Key Data

Neufahrn, Germany is in the northern suburbs of Munich. Fresenius Kabi’s facility there is a center of excellence in aseptic compounding of infusion solutions for individual patients.

 

1. Markets:

   • Compounding of infusion solutions (parenterail nutrition): delivery throughout Germany

   • Clinical trials: International scope

2. Batch-Sizes:

   • Variable

3. Containers:

   • One ore two chamber Bags for parenteral nutrition;

   • Syringes for parenteral nutrition

   • Other containers on request

4. Certifications:

   • Licensed by the competent authority for aseptic manufacturing of parenteral nutrition and products for clinical trials according to GMP guidelines and the German Drug Law (AMG).

   • DIN ISO 9001 (TÜV Süd Management Service)

5. Services:

   • Analytical services (including validation of methods) in collaboration with an external lab

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In the Spotlight

Made to order

About 100 qualified and experienced employees work at the site. The main product group is parenteral nutrition solutions for home care and dialysis patients; for these, the individual compounding enables a precise response to the patients’ nutritional needs.

 

Support & Accessories

In Germany, total parenteral nutrition (TPN) bags have to be delivered through pharmacies. We provide an advisory service to assist clinicians and pharmacists in drawing up therapy plans. Along with the solutions, customers can order all the equipment needed to administer them. Individually compounded products can be packaged with a range of medical devices for delivery, and with additional standard solutions (vitamins, electrolytes, etc.) needed by the same patient. We can also supply infusion stands, fridges, and electronic infusion pumps.

 

Centre of excellence

Besides its role as a national supplier, Neufahrn is also the leading center of competence for Fresenius Kabi’s international network of nearly 20 compounding centers.

 

Clinical trials

The new development in Neufahrn is our service producing infusion solutions (parenteral nutrition) for clinical trials. If you need a trial of parenteral nutrition compounds, we can handle the entire cycle of producing and supplying the drug to trial centers. In case of  i.v. drugs we can offer the same package without compounding.

The package contents the following steps:

• Compounding
• Labelling and blinding
• Secondary and tertiary packaging
• Controlled storage
• Management of retain samples
• Controlled shipment to national and international trial centers
• Management of all investigational medicinal products returned from trial sites

Naturally, these processes are all done in compliance with the relevant national and international guidelines.

 

Quality

The plant is licensed by the competent authority for aseptic manufacturing of parenteral nutrition according to GMP guidelines and the German Drug Law (AMG). An additional license that covers the process of handling (without conpompounding) drug products for clinical trials was granted in 2010. The plant is also certified under DIN ISO 9001 by the TÜV Süd Management Service.

 

History

1993: Compounding of parenteral nutrition solutions begins

1995: Compounding of iv drugs begins

1998: Site acquired by Fresenius; distribution of standard parenteral solutions begins

2003: Site reorganized to a production unit

2006: Start of compounding concept

2010: Launch of clinical trial activities

 

Other activities

The Neufahrn site also carries out stability studies on compounded solutions, in cooperation with a contract laboratory. It is a test center for new developments within Fresenius Kabi (e.g., medical devices, new technologies). And it provides a validation service for in-house and outside clients.