The Merel dissoGUARD® PRO Dissolution Surveillance System is an innovative, non-invasive platform for real-time monitoring and analysis of the entire dissolution process, including imaging and physical parameters, specifically designed for pharmaceutical research and development (R&D), quality control (QC), and formulation development. Utilizing high-resolution multi-channel imaging technology, this system completely eliminates the "black box" blind spots of traditional dissolution tests, recording the complete physical behavior of the drug within the dissolution vessel in real time. It complies with international regulations such as the United States Pharmacopeia (USP <711>), the European Pharmacopoeia (EP <2.9.3>), cGMP, and FDA 21 CFR Part 11.

I. Multiple cups are recorded simultaneously in high definition. Each cup has an independent camera to record the physical phenomena such as drug dosing, disintegration, sedimentation and accumulation, adhesion to the cup and bubbles.

II. Optical non-contact physical measurement automatically monitors the wobble, centering, height, and rotational speed (RPM) of the stirring paddle/spindle using image algorithms.

III. OOS / OOT rapid source tracing images and dissolution data are accurately synchronized in time. When data is abnormal, the image at a specific time point can be played back immediately to find the root cause in seconds.

IV. Compatible with major brand dissolution analyzers with external module design, allowing direct connection to Agilent, Pharma Test, Sotax, Hanson, Erweka and other equipment without modification.

V. 21 CFR Part 11 compliance includes hierarchical access control, electronic signatures, tamper-proof data, and a complete audit trail, and complies with GMP / ALCOA+.

Equipment Introduction

• Multi-Vessel Real-Time Video Surveillance: Real-time monitoring of the entire process with high-definition video from multiple vessels.

  • Independent multi-channel live recording : Each dissolution vessel (supports 6/7/8/12 cups) is equipped with an independent high-resolution miniature lens for continuous synchronous recording throughout the process.

  • Physical behavior visualization recording : accurately captures key phenomena such as sample dosing, disintegration and dispersion, particle suspension, bottom coning, capsule floating, drug adhesion to the wall and solvent bubble generation.

• Patented Optical Physical Qualification (Optical PQ)

  • Real-time monitoring of intelligent geometric parameters : Utilizing advanced image algorithms, automatic non-contact measurement is performed during experimental operation.

    • Concentricity skew (Wobble)

    • Cup centering

    • Shaft Height (Stirring Paddle/Spinner Basket Immersion)

    • Real-time rotational speed (RPM)

  • Reduced human error in mechanical calibration : No need for manual stop measurement, significantly improving test reproducibility and mechanical verification reliability.

• Rapid OOS/OOT anomaly tracing and root cause investigation

  • Precise time-stamped synchronization : The image is completely synchronized and aligned with the dissolution test timeline and sampling point data.

  • Quickly pinpoint the cause of the anomaly : When test data shows an out-of-range (OOS) or out-of-over-time (OOT) error, you can directly click on the time point to replay the high-definition video and instantly check whether it is caused by bubble adsorption, adhesion to the wall, filter head blockage, or abnormal disintegration.

• Universal Compatibility & Retrofit Modular Plugin Design

  • Seamless integration without modification : External dedicated clamp structure, without changing the original structure and fluid dynamics, suitable for dissolution testers from major brands on the market (such as Pharma Test, Agilent, Sotax, Hanson, Erweka, Distek, Logan, etc.).

  • Rapid upgrade of existing equipment : Real-time upgrade of the image monitoring and intelligent diagnostic capabilities of the leaching equipment of various brands currently in use in the laboratory.

• Intuition-specific software complies with 21 CFR Part 11 (Data Integrity & Regulatory Compliance)

  • Data integrity assurance : Built-in complete and tamper-proof audit trail, multi-level user access control, and electronic signatures.

  • Compliant with global pharmaceutical standards : Fully compliant with FDA 21 CFR Part 11, GMP, GLP and ALCOA+ data integrity guidelines, and can automatically export complete image-integrated test reports.