M815 Biopharma

The M815 Biopharma high pressure homogeniser from Microfluidics, takes the advantages of Microfluidizer’s smaller machines and applies them to a pilot scale/ production machine with over 3 times the flow rate of the popular M-110-EH-30.

Like all Microfluidizer processors, the M815 utilises the fixed-geometry interaction chamber and constant pressure pumping system. This technology allows users to achieve smaller particle sizes – with more uniform distribution and scale-up guaranteed (both from lab scale and to larger scale units) – than can be obtained with other methods.

The M815 models are designed to bridge the gap between the biopharma lab scale (M-100EH) and production scale (M-700 Series) models, and they are ideal for manufacturing batches in the range of 100L-300L, which are necessary for PHII and PHIII clinical trials.

Key Benefits:

  • Flow rate of 1 – 1.2LPM, which is required for 100L clinical batches, and is ideal for 100L bio-reactors.
  • Small batch capability; handles a minimum sample size of 200 ml
  • Compact design and mobility on casters.
  • Monitors key process parameters with local display, with the option of CFR Part 11-compliant data acquisition and re-transmission.
  • Facilitates safe and non-destructive processing of heat-sensitive materials.
  • Cost-effective production
  • Assures batch-to-batch process repeatability.

 

Description

Biopharma high pressure homogenisation with the Microfluidizer® M815 pilot scale: Standard Features

  • Achieves processing pressures up to 2068 bar (30,000 psi)
  • Produces product flow rates up to 1000 mL/min at 689 – 2068 bar (10,000 – 30,000 psi).
  • Meets CE compliance standards
  • 7″ Touchscreen HMI
  • Monitoring of key process parameters
  • Easy user maintenance
  • Low product holdup volume (180 ml*)
  • Sanitary-grade and BPE-compliant product paths, instruments and valves
  • Process pressure and temperature monitoring with local display and signal transfer to customer’s data acquisition system
  • CIP process capable — provides Clean-in-Place
  • Complete document turnover package for validation support, including IQ/OQ, material certifications and calibrations
  • Factory Acceptance Testing (FAT)
  • On-site startup assistance, operator and maintenance training, SAT and IQ/OQ execution by our technical staff

Optional Features:

  • Can be upgraded to validatable under 21 CFR to cGMP
  • 2 liter reservoir, pharmaceutical grade
  • Filtered hydraulic oil
  • On-board air compressor for air switch activation
  • Product coolant temperature control, automatic (enhanced model only)

Technical Specifications:

Description
M815
Pressure Range
up to 30,000 psi (2068 bar)
Flowrate range
1.0 – 1.2 L/min
Dimensions
W x D x H
57″L x 34″W x 72″H
(145 x 86 x 183 cm)
Weight
1,950 lbs (886 kg) with oil
1800 lbs (818kg) without oil

Request a quote for M815 or call us on UK: +44 (0)1954 232 776 / Ireland: +353 (0)144 75170.

Applications

  • Nanoemulsions (with or without API)
  • Nanodispersions
  • Deagglomeration
  • Microencapsulation
  • Nanoencapsulation of actives
  • Cell disruption
  • Clinical trials
  • Contract manufacturing organisations (CMOs)
  • Cell Disruption

Datasheets

PDF Icon M815 Datasheet

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