M815 Biopharma Microfluidizer

The new M815 Biopharma Microfluidizer offers the same high level of performance, quality and reliability as other Microfluidizers but with additional unique benefits, including lower flow rates, small batch capability and a greater portability.

Analytik are exclusive UK and Ireland suppliers of Microfluidics’ market leading Microfluidizer® high pressure homogenisers.

Microfluidics, part of IDEX Corporation, are manufacturers of unique high pressure homogeniser fluid processors, that are the gold standard in nano-enabled applications for uniform particle size reduction, cell disruption and nano-emulsion formation.

We will be happy to work together with you on a solution with the full support of the Microfluidics team, based in Westwood, USA. Visit our contact page, request a quote, or call us on +44 (0)1954 232 776.

Product Description

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.

Standard Features M815 pilot scale biopharma Microfluidizer®:

  • 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

Datasheets

PDF Icon M815 Datasheet

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