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.
Knauer’s 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
Impingement Jets Mixing Skids Details
| Number of impingement jets mixers | 4 |
|---|---|
| Number of pumps | 8 |
| Number of flow meter | 8 |
| Number of valves | 2 |
| Process connection inlet | 3/8″ and 1/4″ barbed fitting (6 Inlets) – different connections on request |
| Process connection outlet | 1/4″ barbed fitting (2 Outlets) – different connections on request. |
| Volumetric flow rate (L/min) | up to 2 liter/min |
| Volumetric flow rate (L/hour) | up to 120 liter/h |
| Maximum operation pressure | 100 bar |
| Liquid temperature range | 4−60 °C (39.2−140 °F) |
| Wetted materials | stainless steel, PEEK, Titanium, FFKM, PTFE, GFP (graphite fiber reinforced PTFE), aluminum oxide (Al2O3), ruby, sapphire |
| Software | CDS, 21 CFR part 11 compliant |
| Interfaces | Pump: LAN, RS-232, pin header connectors; Flow meter: RS-232 + FLOWBUS; Valve drive: LAN |
| Power supply | Pump: 100–240 V, 50–60 Hz; Flow meter: +15…24 V DC, Valve drive: 24 V DC |
| Maximum power consumption | Values per device Pump: maximum 320 W; Flow meter: 3 W ; Valve drive: 65 W |
| Ambient conditions | Temperature range: 4–40 °C; 39.2–104 °F; below 90 % humidity (non condensing) |
| Dimensions | 1000 x 1290 x 700 mm |
| Weight | ~ 250kg |
| API-predilution and quenching | YES |
| GMP-ready documentation | YES |
| Factory acceptance test | YES |
| Site acceptance test | YES |
| Purchase order lead time | about 3 months |
| Disclaimer | Depending on the process the end user must consider the legal situation of patents and intellectual property. KNAUER is designing the customized hardware solution on customers request |
ICON Scientific, Inc
