Pilot Scale M815High Shear Microfluidizer® Processor
M815 Microfluidizer® for Processing Pilot Scale and Small Production Batches
Like all production scale processors, the M815 utilizes Microfluidizer® proprietary high shear fluid processing technology for uniform droplet and particle size reduction, which enables the production of stable nanoemulsions, nanosuspensions, liposomes and the nanoencapsulation of actives. Additionally, Microfluidizer® technology offers the most efficient method for disruption of yeast, E. coli, plant and mammalian cells.
How It Works
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 scaleup 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 lab scale (M-110EH) and production scale (M-700 series) models, and they are ideal for manufacturing batches in the range of 100L-300L
Development to Commercialization
While researchers continually identify various new chemical compounds as possible drug candidates, many are only marginally soluble in oil or water. Microfluidizer® technology solves this problem. Our machines create ultra high shear forces that reduce the particle size of active pharmaceutical ingredients to therapeutically relevant sizes, enabling the production of drugs with improved bioavailability and stability.
Cell Disruption for Biotechnology
Microfluidizer® technology meets the demanding needs for cell membrane disruption — from the gentle disruption of cultured cells for virus isolation to the challenging disruption of yeast and other fungi. The M-110EH’s exacting level of process control ensures highly reproducible and efficient cell breakage, while controlling temperatures to prevent denaturing.
Getting to Full Production
The results easily scale up from pilot to production volume under the same operating conditions. The M815 basic biopharmaceutical processor comes standard with a feed pump and heat exchanger, which means that it is a simple matter of attaching your feed vessel and collection vessel and you are ready to run.
The M815 pilot production processor is recommended for processing:
- Nanoemulsions (with and without API)
- Cell Disruption
Every M815 pilot scale Microfluidizer®:
- Has small batch capability; handles a minimum sample size of 200 ml
- 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
- Standard with 7" Touchscreen HMI
- Features accessible maintenance points for easy maintenance
- Allows monitoring of key process parameters
- Facilitates safe processing of thermally sensitive materials
- Has cost-effective production capability
- Assures batch-to-batch process repeatability
- Features a low product holdup volume (180 ml*)
- Is CIP process capable — provides Clean-in-Place
- Includes on-site startup assistance, operator and maintenance training
- Product feed pump, and purge valve
- Integral Heat exchanger
- Diamond interaction chamber
- 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
- 2 liter reservoir, pharmaceutical grade
- Filtered hydraulic oil
- On-board air compressor for air switch activation
- Product coolant temperature control, automatic (enhanced model only)