The Merel dissoBOT® Automated Dissolution Robot System is designed for modern pharmaceutical quality control (QC) and formulation research and development (R&D) laboratories. The system seamlessly integrates media degassing and preheating dispensing, automated precision drug delivery, automated timed sampling and filtration, and in-situ washing into a single intelligent automation platform. This achieves true 24/7 walkaway automation, completely eliminating human error and cumbersome procedures, significantly increasing laboratory throughput and batch turnover, and fully complying with cGMP, USP <711>, EP, and FDA 21 CFR Part 11 data integrity and regulatory validity standards.

I. It integrates media degassing, preheating, and dispensing, automatic synchronous drug dosing, precise sampling and filtration, sample collection/online analysis (can be connected in series with HPLC/UV-Vis), and fully automated cleaning and waste disposal, enabling continuous multi-batch automatic operation around the clock, freeing up manpower and significantly increasing sample throughput.

II. Patented 360° in-situ spraying and powerful vacuum suction technology allows for direct cleaning and emptying in a water bath after testing, without the need to disassemble the dissolution cup. This eliminates the risk of impact damage and ensures the accuracy of USP/FDA mechanical validation parameters (centering, verticality, height).

III. Equipped with a high-precision syringe pump and a multi-channel filtration module (supporting 13/25 mm filter membranes), the sampling volume error is < ±1.0%; samples can be automatically dispensed into HPLC/UPLC sample vials or analyzed online, eliminating human cross-contamination and transfer loss.

IV. Intuitive interface for real-time monitoring of temperature, speed, sampling process and cleaning records; built-in multi-level access control, electronic signatures and tamper-proof audit trails, fully compliant with FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ specifications, supporting standardized IQ/OQ/PQ validation.

Equipment Introduction

• Fully automated, unattended operation (True Walkaway & Multi-Batch Automation)

  • Continuous Multi-Batch Execution: Designed for high-throughput quality control (QC) and formulation research and development (R&D), the system can automatically and continuously execute multiple batches of tests, enabling 24/7 unattended operation and significantly improving laboratory testing capacity and sample turnover rate.

  • All-in-One Closed-Loop Workflow: This process integrates "medium preheating, degassing and dispensing", "automatic synchronous dosing", "dissolution test", "automatic timed sampling and filtration" and "in-situ non-disassembly cleaning" into a single machine, completely eliminating cumbersome manual operations and operational errors.

• In-Line Degassing, Pre-Heating & Quantitative Dosing

  • Pharmacopoeia-grade high-efficiency vacuum degassing (USP/EP Compliant Continuous Degassing): Built-in online high-efficiency vacuum degassing system, which removes dissolved gases simultaneously during liquid addition, fully meeting the stringent requirements of USP <711> and EP <2.9.3> for dissolved oxygen content in the degassed medium.

  • Real-time temperature control and high-precision dosing: The medium is directly and precisely preheated to 37.0°C ± 0.5°C during the dispensing process; coupled with a high-precision metering module (dispensing accuracy better than ±1.0%), the waiting time for the water bath to heat up is greatly shortened and the volume of each cup is ensured to be consistent.

• High-precision sampling, in-line filtration, and multivariate analysis (HPLC/UV integration)

  • Precise Sampling and Automated Multi-Channel Sampling & Media Replacement: Equipped with a high-precision multi-channel metering sampling pump, it automatically samples strictly according to the set time points and supports automatic replacement of equal-volume/isothermal media.

  • In-Line Syringe Filtration & Analytical Coupling: Supports standard syringe microporous membranes (13/25 mm, 0.22/0.45 µm), which can be automatically dispensed and collected directly into standard HPLC/UPLC sample vials or seamlessly connected in series with online UV-Vis/HPLC for real-time direct reading analysis.

• In-situ Vessel Washing & Rapid Vacuum Aspiration – High-efficiency cleaning and wastewater extraction without disassembly.

  • In-Situ Washing Without Vessel Removal: Inheriting the patented 360° high-pressure rotating spray and powerful vacuum suction technology, after the test is completed, each cup is quickly washed and emptied directly in the water bath, eliminating the need for manual handling and disassembly.

  • Maintaining Strict USP/FDA Mechanical Validation: In-situ cleaning thoroughly protects the dissolution cup, fully maintaining existing mechanical calibration parameters (centering, perpendicularity, and stirring height do not shift), and eliminating the industrial safety risk of glass cup breakage and sample contamination risk.

• Intelligent Graphics Control and Strict Data Integrity (Intelligent Software & 21 CFR Part 11 Compliance)

  • Intuitive Graphical UI & Real-Time Monitoring: The color graphic touch interface monitors and records the water bath temperature, temperature of each cup, stirring speed, dosing process, sampling time and cleaning status in real time.

  • Data Integrity & Audit Trail: Built-in multi-level access control, electronic signatures, and an tamper-proof audit trail, fully compliant with FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles, supporting complete IQ/OQ/PQ validation documents.