MEREL
Brand Introduction
Merel doo (official website: https://www.instruments.merel.si/) is headquartered in Slovenia , Europe, and is a leading European manufacturer of innovative instruments specializing in automated auxiliary systems for drug dissolution testing, optical and physical validation, and intelligent real-time image monitoring.
In the field of pharmaceutical analysis and dissolution testing, Merel's core focus is not simply on manufacturing another traditional dissolution instrument, but on solving the most time-consuming and error-prone (OOS/OOT) pain points for pharmaceutical companies worldwide when performing dissolution tests: such as "time-consuming and tedious media preparation and degassing", "disassembly, cleaning and recalibration of dissolution cups", "blind spots in mechanical and physical calibration", and "lack of real-time dynamic video recording of the dissolution process".
Merel has developed universally compatible automated equipment using its unique and revolutionary patented technology, which can be seamlessly integrated into all existing major international dissolution instrument brands.
Core values
Seamless integration across all brands (Universal Plug & Play Retrofit) :
Designed specifically for upgrading existing dissolution test instruments from various global manufacturers, it is fully compatible with major brands such as Pharma Test, Agilent/VanKel, Sotax, Hanson Research/Teledyne, Erweka, Distek, and Logan .
Pharmaceutical companies can achieve high-level automation, in-situ cleaning, and intelligent monitoring directly through non-invasive external modules without having to replace or eliminate their existing expensive dissolution units.
Completely eliminates the risk of human error and glass breakage (Zero-Risk Handling & High Repeatability) :
In-situ cleaning technology completely eliminates the need to disassemble and reassemble the dissolution cup, thus preventing operators from incurring high material losses and occupational safety risks such as breaking glass cups .
The dissolution cup is fixed in the water bath and does not move, completely locking the geometric center and height position , avoiding repeated disassembly and assembly that could cause misalignment of the mechanical qualification.
Dissolution dynamic continuous imaging audit and OOS/OOT root cause investigation :
Overcoming the blind spots of traditional dissolution experiments' "black box" operation, it uses a patented multi-lens optical system for real-time dynamic monitoring every second.
It captures and timestamps in real time the coning, tablet sticking, capsule floating, eccentric dropping, and uneven disintegration of materials, providing irrefutable regulatory-grade video evidence for laboratory anomaly investigations.
Pharmacopeia-Compliant Media Degassing & Dosing :
Integrating online high-vacuum pumping and heating technologies, it strictly follows USP <711> and EP <2.9.3> to eliminate microbubbles and dissolved oxygen (DO) in water, and eliminates false release deviations caused by microbubble adsorption.
The medium is rapidly preheated to 37.0°C ± 0.5°C with a dispensing accuracy of greater than 99.0% (< ±1% error), significantly reducing daily test preparation time by more than 70%.
Strictly adhere to international data integrity regulations (Full ALCOA+ & 21 CFR Part 11 Compliance) :
The system software fully complies with FDA 21 CFR Part 11, EU GMP Annex 11, ALCOA+ principles, and GAMP 5 specifications.
It features comprehensive multi-layered account and password protection, electronic signatures, and tamper-proof audit trails, supporting secure data backup and export.
Product direction
Merel's product line focuses on upgrading conventional dissolution tests into a high-capacity, highly reproducible, and fully visualized automated analysis platform:
1. dissoGUARD® Series: Dissolution Dynamic Real-Time Image Monitoring and Optical Physical Verification System
The industry's only top-tier optical platform combining "non-contact physical verification tools" with "360° dissolution dynamic continuous video monitoring":
Fully automated optical physical qualification (Optical PQ) :
No operator is required to perform time-consuming and complicated manual adjustments using thickness gauges, dial gauges, or mechanical gauges.
Employing high-resolution industrial optical lenses and patented image geometry algorithms, it enables rapid, non-contact, automatic measurement and recording:
Wobble of the mixing shaft
Geometric centering of the dissolution cup
Shaft Height between Stirring Paddle / Spinner Basket and Cup Base
Stirring speed (RPM)
Automatically generates verification reports that fully comply with the FDA Mechanical and Physical Validation Guidance (FDA MQ Guidance) .
