Single-Use Aseptic Transfer and Final Filling Solutions
Designed for Annex 1 Compliance
Final filling is a critical process step where product quality and patient safety are under strict regulatory scrutiny. Our range of single-use technologies for aseptic transfer and final filling reduce the risk of microbial ingress and product cross-contamination — especially from human interventions, component transfer, and fluid-path assembly — while keeping processes flexible and compliant.
In the final filling area, the main sources of contamination are manual handling, the transfer of primary packaging components into Grade A, and the assembly and connection of the sterile fluid path. These risks can be significantly reduced by combining barrier systems such as isolators or restricted access barrier systems (RABS) with single-use transfer and filling solutions.
Engineered, pre-assembled fluid paths replace ad hoc connections and manual workarounds, helping to standardize critical steps and support controlled, repeatable operations that are easier to justify during audits.
Sartorius supports this approach with an integrated solution around the filling line:
- Biosafe® Rapid Transfer Port and Biosafe® bags for the closed transfer of stoppers, plungers, seals, tools, and single-use assemblies into the barrier
- Biosafe® RAFT and SART System™ for the closed transfer of bulk drug product into the isolator and | or for aseptic liquid transfer between cleanrooms
- Octoplus FF® single-use surge tank solutions and Flexsafe® 2D Advanced FF bags for managing product hold and final filling
These technologies are backed by validation data, global and local expertise, and deep Annex 1 understanding. Together, they support the design of efficient final filling setups that demonstrate robust control of risks within a defined Contamination Control Strategy.
Explore the Closed Path Around Your Filling Line
In a RABS or isolator setup, every opening and connection is critical. Components and bulk drug product must cross the barrier, move between rooms, and reach vials or syringes in line with Annex 1 expectations and a robust Contamination Control Strategy.
This graphic shows how Sartorius technologies connect these steps into a closed, single-use path.
Biosafe® Rapid Transfer Port
A Single Transfer Point for Liquids and Components
A reliable rapid transfer port is critical for maintaining containment in your isolator or RABS. The Biosafe® Rapid Transfer Port is available in 110 mm and 200 mm diameters, supporting diverse aseptic transfer requirements. It combines a rotation-free magnetic design with internal- or external-opening options to support Annex 1-aligned, closed transfers. When paired with Biosafe® bags and compatible liquid assemblies, it provides a controlled interface for moving components, liquids, and final filling sets into Grade A while reducing interventions and supporting your Contamination Control Strategy.
The Biosafe® Rapid Transfer Port and Biosafe® bags form a unique, fully single-use aseptic transfer system designed and validated to minimize human error and the risk of contamination.
The same port supports component transfer and liquid entry, simplifying design, validation, and operator training.
Unique, rotation-free magnetic coupling guides the α | β connection between the port and consumable, helping to reduce manual interventions and the risk of particle generation compared with traditional rotative systems. Additional detection features are available on the Biosafe® Rapid Transfer Port 200 mm.
The Biosafe® Rapid Transfer Port is used on isolators and RABS from leading OEMs, and Biosafe® bags have been qualified by key OEM component manufacturers for decades. This facilitates smooth integration into existing lines and provides flexibility for future upgrades without redesigning the barrier interface.
Explore Biosafe® Port
Established in Real Filling Lines
Biosafe® Rapid Transfer Ports and bags are already running on commercial and clinical filling lines worldwide, supporting Annex 1–aligned contamination control, faster changeovers, and reliable component transfer.
Explore Real-World Examples: From first-time single-use users to advanced OEM integrations – discover how Hugel and Bausch + Ströbel run Biosafe® ports and filling sets on real lines.
Component Transfer Solutions
From Supplier to Grade A Without Opening the Barrier
The Biosafe® Rapid Transfer Port coupled with Biosafe® bags enables controlled, repeatable component transfer that aligns with Annex 1 and supports your Contamination Control Strategy. Components are prepared and staged outside the barrier, then transferred into Grade A through a qualified, closed interface.
