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Plant Friedberg; Germany


Key Data

As one oft he most modern production facilities for infusion solution, Fresenius Kabi´s plant in Friedberg, Germany is an important element in our worldwide network of more than 20 sites.

 

  1. Certification:
    • Manufacturing license form competent authority

    • Licenses from health authorities outside the EU: USA, Asia, Latin America, Africa

  2. Main products:

    • Standard infusion solutions

    • Parenteral nutrition products

    • Irrigation solutions

  3. Key Competences:

    • Standard Solutions 50 - 1000 mL

    • Large batches

    • 24 hours distribution

  4. Technologies:

    • Freeflex® IV bag technology

    • Filling of glass bottles

    • Filling of large volume containers

    • Blow-fill-seal technology

    • Filling of 2-chamber bags

    • Filling of large volume bags


 

In the Spotlight

Friedberg produces vast quantities of different solutions every day. Starting materials are stored in special stainless steel tanks or silos. Dedicated and fully validated weighing and transport systems for each starting material ensure precise automated dosage. Pneumatic systems transport these starting materials directly into hermetically sealed compounding tanks, where the dissolution in Water for Injection takes place. Highly sensitive sensors monitor the production process, guaranteeing consistently high product quality.

 

Prior to further processing, solutions are filtered to exclude particles and microbes, and held in intermediate tanks until filling. The system allows optimal, time efficient compounding and filling operations.

 

The star among the container types produced in this plant are Fresenius Kabi´s freeflex® bags. These are made of inert plastic material – free of PVC, plasticizers, adhesives and latex. They meet the highest ecological and drug compatibility standards, and also are highly transparent, flexible, and lightweight. They have two separate ports for injection and infusion, with color-coded, tamper-proof break-off closures. Freeflex® bags are compatible with all commercially available standard IV infusion / transfer sets. Freeflex® bags are manufactured and filled with IV solutions in a highly automated in-line process, in the sizes 250 ml, 500 ml and 1000 ml. They can be sterilized in their overwraps at 121°C.

 

Next up are 2-chamber bags for parenteral nutrition products. The two chambers are separated by a peel seam. Each chamber is filled with a different solution. The components are mixed by light pressing on one chamber. This opens the peel seam and allows easy homogenization of the product.

 

The last bag type filled at Friedberg is the large-volume Careflex, specially designed for irrigation solutions, with volumes from 1.5 to 5 L. They are made from extra strong foils on a special production line.

 

Turning to rigid containers, we come to the KabiPac, a light-weight, PVC-free alternative to glass bottles made of pure polyolefin. KabiPacs are moulded, filled and closed in a single inline, sterile “Blow-Fill-Seal” process. In Friedberg, we make 500 and 1000 ml KabiPacs.

 

We also fill into glass bottles in dedicated clean-room area. The line fills 50 up to 1000 ml bottles. After unpacking, the bottles are cleaned, filled and stoppered under sterile conditions; if necessary in an oxygen-free atmosphere. The filled bottles are then water steam sterilized in a continuously operating rotary autoclave.

 

Finally, Friedberg has a separate filling line for the filling of sterile solutions into 10-liter containers, the Kabi-Container.