F.A.Q.

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.

Send us your CV and covering letter using the contact form.

We offer a wide range of positions: engineering, production, quality, sales, etc., with a variety of profiles: positions for young graduates and experienced professionals.

Yes, absolutely. In addition to our team of sales engineers, we have a Single-Use Applications expert and a Methods department. Depending on your needs, we can involve these 3 complementary areas of expertise in project meetings. We also sometimes call on our manufacturing partners for specific requests.

Aseptic Group provides technical advice and engineering solutions tailored to the biopharmaceutical industry. Whether you need assistance with specific projects, advice on single-use technologies or solutions to improve your production efficiency, our team of experts is here to help, from design to implementation.

With over 30 years’ experience and ISO 13485:2016 certification, Aseptic Group is a trusted partner in the biopharmaceutical industry. We are pioneers in single-use systems and specialise in sterile fluid transfer solutions for critical environments. Our global approach guarantees the best solutions for your production needs.

With the help of ALTOPI, we were able to produce our carbon footprint in 2023. Aseptic Group’s GHG emissions are mainly linked to purchasing, freight and fixed assets.

We want to reduce our emissions by 43% by 2030, to get as close as possible to the European targets.

We have obtained the EcoVadis label and are doing everything we can to be listed in the SBTi and comply with the Paris agreements.

Some challenges may arise with SUS, notably waste management and the durability of materials. However :

• Suppliers now offer recycling options to reduce the environmental footprint.
• Innovations in materials guarantee both performance and durability, while complying with environmental standards.
• SUS systems comply with strict sterility and safety regulations to ensure maximum efficiency.

As a result, single-use solutions are emerging as a viable and sustainable option for the biopharmaceutical industry.

• Installation of beehives on our land and production of our own honey
• Creating a vegetable patch in the Aseptic garden
• Setting up a book box to share books
• Soft mobility project: car pooling, cycling, public transport
• Consideration of the installation of solar panels
• Challenge for our suppliers
• Responsible purchasing…

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!

We offer technical training tailored to your teams. We organise on-site training sessions to optimise the use of our solutions.

Our team of sales engineers provides full technical support. We provide user advice and remain available to optimise the integration of our solutions into your bioproduction processes.

Contact our Quality department as soon as the problem has been identified. To do this, use the form provided, available on our website on the Contacts page. Our Quality team will analyse each situation and propose an appropriate response.

You can either call our customer service department on 04 72 52 02 40, or send us a request by e-mail.

Your order will be delivered according to the availability of the products ordered and the desired delivery date. You will receive an ARC (acknowledgement of receipt of order) as soon as we have all the delivery dates in our possession.

Our offices are open :

• 8.30 a.m. to 12.30 p.m. and 1.30 p.m. to 6 p.m. Monday to Thursday
• 8.30am to 12.30pm and 1.30pm to 5pm on Fridays

Our logistics department (deliveries, carrier collections) is open :

• 8.30am to 12pm and 1.30pm to 5pm Monday to Thursday
• 8.30am to 12pm and 1.30pm to 4pm on Fridays

We are open all year round.

Aseptic Group offers solutions to secure the supply chain:

• Proactive stock management with appropriate levels of security.
• Supply planning based on production forecasts.
• Strategic partnerships with reliable suppliers.
• Real-time monitoring of logistics flows to anticipate requirements.

Working with Aseptic Group means you benefit from :

• Recognised expertise in the biopharmaceutical sector.
• Tailor-made solutions adapted to the specific needs of each customer.
• A proactive approach to anticipating logistical challenges.
• A network of reliable, certified partners to guarantee quality and safety.

• Managing delivery times for critical components.

• The sensitivity of the materials (risk of contamination or damage).

• Traceability and regulatory compliance.

• Stock management to avoid stock-outs.

• Optimising costs while guaranteeing quality

We mainly meet the needs of the biopharmaceutical and biotechnology industries, in particular :

• Production of human and veterinary vaccines.
• Manufacture of injectable medicines.
• Gene and celltherapies.
• Any other manufacturing process requiring a high level of sterility and efficiency.

