Focus On Your Fill and Finish Operations With Confidence
Solutions and Support for Every Step of Fill and Finish
Patient safety and therapeutic efficacy depend on your success in final formulation and filling. As the final step before application in patients, the fill and finish process requires precision, quality, and performance.
Guarantee confidence across steps and products by choosing a supplier who provides peace of mind through flexible single-use solutions, trusted regulatory expertise, and industry-leading support.
Turn Today’s Challenges Into Tomorrow’s Advantages
Today’s Manufacturing Challenges Demand a New Level of Support
As the final step before a product reaches the patient, fill and finish play a critical role in drug development. In addition to quality standards, diverse manufacturing requirements, and the evolving regulatory landscape, the industry is facing increasing pressure from the growth of low-volume therapeutics and multi-product facilities, resulting in a rising need for flexible manufacturing. Meeting therapeutic demands requires embracing adaptable solutions and ensuring seamless support that can turn today’s challenges into tomorrow’s opportunities.
Adapt. Fill. Finish.
What if One Solution Could Meet Multiple Manufacturing Needs?
Being successful in fill and finish often requires juggling diverse manufacturing requirements across multiple products. We leverage decades of experience meeting specific customer needs in fill and finish, and can interface with your customers directly to understand what they need and adapt your process accordingly.
- Flexible single-use design with large component options
- Expertise trusted worldwide to meet intricate manufacturing requirements in final fill
- Comprehensive portfolio of pre-validated solutions
Comply. Fill. Finish.
What if You Could Stay Ahead of Evolving Regulations?
Keeping up with the evolving regulatory landscape requires trusted solutions as well as time that you could be spending on more critical tasks. We apply our experience to enable a stress-free path to regulatory compliance by anticipating challenges and applying solutions early.
- Demonstrated experience navigating regulatory requirements
- Technology designed to support flexibility and minimize contamination risk
- Documentation and validation services
Collaborate. Fill. Finish.
What if One Supplier Could Meet All of Your Service Needs?
Manufacturing often requires selecting multiple suppliers who can manage your needs as they arise. Beyond products you can trust, we provide comprehensive documentation and on-the-field support at every step — so you can maintain quality while spending your time on more critical and productive tasks.
- Both global and local, on-the-field support
- Experienced teams of subject matter experts
- Strong relationships with filling line & primary packaging component manufacturers
How We Help: The Sartorius Approach to Fill and Finish
At Sartorius, we believe fill and finish should never be an afterthought — we treat your last step as our first priority.
Our approach combines proven single-use technologies, regulatory expertise, and hands-on collaboration to help you protect product quality, streamline operations, and scale with confidence. Whether you’re filling high-value biologics or advanced therapies, our solutions are built to adapt — not force-fit — to your process.
Your fill and finish journey, and where we add value
From final formulation to aseptic fill, each step is critical — and carries unique risks. Here’s where Sartorius helps you stay ahead:
Expert Voices
Paolo Sacca
In final formulation and fill, it’s never just about the equipment. It’s about having someone by your side who’s seen it before, solved it before, and can guide you through — with the data, the documentation, and the experience to back it up.
Fritjof Linz
Sustainability is playing a growing role in manufacturing. Authorities around the world are starting to limit the usage of chemical compounds — especially PFAS — and finding alternative materials with similar properties has become critical for the future of liquid filtration.
Magnus Stering
During integrity testing, automatic detection of operator error reduces the RPN and improves QRM. With early detection of false passes, you can retest the filter before it's been discarded — saving the batch — and, more importantly, protecting the patient from receiving an unsterile drug.
Markus Maring
In the final fill process, sterile filtration is critical to meeting product safety standards and ensuring efficacy. To achieve regulatory compliance and maintain product quality, it's crucial to select the appropriate filter material. Newer sterile filters are designed to minimize API adsorption while preserving potency and therapeutic value. Choosing the right filter not only safeguards against microbial contamination — it optimizes the integrity of the product. Expertise in filtration technology is essential for delivering solutions that align with industry standards, and enhance the reliability of your manufacturing process.
Mathias Taillebois
One of the challenges in the Fill & Finish project for pharmaceutical customers is managing the coordination among multiple suppliers. At Sartorius, our local Account Managers, Field Application Specialists, and Product Specialists excel in orchestrating activities related to the implementation of Single-Use systems (SUS design, support during mock-up, demonstrations, trainings etc…). Our strong relationships with manufacturers of isolators, filling lines, and components such as stoppers and plungers enable seamless collaboration and integration, ensuring efficient project execution.
Lucie Clavel
Embarking on a Final Filling Project is a journey that thrives on robust collaboration and the synergy of the right partners. With timelines extending 1 to 2 years before GMP batches, the strategic involvement of the SU supplier is crucial. Engaging us (Sartorius) early, before the design freeze, unlocks our unparalleled expertise in SU handling and manipulation, ensuring unwavering regulatory compliance for commercial production batches. This partnership establishes a gold standard for quality, driving success through meticulous regulatory compliance, while also facilitating pricing discussions and return on investment.
Designed for You: How We Support Different Customers
From global biopharma leaders to agile CDMOs and original equipment manufacturers, Sartorius solutions are delivering real results at every scale. Whether you’re optimizing an existing process, launching a new facility, or building a platform from the ground up, we meet you where you are with flexible solutions, regulatory insight, and hands-on support tailored to your operation. Explore how organizations like yours have overcome challenges in formulation, aseptic filling, and process control with Sartorius by their side.