Prepare & Stage Closures (Outside the Barrier)
Stoppers, plungers, and seals are prepared in Biosafe® bags before transfer into Grade A via the Biosafe® Rapid Transfer Port
Key products & features:
- Biosafe® bags: Developed through decades of application experience and extensively qualified against user lifecycles. Available in various configurations and manufactured from gamma-sterilizable and autoclavable films.
Closed Entry via Biosafe® Rapid Transfer Port
At the RABS | isolator wall, the Biosafe® Bag docks to the Biosafe® Rapid Transfer Port, forming a closed α | β interface. Rotation-free magnetic coupling guides docking, while the external opening option reduces manipulations inside the critical zone. Mechanical interlocks and pin detection systems (200 mm only) confirm correct docking before the open | close sequence proceeds.
Key products & features:
- Biosafe® Rapid Transfer Port: Designed for aseptic transfer of components and bags in line with Annex 1 expectations. Available in 110 mm and 200 mm diameters and with external openings in both left and right configurations.
Explore Biosafe® 100 Rapid Transfer Port and Biosafe® 200 Rapid Transfer Port
Inside Grade A
The Biosafe® system (Biosafe® Rapid Transfer Port and Biosafe® bags) minimizes interventions inside the RABS or isolator, in line with Annex 1 recommendations. The rigid collar of the Biosafe® bag means it can be pushed from the external side, protecting the sensitive “ring of concern” area throughout transfer — with additional protection built in to the Biosafe® Rapid Transfer Port 200 mm thanks to its patented design. These features secure aseptic materials without the need for sterilization accessories.
Key products & features
- Biosafe® system: A complete, Annex 1-compliant aseptic transfer system that ensures process robustness, reduced risk of contamination, and improved operator experience, with different configurations and materials available to suit diverse process needs.
Liquid Transfer Solutions
From Formulation to Final Filling
Bulk drug product is often formulated in one room and filled in another. A single-use, end-to-end approach from the initial barrier entry to the final reservoir and filling set simplifies transfer and minimizes sources of contamination.
Closed Entry to the Isolator
Liquid entry can be configured in two ways, depending on facility layout and process needs. The Biosafe® RAFT system provides reliable zone-to-zone transfer of liquid between cleanrooms of different environmental classification via the Biosafe® Rapid Transfer Port. The SART System™ is a compact alternative that combines a single-use transfer set and Gammasart® ATD connector for transfer into isolators.
Key products & features
- Biosafe® RAFT: A single-use modular assembly for enhanced sterility assurance in aseptic liquid transfer. Configurable for multiple filling lines, supporting modular facilities
SART System™: A sterile connecting system for liquid aseptic transfer between two areas with different containment classifications. Features an integrated rapid transfer port and Gammasart® ATD single-use connector, providing a minimal isolator footprint.
Break Tank and Final Filling
Single-use bags replace traditional stainless-steel break tanks with pre-sterilized, configurable filling sets, eliminating CIP | SIP and cleaning validation. The Octoplus FF® is specifically designed for final filling, with an optimized wallet-shaped 8 L bag compatible with up to ten independent filling line designs. Flexsafe® 2D Advanced FF bags provide a smaller volume alternative with a premium film design to ensure maximum recovery of high-value products.
Key products & features
- Octoplus FF®: An optimized bag design improves filling accuracy and product recovery. Features a large design space, meaning it can adapt into multiple single-use transfer lines.
- Flexsafe® 2D Advanced FF bags: Premium film design for small-volume, high-value applications, such as cell and gene therapy manufacturing. Highly configurable, supporting diverse final filling setups.
From Design to Inspection With One Partner
Behind each of these technologies, Sartorius offers comprehensive support during the development, operation, and audit of your final filling line. Our field specialists possess global and local expertise, working alongside engineering and production teams to optimize your setup and integrate new technologies into your process.
Together, our innovative solutions and expertise help you establish the best final filling solution for your application and deliver the technical documentation and subject-matter expertise required for regulatory discussions.
