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Pilot Plant Graz; Austria


Key Data

 

The Pilot Plant of Fresenius Kabi Austria in Graz offers expertise in manufacturing clinical batches of sterile pharmaceuticals. Due to the regulatory approval by major authorities (FDA & EMEA), the Pilot Plant Graz has become an important manufacturing site for global clinical studies. The flexible setup of the compounding and filling line allows manufacturing of various sterile pharmaceuticals in a range of container closure systems meeting the demands during the clinical trial phases I-III.

 

  1. Manufacturing Competences:
    • Batch sizes: 5L to 1000L
    • secondary and blinding of study medication for clinical studies in cooperation with the plant Neufahrn
    • oxygen-controlled filling
    • compounding of complex aqueous solutions, fat emulsions, liposomal formulations and suspensions
    • static and rotating terminal sterilization
    • aseptic processing in cooperation with the commercial plant Graz
    • lyophilization in cooperation with commercial plant Graz
  2. Primary Packaging:
    • glass vials and bottles from 3 ml to 1000 ml
    • COC vials and bottles from 3 ml to 1000 ml
    • Freeflex bags from 50 ml up to 3000 ml
    • glass and plastic pre-filled syringes from 0,5 ml to 50 ml done in cooperation with commercial plant
  3. Product Groups:
    • infusion solutions such as anesthetics, analgesics and antibiotics (non beta-lactams) 
    • parenteral nutrition products
    • medical devices and diagnostic products, such as irrigation solutions, X-ray contrast agents
  4. Quality Management:
    • excellent audit track record
    • FDA & EMEA approval
    • ISO 9001 and ISO 14001 certification


 

In the Spotlight

 

The Pilot Plant in Graz, Austria and its affiliated analytical laboratory were built in 2004 as an extension of the already existing commercial plant in Graz. While using synergies with the commercial plant, such as common supply for hot purified water and nitrogen, the Pilot Plant Graz offers a higher degree of flexibility for manufacturing GMP batches due to a more manual setup than our highly automated commercial plants. This flexibility enables us to fill multiple container closure systems from a single bulk solution for testing multiple containers during the clinical phase, while saving costs and time for the clinical study.

Over the last decade, the Pilot Plant has become a central manufacturing site for various global clinical studies due to its regulatory approval by major authorities (FDA, EMEA), serving as a reliable partner for study medication.

Besides manufacturing complex aqueous solutions, the Pilot Plant is also equipped with various homogenizers for manufacturing emulsions, liposomal formulations and suspensions from 5 L to 1000 L. The freely programmable autoclave in place includes the option for rotating cycles, meeting the special sterilization needs for various formulations.

For high-potent APIs, a special pharma lab was commissioned in 2008 in order to develop and manufacture pharmaceuticals with APIs up to an OEL level of 4.

 

A team of highly trained engineers and scientists offers their services to implement your product in the Pilot Plant and also supports with the scale-up starting with a lab-scale batch up to 1000L. Sophisticated developmental assays help us to optimize process parameters to guarantee a smooth scale-up and consistent product quality following the Quality by Design (QbD) guideline.

Once the product successfully passed the clinical study, a dedicated project team will coordinate the transfer of the product to one of our commercial plants, taking advantage of the experience and knowledge of the manufacturing process gained during the clinical phase.