RoSS® Shell | Protecting single-use bags
The safest transport solution for all available single-use bioprocess containers. Robust. Scalable. Single-use bag independent.
Single-use manifold assemblies are assembled single-use components that ensure a sterilized fluid flow of pharmaceutical products. The supply of customized composition of tubings, connectors, fittings, primary packagings, beta bags, filters, etc. and sterilization is usually delayed due to bottlenecks in biopharmaceutical manufacturing.
As an expert in single-use solutions, we have made it our goal to deliver vendor agnostic single-use assemblies manufactured with highest quality standards in ISO 7 cleanrooms and sterilized within shortest lead time. Prevent downtime and ensure an uninterrupted supply chain in compliance with GMP and regulatory requirements with our single-use systems using silicone tubing.
Configure your custom single-use assemblies according to individual needs and requirements in the field of aseptic filling. With the online configurator, you can quickly and easily create and order your manifold assembly.
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.
In case of issues or questions regarding configuration, our manifold experts will assist you if there are any issues. You have the option to improve and edit your saved single-use assembly until it meets all your requirements.
The aim is an uninterrupted supply chain and fast delivery worldwide. This is why we guarantee delivery of your single-use assemblies or single-use filtration assemblies and components within 4 weeks of orders received. Our clean room manufacturing capacities make our assembly and packaging process faster than the norm, which is why you can rest assured that your single-use tubing assemblies will arrive no later than 4 weeks after you have placed your order (subject to change depending on complexity).
You have the choice of putting together your single-use manifold assembly using the online configurator. Alternatively, you may select a preset designed by our experts and receive additional advice on it. In both events, our manifolds are double-fixed with ties and gamma irradiated or optionally e-beam sterilized. Thus, a simple connection is possible that meets FDA and ISO regulatory requirements, as well as the highest quality and safety standards for your aseptic filling purposes.
Our single-use manifold experts are ready to assist you with their knowledge at any time.
Speed-to-market, flexibility and process efficiency are more important than ever in biopharmaceutical production. And so is the importance of single-use systems. And yet there is hesitation. Dr. Lorenzo De Benedictis provides insights and outlook on the future of single-use systems in Biopharma.
Click here to download technical product data sheets, design videos, as well as case studies and more.
Datasheet Single-Use Assemblies
Filesize: 0.41 MB – Mime-Type: application/pdf
Case Study - Customized Manifolds
Filesize: 0.46 MB – Mime-Type: application/pdf
Single Use Support Manifold Capabilities
Filesize: 0.59 MB – Mime-Type: application/pdf
Infographic: Single-Use Assemblies in Biopharma Manufacturing
Filesize: 3.58 MB – Mime-Type: application/pdf
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.
Single-use tubing 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.
When put into place, single-use tubing is pre-sterilized (typically sterilized by radiation or e-beam sterilized) to avoid contamination along the entire 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.
All single-use assemblies are sterile and in compliance with cGMP production regulatory standards. They are delivered within sterile packaging.
We offer lead times of 4 weeks for our custom single-use tubing assemblies. Depending on complexity, lead times can vary.
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.
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.