360° continuous video recording and time-lapse photography of the dissolution process :
Each cup is independently equipped with an anti-reflective, low-heat optical lens and light source, which can record the entire process of sample dosing, dissolution, diffusion, and excipient deposition.
The software synchronously overlays time, temperature, speed, and real-time curves. When an OOS/OOT occurs, the corresponding video footage, accurate to the second, can be directly viewed to quickly troubleshoot human error, bubble interference, or formulation physical anomalies.
2. dissoDOSE® Series: Mobile automatic degassing, heating, and high-precision dispensing system for solvent separation media.
All-in-one high-precision media preparation workstation designed specifically for high-performance laboratories:
High-efficiency degassing and precise heating :
The built-in high vacuum system effectively reduces dissolved oxygen in the medium, fully complying with USP/EP pharmacopoeia specifications.
The integrated high-power heating system allows a single batch of medium to be stably preheated to 37.0°C ± 0.5°C in a very short time, eliminating the need to wait for the water bath to heat up after pouring into the dissolution vessel.
High-precision fixed-integration and quantitative dispensing :
Dispensing range from 250 mL to 1,000+ mL, with dispensing volume accuracy better than ±1.0% .
Supports ergonomic single-handed dispensing guns or multi-channel parallel dispensing, with a gentle, turbulent, and bubble-free dispensing process.
Flexible mobile trolley design :
The industrial-grade mobile trolley structure allows a single device to circulate and serve multiple dissolution apparatus main units of different brands throughout the entire laboratory.
3. dissoWASH® / dissoWASH&DOSE® series: In-situ automatic cleaning and integrated media replenishment system for dissolution cups.
A revolutionary in-situ cleaning technology that completely overturns the pain points of traditional manual cup washing:
In-situ 360° high-pressure cleaning and wastewater extraction (dissoWASH®) :
The probe is placed directly into the dissolution cup installed in the water bath, and the 360° rotating high-pressure nozzle is activated to thoroughly rinse the cup wall and stirring components.
The high-speed vacuum suction module thoroughly empties all residual waste liquid during rinsing, completing the cleaning cycle of a single 6-8 cup unit within minutes.
The dissolution cup does not require disassembly throughout the process, completely eliminating the risk of collision and breakage, and maintaining the center and level of the cup as originally installed by the manufacturer.
DissoWASH & DOSE® 2-in-1 fully automated cup washing and dispensing platform :
It perfectly integrates the in-situ cleaning function of dissoWASH with the degassing, preheating and liquid filling function of dissoDOSE into one machine.
The single-button operation of " removing residual waste liquid → 360° high-pressure in-situ cleaning → high-speed evacuation → precise injection of fresh preheated degassing medium " reduces the turnaround time between batch tests by more than 70%.
Brand advantages
European Engineering Excellence : Merel is headquartered in Slovenia, EU. All components are made of high-specification chemically resistant AISI 316L stainless steel, medical-grade PEEK, PTFE, and acid and alkali resistant piping, ensuring durability even under long-term exposure to strong acids, alkalis, and surfactants.
Highest cross-brand compatibility, maximizing ROI of existing assets : Unlike large instrument manufacturers that often tie closed systems to their products, Merel focuses on "Universal Add-on" upgrade accessories. Pharmaceutical companies can directly upgrade their existing, well-maintained used or newly purchased dissolution analyzers (Pharma Test, Agilent, Sotax, etc.) to top-of-the-line test stations with advanced automatic cleaning, automatic media handling, and image recording capabilities, without having to allocate a large budget for a complete replacement of the main unit.
Addressing the most stringent data integrity requirements in regulatory audits : Whether it's FDA inspectors asking questions about dissolution deviation (OOS) or verifying mechanical validity (MQ) accuracy, dissoGUARD® provides time-stamped images and automatically determined optical data, offering objective scientific evidence and significantly reducing the risk of inspection and audit.
Full Validation Support (IQ/OQ Documentation) : All devices come with a complete original manufacturer IQ/OQ validation documentation kit, micron-level optical calibration standards, and instrument history logs that comply with cGMP, GAMP 5, and ALCOA+ standards, helping pharmaceutical QA/QC teams to successfully and quickly pass validation acceptance.
