What is a single-use assembly? A single-use assembly is a ready-to-use custom-made all-in-one solution made from different plastic components that are assembled into one whole, based on a customer-specific design. Assemble yourself or ready-to-use? Companies in the (bio)pharmacy and life science industry sometimes assemble their own single-use process systems. This of course has to happen securely. If the connection between components is not made correctly, it can lead to cross-contamination or leakage. Through this the safety and quality of the end-product could be in danger, and the production process could be delayed. Seeing how delays and lost batches are extremely costly, an optimal and 100% safe production process is an absolute must. To eliminate risks with assemblies and guarantee production-security, ready-to-use single-use assemblies offer the solution.
Innovapure® provides a combination of different components that can be customized to your requirements. Through a broad range of tubing and single-use components combined across an open architecture design, we work with you to create a sterile and dependable fluid path customized to your bioprocessing requirements. Each of our single-use assemblies are manufactured in-house and are lot traceable throughout our process. To ensure our single-use technology comes ready to use, and meets the requirements set by cGMP guidelines, lot traceability of each component can be made available as part of our detailed documentation. Assembly and packaging are carried out in our ISO 14644-1 Class 7 Cleanroom manufacturing sites. Sterile tube assemblies are available with a 10E-6 SAL and a two year sterility shelf life, validated in compliance with ANSI/AAMI/ISO 11137 VDmax 25 methodology.