Microfluidics M815 Microfluidizer® Processor

Biopharma Microfluidizer® for processing Clinical and Production cGMP Batches

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Like all Microfluidizer® processors, the M815 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 scale-up guaranteed (both from lab scale and to larger scale units) — than can be obtained with other methods. The M815 models were designed to bridge the gap between the biopharma lab scale (M-110EH) 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. 

Features

Product feed pump, pharmaceutical grade with pressure gauge and purge valve
Diamond Interaction Chamber™
Ceramic Auxiliary Processing Module (APM)
Ceramic (Zirconia) plunger and seal quench for extended seal life
Pharma grade heat exchanger
Stainless steel enclosure
Gauges for measuring hydraulic drive pressure, hydraulic oil level and temperature
Self-contained unit, mounted on locking casters for portability, standard door width
Feed temperature range 16˚C – 75˚C (35˚F – 165˚F)
TEFC (totally enclosed fan-cooled) motor – starter optional
Sanitary flush diaphragm pressure transducer with digital readout
Class IV seals and gaskets certified
2 RTD temperature sensors

Benefits

Produces product flow rates up to 1200 mL/min at 689 – 2068 bar (10,000 – 30,000 psi)
Has small batch capability; handles a minimum sample size of 200 ml
Features a low product hold-up volume (180 ml)
Is CIP process capable
Integral feed pump
Integral heat exchanger
Lockable casters, standard door width for easy mobility
Is able to validate under 21 CFR to cGMP with purchase of data logging option
Meets CE compliance standards
Standard with 7” touchscreen HMI
Allows monitoring of key process parameters
Facilitates non-destructive processing of heat-sensitive materials
Has cost-effective production capability
Assures batch-to-batch process repeatability
Features sanitary-grade and BPE-compliant product paths, instruments and valves
Offers process pressure and temperature monitoring with local display and signal transfer to customer’s data acquisition system
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 start-up assistance, operator and maintenance training, SAT and IQ/OQ execution by our technical staff

Dimensions

1450mm x 860mm x 1830mm (H x W x L)
Weight 886 kg

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