Ready-to-use, custom single-use assemblies
A single-use assembly is a tailor-made, all-in-one, ready-to-use solution made up of different products, such as hoses, connectors, bottles, filters, sensors, pumps and other components that are assembled together to meet the specific needs of a customer’s process.
Benefit from the advantages of single-use systems
Refocus on your core business and let us produce your custom Single-Use assemblies.
Aseptic Group has a deep expertise in the design and manufacture of SUS and can assist you with your assemblies projects by securing, upgrading and scaling up your production lines. All our custom single-use systems can be easily integrated into your production unit.
Optimise your production processes
Streamline your operations to improve efficiency and performance
- Reduction in overall costs (validation, sterilisation, infrastructure, cleaning)
- Simplified cleaning and maintenance operations
- Fewer production stoppages
- Time savings on preparation, transfers and operator training
- Improved overall yield thanks to an increase in the number of batches produced
Get your products to market faster
Gain in flexibility and responsiveness to market requirements
- Improved availability and flexibility of your facilities
- Quick and easy to implement: simple installation and campaign changeover
- Modular equipment for easy adaptation of production area surfaces
- Easy development of multi-product production lines
- Optimum scalability to support the growth of your business
Reduce the risk of cross-contamination
Ensure the safety and conformity of your products
- No cleaning residues: no associated validations
- Reduced handling
- Enhanced traceability
- Guaranteed sterility thanks to pre-sterilised components (gamma or steam)
- Easier alignment with regulatory compliance
Discover our approach to securing your processes
01.
Specifications
We work with you to define your single-use assembly requirements. Our specialists work with your teams to understand your constraints and determine the most appropriate solutions for your specific production process.
We independently select high-quality components.
02.
Design
Our Methods and Design department carries out a feasibility study and a technical drawing. We produce a prototype and, if necessary, a test phase. Once the official final drawing has been approved by you and the quotation accepted, we can launch supply orders and plan production.
03.
Assembly production
All our custom single-use assemblies are manufactured on our site, in our ISO 14644-1 clean room (Class 7 in operation), by qualified operators. Each assembly is then carefully checked. The assemblies are double-wrapped and packaged according to your specifications. Depending on your requirements, assemblies can be gamma-irradiated or delivered sterile.
04.
Validation files and regulatory support
Our assemblies are then delivered to you, ready to use. All our assemblies are delivered with certificates of conformity and full traceability. We provide you with the validation file and regulatory support.
Why choose Aseptic Group’s custom single-use assemblies?
- Expertise & independence
Deep experience in single-use biopharmaceutical solutions, with total freedom in the choice of a wide range of components. - Custom manufacturing and flexible solutions
Assemblies designed to fit seamlessly into your production unit, processes and production changes. - Quality & safety
An ISO 13485:2016-certified quality management system guaranteeing reliability and traceability. - Customer support and assistance
A personalised relationship, ongoing monitoring and documentary and regulatory assistance at every stage of your projects.
Our production capabilities
We design and manufacture innovative, ready-to-use single-use transfer sets for a wide range of applications.
- Harvesting
- Addition
- Sampling
- Filling
- Tank transfer
- Bulk transfer
- Filtration
- Transport with storage
- Use of peristaltic pumps
- Cleaning
- Sterilisation…
Our ISO 7 production room
We guarantee total mastery of our production environment.
A controlled environment
- 100% on-site manufacture
- Cleanroom production in compliance with ISO 14644-1 (Class 7 in operation)
- Modern facilities
High-performance organisation
- Optimised flow organisation based on Lean management principles
- 100% digital production process for complete traceability
Guaranteed sterility
- Sterility assured on site
- Contamination risk management
Safety & responsibility
- Secure site thanks to total building access control and video surveillance
- Production consistent with our commitment to environmental responsibility
Examples of custom single-use assemblies
How about giving us a try ? Whether it is for :
- the development of a new production line,
- outsourcing your assemblies, allowing you to refocus on your core business,
- an increase in activity,
- Dual Sourcing…
We can produce 1 prototype as well as large-scale assemblies. Test Aseptic Group
Distribution filtration system
2D-Bag-500mL + AQS
Example of a single-use assembly
Example of a single-use assembly
Example of a single-use assembly
entrust us with the production of your custom single-use assemblies
Interested in our custom assemblies? You can consult our experts, who are available to answer your questions and help you determine what will best meet your needs.
