Logan UDT-880DLA 18-Vessel Dissolution Collection System
The Logan UDT 880-18 / SYSTEM 880DLA 18-vessel tablet dissolution tester is designed for ultra-high throughput pharmaceutical quality control (QC), formulation research and development (R&D), and bioequivalence (BE) testing. It adopts the industry's highest specification 18-vessel layout (capable of simultaneously performing 18 samples or 6+6+6 three-batch parallel comparison tests), and can efficiently complete the dissolution-release assessment and dissolution curve comparison test of various solid oral formulations under extremely uniform and precise temperature-controlled water bath flow field conditions.
I. Fully compliant with ICH M9, USP <711/724>, EP, BP, JP and ChP specifications; supports single-zone and dual-zone independent speed control (up to 300 RPM), significantly improving the efficiency of parallel screening and comparison between original drugs and different candidate prescriptions.
II. One-piece molded anti-evaporation double-layer insulation design (18-vessel measured temperature difference < 0.2°C), combined with high-precision automatic positioning sampling (compliant with USP 2% sampling time tolerance) and compatible multi-specification needle filtration; providing excellent data reproducibility in a compact 18-vessel configuration with ultra-high throughput.
III. Independent multi-channel flow path supports automatic pipeline cleaning, online dilution, sample return, and constant temperature/room temperature solvent replenishment; built-in 3-4 level access control (up to 100 independent accounts) and 3 million anti-tampering electronic audit trails.
IV. The system fully complies with FDA 21 CFR Part 11 and ALCOA+ data integrity standards; an optional infrared darkroom real-time video recording and monitoring system can be installed to fully ensure the authenticity and traceability of data throughout the dissolution process.
Equipment Introduction
Compliance with regulations and parallel development of ultra-high throughput.
It complies with the 12-to-12 or 18 complete statistical sample comparison specifications of ICH M9 and various national pharmacopoeias (USP/EP/JP/ChP). A single machine can complete parallel testing of 18 samples or three batches of preparations: "original reference drug (6) vs candidate prescription A (6) vs candidate prescription B (6)", completely eliminating systematic errors caused by cross-batch, cross-day and different water baths.
Multi-Zone Independent Speed Control
It supports independent speed settings for single and dual zones (such as 9+9 zones), enabling formulation development to study the effects of different speeds on shear force in the same experiment, significantly improving R&D efficiency and screening speed.
Fully Sealed & Dual-Layer Thermal Anti-Evaporation Design
It adopts a one-piece molded fully enclosed and double-layer heat-insulating low-evaporation module, which almost completely blocks the contact with the outside air. The temperature difference is extremely small (the actual temperature difference of 18 vessel is within 0.2°C: water tank 37.0°C, cup 37.0–36.8°C), which fully complies with the legal evaporation rate specifications.
Automated Positioning Sampling & Secondary In-Line Filtration
The sampling rack has an automatic positioning function, a fast sampling speed, and fully complies with the 2% sampling time error requirement of USP <711>.
Supports simultaneous drive of 3 sets of SYP-6L syringe pumps with a total of 18 channels, compatible with various specifications of secondary filter heads (no brand restrictions), replacing tedious manual filtration; features an independent pipeline operation design, supports automatic cleaning, dilution, reflux and constant temperature/room temperature replenishment, eliminating cross-contamination.
Real-Time Video Recording & Infrared Darkroom Imaging
It can be expanded to include a basket and paddle real-time recording system (supporting bottom, in-shaft, and side angles), and has a built-in infrared light-avoidance shooting function, which can fully record the sample disintegration and dissolution process under light-avoidance test conditions, accelerating the investigation of OOS/OOT anomalies.
Data Integrity and 21 CFR Part 11 Compliance
It has a storage capacity of 3 million electronic audit trails, and the original files cannot be deleted or edited.
Supports 3-4 levels of user permission management (up to 100 independent operator accounts and passwords can be created).
Ultra-high throughput and optimized footprint
The output capacity of an 18-vessel machine is equivalent to 2.5 to 3 traditional 6/8-vessel machines, maximizing the saving of cleanroom and laboratory table space.
The system controller (DSC-800) is highly expandable and can simultaneously control multiple solvent generators (without brand restrictions). It can also be connected in series with MDS solvent generators and AVC automatic cleaning systems.
Secondary Syringe Filter Compatibility
Fully compatible with standard 13 mm, 25 mm and 38 mm needle filters (small flying saucer) from various brands, and can be freely configured with 0.22 µm or 0.45 µm PTFE / PVDF / Nylon / PES filter membranes according to methodological requirements.
Product Features
Ultra-high throughput 18-vessel configuration
Multi-zone independent speed
Three batches executed
Meets experimental and original control requirements
High-precision independent temperature control; stable fluid dynamics design.
Highly automated and expandable
21 CFR Part 11
Overall Specifications
Vessel configuration : 18-Vessel (ultra-high throughput 3×6 matrix arrangement, supporting 3 independent 6-vessel tests, multi-lot parallel screening, or n=12/n=16 complete parallel validation with standard and blank 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 (speed accuracy ±1 RPM, resolution 0.1 RPM), with 2 or 3 independent speed zone control function (multiple sets of different stirring shear force can be set at the same time for testing).
Temperature control accuracy : room temperature ~ 45.0°C, water bath temperature control accuracy ±0.1°C, temperature difference within each tank strictly controlled within 0.2°C, featuring low heat loss and protection against long-term medium volatilization; large-area, dead-angle-free water bath facilitates daily maintenance.
Dosing and height positioning mechanism : Standard configuration includes multiple sets of synchronous automatic dosing trays (tablet dropping trays, supporting precise synchronous dosing in sections or the entire tank), 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 3 sets of SYP-6L-10 (SYP-6L2B-10ml) high-precision syringe pump modules (integrated into the DSC-800 system controller, driven by matrix synchronous push-pull), using high-torque motors with optical encoder closed-loop feedback control.
Sampling speed and cycle time : The entire 18-vessel 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, supports micro-sampling)
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-18 collector) : Up to 20 rows (18 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 (capable of storing up to 3 million records), 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 (four levels: operator, team leader, administrator, and original equipment engineer), supports 100 sets of account password logins or optional fingerprint scanner, and supports two-way 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 three syringe pump arrays): 12" × 15" × 24" (approximately 30 × 38 × 61 cm)
SCR-DL-18 Sample Collector: 19" × 22" × 19" (approx. 48 × 56 × 48 cm)
Main unit UDT-818-18: Approximately 90 × 65 × 66 cm
Power requirements: 110V / 220V, 50/60 Hz