1. Introduction: The Challenge
- Market demand for a transfer device with filters for vials with a nominal diameter of 32mm and a transfer volume of >100ml, with no comparable solution available.
- The application involves reconstituting a lyophilized drug in a hospital before administration to the patient using an infusion set.
- Alternatively, withdrawal of the prepared drug solution via syringe should also be possible.
- The requirement: a safe, efficient, and user-friendly solution.
2. The Development Process
Together with our customer—a global leader in healthcare, specializing in pharmaceuticals and biopharmaceuticals derived from blood plasma—sfm defined and analyzed the user needs, regulatory requirements, and specific customer specifications.
Development was based on the existing modular nextaro® 20/20 product. Initially, the design was adapted, and functionality tests were conducted with prototypes. During this process, several technical challenges emerged in scaling up to a larger version.
3. The Innovation: nextaro® 32/32
Previously, the medication in question was only available with 1 g of active ingredient, requiring hospital staff to prepare multiple individual solutions based on patient weight. With the introduction of 4 g and 5 g formulations in 32mm vials, combined with nextaro® 32/32, a single transfer process now enables preparation and administration of higher-dosage drug solutions.
The new nextaro® 32/32 was specifically designed for secure connection with custom 32mm vials. One key challenge was ensuring that the device remains securely attached to both vials during solvent transfer, yet can be easily detached afterward to allow administration via an infusion set. All adjustments were made in close collaboration with the customer.
Additionally, the features of the standard nextaro® product line were successfully adapted to the larger version, including:
- Two integrated 15µm (nominal) fabric filters on both the drug and solvent sides
- Pre-alignment and secure vial connection
- Ergonomic design with textured grip surfaces for safe handling
- Needle-free system with robust plastic spikes
- Anti-roll design for added convenience
The nextaro® 32/32 is the first and only MDR-approved transfer device with filters for 32mm vials currently available on the market.
4. Implementation & Market Launch
In early 2024, the combination product was successfully launched by our customer, initially in Germany and Denmark. The first user feedback was overwhelmingly positive, confirming high acceptance in clinical practice. Since then, the product has been introduced in multiple countries, with additional registrations in progress or nearing completion.
5. Customer Benefits & Market Advantage
- Improved drug reconstitution for 32mm vials with maximum safety for users, surpassing traditional double-ended needles.
- Pre-alignment ensures correct vial connection, preventing misalignment and providing a secure hold throughout preparation.
- Increased efficiency in pharmaceutical workflows, streamlining hospital procedures while improving sustainability through optimized material selection.
- Exclusive market positioning as an innovation leader, differentiating from competitors. nextaro® 32/32 is the first and only solution with filters for 32mm vials.
6. Conclusion & Outlook
- The modular nextaro® product family allows for rapid adaptation to new market needs, including additional sizes, new functionalities, and alternative filter options.
- The primary focus remains on high-value medications that require an exceptional transfer system.