We have seen many Bioprocessing end users carry out in-house assembling of their single-use systems. Often this can lead to production delays if connections between the various components aren’t made correctly resulting in cross contamination and leakage. A leak or risk on product integrity of your process can result in lost batches which is extremely costly for many end users. A simple solution to eliminate production stoppages, reduce the risk of contamination, and increase efficiencyis by using a ready to use single use assemblies.
What is a Single Use Assembly?
Developing a customized single use assembly starts with a custom design. This is a drawing of the assembly for the specific bioprocess application. Every single use assembly is custom, using tubing or reinforced hose, fittings, closures, filters, sensors, bottles and other components. Each component is identified and listed on the drawing which is sent to the customer for approval prior to production being carried out. Each drawing has a unique number for quality and identification purposes. Once the design is approved by the end user, assembly and packaging is carried out in an ISO-certified cleanroom.
Benefits to Single Use Assemblies?
Reduced labour, expense and time for end user.
Reduced risk with cross contamination and leaks.
Eliminates cleaning and downtime.
Water and energy cost reduction.
Quality and documentation control.
Supplied gamma irradiated.
Single Use Assemblies from ESI Ultrapure
ESI Ultrapure has a wide range of standard and custom single use assemblies. Together we can help you develop from concept stage to preliminary drawings, vendor qualification, approved drawings, prototypes, implementation and GMP assemblies. Each application within USP and DSP needs a different approach.
ESI will work with you to design and optimize your process with any component you specify. Our technical expertise enables us to provide valuable feedback for process improvements or even to avoid costly mistakes.