter membrane is backflushed during replenishment. After the test, it is automatically emptied and cleaned, and the sampling, replenishment and needle tubing are cleaned, leaving zero sample residue.
Fully enclosed anti-evaporation and low thermal loss water bath
The one-piece molded water bath has no dead corners and is equipped with patented double-layer anti-evaporation cup covers. The water bath temperature control accuracy reaches ±0.1°C, and the temperature difference in each cup is strictly controlled within 0.2°C, effectively preventing the volatilization of the released medium over a long period of time.
Multi-view real-time recording and infrared light-shielding monitoring (Three Camera System & Darkroom Monitoring)
Optional three-view camera system: bottom camera view, in-shaft camera view, and side camera view. Supports darkroom infrared imaging, and can record sample breakage, coning, and adhesion of photosensitive drugs throughout the process, quickly pinpointing the cause of OOS/OOT anomalies.
Smart Remote Monitoring System
It supports real-time viewing of test status, water bath temperature, speed and remaining time on mobile devices (phones/tablets), and has real-time alarm push notifications for abnormal deviations, greatly improving the management efficiency of unattended testing.
Data Integrity and 21 CFR Part 11 Compliance
Compliant with FDA 21 CFR Part 11 and GMP/GLP regulations, and features a built-in tamper-proof Audit Trail electronic audit track.
Supports multi-level access control (password protection or optional fingerprint scanner).
Supports two-way networking integration with the LIMS laboratory information management system.
Product Features
Ultra-high throughput 15-vessel configuration
2 or 3 independent speed settings
n=12 complete parallel statistics
Dual precision syringe pumps for sampling
Automatic tubing cleaning
Secondary filtration
Sampling accuracy up to ±0.05 mL
Compliant with 21 CFR Part 11
Overall Specifications
Vessel configuration : 15 vessel (compact matrix arrangement, supporting single-batch 12 tablets n=12 dissolution uniformity assessment, with standard sample vessel, blank vessel or solvent replenishment vessels, fully compliant with ICH M9, USP, EP, JP and ChP specifications)
Applicable vessel specifications : Standard configuration includes a 1000 mL one-piece seamless water bath (with patented dual vessel covers, compatible with USP Apparatus 1, 2, 5, and 6).
Stirring speed range : 25 ~ 300 RPM (customizable) (speed accuracy ±1 RPM, resolution 0.1 RPM), with 2-zone or 3-zone independent speed control function.
Temperature control accuracy : room temperature ~ 45.0°C, water bath temperature control accuracy ±0.1°C, temperature difference within each bath strictly controlled within 0.2°C, featuring low heat loss and protection against long-term medium volatilization.
Dosing and height positioning mechanism : Standard configuration includes an automatic dosing tray (Tablet Dropping Trays, supporting simultaneous and precise dosing of 1 or 2 samples), accurately corresponding to the specified heights of the USP basket method, paddle method, rotary drum method, and disc method.
Sampling System and Pump Unit : Equipped with 2 sets of SYP-8L-10 (SYP-8L2B-10ml) high-precision syringe pump modules (built into the DSC-800 system controller, saving desktop space), using a high-torque motor paired with an optical encoder closed-loop feedback control.
Sampling speed and cycle time : The entire channel synchronous sampling cycle is completed within 3 minutes, meeting the USP <711> 2% sampling time error specification requirements.
Sampling volume range : 1.0 ~ 10.0 mL (maximum 10 mL per stroke; transmission accuracy better than ±0.05 mL when sampling volume > 1 mL)
Filtration and flow path self-cleaning functions : compatible with 13 mm, 25 mm, and 38 mm syringe filters (small disc, 0.22 µm or 0.45 µm secondary filtration); features pre-wetting of the medium before sampling, isochoric and isothermal replenishment of the medium after sampling (maintaining sink condition), membrane backwashing, and fully automatic emptying and self-cleaning of tubing and syringes after testing.
Method storage capacity : The DSC-800 system controller has a built-in storage of up to 100 single-page test method protocols.
Number of sampling points : Up to 20 sampling time points can be set for a single method; supports pre-sampling alarm reminders and automatic scheduling of multiple time periods.
Sample rack compatibility specifications (SCR-DL-15 collector) : Up to 20 rows (8 or 16 vials per row), standard 1.5/2.0 mL HPLC/UPLC sample vial tray and 10 mL glass tube tray; equipped with automatic piercing needles, compatible with pre-compressed sealing gaskets.
Data storage and audit trail : Compliant with FDA 21 CFR Part 11, GMP/GLP, and ALCOA+ standards; built-in tamper-proof electronic audit trail, original data files are tamper-proof, and complete PVT validation data and IQ/OQ validation documents are included as standard.
User access control : Hierarchical access control, supports password login or optional fingerprint scanner, and supports bidirectional network integration with the LIMS laboratory information management system.
External analysis and coupling expansion : Supports online ultraviolet spectrophotometry (UV-1900 + ADUV), online liquid chromatography (FC-1200 / SYP-1200 + ADLC), in-situ fiber optic continuous monitoring (Rainbow R6), 1-100x online automatic dilution, and coupling with the PERMETRO biomimetic membrane permeation system (IVIVC evaluation).
Image monitoring and remote management (optional) : Optional three-view camera system (bottom view, stirring axis, side view), supporting infrared imaging monitoring of sample scattering and coning in a darkroom; supports remote real-time monitoring and anomaly push notifications via smart mobile devices.
Equipment dimensions and power supply :
DSC-800 controller (including dual injection pumps): 12" × 15" × 24" (approx. 30 × 38 × 61 cm)
SCR-DL-15 Sample Collector: 19" × 22" × 19" (approx. 48 × 56 × 48 cm)
Main unit UDT-818-15: Approximately 80 × 65 × 66 cm
Power requirements: 110V / 220V, 50/60 Hz