Friedberg, Germany

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 manufacturing facility in Friedberg is equipped to produce a vast arrange of primary containers such as freeflex^® bags, our proprietary IV bags and Careflex^® bags, designed for large-volume irrigation solutions with volumes from 1.5 to 5 L. In Friedberg we can also fill 2-chamber bags for parenteral nutrition products. The two chambers bags allow for separation of two different solutionare through a peel seam. The components can be mixed, when needed, by light pressing on one chamber. This opens the peel seam and allows easy homogenization of the product.

Furthermore, Friedberg can manufacture 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 (B/F/S) 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.

Technologies:

• Freeflex® IV bag technology
• Filling of glass bottles
• Filling of large volume containers
• B/F/S technology
• Filling of 2-chamber bags
• Filling of large volume bags

Products:

• Standard infusion solutions
• Parenteral nutrition products
• Irrigation solutions
• Standard Solutions

Containers:

• Freeflex® bags
• Careflex® bags (1.5-5 L)
• KabiPac® (500-1000 mL)
• Glass bottles (50-1000 mL)
• Kabi-Container (10 L)

Certificates:

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

Market:

• Worldwide