Single-Use Filling Assemblies
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Send a message to our
industry experts.
Fill and finish operations that take advantage of single-use systems offer a number of benefits. These include facilitating the portability of the operation, supporting rapid changeover for multi-product filling suites, accommodating a wide range of dosage form factors, as well as the understood advantages associated with single-use systems, which apply to upstream operations as well. However, they also can provide unique challenges in terms of system complexity, dosing accuracy, and sterility assurance. Meissner’s applications specialists have been involved in the design and implementation of single-use filling systems for years. Leverage our experience and expertise to rapidly get your system qualified and operational.
Meissner also offers a number of unique items to address some of the more pervasive challenges associated with single-use filling assemblies. These include truly single-use filling needles as well as unique porting to seamlessly introduce multiple small bore filling lines into an isolator.
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Single-Use Filling Assembly
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Single-Use Filling Assemblies FAQs
Single-Use Filling Assemblies are sterile, preconfigured systems designed to transfer and fill drug products into final containers while minimizing contamination risks. They streamline aseptic fill and finish operations, reduce changeover time, and enhance process reliability.
Meissner’s assemblies offer secure fluid pathways, portability, rapid changeover, and compatibility with a wide range of dosage forms. They are engineered to meet stringent biopharmaceutical manufacturing requirements and help optimize both upstream and downstream operations.
All assemblies are manufactured in ISO Class 7 cleanrooms, can undergo validated sterilization methods (e.g., gamma irradiation), and are integrity-tested to ensure a sterile fluid path. Components are designed and assembled under strict quality systems to meet global regulatory standards.
Assemblies can be configured for vials, syringes, bottles, or single-use bags, depending on the application and scale. They support both small-scale clinical fills and large-scale commercial manufacturing.
Aseptic filling refers to the process of filling a product into a sterile container under sterile conditions, ensuring no microbial contamination occurs.
Sterile filling typically refers to filling a product that has already been sterilized into a sterile container. Both are critical to maintaining product integrity and patient safety.
Assemblies are configured based on application requirements, including fluid type, volume, container type, filtration needs, and integration with existing equipment. Customization ensures efficiency and flexibility across different processes.
Filters are integrated into assemblies to provide sterilizing-grade filtration or particulate control during filling. This step ensures drug product purity, safeguards patient safety, and complies with regulatory expectations.
Assemblies are manufactured under ISO-certified quality systems and are fully documented with Certificates of Conformance and Integrity Test Reports. They support compliance with FDA, EMA, and other global regulatory requirements for sterile drug manufacturing.
Yes, the assemblies are specifically designed for sensitive biologics, vaccines, and cell and gene therapies where product integrity and sterility are paramount.
Single-use systems eliminate the need for cleaning validation, reduce cross-contamination risks, and streamline setup/changeover between batches, supporting faster, safer, and more flexible manufacturing.
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