The Logan USP III-7 reciprocating dissolution assay system is specifically designed for the development and quality control of pH gradient release, long-acting sustained-release formulations, microparticle oral dosage forms, and specialty drug delivery systems. The system fully supports rapid switching between USP Apparatus 3 (reciprocating cylinder method) and USP Apparatus 7 (reciprocating holder method) and can be expanded with custom multi-row compartments (such as 12 × 6 rows, 12 × 12 rows) and a 1L large-capacity dissolution cup, accurately simulating the human gastrointestinal environment and continuous release characteristics of pH gradients. This instrument fully complies with the specifications and standards of the United States Pharmacopeia (USP) <711/724>, the European Pharmacopoeia (EP), the British Pharmacopoeia (BP), and the Japanese Pharmacopoeia (JP).

I. Patented Automatic Anti-evaporation and Anti-contamination (Auto-Flip Cover & Evaporation Trap): The cover automatically closes when switching solvents in a row-to-row configuration, preventing evaporation and cross-contamination; combined with a patented conical liquid collection cover, it guides the condensate backflow, ensuring a constant volume of the test medium over a long period of time.

II. Brushless Drive & Multi-Stroke: The industrial-grade brushless motor operates smoothly with low vibration, providing a reciprocating frequency of 4–40 dpm (4–10 dpm with an accuracy of ±0.1 dpm); it fully supports USP 3 standard 10 cm, USP 7 standard 2 cm, and 4/6/8 cm multi-stroke settings.

III. Isothermal Refill & DSC-800 Station: Each row features a "7 test cups + 1 solvent refill cup" design with uniform preheating; integrates the DSC-800 workstation (12-24 independent channels, 10 mL sampling in just 27.9 seconds), supporting automatic cleaning, isothermal refill, tubing dilution, and manual secondary filtration.

IV. Touchscreen GUI and 21 CFR Part 11 Compliance (Touchscreen GUI & Data Integrity): Intuitive full-color touchscreen with 20 built-in methods and multi-level access control; features 3 million tamper-proof audit trails, fully compliant with FDA 21 CFR Part 11, GMP, and ALCOA+ data integrity standards.

Equipment Introduction

• Multi-country pharmacopoeia compliance: Fully compliant with the United States Pharmacopeia (USP <711/724> Apparatus 3 reciprocating cylinder method & Apparatus 7 reciprocating disc method), European Pharmacopoeia (EP), British Pharmacopoeia (BP), Japanese Pharmacopoeia (JP) and Chinese Pharmacopoeia (ChP) specifications, specially designed for controlled release, sustained release, enteric-coated formulations and multi-stage pH gradient dissolution analysis (R&D and QC).

• Highly flexible modular configuration: It features highly modular expansion flexibility, allowing for quick switching between USP 3 / USP 7 test modules; in addition to the standard configuration, it also supports 1L large capacity, as well as customized 12×6 rows, 12×12 rows and other multi-slot high-throughput specifications, realizing one machine for multiple uses.

• Extremely smooth drive: It adopts a high-performance brushless motor drive module, which ensures extremely smooth operation without any lag.

• Wide reciprocating frequency: Supports reciprocating frequencies of 4–40 dpm (4–10 dpm with an accuracy of ±0.1 dpm; 10–40 dpm with an accuracy of ±0.5 dpm).

• Multi-segment flexible travel: Supports multiple standard reciprocating travel settings, including USP 3 standard 10 cm, USP 7 standard 2 cm, and can flexibly switch to different travels such as 4 cm, 6 cm, 8 cm, etc., to accurately simulate the flow field conditions of gastrointestinal peristalsis in the body.

• Patented flip-top isolation design prevents contamination: The patented automatic flip-top isolation design completely isolates the interaction and volatilization between different solvents when switching between different rows of solvent tanks for immersion dissolution, thus completely eliminating cross-contamination.

• Patented conical reflux condensation: Each solvent cup is equipped with an independent anti-evaporation sealing cap, and is equipped with a patented conical cover design, which can efficiently collect condensed and evaporated liquid and allow it to flow back naturally, effectively preventing solvent accumulation and loss during long-term experiments; the body structure is integrally molded, not easy to mold, and easy to clean and maintain daily.

• Isothermal zero-temperature-difference replenishment: Innovative configuration of "7 sample cups + 1 replenishment solvent cup" (or configuration according to the number of rows), the replenishment solution is preheated in a water bath to ensure zero temperature difference between the replenishment solvent and the test tank (T < 0.1°C).

• Multi-stage pH gradient switching: Supports independent switching of different pH solvents at different times for each row/time point, seamlessly connecting complex pH release curve studies.

• One-piece molded water tank with no blind spots: The one-piece molded constant temperature water bath with high light transmittance and no blind spots allows the experimenters to clearly observe the drug disintegration and release process throughout the process.

• Medical-grade corrosion-resistant material: The entire dissolution cup holder is made of high-quality AISI 316 medical-grade stainless steel, and has a dedicated independent positioning ring for the dissolution cup to ensure the verticality, concentricity and consistency of the cup body with each slot.

• Emergency safety protection: An emergency power off button (E-Stop) is located on the front of the machine. In case of an emergency, the power can be cut off immediately with one button, fully ensuring the safety of operators and instruments.

• High-throughput independent sampling tubing: The system controller (DSC-800) can be wired to drive 12 to 24 high-throughput sampling needle modules. Each channel has an independent dedicated tubing design, which fully covers automatic cleaning, constant temperature replenishment, automatic dilution, precise sampling and reflux functions, eliminating tubing residue and cross-contamination.

• High-precision and rapid sampling: The sampling stroke is adjustable from 1 to 20 mL, with an accuracy error within 0.2 mL. A single 10 mL sample takes only about 27 seconds. It comes standard with a 10×16 mm glass tube rack and an HPLC autosampler (Vial) rack, which can be expanded to a maximum of 20 sampling points.

• Universal syringe filter head module: Standard configuration includes a universal filter head fixing module, compatible with various brands of syringe filter heads (supports 1-2 filtrations for 1.3 cm diameter, 3-4 filtrations for 2.5 cm diameter, and 5-6 filtrations for 3.8 cm diameter), completely replacing tedious manual filtration operations.

• Intuitive single-page touch interface: Equipped with a large full-color touch screen, it adopts an intuitive single-page integrated control screen, which can quickly edit and save up to 20 dissolution methods.

• Compliant with ALCOA+ and audit trails: Strictly adheres to 21 CFR Part 11 and ALCOA+ specifications, featuring up to 3 million electronic audit trail logs. Original files cannot be altered or deleted, and supports USB data export and dot matrix printer connection output.

• Four-level strict access control: It has a complete four-level user access control architecture (Operator / Manager / Administrator / Factory), and can create independent exclusive accounts and encrypted passwords for each person.