Master. Fill. Finish. Take Control of Final Formulation and Filling
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 어플리케이션 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.
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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.
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.
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.
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.
At 싸토리우스, 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 싸토리우스 helps you stay ahead:
“Aseptic manipulations should be minimized through the use of engineering design solutions such as pre-assembled and sterilized equipment.” —EudraLex Vol. 4 | Annex 1 (EU GMP), Section 2.2
Product quality, yield, safe operation
Safe handling, risk of hazardous product, product loss
Solutions:Fully scalable cold chain management, controlled thawing equipment, total containment configurations available
싸토리우스 Solutions in Focus:
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“The use of closed systems can reduce the risk of microbial, particle, and chemical contamination from the adjacent environment.” —EudraLex Vol. 4 | Annex 1 (EU GMP), Section 4.3
Homogeneity, product quality, yield
Challenges:Shear sensitivity, High viscosity, toxic payloads
Solutions:Single-use mixers, closed-loop formulation systems, scalable buffer prep platforms
“The integrity of the sterilised filter assembly should be verified by integrity testing before use (PUPSIT) [...]” —EudraLex Vol. 4 | Annex 1 (EU GMP), Section 8.87
Product quality and yield, sterility assurance, regulatory compliance (Annex 1)
Challenges:Product loss, excipient and protein adsorption, operator inefficiency and errors, risk of contamination and leaks, PUPSIT without breaking sterility, Long design phase and delivery times for single-use filter assemblies
Solutions:Low adsorptive sterile filter, PUPSIT-ready, standardized filter assemblies for final sterile filtration, automated filter integrity testing
“The transfer of materials, equipment and components into the grade A or B areas should be carried out via undirectional process [...] Where sterilisation upon transfer of the items is not possible, a procedure which achieves the same objective of not introducing contamination should be validated.” —EudraLex Vol. 4 | Annex 1 (EU GMP), Section 4.11
Goals:Safe liquid and component transfer, sterility assurance
Challenges:Preventing product loss, avoiding contamination (particulates, microbial, leachables), isolator footprint, gloveless transfer, risk for hazardous product
Solutions:Contamination control strategy, flexible single-use devices, external openings for gloveless transfer, total containment after beta-port closure
“Aseptic manipulations should be minimized through the use of engineering design solutions such as pre-assembled and sterilized equipment.” —EudraLex Vol. 4 | Annex 1 (EU GMP), Section 8.15
Goals:Dose accuracy, product recovery, accelerate time to market
Challenges:Preventing product loss, ensuring flexibility across filling lines, minimizing contamination risk to product and environment, changeover time between batches
Solutions:Pre-sterilized single-use filling sets,removing the need for CIP|SIP 밸리데이션, maximize product recovery by design, shorten installation time
An interactive guide to a portfolio designed for flexibility, quality and safety from thaw to final fill.
From global biopharma leaders to agile CDMOs and original equipment manufacturers, 싸토리우스 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 싸토리우스 by their side.
In-house manufacturing (pharma) teams face constant pressure to navigate fluctuating markets, diverse molecules, and complex regulatory requirements — all while maintaining time-to-market and patient accessibility. 싸토리우스 offers tailored solutions with advanced technologies and comprehensive support to help you minimize risk, enhance process automation, and streamline core operations at every stage.
제한 experience with single-use systems
Hands-on training, design collaboration, and on-site demos
Confident adoption of fit-for-purpose single-use filling sets
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Insufficient space within isolator
External flexible single-use bag with aseptic transfer setup
Achieved safe, efficient filling without modifying isolator infrastructure
: Contamination risk during aseptic transfer.
: Customized 신속 이동 포트 supporting full automation.
Reduced contamination risk while enabling seamless automated workflows.
Challenge: Safe handling of toxic waste
Solution: Closed, gamma-irradiated beta-bag system
Key Result: Protected operators while maintaining sterility during waste disposal
Challenge: Need for better service and port reliability
: Improved biosafe ports and expanded US service coverage
Enhanced system uptime and local support for critical filling operations
Challenge: Small-scale CGT 어플리케이션 with space limits
Solution: Use of small Flexsafe surge bags in fill and finish
Key Result: Optimized final filling for CGT with minimal footprint and maximum flexibility
Read about how HUGEL cut setup time by 90%, boosted batch output, and met Annex 1 standards.
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.
: Demanding formulation processes
: Integration of advanced mixing technology
: Achieved consistent, scalable formulations with simplified handling
Challenge: Inefficient removal of petri plates
Solution: Sterile, customized beta-bag for aseptic transfer
Key Result: Streamlined petri plate handling with reduced contamination risk
At OEMs, you’re tasked with finding flexible suppliers who can provide both technical expertise and regulatory support throughout your process. Our fill and finish solutions are backed by advanced technology, extensive components, and on-the-field support to enable you to remove barriers, optimize footprint, and ensure product quality while adapting to diverse customer needs and regulatory changes.
제한 isolator space and need for gloveless intervention
Customized 신속 이동 포트 and 2D filling bag in a beta-bag for automated needle transfer
Enabled fully automated filling inside tight isolator space without operator intervention
Challenge: Automation complexity around PUPSIT
Solution: Technical support for single-use PUPSIT setup to support automated processes
Accelerated collaboration development of a reliable, automated PUPSIT workflow
Challenge: Control of visible particles
Solution: 품질위험관리 and product refinements
Improved product quality and compliance with adapted particle specifications
Challenge: Compact design with gloveless isolator interaction
Solution: Standardized tubing, needle, and surge bag for small machines
Key Result: Enabled space-saving, compliant filling setup for smaller-scale systems
At Bausch+Ströbel, we recognize 싸토리우스’ 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 싸토리우스 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.
Featuring real-world insights and stories from the field, discover how our global Fill & Finish team supports partners at every step.
In this webinar, 싸토리우스 product experts introduce the newest generation of Celsius® single-use freeze and thaw containers.
Watch Live Demonstration of Single-Use Final Filling Solutions
Secure your sensitive drug substances with advanced plate freezing technology.
Mix smarter, not harder! Learn how to master bioprocessing mixing with Computational Fluid Dynamics and the Flexsafe® Pro Mixer.
Learn about overcoming frustrations in Final Filtration applications, including PUPSIT requirements and implementation.
This webinar covers single-use technologies and their compliance with the latest Annex 1 of the EU GMP.
Boost flexibility and reduce risk in final formulation. Discover how single-use mixers optimize your drug product process.
Envision a world without PVDF filters. With potential PFAS restrictions, it's critical to plan ahead.
This episode dives into the global debate on PFAS—procedures, potential impact, and evolving restrictions.
PUPSIT made simple: Why it matters, how it works, and what regulators expect. Explore the essentials in this quick-read guide.
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