Line concept for processing vials, syringes and cartridges

flexpro 50

The market standard for flexible filling of small to medium-sized batches.

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 only standardized and coordinated for the flexpro 50 allow for 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.

Filling and closing of nested vials on the flexpro 50
Filling and closing of nested vials on the flexpro 50

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). 
Antibody-drug conjugate (ADC), orphan drug, hormone or advanced therapy medicinal product (ATMP).
Overview of possible applications of the flexpro 50

The line meets the highest process requirements that are required 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.

Ergonomisches Design der FLEXPRO 50

Ease of use

Ergonomic design with attention to the operator and interventions to minimize risk.

Integration of the LyoShuttle system from Martin Christ

LyoShuttle loading system

Integration of the LyoShuttle system by Martin Christ - the innovative, robust and wireless isolator-friendly loading and unloading system for freeze dryers.

Integrated containment system to prevent leakage of highly active substances

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).

Overall height optimal for a standard clean room

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.

Processing of syringes, cartridges and vials

Three objects on one machine

Processing of syringes, cartridges and vials.

Robotic arms eliminate the need for human intervention and reduce the risk to the product

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 Martin Christ 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 sterilization through an integrated vH2O2 gas supply system of monitoring material and small tools for a smooth process flow.

Project management

With our turnkey machine concept, you will receive a joint project plan from us partners (groninger, Ziel and Christ) 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 partners support you with all GMP-related questions.

This is what our customers say

With the FLEXPRO 50, we accommodate all our requirements as a CMO for potent products.

Dermot O‘Riordan
Business Development Manager, EirGen Pharma Ireland

The FLEXPRO 50 gives us the flexibility we need to serve our customers.

BJ Hull
Vice President and General Manager, Emergent USA

Impressed by technician's attention to detail and attentiveness to our questions and concerns.

Mike Cross
Manufacturing Associate, Drug Product Operations TEVA (USA)