M815 Microfluidizer®Pilot and small Production scale homogenizer

for High Shear Fluid Processing of small batches

Bridging the gap between the lab and production the M815 processor enables users to replicate operating conditions as each batch scales up.

Like all Microfluidizer® processors, the M815 utilizes the fixed-geometry Interaction ChamberTM and constant pressure pumping system which enables users to achieve small particle sizes with uniform, tight particle size distribution with scale up guaranteed.

M815 Microfluidizer® Pilot and small Production scale homogenizer

 

The M815 models are designed to span the gap between the lab scale (M110P) and production scale (M700 series) models, and they are ideal for manufacturing batches in the range of 5L-300L. 

It acheives product flow rates up to 1,000 mL/min at 689-2068 bar (10,000-30,000 psi).

This technology enables easy monitoring of key process parameters and facilitates the safe processing of thermally sensitive materials.  As a self-contained unit, mounted on locking casters for portability, it features accessible maintenance points for easy upkeep. 

Download the M815 brochure

Available For

Pharma and Biotech

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Options are available for pilot batch processing to meet the needs of Pharma & Biotech customers. A range of options are available to suit specific requirements.

The M815 can be designed to achieve cGMP standards, vital when researching applications such as vaccine adjuvants and creating sterile nanoemulsions. Each machine comes standard with a feed pump and heat exchanger, which makes it easy to use simply by attaching the feed vessel and collection vessel then it's ready to run.

Basic Biopharma:

  • cGMP as specified by the American Society for Mechanical Engineers
  • Traceability – Material Certificates for all product contact parts included in an electronic Turnover Package (TOP)
  • Surface Finish – Electropolished and passivated - surface finish of < 20 Ra 
  • USP Class VI elastomers
  • Drainability – A sanitary heat exchanger, a sanitary flush pressure transducer and pitched piping are included to ensure all equipment can be drained effectively
  • IQ/OQ Documentation
  • CIP - clean in place

 

Enhanced Biopharma:

  • includes all of the above features plus 21 CFR Part 11 Data Acquisition
  • Industrial Personal Computer (IPC)
  • other options include - automation, conductivity sensors & mass flow meter

 

Aseptic Biopharma:

  • all of the above features plus Steam in Place (SIP) for processing in a sterile environment
  • equipment is fully automated
  • also recipes for Steam, Prime, Run & Drain

Biopharma model:

M815 BioPharma model

 

For all enquiries, click the link below or call:
800-370-5452

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In detail

M815 pilot scale

The M815 pilot scale model has a range of optional features designed for each application

Standard Features:

  • Product feed pump, and purge valve
  • Integral Heat exchanger
  • Diamond Interaction ChamberTM
  • 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 2˚C – 75˚C (35˚F – 165˚F)
  • TEFC (totally enclosed fan-cooled) motor, starter, controls and power cord

Optional Features:

  • 2 liter reservoir, pharmaceutical grade
  • Filtered hydraulic oil
  • On-board air compressor for air switch activation
  • Product coolant temperature control, automatic (enhanced model only)

The specifications of the M815 pilot scale Microfluidizer®:

  • Operating pressure of up to 30,000 psi/2068 bar
  • Minimum sample size - 200 mL
  • Flow rate - up to 1.0 - 1.2 mL/min
  • Power - 50 hz / 460 V 3 phase
  • Noise - 80 dB TWA

 

M815 details-1

 

The M815 pilot production processor is recommended for processing:

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

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Alternative Pilot scale equipment

Reduce time to market with linear scaleup from the lab to the production line

Pilot scale M110EH

For continuous, high shear fluid processing

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