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  • Production Scale M-700 Series
    Biopharma Microfluidizer® Processor Series

    M-7125, M-7250 Biopharma Microfluidizer® processor for Robust Manufacturing of Production Batches

    While each of our M-700 series processors is available as a basic, enhanced or aseptic model, all our production-scale biopharma models utilize the same Microfluidizer® proprietary continuous high shear fluid processing technology. This technology results in uniform droplet and particle size reduction (often submicron), which allows the production of stable nanoemulsions, nanosuspensions, liposomes and the nanoencapsulation of actives. Our production scale processors are designed for the seamless scaleup from lab or pilot machines, under the same operating conditions.

  • Production Scale Microfluidizer Processor M-700
  • Inside View of an M-700 Production Scale Biopharma Microfluidizer processor
  • M-700 Series Production Scale Biopharma Microfluidizer processor

The fully cGMP-compliant M-700 series includes many biopharma features that facilitate cGMP manufacturing so you can bring your drug products to market in the most efficient manner. Because we offer several designs with many options, the Microfluidics experts are always available to help you determine the model and features that best fit your unique processing application and requirements. Our team of senior engineers is very familiar with the ever-changing requirements of the pharmaceutical and biotech industries, and is a valuable resource for customers who are moving to production.

How It Works

Our multi-slotted fixed-geometry interaction chamber is at the heart of our machines, generating identical high shear levels as lab scale equipment and delivering unparalleled particle size reductions, flawless particle dispersions and the tightest particle size distributions in the industry.

From Development to Market

Researchers often find it difficult to transform many potential chemical compounds into drug products because the compounds are only marginally soluble in water or oil. That’s where Microfluidizer® technology comes in. The ultra high shear forces created by our processors easily reduce the particle size of active pharmaceutical ingredients to therapeutically relevant sizes, facilitating the production of drugs with improved stability and bioavailability.

Efficient Biotechnology Cell Disruption

Microfluidizer® technology is ideal for cell membrane disruption. As a matter of fact, our processors are much more efficient than our competitors’ machines when it comes to the disruption of E. coli, yeast, plant and mammalian cells. With their precise level of process control, our biopharma processors ensure highly repeatable and efficient cell breakage, the best possible cell recovery results, and low denaturation rates. 

Recommended Uses

The M-7125 and M-7250 high shear fluid processors are recommended for the non-sterile processing of:

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

Unique Benefits

The M-700 series production scale biopharma Microfluidizer®:

  • Achieves processing pressures up to 689, 1379 or 2068 bar (10,000, 20,000 or 30,000 psi)
  • Produces product flow rates up to 7.56 lpm (2.0 gpm) (Model M-7125) or up to 15.12 lpm (4.0 gpm (Model M-7250)
  • Features a low product holdup volume (less than 5 liters depending on heat exchanger)
  • Is small batch capable (minimum 6 liters)
  • Guarantees scaleup from lab and pilot Microfluidizer® processors
  • Is validatable under 21 CFR to cGMP (enhanced and basic models)
  • Creates highly secure batch records, 21 CFR Part 11 compliant (enhanced and aseptic models)
  • Is easy to operate with simple manual controls
  • Is easy to maintain with most maintenance points easily accessed
  • Requires no equipment takedown for CIP process
  • Safely processes thermally sensitive materials
  • Provides more efficient processing, usually requiring fewer passes than other processing machinery
  • Assures batch-to-batch process reproducibility
  • Contains only sanitary-grade and BPE-compliant product paths, instruments and valves
  • Includes complete document turnover package for validation support, including IQ/OQ documentation, material certification and calibrations
  • Offers key process parameter monitoring (basic model only)
  • Provides product temperature management via PID control of process chilled water (enhanced and aseptic models)
  • Offers on-board data acquisition for complete batch record audit trail (enhanced and aseptic models)
  • Has on-board flow meter to measure product and CIP flow rates (enhanced and aseptic models)

Standard Features

Basic processor includes:

  • Features and documentation to enable validation under 21 CFR for cGMP, including:
  • Turnover documentation package for validation
  • IQ/OQ documentation
  • Startup and training
  • Product-wetted surfaces finished to 0.5 µm (20 Ra) nominal, electropolished and passivated
  • Feed pump, pharma grade
  • Ultra Clean-in-Place (UCIP) piping
  • Manual controls
  • Stainless steel construction
  • CE compliant
  • Interaction chamber selected for your application
  • Proprietary high-pressure diaphragm priming valve

Enhanced processor includes:
Everything included with the basic model PLUS:

  • IQ/OQ execution
  • FAT and SAT
  • Motor starter panel
  • Product heat exchanger, pharma grade with active product temperature control, double tube sheet tube style
  • Mass flow meter, pharma grade
  • Data acquisition and recorder system using an IPC
  • 21 CFR Part 11 compliant for electronic signature and record keeping
  • Process pressure and temperature sensing
  • Complete package unit including motor starter panel and process interlocks

Aseptic processor includes:

  • IQ/OQ documentation and execution
  • FAT and SAT
  • Steam-in-Place (SIP) with multiple RTDs to assure complete sterilization
  • Ultra Clean-in-Place (UCIP)
  • Heat exchanger with product temperature control, pharma grade, double tube sheet style
  • Flow meter for batch monitoring and validation
  • IPC data acquisition station for temperatures, pressures and flows
  • Product wetted surfaces at 20 Ra max
  • Feed pump, sanitary cGMP grade
  • 21 CFR Part 11 compliant for electronic signature and batch record keeping
  • Motor starter panel with machine and process interlocks
  • CE compliant

Optional Features

Every M-700 model offers:

  • Explosion-proof (XP) compliant version available
  • ATEX compliant version available

Additional Options for Basic Model:

  • Product inlet strainer
  • Product heat exchanger, pharma grade, double tube sheet style
  • Motor starter panel and process interlocks
  • Dual product temperature sensing and readouts (two RTDs with two digital displays with signal retransmission in a black anodized enclosure)
  • Single product temperature sensor and display (one RTD and digital display with signal retransmission in black anodized enclosure))
  • FAT, SAT and IQ/OQ execution by our technical staff

Additional Options for Enhanced Model:

  • Product inlet
  • Hydraulic oil

Additional Options for Aseptic Model:

  • Motor voltage as needed

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Proven Results

Let us demonstrate how a Microfluidizer® can achieve your nanomaterial processing and product quality goals.

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