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.
- 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
- 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)
up to 30,000 psi (2068 bar)
1.0 – 1.2 L/min
W x D x H
|57″L x 34″W x 72″H|
(145 x 86 x 183 cm)
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.