Read More Stories
CDMOs must manage diverse customer needs, maintain product quality, and navigate regulatory complexities, all while facing increasing pressure to stay competitive in a rapidly evolving landscape. Our fill and finish solutions combine advanced technologies, customizable products, and comprehensive support to help you optimize operations, reduce risk, and ensure consistent productivity from start to finish.
CDMO | Italy
Challenge: Demanding formulation processes
Solution: Integration of advanced mixing technology
Key Result: Achieved consistent, scalable formulations with simplified handling
CDMO | France
Challenge: Inefficient removal of petri plates
Solution: Sterile, customized beta-bag for aseptic transfer
Key Result: Streamlined petri plate handling with reduced contamination risk
Customer Testimonial
Jürgen M. Metzger
At Bausch+Ströbel, we recognize Sartorius’ crucial role in aseptic transfer systems, such as Biosafe® ports and consumable transfer bags. I’ve seen firsthand how essential these solutions are for maintaining sterility, compliance, and operational efficiency. The pharmaceutical industry thrives on collaboration, and our partnerships with Sartorius exemplify a shared commitment to innovation, quality, and regulatory excellence. By working together, we continue to deliver cutting-edge solutions for both large-scale and small-batch manufacturing, ensuring we meet the ever-evolving needs of the industry.
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Frequently Asked Questions
Fill-finish manufacturing is the final step in biopharmaceutical production, where drug products are aseptically filled into vials, syringes, or cartridges and then sealed for patient use. Because this step involves a high-value product and must meet strict regulatory standards, it requires precision, sterility, and reliability. Sartorius supports fill and finish operations with single-use technologies, aseptic transfer systems, filtration, and validation services that help customers reduce risk and ensure compliance.
Biopharmaceutical filling machines are specialized systems that transfer sterile drug products into final containers such as vials, syringes, ampoules, or cartridges. They are typically integrated with isolators or restricted access barrier systems (RABS) to maintain sterility and prevent contamination. Sartorius partners with final filling line manufacturers and provides flexible single-use assemblies, aseptic transfer ports, and formulation mixing solutions that integrate seamlessly with filling lines to ensure safety and efficiency.
Aseptic fill and finish involves receiving the frozen drug substance, thawing it under controlled conditions, performing formulation steps, and transferring it through final sterile filtration before filling it into sterile containers using validated, closed systems. Critical steps include sterile filtration, aseptic transfer, final filling, and container closure — all performed without compromising sterility. Sartorius provides end-to-end support, from controlled thawing and scalable mixing systems to sterile filtration, integrity testing, and component or liquid transfer — ensuring consistent product quality and regulatory compliance.
The terms “aseptic fill and finish” and “sterile fill and finish” are often used interchangeably. Both refer to the final step of manufacturing, where a sterile drug product is filled and sealed into its container. The distinction lies in process control: aseptic filling emphasizes maintaining sterility throughout open operations, while sterile filling may also include terminal sterilization. Sartorius’ solutions — including sterile filtration, aseptic transfer systems, and validation services — are designed to support both approaches.
A bioprocess filling assembly typically includes tubing, sterile filters, bags, rapid transfer ports, a beta-bag, and connectors arranged in a closed, single-use system. These assemblies ensure sterile transfer and filling while minimizing the need for operator intervention and reducing contamination risks. Sartorius designs and supplies customized single-use assemblies — including Flexsafe® bags for mixing and storage, Biosafe® and SART rapid transfer ports for solid or liquid transfer, Filter Transfer Sets, Sartopore® filters, and Octoplus® FF systems for drug product repartition— all supported by validation data and regulatory expertise to enable reliable and compliant filling operations.
Annex 1 of the EU GMP regulations sets strict requirements for sterile drug manufacturing, including contamination control strategies, sterile filtration, and integrity testing. For fill and finish, this means minimizing operator intervention, reducing the complexity of manual interventions, ensuring aseptic transfer, and validating every step of the process. Sartorius provides Annex 1-ready solutions, including pre-assembled, sterilized, and ready-to-use single-use systems, external opening rapid transfer ports for gloveless intervention, and integrity testing systems, all supported by validation services that help customers stay audit-ready.
Common challenges include maintaining sterility, avoiding particulate contamination, minimizing product loss, and ensuring compliance with evolving regulations. Space constraints in isolators and the need for flexible, multi-format setups also add complexity. Sartorius addresses these challenges with scalable single-use assemblies, controlled thawing systems, advanced mixing, and aseptic transfer technologies — all backed by global support and validation expertise.
By the time a drug product reaches the fill and finish steps, it has already passed through the entire upstream and downstream process, making it highly valuable and costly. Any contamination, product loss, or non-compliance at this stage can have significant financial and patient safety consequences. Sartorius helps mitigate these risks with closed single-use systems, validated sterile filters, and aseptic transfer solutions that protect both product integrity and operator safety.
Single-use systems play a critical role in securing aseptic processing by using pre-assembled, pre-sterilized, ready-to-use assemblies. They reduce key contamination risks associated with human intervention and CIP | SIP operations, while significantly increasing productivity — cutting installation and setup time from four hours to just 15 minutes. By eliminating the need for cleaning and validation steps, single-use solutions also minimize production costs and product losses, ensuring maximum product recovery and consistent, compliant performance across fill-and-finish operations.
Fill and finish operations can enhance sustainability through the use of single-use closed systems. These systems significantly reduce the consumption of water, energy, and chemicals, while minimizing contamination risks and hazardous cleaning waste. Additionally, Sartorius further advances sustainability by integrating life cycle thinking into its solutions. We have introduced ISCC+ certified biobased materials, offer PFAS-free alternatives, and provide recyclable products, further reducing the environmental impact of single-use technology.