The Downstream process includes the purification and recovery of the biological product after cell culture. This involves stages such as clarification, filtration and chromatography. SUS plays a key role here by offering :

• Significantly reduced downtime thanks to rapid installation.
• Space-saving: the SUS are designed to optimise space in production facilities.
• Reduced environmental impact thanks to well-defined waste management options.
• Compatibility with modern filtration systems, such as tangential or depth filtration, for effective purification.

These solutions enable a rapid transition from one production campaign to another, increasing the overall efficiency of operations.

Fill-and-finish corresponds to the final stages of the bioproduction process, where the product is packaged in its final containers (syringes, vials or pouches).

Single-use technologies offer advantages such as :

• Sterile processes guaranteed thanks to pre-sterilised components.
• Reducing the risk of contamination by minimising handling and using closed systems.
• Shorter set-up times: the systems are ready to be integrated directly into the filling lines.
• Adaptability: suitable for different formats and volumes to meet the specific needs of bioproducts.

This is particularly valuable for high added-value organic products with limited production volumes.

The upstream biomanufacturing process involves growing and multiplying cells in bioreactors to produce the desired biological product. Single-use technologies (Single-Use Systems or SUS) offer a number of advantages:

• Reduced cross-contamination thanks to dedicated, sterile equipment.
• Greater flexibility: they facilitate frequent changes between batches and adapt to different production volumes.
• Cleaning costs eliminated, as equipment is disposed of after use.
• Quick to install: the systems are pre-sterilised and ready to use.

Aseptic Group’s Single-Use systems are ideal for many sectors, including biopharmaceuticals and biotechnology, and can be used 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.

Yes, Single-Use components offer financial benefits. They eliminate the need to clean equipment, saving time and resources. In addition, their sterility and convenience help to reduce downtime, improving production efficiency. For large-scale applications, the initial investment is often offset by long-term savings.

Choosing the right Single-Use components depends on the specific requirements of your application. Factors such as material compatibility, sterility, throughput and durability are key considerations.

Our team of experts offers you personalised advice and technical support to help you choose the most appropriate solutions. Explore our wide range of products. For more information, technical assistance or product recommendations, please contact us.

Single-use components are disposable products used for specific tasks in critical environments, such as pharmaceutical manufacturing or bioproduction. They reduce the risk of contamination, eliminate the need for extensive cleaning processes and improve operational efficiency. What’s more, they guarantee sterility and save time compared with traditional reusable systems.

Not all our products are available on our site. Our sales engineers will be happy to answer any questions you may have about products or applications. We are able to offer alternatives to suit your needs. You can either call us on +33 (0)4 72 52 02 40, or send us a request using the contact form.

Single-Use components are particularly useful in sectors such as pharmaceuticals, biotechnology and advanced manufacturing. They are ideal for environments requiring rigorous sterility, such as biomanufacturing, vaccine development and the transfer of high-purity fluids. Their versatility also makes them suitable for other sectors with stringent regulatory requirements.

Our four core values are :

• Safety: a safe and healthy working environment
• Excellence: Superior quality at every level
• Respect: Diversity and collaboration based on mutual respect
• Trust: Collaborative work and autonomy encouraged

Corporate culture is a key element at Aseptic Group, reflecting the values, behaviours and principles that guide our organisation in its day-to-day activities.

Team alignment: a strong culture brings our employees together around a common vision and shared values. This fosters collaboration, cohesion and a sense of belonging.

Employee engagement: a positive culture motivates our employees, increases their job satisfaction and encourages them to give their best. It also helps to attract and retain talent.

Quality and innovation: in a sector like ours where quality and precision are essential, a culture of excellence and innovation ensures that the highest standards are met.

Customer focus: a customer-centric culture helps us to better understand and respond to the needs of our partners and customers, strengthening trust and long-term relationships.

