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Single-Use-Systems and its Benefits in Biotherapeutics Manufacturing

Single-Use-Systems and its Benefits in Biotherapeutics Manufacturing

Applications of Single Use Systems

 

Single-use systems, are designed for use through the entire production process of a single batch of therapeutics and then discarded. The adaptation of single-use technologies reduces product cross contamination risks by eliminating the need for expensive cleaning and validation between batches. Assembled in a Class 7 cleanroom, double bagged and then sterilized by gamma, sterilization 10ˉ6, these systems ensure every batch is a sterile system. Single-use Systems are highly efficient and cost effective.

 

Vaccines manufacturing unit

 

Foxx Life Sciences as a leading manufacturer of Single Use Systems

 

Foxx Life Sciences®’ Single-Use Biopharmaceutic processing and Single-Use Systems include a broad range of products developed by our Biomedical engineering staff and/or with customer collaboration.  Engineering solutions in support of customer needs has driven the success of Foxx’s Single-Use business.  Foxx Single-Use products strictly adhere to ISO 13485 Certification guidelines and are assembled in ISO Class 7 (10k) Certified Cleanrooms to ensure cleanliness and quality of products.  All material used in assemblies are UPS Class VI certified. Completed projects have validation packages documenting of the entire production process, including, Batch Records, COCs for each component and Finished Goods Records.

Foxx Life Sciences®’ Single Use Biopharmaceutical processing and Single Use Systems are used in a wide range of production applications, including vaccine production, therapeutic protein processing, monoclonal Antibody therapeutics, blood components, and Fermentations products. Foxx Single use products are well suited for scale down biologic manufacturing process a key trend in biologic Active Pharma Ingredients (APIs).

 

Foxx Life Sciences is known as a world leader in custom Single-Use Systems (SUS) including tubing, bag, bottle, flask, needle and carboy assemblies, as well as filtration, fluid management, laboratory safety products, and glassware.

 

Single use product portfolio - custom made and made to order

 

Products for Biotherapeutics Research and Manufacturing

 

Foxx Life Sciences® Single-Use Bioprocess Products are design variants of the EZBio® Single-Use Assembly product line, perfected for fluid transfer, dilution, mixing and storage. All assemblies take advantage of Foxx’s patented VersaCap® technology which means there is no unnecessary tangling of tubing during set-up or use.

Also offered are large library of custom assemblies, filling/venting products, sanitary clamps, and EZTop® fluid transfer caps.

If you have any questions or inquiries, please email us at sales@foxxlifesciences.com or call 1-603-890-3699.

 



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Frequently Asked Questions

Assess your fluid handling volumes, sterility requirements, compatibility with solvents or reagents, and workflow endpoints. Foxx’s technical support team can assist in selecting assemblies and filtration components suited to your process.
Biotech, pharmaceutical manufacturing, vaccine production, research laboratories, clinical development, and diagnostic centres widely use Foxx single-use systems and consumables.
Yes. With global manufacturing facilities and strict quality control, Foxx products meet regulatory requirements in major markets including the US, EU, and Asia for scientific, clinical, and manufacturing applications.
Labs should follow regulatory guidelines for sterility assurance levels, validate fluid handling pathways, perform risk assessments per relevant standards (e.g., FDA, USP), and maintain traceability documentation for audit readiness. (Industry practice)
Yes. The company’s cleanroom manufacturing and quality certifications make its products suitable for Good Manufacturing Practice (GMP) environments where sterility and documentation standards are required.
Foxx Life Sciences offers Autofil® 2, EZlabpure™ and APEX™ bottle top filters, EZlabpure™ and EZFlow syringe filters, membrane disc filters, vent filters, and cell strainers engineered for high-purity filtration in analytical labs, bioprocessing, and cell culture workflows.
Foxx stands out for its ISO-certified quality, USP Class VI materials, extensive SKU portfolio with patented designs, rapid shipment, and global manufacturing footprint, providing superior compliance, performance, and cost value.
Foxx offers custom single-use solutions and assemblies designed to meet unique workflow requirements, enabling bespoke fluid paths, connectors, and tailored assemblies to optimize specific lab processes.
Standard Foxx products typically ship within 24–48 hours, while Made-to-Order (MTO) or custom SUT assemblies generally ship in 4–6 weeks, balancing speed with tailored specifications.
Single-use systems reduce contamination risk, eliminate cleaning and sterilization validation needs, cut turnaround times, lower labour and water use, and improve overall operational efficiency.
Foxx products are manufactured under ISO 13485 quality management systems in ISO Class 7 certified cleanrooms, use USP Class VI materials, and many are FDA registered. This ensures reliability, compliance, and suitability for regulated environments.
Single-Use Technology refers to disposable fluid handling and storage assemblies used in biopharmaceutical manufacturing and labs that eliminate traditional cleaning and sterilization processes, reducing contamination risk and operational complexity.
Foxx Life Sciences provides a broad range of life science and bioprocess consumables, including single-use systems (SUS), custom tubing & bottle assemblies, filtration products, lab safety equipment, glassware, plasticware, caps & gaskets, connectors, vent filters, and stainless-steel components for research, biotech, and pharmaceutical applications.
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