The Logan Super-4 Flow-Through Cell Dissolution Assay System is specifically designed for the development and quality control of poorly soluble drugs (BCS Class II/IV), long-acting sustained-release formulations, microspheres, implants, nano-suspensions, liposomes, drug-eluting stents (DES), suppositories, and specialized drug delivery systems. The instrument fully supports rapid switching between open-loop and closed-loop modes according to the United States Pharmacopeia (USP) Apparatus 4 (flow-through cell method) and can be expanded to include automatic pH gradient solvent switching and online analysis systems. This instrument fully complies with the specifications and standards of the United States Pharmacopeia (USP) <711>, the European Pharmacopeia (EP), the British Pharmacopeia (BP), the Japanese Pharmacopoeia (JP), and the Chinese Pharmacopoeia (ChP).

I. Equipped with 8 sets of patented quick-release pin flow cells (compatible with 22.6 / 12 mm, powder, suppository, gel, stent and dialysis adapter); realizes constant temperature of water bath, solvent and pipeline in the whole environment, with independent real-time temperature measurement of 8 cells (standard 37.0 ± 0.5 °C, expandable to > 60 °C), and can be equipped with darkroom infrared night vision real-time recording.

II. The industrial-grade high-precision dual piston pump provides a flow rate of 0–24 mL/min (standard 4 / 8 / 16 mL/min, accuracy ±5%); it supports single-batch 4-zone independent flow rate (2+2+2+2 configuration) and pulseless/weak pulse/strong pulse (120 ± 10 bpm) mode switching, and has a built-in 2.5 kg overpressure safety relief valve.

III. Supports continuous, breakpoint, and split sampling modes for both open-loop and closed-loop systems; when paired with the MC-4000 solvent switching module, it can automatically and sequentially switch between four pH buffer solutions to simulate the gastrointestinal environment; the open architecture allows for seamless online connection to UV-Vis, HPLC, or PERMETRO membrane osmosis systems (to establish an IVIVC model).

IV. Equipped with a high-precision infusion pump and fully independent tubing (resistant to 10% SLS high surfactant), supporting 13-38 mm bipolar needle filtration and 20 sampling points; providing three-level access control, 100 method storage sets and 3 million tamper-proof electronic audit trails, fully compliant with FDA 21 CFR Part 11 and ALCOA+ standards.

Equipment Introduction

• Regulatory compliance and dual open/closed loop testing.

  • Fully compliant with the United States Pharmacopeia (USP <711> Apparatus 4), European Pharmacopeia (EP <2.9.3>), British Pharmacopeia (BP), Japanese Pharmacopeia (JP), and Chinese Pharmacopeia (ChP), it is specifically designed for the research and quality control of poorly soluble drugs (BCS Class II/IV), long-acting sustained-release microspheres, implants, liposomes, drug-eluting stents (DES), and special dosage forms.

  • It supports quick switching between open-loop and closed-loop modes, providing excellent experimental flexibility to meet different dissolution characteristics and sink conditions.

• Modular Flow-Through Cells & Real-Time Temperature Monitoring System

  • It comes standard with 8 flow cells, featuring a patented external pin mechanism for easy disassembly and cleaning; it also offers a variety of specialized cells, including 22.6 mm large cells, 12 mm small cells, powder cells, suppository cells, gel cells, stent cells, and dialysis adapters.

  • The solvent storage tank, water bath, and delivery pipeline are designed as an integrated constant temperature system, with 8 independent real-time temperature sensing and monitoring units (standard configuration 37.0 ± 0.5 °C). The temperature difference is minimal, ensuring a high degree of consistency between the flow field and heat conduction.

• High-precision dual-piston pump drive and multi-zone independent flow/pulse control.

  • It adopts a wear-resistant industrial-grade high-precision dual piston pump with a flow rate range of 0 to 24 mL/min (standard 4 / 8 / 16 mL/min, accuracy ±5%), and can withstand continuous operation for several months.

  • It supports single-batch operation of 4 independent flow rate zones (2+2+2+2 configuration), which greatly speeds up prescription screening efficiency; it has multiple modes including flat flow (no pulse), weak pulse and strong pulse (120 ± 10 pulses/min), and has a built-in 2.5 kg pressure safety protection valve.

• Automated pH Gradient Switching & Versatile Split-Sampling

  • The optional MC-4000 solvent switcher can automatically switch between up to 4 different pH buffer solutions in the same experiment, accurately simulating the gradual pH change environment of the gastrointestinal tract in vivo.

  • It features "continuous sampling", "breakpoint shunting" and "continuous shunting" sampling modes, and with the micro-volume storage tank, it can automatically calculate the volumetric flow rate and dilution ratio, greatly improving the automation and accuracy of sampling.

• DSC-800 Autosampler Workstation & Precision In-Line Filtration

  • Integrating the DSC-800 control workstation, it adopts a push-down high-precision piston injection pump, and the sampling, cleaning, replenishment and dilution pipelines are completely independent, resistant to high concentrations of surfactants (such as 10% SLS) and viscous media.

  • Supports multiple brands of 13-38 mm syringe filters and dual-stage multilayer stacked filter membranes (Glass fiber/PE), and can be configured with 20 sampling time points (automatic dispensing of test tubes or HPLC sample vials).

• Data Integrity and 21 CFR Part 11 Compliance

  • It features a built-in color touchscreen interface, a storage capacity of up to 3 million electronic audit trails, and original records that cannot be deleted or edited, fully complying with FDA 21 CFR Part 11 and ALCOA+ principles.

  • It features 3-4 levels of user access control, allows the creation of 100 independent operator accounts and passwords, and has a built-in function to remember and store 100 methods.

• High System Compatibility & Online Analytical Integration

  • It features a highly open architecture, allowing direct online connection to various brands of UV-Vis spectrophotometers or HPLC chromatographs for real-time automatic analysis. It can also be connected in series with the PERMETRO penetration system for in vivo and in vitro correlation studies of IVIVC.