SPG KH-125 High-Throughput Membrane Emulsifier

Overview

The SPG KH-125 High-Throughput Membrane Emulsifier is an engineered platform for reproducible, scalable production of monodisperse emulsions and colloidal dispersions via Shirasu Porous Glass (SPG) membrane technology. Unlike conventional rotor-stator or ultrasonic emulsification systems, the KH-125 operates on a controlled cross-flow membrane emulsification principle: the dispersed phase is pressurized externally—typically using regulated nitrogen gas—against the outer surface of a cylindrical SPG membrane tube, while the continuous phase flows laminarly inside the membrane lumen. This configuration enables precise droplet formation at the pore mouths through hydrodynamic shear and capillary pressure balance, resulting in narrow droplet size distributions (CV < 10%) without high-energy mechanical disruption. Designed for laboratory-to-pilot scale development, the system supports process transfer to GMP-compliant manufacturing environments where batch consistency, low thermal load, and minimal surfactant degradation are critical—particularly in pharmaceutical nanoemulsion formulation, functional food delivery systems, and microencapsulation R&D.

Key Features

• Externally pressurized SPG membrane module with standardized Ø10 × 125 mm geometry (105 mm effective filtration length), enabling rapid membrane replacement and cross-system method transfer
• Maximum operating pressure of 900 kPa—sufficient to generate submicron to micron-scale droplets across a broad viscosity range (up to 500 mPa·s dispersed phase)
• Modular fluidic architecture supporting independent flow control of both continuous and dispersed phases; compatible with peristaltic, diaphragm, or syringe pumps
• Stainless steel and PTFE-wetted materials compliant with USP Class VI and FDA 21 CFR Part 11 requirements for audit-ready operation
• Integrated pressure monitoring and safety relief valve (set at 950 kPa) to prevent membrane over-pressurization and ensure operational integrity
• Compact benchtop footprint (W450 × D380 × H320 mm) with CE-marked electrical interface and IP54-rated enclosure

Sample Compatibility & Compliance

The KH-125 accommodates aqueous, organic, and biphasic systems—including oil-in-water (O/W), water-in-oil (W/O), and multiple emulsions (e.g., W/O/W). Its SPG membrane exhibits chemical inertness toward acids (pH ≥ 2), bases (pH ≤ 12), and common organic solvents (e.g., ethanol, ethyl acetate, chloroform), facilitating cleaning-in-place (CIP) and reuse over ≥50 cycles when handled per SPG Technical Bulletin TB-EM-07. The system conforms to ISO 22196:2011 (antimicrobial activity testing) and ASTM D7777-17 (emulsion stability assessment protocols). For regulated applications, it supports GLP/GMP documentation workflows including electronic batch records, user access control, and full audit trails when integrated with validated LIMS or ELN platforms.

Software & Data Management

The KH-125 operates as a hardware-controlled unit without embedded firmware or proprietary software. All process parameters—including transmembrane pressure (0–900 kPa, ±2 kPa accuracy), continuous phase flow rate (0.5–500 mL/min), and temperature (via external probe input) —are monitored and logged via third-party data acquisition systems (e.g., LabVIEW, MATLAB, or DeltaV). Raw pressure and flow datasets export in CSV/ASCII format for post-processing in particle sizing software (e.g., Malvern Panalytical Mastersizer or Beckman Coulter LS series) or statistical process control (SPC) packages. Calibration certificates for pressure transducers and flow meters are supplied with NIST-traceable documentation upon installation.

Applications

• Preclinical development of lipid nanoparticles (LNPs) and polymeric micelles for nucleic acid delivery
• Routine preparation of calibration standards for dynamic light scattering (DLS) and laser diffraction instrumentation
• Scale-down modeling of industrial membrane emulsification processes per ICH Q5A(R2) comparability guidelines
• Formulation screening of sustained-release microspheres (PLGA, chitosan, alginate) under low-shear conditions
• Production of uniform Pickering emulsions using silica, cellulose nanocrystals, or clay-based stabilizers
• Teaching modules in colloid science, interfacial engineering, and process intensification at university laboratories

FAQ

What pore sizes are available for the KH-125 SPG membrane module?

Standard configurations include 0.1 µm, 0.2 µm, 0.5 µm, 1.0 µm, and 2.0 µm nominal pore diameters—all manufactured under JIS R 3251 certification and supplied with individual pore size distribution reports.
Can the KH-125 be used for sterile emulsification?

Yes, when coupled with pre-sterilized SPG membranes (autoclavable at 121°C, 20 min) and aseptic fluid path components, the system supports ISO 13408-1 compliant operations; validation protocols for bacterial retention (Brevundimonas diminuta challenge) are available upon request.
Is membrane fouling a concern during extended operation?

Fouling is minimized by the external pressure design and laminar internal flow; typical run times exceed 4 hours uninterrupted. Post-run cleaning follows a three-step protocol: water rinse → 0.1 M NaOH soak (30 min) → 0.5% citric acid flush, validated per SPG Cleaning Validation Guide CVG-EM-03.
Does the system support real-time droplet size monitoring?

No native inline particle sizing is integrated; however, the KH-125 is fully compatible with commercial inline FBRM (ParticleTrack) or focused beam reflectance measurement probes mounted downstream of the emulsion outlet.
What regulatory documentation is provided with the instrument?

Each unit ships with Declaration of Conformity (CE), Factory Calibration Report, SPG Membrane Certificate of Analysis (CoA), and Material Compliance Statement (RoHS/REACH/UKCA).