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Manufacturing

Facilities

 Sterile devices - ManufacturingWe offer access to four facilities for manufacturing sterile medical devices, all operating to high quality standards (ISO9001, ISO13485).
 

Sterile devices - ManufacturingWith production locations in Germany, Poland and China as well as the required licenses (US FDA, etc.) we are able to choose a manufacturing location in the area that best suits our partners' wishes and requirements. Our range of product services extends from prototypes and pilot production runs in our factory in Eisenach, Germany to semi- or fully automated mass production in our factories in Wroclaw, Poland and Nanchang, China. The manufacturing range extends from mould making/injection moulding to sterile finished products for all common manufacturing methods of plastic medical devices. All our production locations have ETO sterilization installations as well as distribution depots.
Fresenius Kabi Product Partnering offers access to four facilities for manufacturing sterile medical devices, all operating to high quality standards (ISO9001, ISO13485). With production locations in Germany, Poland and China as well as the required licenses (US FDA, etc.) we are able to choose a manufacturing location in the area that best suits our partners' wishes and requirements. Our range of product services extends from prototypes and pilot production runs in our factory in Eisenach, Germany to semi- or fully automated mass production in our factories in Wroclaw, Poland and Nanchang, China. The manufacturing range extends from mould making/injection moulding to sterile finished products for all common manufacturing methods of plastic medical devices. All our production locations have ETO sterilization installations as well as distribution depots.
 

Capabilities

FILL INFresenius Kabi Product Partnering Medical Devices is a leading manufacturer of sterile disposable products for drug application. Using validated manufacturing methods, we produce high-quality, sterile and latex-free infusion and transfusion sets, products for insulin therapy, pumps and sets for enteral nutrition as well as a comprehensive range of accessories for each of these applications. We use state-of-the art materials that meet performance requirements such as inertness and light protection. Our processes and products are also optimized to make best use of resources and reduce environmental impacts as far as possible.
 

Therapy Program


Enteral Nutrition

FILL INAs your partner for manufacturing enteral nutrition, we offer a complete range of products. Transnasal and percutaneous feeding probes are available in single or multi-lumen versions for gravity or pump application, and we also offer enteral feeding pumps. We pay close attention to ensuring cross-compatibility with other products available on the market, so that our end users can rely on being able to use our products universally.
 

Subcutaneous Application

Subcutan c.Our insulin catheter ensures the highest possible level of portable comfort for patients thanks to our continual improvement of elements such as the uncoupling system, the easy handling and the variable hoses and needle lengths. There are several systems available for diverse applications, such as e.g. apomorphine therapy, pain treatment and for the application of immunoglobulin. So that our customers can market the catheters worldwide, we have added a version with a flexible hose to complement the usual European version with a steel cannula.
 

Infusion Therapy

AnstickdornOf course we are also the right partner when it comes to systems for infusion therapy. We develop special application systems to customers need for the most diverse medicines or also pump systems. We can offer the complete development range supported by our 3D construction including tool manufacture and injection molding. We can offer you full-range project processing in our company with our downstream sterilization manufacturing. This guarantees fast and above all smooth handling of the project for our customers. However, we have remained flexible, in order to give our customers the possibility to assign subprojects to us.
 

Quality Compliance

Sterile devices - Manufacturing - Quality ComplianceAll factories of the Fresenius Kabi Product Partnering Medical Devices group are certified according to DIN EN ISO 13485 and DIN EN ISO 9001. The following supplementary requirements are also met.
QSIT, Regulations of FDA USA, CMDCAS, Regulations Canada SDA, Regulations PR China and QSD Regulation Taiwan.

The quality units have 3 laboratories for microbiological examinations. There are also 8 laboratories for quality control of incoming merchandise, in-process control and final inspections. An extensive system of production tests helps to detect errors promptly. All equipment complies with the latest state of the art. The Fresenius Product Partnering Medical Devices quality philosophy works on the fundamental principle of eliminating errors early on in all company divisions.