Single Use Assemblies
ESI Ultrapure offers a wide range of single use assemblies; custom made in a clean room but also standardized assemblies. Either Single use barbed or molded assemblies can be designed for autoclave applications or can be provided gamma irradiated with complete sterility validation support data. Every production process/application within USP and DSP is different and due to that, needs a different approach/need. As an example for USP applications, a fully single use seed train assembly, made of bottles, tubing and filters can be built to provide a plug and play system which can be installed directly in the application without any cleaning or validation. An example of DPS can be a sterile single use filling assembly, which can be placed into the filling machine to fill vials with vaccine.
- Bag assemblies can be used to prepare the buffers or can be used for storage of products.
- Tubing assemblies in both standard and customized design can be installed in the application to transport liquids.
- Bottle assemblies are very useful to make a sterile single use train for cell culture or you can use them for sterile sampling.
- TFF assemblies are specifically designed to create a sterile single use system for tangential flow filtration.
- Fill and finish assemblies, plug and play sterile single use assemblies to install directly into the filling machine.
- Pump assemblies can be used in peristaltic pump or they can have a single use pumphead for Levitronix pumps.
- Sterile filtration assemblies can be added in the last steps of DSP.
- Mixing system (assemblies). Cost effective bag assemblies including customized plastic totes and chart to have a manual simple and complete mixing system.
- Hose assemblies are specially designed to use in high pressure application.
- Molded TC tubing assembly
Important if you are considering buying assemblies is to think about these topics regarding your process.
You can assemble your own single use manifolds where you are responsible for the risks of product failure or we can assemble the customized manifold in our cleanroom. ESI is specialized in developing customized plug and play assemblies. These sterile plug and play manifolds can be installed directly in your process.
Contamination is a big issue, so we will try to develop an assembly with less connections. The risk of (cross) contamination will be reduced.
ESI focus on the customer benefits by reviewing the process and always finding the solution with the lowest cost of ownership. We can do this by standardization of the assembly, so you have to validate only one material of tubing instead of two.