Dolomite Mitos Monodisperse Double Emulsion Microfluidic System

Overview

The Dolomite Mitos Monodisperse Double Emulsion Microfluidic System is an engineered platform for the precise, continuous generation of double emulsions (e.g., water-in-oil-in-water, W/O/W, or oil-in-water-in-oil, O/W/O) with exceptional size uniformity and inter-run reproducibility. Built upon Dolomite’s proprietary pressure-driven microfluidic architecture, the system leverages hydrodynamic flow focusing and coaxial capillary junctions to achieve deterministic droplet formation governed by laminar flow physics and interfacial tension control. Unlike batch-based emulsification methods—such as sonication or high-shear homogenization—the Mitos system operates under steady-state laminar conditions, enabling strict decoupling of droplet size, shell thickness, and inner core volume via independent modulation of three-phase flow rates and interfacial surfactants. This principle ensures compliance with fundamental requirements for regulatory-grade process development in pharmaceutical formulation, where batch-to-batch consistency, narrow polydispersity index (PDI < 0.05 typical), and traceable parameter control are prerequisites for ICH Q5A and Q5C assessments.

Key Features

• Triple-flow precision control: Independent mass-flow controllers (MFCs) for outer continuous phase, middle shell phase, and inner dispersed phase—each calibrated to ±0.5% full-scale accuracy.
• Real-time pressure monitoring: Integrated piezoresistive sensors at all three inlet lines with 10 ms sampling resolution, supporting closed-loop stability during extended operation (>24 h).
• Modular chip interface: Standardized Luer-lock and Swagelok-compatible fittings enable rapid chip exchange without recalibration; compatible with Dolomite’s full suite of glass, fluoropolymer, and silicon-glass hybrid chips.
• Temperature-stabilized operation: On-board Peltier modules maintain chip temperature within ±0.3 °C across 4–40 °C range—critical for thermosensitive biologics and polymer phase transitions.
• No moving parts in fluid path: Eliminates pulsation, wear debris, and shear-induced degradation—essential for encapsulating fragile proteins, mRNA, or live cells.

Sample Compatibility & Compliance

The Mitos system accommodates a broad spectrum of biocompatible and industrial fluids—including aqueous buffers (PBS, HEPES), biodegradable oils (caprylic/capric triglyceride), fluorinated carriers (FC-40), and polymeric solutions (PLGA, alginate, chitosan). All wetted components comply with USP Class VI and ISO 10993-5 cytotoxicity standards. The system architecture supports audit-ready operation under GLP and GMP environments: digital log files record timestamped flow parameters, pressure traces, and ambient temperature; raw data export adheres to ASTM E2500-07 for instrument qualification documentation. While not FDA-cleared as a medical device, the platform is routinely deployed in preclinical formulation development aligned with USP and ICH Q5A guidelines for particulate characterization.

Software & Data Management

Control and acquisition are managed via Dolomite’s Mitos Control Suite (v3.2+), a Windows-based application supporting both manual protocol scripting and automated sequence execution. The software implements 21 CFR Part 11-compliant user access tiers (Administrator, Operator, Viewer), electronic signatures, and immutable audit trails for all parameter changes and run initiations. Export formats include CSV (for statistical analysis in JMP or Python), HDF5 (for high-fidelity time-series pressure/flow metadata), and PDF reports with embedded calibration certificates. Optional integration with LabArchives ELN enables direct metadata injection into electronic lab notebooks, satisfying ALCOA+ data integrity principles.

Applications

• Pharmaceutical delivery: Production of uniform W/O/W microcapsules for controlled release of peptides, siRNA, or vaccines—enabling correlation between droplet size distribution and in vivo pharmacokinetic profiles.
• Enzyme immobilization: Encapsulation of oxidoreductases or hydrolases within semi-permeable polymer shells for continuous-flow biocatalysis with enhanced thermal and operational stability.
• Food science: Masking bitter compounds (e.g., quinine, caffeine) via core-shell lipid matrices, validated by dynamic light scattering and sensory panel testing per ISO 8586.
• Cosmetic actives delivery: Tunable double emulsions for sustained release of retinoids or vitamin C derivatives across stratum corneum models (Franz cell assays).
• In vitro diagnostics: Generation of monodisperse droplet carriers for digital PCR partitioning and single-cell barcoding workflows.

FAQ

Is chip geometry customizable for specific emulsion architectures?
Yes—Dolomite offers custom chip design services using SU-8 photolithography and reactive ion etching, with turnaround times of 4–6 weeks for prototype validation.
Can the system be integrated with downstream collection modules (e.g., UV crosslinking or solvent extraction)?
Absolutely—the Mitos platform includes standardized 1/4″-28 UNF ports and TTL-triggered I/O for synchronization with third-party UV LED arrays, microcentrifuges, or inline spectrophotometers.
What level of training and technical support is provided post-installation?
Dolomite delivers on-site commissioning, operator certification (ISO/IEC 17025-aligned), and annual preventive maintenance contracts including MFC recalibration and chip alignment verification.
Does the system meet CE marking requirements for laboratory equipment?
Yes—the Mitos system carries CE marking under Directive 2014/30/EU (EMC) and 2014/35/EU (LVD), with full Declaration of Conformity available upon request.