NY och STÖRRE Pilothomogenisator från Microfluidics för kliniska processer med cGMP krav.

MaskinMicrofluidics International Corporation is pleased to announce the commercial release of the new M815 Pilot Scale MicrofluidizerTM. The M815 biopharma series processor offers the same high level of performance, quality and reliability that MicrofluidizerTM customers have come to expect, while improving on the value-added benefits and competitive positioning in the market.
Unique value-added customer benefits of the new M815 MicrofluidizerTM includes the following:
–  Offers a flow rate of 1 – 1.2LPM, which is required for 100L clinical batches, and is ideal for 100L bio-reactors.
–  Supports installation in problematic facilities due to compact design and mobility on casters.
– Has small batch capability; handles a minimum sample size of 200ml.
– Monitors key process parameters with local display, with the option of CFR Part 11-compliant data acquisition and re-transmission.
–  Facilitates non-destructive processing of heat-sensitive materials.
–  Has cost-effective production capability.
–  Assures batch-to-batch process repeatability.
–  Includes a complete document turnover package for validation support, including IQ/OQ, material certifications and calibrations.

Download the new M815 brochure!

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