Our services
We go far beyond the supply of components or single-use assemblies.
As your trusted partner, we offer a comprehensive range of services: advice, selection of the right solution, integration into your processes, monitoring and maintenance. Our aim is to work with you every step of the way to integrate our Single-Use solutions into your environment, while complying with regulatory standards.
Advice and technical support
For over 30 years, we have been supporting biomanufacturers with our recognised expertise in single-use systems.
Our sales engineers, methods engineers and Single-Use Expert will advise you at every stage: defining your needs, selecting components and integrating them into your processes.
Their role is to understand your constraints, translate your requirements and guide you towards the most appropriate Single-Use solution.
Regulatory Support
In addition to the quality of our components and our custom single-use assemblies, we provide you with comprehensive documentation and regulatory support, that complies with pharmaceutical industry requirements.
Each product is delivered with its certificate of conformity, which is also available at any time from your Customer Area.
We can provide you with validation files and different types of studies (extractables, leachables, etc), to secure your processes and simplify your procedures.
Training
For the installation of certain technical products, such as our Single-Use pumps, our experts can come directly to your premises and train your production teams.
Each training course is tailor-made, adapted to your operational needs and your constraints in the field. The aim is to quickly make your operators autonomous and ensure optimal use of our solutions.
After-sales service
Customer Service
Our Customer Service team is on hand to answer all your questions: order tracking, delivery times, invoicing. You will receive responsive, personalised support.
Maintenance
We repair and maintain certain equipment to extend its life and guarantee its performance in your processes.
Quality
Our Quality Department will be happy to provide you with any additional information you may require, and will handle every complaint with a traceability reference.
Logistics & Supply Chain
Our priority is to ensure the continuous availability of your facilities.
With a storage area of 1,600 m² and over 1,000 items in stock, we guarantee maximum responsiveness and fast delivery of your components.
We can also set up tailored annual contracts to give you access to preferential logistics conditions and secure your supplies in the long term.
FAQ
Custom single-use assemblies
Yes, perfectly. We work closely with our customers to design and optimise solutions tailored to their requirements. Our total independence in the choice of materials and components enables us to select the options best suited to your business. Each assembly is unique and is the subject of a technical plan drawn up by our Methods Department and validated by our customers. We guarantee total confidentiality regarding your assemblies.
Yes, we guarantee :
- Components and our assemblies.
- A personalised customer relationship to meet your specific needs.
- Monitoring your case
If you have any questions or require further information, please visit our website and download our detailed technical data sheets, or get in touch with your sales contact.
You can contact us using our online form. You will be contacted by the sales engineer responsible for your sector. Our team of experts is on hand to answer all your questions and help you with your custom assembly project.
All our assemblies are manufactured on our premises, in a clean room certified to ISO 7 under the ISO 14644-1 standard. We guarantee controlled production conditions thanks to a Lean organisation flow and rigorous control processes.
Customised single-use assemblies allow you to:
- Optimise your production processes,
- Get your products to market faster,
- Reduce the risk of cross-contamination.
In particular, SUS are ideal for :
- Small and medium-sized volumes: preclinical biomanufacturing, clinical batches or production of gene/cell therapies.
- Multi-product: site manufacturing several different molecules, often in parallel.
- Flexibility: need to change product, format or configuration quickly.
- Pilot or mobile sites: modular plants, PODs or sites under development.
- Fast start-up: quick set-up for new sites or products.
A Single-Use Assembly is a system or set of components designed to be used only once in a sterile or controlled environment, before being disposed of. These assemblies are often used in industries such as biotechnology and biopharmaceuticals where sterility, safety and reduced risk of cross-contamination are essential.
They can include items such as hoses, bags, filters, connectors and other pre-assembled components, often made from plastic materials. Their use can simplify processes, reduce cleaning and sterilisation costs, and speed up production times.
None of our customers’ applications are alike. We work with you to create a tailor-made solution that meets your needs. Every assembly is unique.
- Independent integrator.
- Wide choice of components.
- Technical drawing produced by our Methods department.
- Advice and expertise from our sales engineers.
- Made-to-measure design.
- Flexibility.
- Prototyping.
- Documentary and regulatory support.
- Follow-up and training.
- From one-off assemblies to larger production runs.
Contact us to find out more!
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