Designing Your Final Filling Process in Line with Annex 1
The revised EU GMP Annex 1 guidelines place increased emphasis on how materials and product enter Grade A | B environments and how work is performed in the critical zone. RABS and isolators are identified as key means of separation, material transfers are expected to be controlled and unidirectional, and aseptic manipulations should be minimized through the use of engineered, pre-assembled, and sterilized equipment, all within the framework of a documented Contamination Control Strategy.
Our final filling portfolio addresses these expectations through single-use design approaches that reduce manual handling and standardize interventions.
Future-Proof Your Fill & Finish Read the eBook
Closed Transfer into Grade A | B
“The transfer of materials, equipment and components into the grade A or B areas should be carried out via a unidirectional process.”
EudraLex Vol. 4 | Annex 1 (EU GMP Regulation), 4.11
Expectation: Materials and components should enter Grade A | B via a controlled, unidirectional, closed path.
Solution: The Biosafe® system provides a sealed and secure interface for transfer — reducing manipulations and supporting effective contamination control strategies.
Download the Poster: Single Use Technologies — Final Filling
Watch the Webinar: Annex 1: How SUS can support new challenges
Minimize Aseptic Manipulations
“Direct intervention … into the grade A area by operators should be minimized by premises, equipment, process and procedural design.”
EudraLex Vol. 4 | Annex 1 (EU GMP Regulation), 4.4
Expectation: Use engineered, pre assembled, sterilized equipment to limit interventions in the critical zone.
Solution: Single-use Octoplus FF® and Flexsafe® 2D Advanced FF bags with custom final filling sets arrive pre assembled and gamma sterilized — limiting manual connections and changeover delays while protecting yield.
Read the Application Note: Octoplus FF®: Maximize Accuracy, Recovery & Flexibility
Validated, Defensible Procedures
“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 Regulation), 4.11
Expectation: Where in‑line sterilization isn’t feasible, procedures that achieve the same objective must be validated and documented.
Solution: Confidence® Validation Services provide extractables & leachables, integrity, and compatibility data, helping you develop your Contamination Control Strategy.
Watch the Webinar: Stories From the Field: Supporting Critical Steps in Fill & Finish
Watch the Webinar - Annex 1: How SUS can support new challenges
Build a Robust Contamination Control Strategy End‑to‑End
“A Contamination Control Strategy (CCS) should be implemented across the facility… The combined strategy of the CCS should establish robust assurance of contamination prevention… Its effectiveness should form part of the periodic management review.”
EudraLex Vol. 4 | Annex 1 (EU GMP Regulation), 2.3
Expectation: Compliance is assessed at the level of your overall Contamination Control Strategy, not individual products.
Solution: Combining the Biosafe® Rapid Transfer Port and Biosafe® bags for component transfer with Biosafe® RAFT for liquid transfer, alongside Octoplus FF® or Flexsafe® FF bags for final filling, creates a coherent, closed single use pathway. Validation and technical support provide the documentation and implementation support needed to justify this approach within your Contamination Control Strategy and maintain inspection readiness over time.
Read the eBook: Future Proof Your Fill & Finish
Download the Poster: Final Filling SUS
Related Assets
Octoplus FF®: How to Maximize Accuracy, Product Recovery, and Flexibility
PDF | 655.4 KB
Flexibility First: How Bausch+Ströbel Streamlined Aseptic Manufacturing With Sartorius
PDF | 114.6 KB
FAQs - Final Filling
Rapid transfer ports (RTPs) and beta bags improve aseptic transfer by creating a closed, standardized interface between the outside environment and the RABS or isolator.
- Mechanism: Components like stoppers, plungers, and seals are pre-loaded into beta bags and docked to the RTP to enable transfer without opening the barrier.
- Compliance: This setup reduces manual handling, supports Annex 1-aligned contamination control strategies (CCS), and makes transfers more repeatable and auditable.
To keep the product path closed, bulk drug products can be transferred through a single-use system designed specifically for isolator entry.
