The Impingement Jets Mixing (IJM) Pilot Scale Unit for high-flow production of nanoparticles (LNP, microemulsions, etc.) is the perfect choice for R&D purposes and small productions batches.
The unit contains of four pumps enabling all the steps from predilution of the Concentrated Active Pharmaceutical Ingredient (API), Impingement Jets Mixing of lipid and API phase and finally the quenching of the nanoparticle solution.
Furthermore the unit is equipped with four flowmeters for flow monitoring, one jets mixer and two mixers for predilution and quenching. Our CDS software provides an intuitive and easy operating of the IJM-SKID. The system visualization offers a graphical representation and allows easy handling of the complex flow processes. Additionaly, each device which is displayed in the fluidic scheme can be manually controlled, giving the opportunity to optimize, change and adapt your conditions also during the run. The software complies with 21 CFR Part 11.
The skid is built in a stainless steel frame on casters and are suitable for CIP cleaning procedure in pharmaceutical production.
The Impingement Jets Mixing (IJM) Pilot Scale Unit for high flow production of nanoparticles (LNP, microemulsions, etc.) consisting of:
- 4 KNAUER high-pressure dosing pumps 80P
- 4 Coriolis flow meters
- 1 KNAUER IJM mixers
- 2 Mixers
- 8-port multiposition Valve
- Inlet for Lipid and mRNA (Sanitary Clamp Connector)
- Inlet for buffer (Sanitary Clamp Connector)
- Outlet for LNP solution (Sanitary Clamp Connector)
- Internal piping
- Frame (stainless steel system 1.4301)
- CDS software, 21 CFR part 11 compliant
- Chromatography workstation with 27" monitor
- Installation & familiarization by KNAUER
In addition, we offer for our customers:
• Material Documentation of wetted surfaces
• Customer Service before, during and after the set up
• Capillary customization and labeling
• FAT (Factory Acceptance Test at KNAUER Berlin)
• SAT (Site Acceptance Test at customer site)