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Logan
12-Vessel Dissolution Collection System

Logan
12-Vessel Dissolution Collection System

Logan UDT-860DLA 12-Vessel Dissolution Collection System

The Logan UDT 880-18 / SYSTEM 860DLA 12-vessel tablet dissolution tester is designed for high-throughput pharmaceutical quality control (QC), formulation research and development (R&D), and bioequivalence (BE) testing. It features a high-throughput 12-vessel layout (capable of simultaneously performing 12 samples or 6+6 dual-batch parallel comparison tests), efficiently completing dissolution-release assessments and dissolution curve comparison tests for various solid oral formulations under extremely uniform and precise temperature-controlled water bath flow conditions.


I. Fully compliant with ICH M9, USP <711/724>, EP, BP, JP and ChP specifications; supports dual-zone and tri-zone independent speed control (up to 300 RPM), significantly improving the efficiency of parallel screening and comparison of different prescriptions.


II. One-piece molded anti-evaporation double-layer insulation design (12 vessel with 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 standard 8 vessel compact footprint.


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 (can set up 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 high-throughput parallel development.

    • It complies with the 12-to-12 development comparison specifications of ICH M9 and various national pharmacopoeias (USP/EP/JP/CP), and can complete parallel testing of 12 samples or two batches of preparations with a single machine.

  • Multi-Zone Independent Speed Control

    • It supports independent speed settings for dual-zone and tri-zone systems, enabling formula development at different speeds in the same experiment, significantly improving R&D efficiency.

  • Fully Sealed & Dual-Layer Thermal Anti-Evaporation Design

    • It adopts a one-piece molded fully enclosed and double-layered 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 12 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 multiple specifications of secondary filter heads (regardless of brand), replacing tedious manual filtration; features an independent pipeline operation design, supporting 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 method and a paddle method real-time recording system, and has a built-in infrared light-shielding shooting function, which can completely record the sample disintegration and dissolution process under light-shielding test conditions.

  • 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).

  • High compatibility and compact footprint

    • The 12-vessel machine is about the same size as a typical 8-vessel machine (approximately 140 cm in length and 65 cm in depth), saving laboratory counter space.

    • The system controller (DSC-800) is highly expandable and can simultaneously control up to 2 12-tank or 4 8-tank solvent extractors (no brand restrictions). It can also be connected in series with MDS solvent preparation machines and AVC automatic cleaning systems.

  • Secondary Syringe Filter Compatibility

    • Supports syringe-type filter membranes with diameters of 1.3 cm (1–2 filtrations), 2.5 cm (3–4 filtrations), and 3.8 cm (5–6 filtrations).

  • Dedicated Apparatus 1/2 Storage Design

    • It allows for easy securing of the dual-section device (1/2) to the storage area, ensuring the device remains in place and preventing damage.


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Product Features

High-throughput 12-slot configuration
Dual-zone speed
Two batches of experiments and controls were performed.
High-precision independent temperature control; stable fluid dynamics design.
Highly automated and expandable

21 CFR Part 11

Overall Specifications


  • Vessel configuration : 12 vessel (compact 2×6 matrix arrangement, supporting 6+6 dual-group parallel tests, comparison between original manufacturer and generic drug, or complete parallel testing of n=12 per batch; 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 or 3 independent speed zone control function (can simultaneously conduct shear force tests at different speeds or compare basket method/paddle method)

  • Temperature control accuracy : room temperature ~ 45.0°C, water bath temperature control accuracy ±0.1°C, temperature difference within each cup strictly controlled within 0.2°C, featuring low heat loss and protection against long-term medium volatilization; bottom-mounted reflector facilitates observation of the rear cups.

  • Dosing and height positioning mechanism : Standard configuration includes an automatic dosing tray (tablet dropping trays, supporting simultaneous and precise dosing in 6+6 zones or 12 vessel), and a two-stage quick-release stirring shaft that automatically and precisely aligns with the heights specified in various USP regulations.

  • Sampling System and Pump Unit : Equipped with two SYP-6L-10 (SYP-6L2B-10ml) high-precision 6-channel syringe pump modules (integrated into the DSC-800 system controller, saving desktop space), featuring 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 (approximately 27.9 seconds for a 10 mL sample), 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-12 collector) : Up to 20 rows (12 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 dual injection pumps): 12" × 15" × 24" (approx. 30 × 38 × 61 cm)

    • SCR-DL-12 Sample Collector: 19" × 22" × 19" (approx. 48 × 56 × 48 cm)

    • Main unit UDT-818-12: Approximately 90 × 54 × 66 cm

    • Power requirements: 110V / 220V, 50/60 Hz


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