flexfill: Setting the highest standards for safety and flexibility
Aseptic filling with short lead times, a validated concept and production start in just 8 months
Discover the flexfill syringe filling machine, a state-of-the-art filling and closing solution for ready-to-use syringes, vials, and cartridges. Designed to meet the demanding needs of small to large pharmaceutical manufacturers and Contract Development and Manufacturing Organizations (CDMOs), flexfill delivers unmatched flexibility and reliability for medium-volume production.
The flexfill system offers a standardized, qualified, and validated machine concept that supports your pharmaceutical production goals. Its modular design enables 80% pre-defined configuration, allowing for fast deployment and commissioning. This streamlined setup minimizes lead time for qualification and validation, helping you meet regulatory requirements quickly and reliably.
With flexfill, choose from pre-configured modules to customize your system according to specific needs. This modular approach not only accelerates delivery times to 8 month but also helps meet tight timelines, ensuring rapid response to patient demands. Developed from decades of expertise in specialized machine engineering, flexfill redefines syringe filling machines by offering a blend of precision, speed, and adaptability in an off-the-shelf solution.
FLEXIBILITY
With the flexfill, we offer a flexible solution that enables attractive delivery times without any loss of quality or compromises compared to complex customized machines. It is cost-effective, versatile and can be adapted to your requirements with our modular options.
PERFECTION
Many years of experience in special machine construction have made us experts, thanks to our collaboration with numerous customers from the pharmaceutical industry. All this expertise is combined in flexfill and has proven itself in practice.
Ready for rapid success?
Then discover the world of flexfill!
Fast validation. Reliable production. Proven technology.
Your benefits at a glance
- Short time-to-market and boost ROI due to the pre-configured modules of the flexfill
- Design and qualification documentation available from day one to leverage your validation
- Compliant with all major regulatory requirements
- Save time and money while eliminating risk by testing the flexfill with us in advance
- Optimized for filling syringes, vials, and cartridges
Performance and process reliability for aseptic filling
Process steps for handling RTU containers
Our latest flexfill machine portfolio is perfectly adapted to the current market situation. These pre-designed and configurable filling lines offer you unrivalled delivery times for cutting-edge technology for pharmaceutical fill and finish solutions for ready-to-use (RTU) syringes, vials and cartridges. The standardization and modularization of industry-leading groninger technology enables shortened times to production start-up while meeting the highest standards of safety and flexibility.
Debagging
- No-touch transfer (NTT) for an aseptic transfer of ready-to-use containers to grade A
- Highest process reliability and safety due to automatic clamping and cutting
Opening
- Particle reduced opening of lid and liner due to infrared heating of the glue
- Disposal of the lid and liner to the outside of the containment/barrier
- Recognition of 1st air principle during opening of the tub
Filling and closing
- Flexible filling system (rotary piston and/or peristaltic pump filling technology)
- Highest effective output with In-Process-Control (IPC) for filling
- Possibility for gassing for oxygen sensitive products and vacuum for high viscous products, polymer containers or cartridges
- Sorting of closures in feeding tracks to eliminate the need for long lead time items like sorting bowls
- Camera systems for stopper presence and orientation for optimal reject handling
- Hygienic design for fast and easy cleaning operations
- Standard gassing and vacuum functions
Denesting
- Removal of single rejected vials, syringes and cartridges out of the tub
- Transfer Module with tub reject handling
- De-nesting of vials for downstream processing at sealing machine
Sealing
- Camera system will be available soon to check the gap and presence of the stopper with a separate reject prior to the capping station
- Crimp quality control with camera tracking available
- Lowest particle generation during sealing due to groninger's high-end capping technology
Why choose flexfill?
Technical features and performance specifications of flexfill
Technical data
/Features
- Compatible with all standard stoppers and caps
- RABS or isolator configuration
- Various feeding options – non-contact transfer or eBeam
- Peristaltic pump, rotary piston pump, or a combination of both
- Gas flushing and vacuum functions
- Maximum efficiency with in-process control (IPK) for filling
- Sorting of stoppers into feed lanes
- Camera systems available to verify the presence and orientation of stoppers for optimal ejection
- Proven and reliable no-touch transfer (NTT) of pre-sterilized primary packaging containers into the aseptic zone as part of groninger’s safetransfer technology
- Minimization of product losses through our smartfill technology
- 3-in-1: groninger’s combifill technology enables the processing of nested syringes, vials, and cartridges on a single machine platform by simply swapping out the format parts
- quickconnect technology enables the fastest, tool-free changeover of the entire system
flexfill in detail: Insights into modular filling technology
Achieving the highest standards of safety and sterility together
Our partners for isolators
SKAN
SKAN is a Swiss company and a global market and technological leader for isolators, cleanroom devices, and decontamination processes for the aseptic production of biopharmaceutical substances. SKAN’s core competency is the design and development of process isolators for the aseptic filling of biopharmaceutical products.
Franz Ziel GmbH
Franz Ziel GmbH stands for innovation, reliability and development in cleanroom technology. With more than 40 years of experience, they have constantly implemented new technologies and state-of-the-art product solutions. As a leading company in the sector of cleanroom technology, they operate globally for renowned companies.
