The Impingement Jets Mixing (IJM) Small Production Scale Unit for high flow production of nanoparticles (LNP, microemulsions, etc.) contains two parallel mixing units. Each unit consists 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, each 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. Additionally, each device that is displayed in the fluidic scheme can be manually controlled. You have the opportunity to optimize, change and adapt your conditions also during the run. The software complies with 21 CFR Part 11.
All skids are built in a stainless steel frame on casters and are suitable for CIP cleaning procedures in pharmaceutical production.
The Impingement Jets Mixing (IJM) Small Production Scale Unit for high flow production of nanoparticles (LNP, microemulsions, etc.) consisting of:
- 8 KNAUER high-pressure dosing pumps 80P
- 8 Coriolis flow meters
- 2 Impingement jet mixers
- 4 Mixers
- 2 8-port multiposition Valve
- Inlet for Lipid and mRNA (Sanitary Clamp Connector)
- Inlet for citrate buffer (Sanitary Clamp Connector)
- An outlet for LNP solution (Sanitary Clamp Connector)
- Internal piping
- Frame (Stainless Steel system 1.4301; 1000 x 1310 x 800 mm (WxHxD))
- CDS software, 21 CFR part 11 compliant
- Chromatography workstation with 27" monitor
In addition, we offer for our customers:
- Material Documentation of wetted surfaces
- Customer Service before, during, and after the setup
- Capillary customization and labeling
- FAT (Factory Acceptance Test at KNAUER Berlin)
- SAT (Site Acceptance Test at customer site)