- Pilot Scale M815Biopharma Microfluidizer® Processor Series
M815 Biopharma Microfluidizer® processor for Processing Clinical and Production cGMP Batches
We offer the M815 basic biopharmaceutical model for pharmaceutical and biotech applications. 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 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.
Discovery 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, heat exchanger and all required features for most cGMP operations, 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 the non-sterile processing of:
- Nanoemulsions (with and without API)
- Cell Disruption
Every M815 pilot scale biopharma 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*)
- 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
- Is CIP process capable — provides Clean-in-Place
- 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 startup assistance, operator and maintenance training, SAT and IQ/OQ execution by our technical staff
- Product feed pump, pharmaceutical grade with pressure gauge 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
- Sanitary flush diaphragm pressure transducer with digital readout
- Class IV seals and gaskets certified (enhanced and aseptic models only)
- Can be upgraded tp 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)
- M-110EH-30 Enhanced Biopharmaceutical Microfluidizer Processor for processing clinical and production batches
- M-110EH-30 Aseptic BioPharm Microfluidizer processor for sterile processing of clinical and production batches
- Microfluidics Model M110EH Configurations – Standard items