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  • Pilot Scale M-110EH
    Biopharma Microfluidizer® Processor Series

    M-110EH Biopharma Microfluidizer® processor for Processing Clinical and Small Production cGMP Batches

    We offer basic, enhanced and aseptic models for pharmaceutical and biotech applications. All three models utilize Microfluidizer® proprietary high shear fluid processing technology for uniform droplet and particle size reduction, which enables the production of stable nanoemulsions, nanosuspensions, liposomes and the nanoencapsulation of actives. Additionally, Microfluidizer® technology offers the most efficient method for disruption of yeast, E. coli, plant and mammalian cells.

How It Works

Like all Microfluidizer® processors, the M-110EH utilizes the fixed-geometry interaction chamber and constant pressure pumping system. This technology allows users to achieve smaller particle sizes — with more uniform distribution and scaleup guaranteed — than can be obtained with other methods.

The M-110EH models were designed to bridge the gap between the biopharma lab scale (M-110P) and production scale (M-700 series) models, and they are ideal for manufacturing batches necessary for PHII and PHIII clinical trials.  

Discovery to Commercialization

While researchers continually identify various new chemical compounds as possible drug candidates, many are only marginally soluble in oil or water. Microfluidizer® technology solves this problem. Our machines create ultra high shear forces that reduce the particle size of active pharmaceutical ingredients to therapeutically relevant sizes, enabling the production of drugs with improved bioavailability and stability.

Cell Disruption for Biotechnology

Microfluidizer® technology meets the demanding needs for cell membrane disruption — from the gentle disruption of cultured cells for virus isolation to the challenging disruption of yeast and other fungi. The M-110EH’s exacting level of process control ensures highly reproducible and efficient cell breakage, while controlling temperatures to prevent denaturing. 

Getting to Full Production

The results easily scale up from pilot to production volume under the same operating conditions. The M-110EH processor is available with Steam-in-Place for aseptic processing, Ultra Clean-in-Place to eliminate the need for disassembly, and Clean-out-of-Place. Data recording and validation support documentation ensure compliance with 21 CFR Part 11 guidelines.

Recommended Uses

The M-110EH pilot production processor is recommended for the non-sterile processing of: 

  • Nanoemulsions (with and without API)
  • Nanodispersions
  • Microencapsulation
  • Deagglomeration
  • Cell Disruption

Unique Benefits

Every M-110EH pilot scale biopharma Microfluidizer®:

  • Has small batch capability; handles a minimum sample size of 200 ml*
  • Achieves processing pressures up to 2068 bar (30,000 psi)
  • Produces product flow rates up to 320 ml/min at 2068 bar (30,000 psi) or 450 ml/min at 1724 bar (25,000 psi)
  • Is validatable under 21 CFR to cGMP
  • Meets CE compliance standards
  • Provides validatable sterility that will pass the Sterile Fill Test (aseptic model only)
  • Has simple manual controls for easy operation
  • Features accessible maintenance points for easy maintenance
  • Allows monitoring of key process parameters
  • Facilitates safe processing of thermally sensitive materials
  • Has cost-effective production capability
  • Assures batch-to-batch process repeatability
  • Features a low product holdup volume (180 ml*)
  • Includes motor starter and process interlocks
  • Features sanitary-grade and BPE-compliant product paths, instruments and valves
  • Includes a complete document turnover package for validation support, including IQ/OQ, material certifications and calibrations
  • Comes with Factory Acceptance Testing (FAT)
  • Includes on-site startup assistance, operator and maintenance training, SAT and IQ/OQ execution by our technical staff

* Depending on heat exchanger option selected.

Additional Benefits of Basic Model:

  • Offers process pressure and temperature monitoring with local display and signal transfer to customer’s data acquisition system
  • Is CIP process capable — provides manual Clean-in-Place

Additional Benefits of Enhanced Model:

  • Offers on-board data acquisition for complete batch record audit trail (enhanced and aseptic models only)
  • Is validatable under 21 CFR to cGMP
  • Is CIP process capable — provides manual Clean-in-Place

Additional Benefits of Aseptic Model:

  • Offers on-board data acquisition for complete batch record audit trail
  • Is validatable under 21 CFR to cGMP
  • Includes multi-point temperature sensing for assured Steam-in-Place (SIP) process
  • Features flow totalizer to record product and CIP volume
  • Enables PID control of process-chilled water for product temperature management
  • Is CIP process capable — provides Ultra Clean-in-Place (UCIP) using customer’s CIP system pump or optional feed pump

Standard Features

  • Diamond interaction chamber
  • Ceramic Auxiliary Processing Module (APM)
  • Ceramic (Zirconia) plunger and seal quench for extended seal life
  • Stainless steel enclosure
  • Gauges for measuring hydraulic drive pressure, hydraulic oil level and temperature
  • Self-contained unit, mounted on locking casters for portability
  • Feed temperature range 16˚C – 75˚C (35˚F – 165˚F)
  • TEFC (totally enclosed fan-cooled) motor, starter, controls and power cord
  • Sanitary flush diaphragm pressure transducer with digital readout
  • Class IV seals and gaskets certified (enhanced and aseptic models only)
  • Flow totalizer input to process monitor and HMI panel (enhanced and aseptic models only)

Optional Features

  • Product feed pump, pharmaceutical grade with pressure gauge and purge valve
  • 2 liter reservoir, pharmaceutical grade
  • Filtered hydraulic oil
  • On-board air compressor for air switch activation
  • Product coolant temperature control, automatic (enhanced model only)

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Proven Results

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