Microfluidics M700 Series Microfluidizer® Processor

Pharma Enhanced Microfluidizer® Processors

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M7125 and M7250 Pharma enhanced Microfluidizer®processor provides superior results for pilot and production environments. As a result of recent advances in high throughput screening and drug discovery, many new chemical compounds have been identified as possible drug candidates. Unfortunately, many of these compounds show poor water solubility and often are only marginally soluble in oil-based solvents.

The ultra high shear force developed by Microfluidizer® processors solves this problem by reducing the particle size of active pharmaceutical ingredients to therapeutically relevant sizes that enables the production of drug products with improved bioavailability and stability. Results obtained on all laboratory units will scale up easily and in a linear manner to production volumes when the same operating conditions are employed. Enhanced Microfluidizer processors include Ultra Clean In Place (UCIP) eliminating the need for disassembly and Clean Out of Place (COP). Data recording and validation support documentation including IQ/OQ is included to ensure your ability to comply with 21CFR part 11 guidelines. 

Features

21 CFR for cGMP
Turnover documentation package for validation
Installation Qualification / Operational Qualification (IQ/OQ) documentation
Installation Qualification / Operational Qualification (IQ/OQ) execution
Startup and training
Stainless steel construction
Product wetted surfaces finish to 0.5µm (20 Ra) nominal, electropolished and passivated
Manual controls
Feed pump, pharmaceutical grade
CE compliant
Interaction Chamber™ selected for your application
Factory Acceptance Testing (FAT) / Site Acceptance Testing (SAT)
Motor starter panel
Ultra-Clean-In-Place (UCIP)
Product heat exchanger – Pharma grade with active product temperature control, double tube sheet style
Mass flow meter – Pharma grade
Data acquisition and recorder system, Industrial Personal Computer (IPC); 21 CFR Part 11 compliant for electronic signature and record keeping
Proprietary high pressure diaphragm priming valve
Process pressure and temperature sensing

Specifications

Pressure range: up to 2068 bar (30’000 psi)
Up to 15 lpm @ 690 bar (4.0 gpm @ 10,000 psi) product flow rates
7.5 lpm @ 1,379 bar (2.0 gpm @ 20,000 psi) product flow rates
5.1 lpm @ 2,068 bar (1.3 gpm @ 30,000 psi) product flow rates
Power requirement: 18.6 kW (M7125); 37.5 kW (M7250)
Low product holdup volume (<1 liter)
Small batch capable (minimum 5 liters)
All product paths are sanitary grade and BPE compliant
Complete package unit including motor starter panel and process interlocks
Ultra Clean In Place (UCIP) using supplied feed pump or your CIP system pump
All instruments and valves are sanitary grade, BPE compliant
On board data acquisition for complete batch record audit trail
On board flow meter to measure product and CIP flow rates
PID control of process chilled water for product temperature management
Factory Acceptance Testing (FAT)
Complete document turn over package for validation support including IQ/OQ,
material certification and calibrations
On site start-up assistance, operator and maintenance training, SAT and IQ/OQ
execution by our technical staff

Dimensions

2360mm x 1420mm x 2010mm (H x W x L)
Weight: 816 kg (M7125); 1089 kg (M7250)

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