Single Use System

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.

7 benefits of ready-to-use single-use assemblies

• Shorten working time and thus cost reduction
• Less risks of cross-contamination and leakage
• Less production downtime through shorter cleaning time
• Saving on water- and energy costs
• Ensuring of the complete supply chain
• Higher efficiency throughout the entire production process
• Improvement of production process through quality guarantee and documentation control

Custom Single Use Assembly Design Flow

• 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 Innovapure® 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.

Single Use Assemblies from Innovapure®

• Sterile tube assemblies are available with a 10E-6 SAL (sterility assurance level)
• Safe, flexible and quick turnaround backed with a robust supply chain.
• Complete product traceability.
• Large component library to choose from.
• Documented quality systems compliant with ISO 9001 and ISO13485.

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 customised 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.