Single-Use solutions for fluid transfer in biopharmaceutical production
Certification
ISO 13485 : 2016
Technical expertise
for 30 years
Independence in
choice of
components
Production
production room ISO 7
single-use Custom assemblies and components for biopharma and biotech companies
An independent pioneer in single-use systems dedicated to biomanufacturing applications, we are the specialist in sterile fluid transfer solutions in critical environments.
Our 2 complementary activities make us an experienced partner that is recognised in the market, notably :
The design and production of ready-to-use, custom Single-Use assemblies to meet your specific requirements, at every stage of your production process.
Proven expertise for more than 30 years in marketing single-Use components suited to a wide range of applications
TUBING
MOLDED SOLUTIONS
Connections & disconnections
ADAPTERS AND FITTINGS
Sensors & monitors
Pumps
CONTAINERS AND CLOSURES
GASKETS
sampling systems
Filling needles
Tailor-made solutions to boost your production performance
Over the last few decades, the biopharmaceutical market has undergone unprecedented change.
Single-use technology has revolutionised the sector’s production processes, providing the operational flexibility needed for a rapidly evolving market and reducing time-to-market.
With new challenges emerging every day, the need for reliable solutions that are quick and easy to install is greater than ever.
Aseptic Group, an independent pioneer in single-use systems, has expertise in biopharmaceutical and biotechnology manufacturing processes and can help you with your choice of single-use products and your custom single-use assembly projects.
Optimise your production processes
- Reduce costs and simplify your cleaning operations
- Reduced validation costs
- Lower infrastructure costs
- Reduced sterilisation costs
- Simplified maintenance
- Saves preparation, transfer and operator training time
- Increase in the number of batches produced
Get your products to market faster
- Improving the flexibility and availability of your facilities
- Quick and easy to install: quick installation and quick campaign changeover
- Modularity of equipment: adaptation of the surface areas of the production areas used
- Development of multi-product production lines
- Easy scalability
Reduce the risk of cross-contamination
- No cleaning residues: no need to validate cleaning
- Less handling
- Enhanced traceability
- Guaranteed sterility: pre-sterilised components, often gamma or steam sterilised.
- Facilitates alignment with regulatory compliance
Quality & Regulatory Support
Quality Management System
We rely on processes and procedures that enable us to establish and successfully achieve our quality objectives. As a result, we are committed to providing you with safe products and accessible, up-to-date product information.
ISO 13485: 2016 certification
We are certified to manufacture bespoke single-use assemblies.
We guarantee that we comply with regulations, take your requirements into account, and control our activity and the associated risks.
> Download the ISO certificate
Customer Support at your disposal
We have a range of tools at your disposal, including :
- our customer portal where you can retrieve your certificates of conformity:
> Log in to your customer area - contact forms for all your quality-related queries.
> Go to the contact form
Our services
Our offer is not limited to the marketing of single-use components or the manufacture of customised assemblies.
As your preferred partner, we offer you a complete range of services. From solution selection to maintenance, we help you to integrate our Single-Use solutions effectively into your environment and meet regulatory requirements.
Advice and technical support
Our company has been active in the Single-Use Systems market for 30 years, and has built up considerable technical expertise.
Our team of sales engineers, as well as our Methods engineers, are at your side throughout the process of selecting and implementing our solutions. Depending on your constraints and requirements, they will provide you with their knowledge of Single-Use technology, to help you make your choice.
Regulatory Support
In addition to the quality of our components and customised Single-Use assemblies, we provide you with all the necessary documentary and regulatory support, in compliance with the requirements of the pharmaceutical industry.
All our products come with a certificate of conformity, which you can also find in your Customer Area.
We can also provide you with validation files and various types of studies (extractables, releasables, etc.).
Training
For the installation of some of our technical products, such as Single-Use pumps for example, we can come to your site and train your production operators.
All our training courses are organised on demand and the content is entirely customised to your specific requirements.
After-sales service
Customer service
Our customer service team will be happy to answer any questions you may have about your orders, delivery times, invoices, etc.
