RTU Vial, Cartridge & Syringe Filling Machines

Solution for processing syringes, vials and cartridges of nested ready-to-use packaging

Instead of a mono line, are you in need of a compact and, above all, highly flexible filling line allowing you to react flexibly to new product developments at any time? Do you need to speed up the market entry of your medicines after approval?

The flexpro 50 series equips you ideally for these requirements. It offers maximum flexibility when processing small and medium batch sizes, perfectly suited, particularly, for products in the biotech industry and personalized medicine.

The flexpro 50 processes pre-sterilized nested RTU syringes, cartridges and vials, but also vials in trays or in bulk. You have the choice between process lines in separate or integrated nest/bulk versions.

Turnkey machine concept - ready engineered

The lines are implemented in a standardized modular design: On the one hand, it offers great cost advantages and the shortest possible delivery times, but it also allows rapid use and easy combination of the various modules (ready engineered). We planned and implemented the line in cooperation with Franz Ziel (isolator technology) and Martin Christ (freeze dryer) as a turnkey project. The machines and isolator modules, which are standardized and harmonized only for flexpro 50, allow a very compact design, but above all a complete technical and commercial integration of all components. The series can be used in aseptic and aseptic-toxic processing as well as as a proven system in the processing of live viruses.

Areas of application

With its specific properties, the flexpro 50 is particularly suitable for filling new medicines that are manufactured in small batch sizes, e.g.

• antibody-drug conjugate (ADC),
• orphan drug,
• hormones or
• advanced therapy medicinal product (ATMP).

The line meets the highest process requirements that are demanded for processing these pharmaceuticals. This definitely includes the requirements of regulatory authorities for containment and aseptic processing and the use of different zone concepts for processing pharmaceutical products with different OEB and BSL levels.

The design of the flexpro 50 also allows operation with maximum use of your resources: Our technology ensures only minimal product loss during start-up and emptying as well as during production. The entire line is also optimally accessible for easy handling and cleaning to avoid cross-contamination.

flexpro 50 highlights

We placed great value on the flexibility and ergonomics of the system right from the beginning. In the meantime, the system with suitable accessories is one of the most frequently supplied machine solutions on the international pharmaceutical market.

Ease of use Ergonomic design with attention to the operator and interventions to minimize risk.	LyoShuttle loading system Integration of the LyoShuttle system - the innovative, robust and wireless isolator-friendly loading and unloading system for freeze dryers.
Containment The integrated automatic Toxic Air Filter Module (FZ-ATAF) is positioned near the containment source and reliably prevents the escape of highly active substances. Simple operation via the HMI, easy cleaning (WiP) and safe (OEB6).	Low overall height With the isolator, the system reaches a height of 3 meters or 10 ft. The integrated Franz Ziel isolator technology fits into a standard cleanroom. This makes the solution ideal for retrofits in existing buildings or modular facilities where technical space is unavailable or space is limited.
Three objects on one machine Processing of syringes, vials and cartridges.	Robotic handling Robotic arms eliminate the need for human intervention and reduce risk to the product.

Additional features of the flexpro 50

Pharmaceutical customers and biotech companies today place great value on proven systems and process know-how from their partners into minimize risks and shorten their time to market.

The partners involved in the flexpro 50 manufacture have recognized these needs and developed a comprehensive and proven portfolio of accessories related to filling. This enables us to support our customers far beyond the filling line.

Feeding options groninger no-touch transfer technology or a H2O2 external decontamination system can be used to transfer RTU tubs directly into the isolator.	Wash-in-place (WIP) kit In order to avoid cross-contamination in multi-product lines, groninger offers manual and fully automatic cleaning processes for the flexpro 50.	Single-use filling technology Maximum flexibility with the groninger single-hose peristaltic pumps or the unique disposable rotary piston pump.
PAT tools Innovative freeze-dryers such as the WTMplus wireless temperature sensors or the LyoCam camera system support the monitoring of the freeze-drying cycle from start to finish.	FZ-RDS The Franz Ziel Rapid Decontamination System enables offline sterilisation of monitoring material and small tools through an integrated vH2O2 gas supply for a smooth process flow.	Project management With our turnkey machine concept, you will receive a joint project plan from us partners (groninger and Franz Ziel) with a designated contact person.
External washing machine The groninger external washing machine is the ideal supplement for processing potent drugs.	Risk analysis groninger offers a risk analysis to determine, for example, relevant monitoring points.	GMP regulations The flexpro 50 partners support you with all GMP-related questions.