We mainly meet the needs of the biopharmaceutical and biotechnology industries, in particular :

• Production of human and veterinary vaccines
• Manufacture of injectable medicines
• Gene and cell therapies
• Any other manufacturing process requiring a high level of sterility and efficiency.

Yes, our Customer Service team can be contacted by e-mail or telephone during the day for any questions relating to orders, delivery times, invoicing, etc.

Our training sessions are entirely tailored to your needs and cover key aspects such as improving operators’ knowledge, validating the effectiveness of installation and assembly procedures and reducing the risk of handling errors. Training sessions are essentially practice-based for maximum effectiveness.

Aseptic Group provides technical advice and engineering solutions tailored to the biopharmaceutical industry. Whether you need assistance with specific projects, advice on single-use technologies or solutions to improve your production efficiency, our team of experts is here to help, from design to implementation.

Response

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 ensure an optimal 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.

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.

Yes, we only work with partners who share our values and respect our strict quality and ethical standards.

You can contact us by email, telephone or online form. Our team will be happy to help you solve any problem.

We take every return very seriously. If you have a problem, our quality department is there to help you and find a quick solution, whether it’s a replacement or a refund.

We encourage our customers to share their feedback via surveys or directly with our customer service department. All feedback is taken into account to improve our products/services.

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 .

Quality is controlled at every stage: from the selection of raw materials through to production, packaging and distribution. This includes rigorous testing, internal and external audits, and full documentation.

Challenges include contamination management, the complexity of biological processes, compliance with ever-changing regulations and the need for complete traceability.

A notification of change contains information about changes associated with the manufacture of products, in accordance with our standards.

The most common standards include Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and ISO standards (such as ISO 9001). These standards guarantee rigorous processes and complete traceability.

These biomanufacturing studies are scientific analyses aimed at identifying and quantifying the chemical substances that can be extracted from a material when it is exposed to specific conditions, as well as the chemical substances that actually migrate from a material or component in direct contact with the biopharmaceutical product, under normal conditions of use. These materials may include components used in biomanufacturing equipment, such as chromatography resins, cell culture bags, tubing, filters or storage systems.

These studies are essential in bioproduction for :

• Patient safety: biopharmaceutical products are often administered directly to patients, making it essential to control potential contaminants.
• Product quality: extractives can interact with the biopharmaceutical product and alter its stability or efficacy.
• Regulatory compliance: agencies require extractives data to approve materials used in manufacturing processes.

These studies identify :

• List of compounds identified (e.g. plasticisers, additives, stabilisers, manufacturing residues).
• Maximum concentrations of compounds under extreme conditions.
• Toxicological risk assessment for identified compounds.

These studies are a crucial step in guaranteeing the safety, quality and conformity of biopharmaceutical products throughout their production cycle.

Yes, absolutely! Each training session is designed to meet your specific needs. Whether you have particular operational challenges or require product-specific training, we customise everything to ensure relevance and added value for your team.

Fill in our contact form here. We’ll call you back and work with you to design and plan the training.

Our training services help you to :

• Deepen your team’s technical knowledge.
• Improve the efficiency of your production processes.
• Minimise costly errors and the risk of mishandling.
• Improve overall operational productivity.

Our training sessions are entirely tailored to your needs and cover key aspects such as improving operators’ knowledge, validating the effectiveness of installation and assembly procedures and reducing the risk of handling errors. Training sessions are essentially practice-based for maximum effectiveness.

The sessions are suitable for :

• Companies introducing new products into their business.
• Companies integrating new members into their production team.
• Organisations wishing to guarantee the control and consistency of specific operational processes.

Our live webinars include interactive Q&A sessions, allowing you to put your questions directly to our experts and guest speakers. This gives you a valuable opportunity to get specific and reliable answers to your operational challenges.

Registration details are provided on the specific information page for each webinar. Simply go to the session you are interested in and follow the registration instructions. To be kept informed of future events, please contact our marketing team.

Our lecturers are our own experts as well as technical experts, sales engineers and applications engineers from our partner companies. This ensures that the content is not only technically accurate, but also rich in practical, real-world experience of the sector.