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Biopharma fluid transfer | IRIS Single-Use Assemblies

Biopharma fluid transfer | IRIS Single-Use Assemblies

As an expert in single-use solutions, we have made it our goal to deliver vendor agnostic single-use assemblies manufactured at highest quality standards in ISO 7 cleanrooms and sterilized within shortest lead times. Prevent downtime and ensure an uninterrupted supply chain with our ready for GMP use single-use manifold assemblies using silicone tubing and connectors of your choice.

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100% customizable
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Dual sourcing
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GMP-compatible

Components used for IRIS Single-Use Assemblies

Single Use Support provides high quality, reliable and customizedassemblies of tubing, connectors, fittings, primary packagings, beta bags, filters, and more. As experts in biopharmaceutical process solutions, we streamline your process by assisting you from component configuration to drawings to use. 

  • Clear medical tubing with connectors on a light gray background
  • An image of a fluid transfer filter held by a person wearing blue gloves.
  • A close-up image of an IRIS single-use assembly sample bag.
  • A single-use five way distributor on a white background.

Our customers trust in us:

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From component configuration to drawings to usage

First, the single-use assembly components must be defined and designed. Then, the required components are determined and the final drawing are added to the product drawing. Once approved the manufacturing is performed in ISO 7 cleanrooms, followed by labeling, packaging and sterilization.

Single-use assembly catalogue

Design and configure your custom single-use assemblies according to individual needs and requirements. All our single-use components comply with any FDA, ISO and other regulatory standards and guarantee aseptic handling of your matter. After all, you want to avoid leachables, extractables or any kind of cross-contamination to impact your product before it reaches the end user.

Downloads

Preview of datasheet for IRIS single-use assemblies by Single Use Support
Datasheet: IRIS Single-Use Assemblies
Preview of datasheet for IRIS single-use assemblies by Single Use Support
Datasheet: IRIS Single-Use Assemblies
 
Preview of Single Use Support's case study about single-use assembly capabilities
Case study: IRIS Single-Use Assemblies Capabilites
Preview of Single Use Support's case study about single-use assembly capabilities
Case study: IRIS Single-Use Assemblies Capabilites
 
Preview of Single Use Support's whitepaper about the creation of single-use assemblies for pharmaceutical fluid management
Whitepaper: IRIS Single-Use Assemblies - Connecting the dots
Preview of Single Use Support's whitepaper about the creation of single-use assemblies for pharmaceutical fluid management
Whitepaper: IRIS Single-Use Assemblies - Connecting the dots
 

More solutions

More information

RNase Contamination Challenges - Single Use Support

RNase Contamination – Challenges & Solutions

In the world of biopharmaceutical manufacturing, ensuring the integrity and stability of drug products is paramount. One of the significant challenges faced by manufacturers, especially those involved in mRNA production, is RNase contamination....

David Seifert
David Seifert
Interview: Considerations for Sterilization of single-use assemblies

Interview: Considerations for Sterilization of single-use assemblies

David Seifert is Teamlead of Sales Application Engineering of Single-Use Assemblies at Single Use Support. As single-use system enthusiast, he has led several projects to deliver single-use assemblies. Sometimes within only 16 days – from drawing ...

David Seifert
David Seifert
Sterile Connectors for use in Pharma

Sterile Connectors for use in Pharma

Manufacturers of aseptic single-use connectors: Their advantages in an overview Aseptic connectors link important medical applications with one another. Preferrably easy and quick to use and it must grant sterility, even if the environment around ...

David Seifert
David Seifert

Frequently asked questions

What is a single-use assembly?

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A single-use assembly is a custom-made component for processing various goods, such as biologics or other products, that need to be kept germ-free. 

Single-use assemblies are often made out of plastic and make sure that workflows are seamless and safe during production and processing, e.g. single-use filtration assemblies.

One great advantage of single-use assemblies is that they are sterile when firstly (and lastly) used and do not need to be cleaned for any additional use, which is both cost- and risk-minimizing.

What validation guidelines are in place at Single Use Support manifolds?

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​​Single Use Support’s commitment to qualification standards means providing solutions that adhere to the stringent requirements of GMP, including Annex 1 guidelines. We assist clients in qualifying their processes with comprehensive documentation aligned with current Good Documentation Practices (cGDP).

The manufacturing of single-use assemblies is performed in ISO 7 cleanrooms, followed by labeling, packaging and sterilization.

Is it possible to customize single-use assemblies?

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Yes, Single Use Support offers customized solutions, where CDMOs and manufacturers can develop single-use manifolds tailored to their specific fluid paths. Once customized, they can get their single-use assembly off-the-shelf, anytime.

What single-use components can be purchased via Single Use Support?

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Anything you require can be included in your single-use manifold assembly. Be it equipment for filtration, clamps, gaskets, beta bags and stainless-steel protective shells for cell culture media, or other components based on single-use technology.

Are single-use filtration assemblies from Single Use Support compatible with other manufacturers?

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IRIS Single-use filtration assemblies offer full flexibility since they are manufactuerer-independent. The filtration assemblies are easy to use with our RoSS.Fill platform system or any other platform from other suppliers. 

Why should I implement a dual sourcing strategy?

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Dual- or multiple sourcing strengthens the biopharmaceutical supply chain by providing a validated safety net, increasing flexibility, and promoting long-term stability, based on your preferred single-use components. It ensures that supply sources are well-managed, with contingency plans in place to handle unforeseen disruptions. For example, if a specific single-use component from Vendor X is unavailable, a Vendor Y alternative can be seamlessly integrated, maintaining production continuity.

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