Pilot homogenizer (microfluidizer) M815
Артикул: М15
Bridging the gap between the lab and production the M815 processor enables users to replicate operating conditions as each batch scales up.
Like all Microfluidizer® processors, the M815 utilizes the fixed-geometry Interaction Chamber™ and constant pressure pumping system which enables users to achieve small particle sizes with uniform, tight particle size distribution with scale-up guaranteed.
The M815 models are designed to span the gap between the lab scale (M110P) and production scale (M700 series) models. It achieves product flow rates to 1.0-1.2l/min up to 2068 bar (30,000 psi).
This technology enables easy monitoring of key process parameters and facilitates the safe processing of thermally sensitive materials. As a self-contained unit, mounted on locking casters for portability, it features accessible maintenance points for easy upkeep.
Standard Features
- Product feed pump, with pressure gauge & purge valve
- Heat exchanger
- Diamond Interaction Chamber™
- Ceramic Auxiliary Processing Module™ (APM™)
- Ceramic (Zirconia) plunger with seal quench for extended seal life
- Stainless steel enclosure
- Gauges for measuring hydraulic drive pressure, hydraulic oil level and temperature
- Mounted on locking casters for portability, standard door width
- Maximum feed temperature range of 70˚C (158˚F)
Optional Features
- Motor starter panel
- RTD temperature sensors
- Sanitary flush diaphragm pressure transducer with digital readout
- Product inlet strainer
- IQ/OQ documentation & execution
Pharma and Biotech
Options are available for pilot batch processing to meet the needs of pharmaceutical and biotechnology customers. A range of options are available to suit specific requirements.
The M815 can be designed to achieve cGMP standards which is vital for applications such as: vaccine adjuvants and sterile nanoemulsions. Each machine comes equipped with a standard with a feed pump and heat exchanger, which makes it easy to use simply by attaching the feed vessel and collection vessel then it's ready to run.
Basic Biopharma:
- cGMP as specified by the American Society for Mechanical Engineers – Material Certificates for all product contact parts included in an electronic Turnover Package (TOP)
- Surface Finish – Electropolished and passivated - surface finish of < 20 Ra
- USP Class VI elastomers
- Drainability – A sanitary heat exchanger, a sanitary flush pressure transducer and pitched piping are included to ensure all equipment can be drained effectively.
- CIP - clean in place
Enhanced Biopharma:
- Includes all of the features of the Basic Biopharma plus:
- 21 CFR Part 11 Data Acquisition
- Industrial Personal Computer (IPC)
- Other options include - automation, conductivity sensors & mass flow meter
Aseptic Biopharma:
- All of the Enhanced Biopharma features plus:
- Steam in Place (SIP) for processing in a sterile environment
- Equipment is fully automated
- Also recipes for Steam, Prime, Run & Drain
The M815 processor is recommended for the following applications:
- Nanoemulsions (with and without API)
- Nanodispersions
- Microencapsulation
- Deagglomeration
- Cell Disruption
Specifications
The Specifications for the M815 Pilot Scale Microfluidizer® Processor Include:
- Operating pressure of up to 30,000 psi/2068 bar
- Minimum sample size - 1.5 l
- Flow rate - up to 1.0 - 1.2 l/min
- Power - 60 hz / 460 V 3 phase
- Noise - 80 dB TWA