Maintenance
We can carry out certain repairs and maintain certain equipment.
Quality department
Our Quality team is at your disposal for any additional quality information you may require and to deal with any complaints.
Logistics & Supply Chain
Our aim is to guarantee you optimum availability of your installations.
To achieve this, we have a 1,600 m² storage area and keep around 1,000 items in stock.
We can set up annual contracts with you to enable you to benefit from specific logistics conditions.
Aseptic group
Aseptic Group is a trusted partner to the biopharmaceutical industry and a pioneer of single-use technology in Europe. We are now part of a major international group, Enpro, in the GHT (Garlock Hygienic Technologies) division, giving us the financial strength to support our customers internationally.
Events and news
Meet us at our next trade fairs and follow our news.
Exhibitions 2025
News
ASEPTIC GROUP awarded the EcoVadis 2026 Bronze Medal: Our CSR approach at the service of our customers.
ASEPTIC GROUP has reached a major milestone at the start of 2026 by being awarded…
ASEPTIC GROUP obtains ISO 13485 recertification.
The ASEPTIC GROUP site once again meets the rigorous standards for quality management of medical…
Driving Growth Through Innovation and Learning
Recently, a team of six colleagues from Aseptic Group – representing Sales, Methods, and Marketing…
Aseptic Group strengthens its sales team
To better serve our customers, the Aseptic Group sales team is expanding. Martina Tognazzi joined…
Quality Excellence Week – Together towards excellence at Aseptic Group
A look back at our Quality Excellence Week: a time for exchange, conviviality and commitment….
Our partners
We rely on a large network of carefully selected, recognised international suppliers. The reliability of our partners is of paramount importance to us. We attach great importance to the solidity and durability of our relationships with our partners.
We are members of international networks of single-use experts whose aim is to share, encourage and accelerate the adoption of single-use technologies in industry.
OUR international networks
We are members of international networks of single-use experts whose aim is to share, encourage and accelerate the adoption of single-use manufacturing technologies in industry.
FAQ
Aseptic Group
Aseptic Group specialises in the design and manufacture of bespoke single-use assemblies tailored to your biopharmaceutical production needs. Our process includes :
- Detailed consultation: a dedicated team of experts assesses your needs and process constraints.
- Flexible component sourcing: we remain independent in the selection of components to guarantee an optimum solution.
- Rapid prototyping: customised solutions are developed with your input and ready for rapid implementation.
To find out more about our bespoke design and manufacturing services, visit our dedicated page.
At Aseptic Group, quality assurance is at the heart of our operations. We strictly adhere to ISO 13485:2016 certification for the manufacture of single-use systems. Key points include:
- Certified production environment: all products are assembled in ISO 7-compliant facilities.
- Regulatory support: full documentation and regulatory compliance to meet industry standards.
For more details, visit our Quality Assurance page.
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.
Single-use solutions in biomanufacturing refer to the use of single-use systems and equipment designed for biological manufacturing processes. These solutions include components such as bioreactors, culture bags, filtration systems and containers. They simplify operations, reduce the risk of cross-contamination and eliminate the need for cleaning and sterilisation, while offering greater flexibility for multiple batches and productions. These technologies are particularly well suited to modern biomanufacturing environments, where efficiency and regulatory compliance are essential.
Aseptic Group’s Single-Use systems are ideal for a wide range of sectors, including biopharmaceuticals, biotechnology and life sciences, and are suitable for a wide range of applications:
- Managing fluid transfers in sterile environments,
- Sampling systems for critical production phases,
- Storage and sealing solutions to guarantee sterility during transport,
- Sealing and critical components,
- Aseptic filling.
If you’re not sure whether our single-use solutions are right for your processes, contact our team.
Aseptic Group is the trusted partner of the biopharmaceutical industry and a pioneer of single-use technology in Europe. With 30 years’ expertise in this field, and our ISO 13485: 2016 certification, we are the specialist in sterile fluid transfer solutions in critical environments. We work with suppliers who are recognised in the market. Our customer references include major biopharmaceutical manufacturers.
Don’t hesitate to contact us for more information.