IRIS Single-Use Bioprocess Container

Qualified for ambient use, low and cryogenic temperature

IRIS Single-Use Bioprocess Containers are fully qualified for the usage from -196°C to +50°C (-320°F to +122°F). IRIS: Innovative. Robust. Individual. Single-Use.

Store, ship and freeze anything from cell culture samples to large volume drug substances. IRIS single-use bags are tailored to your needs .

 

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Single-use bag in RoSS shell

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IRIS 2D Bag | Single-Use Bioprocess Container

Our IRIS single-use bags ensure 100% secure primary packaging for handling cell culture media and drug substance required in the biopharmaceutical industry. As trusted supplier of the life science industry, we know how important it is to have 0% product loss during freezing, storage and transportation.

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Single-use bioprocess container by Single Use Support

IRIS 2D Bag | Small Volume for Cell & Gene Therapy

With our small IRIS single-use containers we meet the high demands of CGT manufacturing processes. These cost-effective single-use bioprocess containers with capacities of 10mL to 250 mL provide the highest protection of any liquid formulation during storage and transport. At the same time, their compatibility allows for utilization with a number of configurations and fluid transfer assemblies.

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RoSS® Shell | Protection of single-use bags

The RoSS® Shell is the solution for Robust Storage and Shipping of biopharmaceuticals. It is a robust case designed to protect 2D single-use bags of any size and vendor in any process step. The shell is optimized for transport, freeze and thaw steps, in which manufacturers see product loss of around 1.5% with traditional methods. In over 200,000 RoSS® Shells sold the product loss was <0.001%.

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Our customers trust in us:

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SCHOTT Pharma Logo

Rentschler Biopharma SE

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SCHOTT Pharma

Features and benefits

A smart material composition of PE and EVOH enables robustness and flexibility at the same time. Suitable for all freezing technologies at temperatures down to -150°C this bioprocess container offers protection for your liquids during transport and storage. All our single-use bags are individually customizable in their size and fill volume. In addition, no limitations in tubing, ports and connectors are given.

  • Customizable: any size/fill volume, any tubing, any connector, any port fitting
  • Highly protective, low permeability, inert PE multilayer film
  • PE film with ultra-low extractables & leachable profile. Data available upon request.
  • Suitable for all freezing technologies
  • Gamma irradiated
  • Compatible with Single Use Support manifolds assemblies for a fully closed sterile ready to use system
  • Compatible with the protective RoSS® Shell

100% safe liquid handling & 0% product loss

Safe storage and packaging are the factors that matter in liquid drug substance management. Our 2D single-use bags protect your high-value liquids. Product loss will be reduced towards 0%.

In the bioprocess containers the fluids are safe for freezing, transport and storage. Its PE film with ultra-low extractables & leachable profile is tested according to BPOG protocol. The bags are fully customizable and available in all desired volumes. 

They are the perfect solution for cell and gene therapies up to bulk drug substance filling. Bioreactors like BPCs based on single-use technology are flexible and can be combined with extra components, such as for filtration or aseptic filling.

Single-use bags with different sizes fit all into the RoSS single-use container protecting system

Time matters – fast delivery of single-use bioprocess containers

Single-use systems and consumables are the future in terms of liquid-handling applications and fluid transfer assemblies, be it for small amounts of cell culture in CGT area or for large volumes of drug substances. In order to use the full potential of these solutions, constant supply needs to be guaranteed. The most flexible and cost-effective single-use system is of no use to the biopharmaceutical industry if it is not readily available. 

But biomanufacturing is facing challenging times due to aftermath of the Covid-19 pandemic. What counts are fast supply chains and trusted suppliers. We meet these challenges and offer our customers an uninterrupted supply chain for our fully customizable single-use bags/bioprocess containers that fulfill all requirements

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Data sheets

Click here to download technical product data sheets, design videos, as well as case studies, whitepapers and more.

Datasheet_IRIS 2D Bag

Datasheet IRIS 2D Bag

Filesize: 0.33 MB – Mime-Type: application/pdf

Compatible with our IRIS single-use assemblies and RoSS® Shell

All single-use bags are fully compatible with our single-use assemblies and protective shells RoSS® and RoSS.KSET, which consist of stainless steel and 3D foam. 

This allows for a fast and safe handling of your liquids to the usual standards from a single source.

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RoSS.KSET top view

Configure your bag and tubing assemblies

Single-use assembly configurator - Single Use Support

Single-Use Assembly Configurator

Configure your custom bag and single-use assemblies with our free configurator. Fluid management for bioprocessing, cell & gene therapies, life sciences & more.

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Bulk.Stream RoSS shell

RoSS® Shell | Protecting single-use bags

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

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IRIS Single-Use Assmeblies_Production Kufstein-29

IRIS Manifold | 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 in compliance with GMP and regulatory requirements with our single-use manifold assemblies using silicone tubing and connectors of your choice.

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RoSS.FILL Bag | Fill-Filtration

Fully automated filling & filtration system used for single use bags. Contains 1 control unit and 1 bag filling rack with 20 invididual scales.

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RoSS.pFTU Large-Scale | Freeze-Thaw

Our large scale freezing platform system is a plate-based freeze-thaw unit for any scale and batch size. Well-established RoSS.pFTU large scale is compatible with single-use bags of all sizes and manufacturers. The hybrid solution offers freeze-thaw capabilities for bags and bottles up to 220L in one platform.  

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Ultra-cold storage RoSS.FRDG

RoSS.FRDG | Ultra Cold Storage

RoSS.FRDG is a storage freezer for frozen drug substances in different sizes. It keeps the desired set point temperature down to -80°C. RoSS.FRDG is compatible with RoSS Shells, stackable itself, fully moveable and shippable. 

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Single Use Support shipper

RoSS.SHIP | Cold Chain Shipping

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

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FAQ

What sizes of single-use bags are available?

Single-use bioprocess containers from Single Use Support are available from 10mL to 50L.

Standard BPC sizes are 10ml, 20ml, 50ml, 100ml, 250ml, 500ml, 750ml, 1L, 2L, 5L, 10L, 20L and 50L. However, if you require customized single-use bag sizes, let us know and we will find a solution!

What validation guidelines are in place at Single Use Support bioprocess bags?

All single-use assemblies are sterile for cGMP production and are delivered within sterile packaging. They are compliant with FDA, ISO and other regulatory standards for the bioproduction and biotech industries, in line with what is necessary for you to prevent cross-contamination of your reagents.

For detailed information regarding steriliziation guidelines, Pharmacopoeia compliance and biocompatibility, please refer to our datasheet.

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RoSS shell fits for all single use bag manufacturers

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. 

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Protection of small single-use bags at it's best

Safe transport of single use bags in cell and gene therapies

Cell and Gene therapies such as CAR T-cell therapy have proven their potential to become standard treatments to hard-to-treat diseases. Single Use Support has developed solutions for crucial challenges - read more!

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Single-use technology

Single-use technology & the implementation in biopharma

Single-use technologies, which reduce the risk of cross-contamination of high-quality bulk drug substances, are becoming increasingly popular in the pharmaceutical industry. You can find out the reason for this in the blog post!
 

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Cold chain logistic for single-use bag

Cold Chain Logistics in the pharmaceutical industry with Single-Use Bags

The Single Use Bag has many advantages in the manufacturing and development process of biopharmaceutical products. Find out what these advantages are in this blog post!

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