IRIS Single-Use Assemblies | Fluid transfer tubings

Single-use manifold assemblies are assembled single-use components that priovide a sterile fluid flow of pharmaceutical products. We deliver manufacturer-independent single-use assemblies built to the highest quality standards in ISO 7 cleanrooms and sterilized within the shortest lead times.

IRIS Single-Use Assmeblies_Production Kufstein-29
customizable (1)

100% Customizable

Develop your own off-the-shelf assemblies

Icon_Dual_Sourcing

Dual Sourcing

Strengthening the supply chain

Qualified

GMP-compliant solutions

Components used for Assemblies

Single Use Support provides high quality, reliable and customized assemblies of tubings, 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. 

Preview_connecting-the-dots-single-use-assemblies

DOWNLOAD WHITEPAPER

Creation of Single-Use Assemblies for Pharmaceutical Fluid Management

Throughout the entire manufacturing process, pharmaceutical liquids are transferred and have touchpoints within upstream bioprocessing, downstream bioprocessing and fill/finish. Single Use Support provides single-use assemblies of highest quality, reliability and speed of delivery. And with it capabilities in 

  • Dual Sourcing | Strengthening the Supply Chain
  • Customization | Developing off-the-shelf assemblies
  • Qualification | Providing GMP-compliant solutions

Our customers trust in us:

Rentschler Biopharma SE

Lonza

SCHOTT Pharma

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.

MANI_X001_00000024-0-01

Distributor Single-Use Assemblies

MANI_X001_00000126-A

Filter Single-Use Assemblies

MANI_C001_00000022-A

Fill Single-Use Assemblies

See Full Catalogue

Choose from a wide range of standardized single-use tubing and manifold assemblies for your fluid transfer processes in biopharma processes.

Download more datasheets

Click here to download technical product data sheets, case studies and more.

Datasheet_IRIS_Single-Use Assemblies_Single Use Support

Datasheet Single-Use Assemblies

Filesize: 0.7 MB – Mime-Type: application/pdf

Case Study - Customized IRIS Single Use Assemblies

Case Study - Customized Manifolds

Filesize: 0.65 MB – Mime-Type: application/pdf

Whitepaper_Connecting-the-Dots_IRIS-Single-Use-Assemblies_SingleUseSupport

Whitepaper: Connecting the Dots - IRIS Single-Use Assemblies

Filesize: 1.96 MB – Mime-Type: application/pdf

More solutions

Single use bag protection for drug substances in bulk stream with RoSS shell by Single Use Support

RoSS® Shell | Protecting single-use bags

The safest transport solution for all available single-use bioprocess containers. Robust. Scalable. Single-use bag independent.

Bag Independent
< 0.001 % Product Loss
Best Freezing Results
IRIS Bag

IRIS Single-Use Bioprocess Container

Innovative. Robust. Individual. Single-Use. Make sure your supply chain is uninterrupted. Get your IRIS 2D single-use bioprocess container from Single Use Support in any size with the fastest possible delivery times. Store and ship anything from cell culture samples to large drug substance volumes reliably and on time.

Sizes from 50mL-50L
Freezing to -196°C/-320°F
Reliable partner
RoSS.FILL Bag - single use bag filling and draining system machine

RoSS.FILL Bag | Single-use aseptic fill-filtration system for bags

RoSS.FILL Bag is a flexible automated single-use aseptic bag filling machine for dispensing biopharmaceuticals into single-use bags. The fluid path is designed to be fully disposable and is able to accommodate a variety of sterile connection and disconnection options.

Up to 400L+/Batch
Highest Accuracy
Fast Throughput
ross-pftu-large-scale

RoSS.pFTU Large-Scale | Plate Freeze & Thaw

Up to 400L: Our large scale freezing platform system is a plate-based pharmaceutical freeze and thaw unit. The system enables controlled rate freezing and is compatible with single-use bags of all sizes and manufacturers.

Down to -80°C / -112°F
Up to 400L
Controlled rate freezing & thawing
RoSS.FRDG-Rendering

RoSS.FRDG | Ultra Cold Storage Freezer

RoSS.FRDG is an ultra cold storage fridge for frozen drug substances in different sizes. The ultra cold freezer keeps the desired set point temperature down to -80°C/-112°F. RoSS.FRDG offers highest storage density, is fully movable and can be modularly adapted to your individual needs.

Down to -80°C / -112°F
Capacity for up to 300L
Modular Interior
Single Use Support shipper

RoSS.SHIP | Ship, Track & Trace

RoSS.SHIP secures the cold chain shipping and storing of bulk drug substance for almost one week. Highly robust, stackable, coolable and compact – Fort Knox for high-quality substances!

Below -60°C for at least 6 days
Track & Trace 24/7
Up to 55 RoSS® Shells

FAQ about single-use assemblies

What is a single-use assembly?

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 are single-use tubings?

Single-use tubings are components used in fluid management of biologics; often made out of plastic, these fluid transfer tubing are necessary when processing various liquids that need to be kept germ-free.

Single-use tubings are pre-sterilized (typically by radiation or e-beam) prior to installation to ensure contamination is prevented throughout the fluid transfer process.

Since they are single-use products, cleaning and sterilization after their application is not necessary, which is both cost-saving and risk-minimizing.

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

​​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 6 cleanrooms, followed by labeling, packaging and sterilization.

Is it possible to customize single-use assemblies?

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 are the lead times for single-use assemblies from Single Use Support?

We offer lead times of 8-10 weeks after design approval and PO for our custom single-use tubing assemblies.

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

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?

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?

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.

More information

mRNA & LNPs

RNase Contamination – Challenges & Solutions

This article explores the challenges posed by RNase contamination and the solutions that can be employed to mitigate these risks. RNase contamination | Ribonuclease inhibitors | RNase-free equipment

1640281789974

David Seifert

August 13, 2024

Single-use Consumables

Navigating GMP Annex 1: How Single-Use Assemblies will Comply

GMP Annex 1 significantly impacts the use of single-use assemblies in fluid management processes within the biopharmaceutical industry. It requires manufacturers and stakeholders to adopt a risk-based approach, implement proper controls, and ensure the integrity and sterility of single-use systems.

1640281789974

David Seifert

June 13, 2023

Single-use Consumables

Interview: Considerations for Sterilization of single-use assemblies

In an interview with single-use systems expert David Seifert, he compares sterilization methods and shares insights, benefits and outlooks in the field of single-use sterilization technology.

1640281789974

David Seifert

July 14, 2023

Single-use Consumables

Sterile Connectors for use in Pharma

An overview of manufacturers and its brands of sterile and aseptic connectors for biopharmaceutical fluid management.

BRMO

Brian Moloney

December 27, 2021

Single-use Consumables

Protecting single-use bags to foster their progress

Single-use systems are on the rise. And yet there is hesitation to make single-use technologies continue to thrive. Get to know how single-use systems get full acceptance. 

micheal-eder

Michael Eder

November 29, 2021

Send a request