- Solutions: Technologies like SART System™ and Biosafe® RAFT connect preparation areas to filling isolators via compatible ports and disposable assemblies.
- Strategic benefit: This approach eliminates open connections at the barrier, reduces operator exposure to high-potency products, and supports a robust contamination control strategy.
Single-use surge or break tank assemblies, such as Octoplus FF®, replace fixed stainless-steel tanks with pre-assembled sterile bags, tubing, and connectors.
- Operational speed: The need for CIP | SIP is eliminated, reducing cleaning validation effort and significantly shortening changeover times on multi-product lines.
- Process integrity: Closed handling is maintained directly upstream of the filler, balancing efficiency with strict aseptic control.
Flexsafe® 2D Advanced FF bags are available in 1 – 5 L volumes, supporting smaller batch sizes. Their premium film and low hold-up volume protect yield and quality, which is especially important for high-value products.
- Application: Flexsafe® 2D Advanced FF bags are used as the product reservoir in a single-use filling path in small-volume applications such as cell and gene therapies.
Sartorius solutions support Annex 1 alignment by providing a fully single-use closed path around the filling line through integrated RTPs, liquid transfer systems, and surge tanks.
- Intervention reduction: Our aseptic transfer systems minimize contamination risk from manual interventions through the design of the Biosafe® Rapid Transfer Port, which supports rotation-free connection and external opening. Biosafe® bags are equipped with a rigid collar that can be pushed from the outside, meaning no sterilized accessories or human intervention are needed inside Grade A.
- Expertise: Our field application specialists bring deep expertise in fill and finish to help you design, integrate, and validate your final filling setups. With a coordinated global network and strong regional presence, they combine worldwide best practices with local support to ensure efficient implementation and regulatory alignment.
Final filling is a critical step in which the formulated drug product is dispensed into its final containers (vials, syringes, or cartridges) under aseptic conditions. Processing must occur in a highly controlled environment to maintain sterility and drug quality for patient safety.
Modern systems maintain cleanliness by using barrier technologies like isolators or RABS that separate the filling process from personnel and the external environment.
- Technology: Closed, pre-sterilized single-use assemblies and secure transfer methods like RTPs maintain aseptic conditions.
- Reduced risk: By minimizing human intervention and using dedicated flow paths for each batch, single-use systems greatly reduce cross-contamination risk.
A rapid transfer port (RTP) is a sealed interface that allows materials to pass into or out of a sterile isolator or cleanroom without breaking containment.
- System design: An RTP typically consists of a fixed alpha port on the isolator and a detachable beta container (often a beta bag) that locks onto it to form a secure connection.
- Process protection: Using an RTP protects the process by preventing external contaminants from entering during the transfer.
- Example: Solutions like the Biosafe® Rapid Transfer Port use this mechanism to ensure sterile transfer in aseptic filling operations.
Beta bags are specialized sterile containers that connect with an isolator’s alpha port to facilitate aseptic transfer.
- Function: They allow components to be moved into a sterile area without environmental exposure.
- Seal design: The isolator's alpha port connects with the beta bag to create a sealed interface.
- Safety: The Biosafe® Rapid Transfer Port has additional safety features, including magnetic, rotation-free coupling and external opening to minimize manual interventions.
Single-use systems improve sterility assurance and operational efficiency by providing a new, pre-assembled sterile flow path for every production run.
- Downtime reduction: Pre-sterilized components eliminate the need for cleaning and sterilization between batches, reducing carryover risk.
- Flexibility: Manufacturers gain the ability to switch between different products or batch sizes quickly by swapping out single-use kits.
Accurate filling is critical to ensure patient safety and to prevent the waste of high-value drug products.
- Precision hardware: High-precision needle assemblies and dosing pumps, including peristaltic, piston, or time-pressure pumps are calibrated to deliver exact volumes.
- System design: Specialized bags like Octoplus FF® are engineered for high accuracy and maximum product recovery to minimize hold-up.
