São Paulo, Brazil
Fresenius Hemocare Brasil is located in Itapecerica da Serra, close to the city of São Paulo, in the Southeast Region of Brazil. The plant was taken into operation in 1989 and now employs more than 300 people.
This production site plays an important part in the global network of Fresenius Kabi, which owns profound expertise in manufacturing of blood bags systems. It offers an impressive range of blood bags products, serving the national and Latin American markets. Its product portfolio contains standard blood bags systems and inline blood bags systems (CompoSelect® / CompoFlow® Select). Furthermore, the plant has also a remarkable range of dry sets products as well, such as stand-alone filters (BioR / BioP / CompoStop), transfer sets (CompoFlex®) and compounding bags (Freka® Bags). The diagnostic product scope comprises reagents from human red cells and products from monoclones.
With its experienced team, outstanding service level and key competences in tube extrusion, numbering and cutting tubing; RF bag welding, manual assembling, solution preparation (CPD; CPDA-1 and SAG-M), solution filling as well as steam sterilization and flow wrap packaging process, the plant is capable to meet any needs of our customers.
Besides the manufacturing unit with state-of-the art machinery, the plant has the onsite warehouse with capacity of more than 1,200 pallet positions and operates the cleanroom areas: ISO 8 of 867 square meters in total, ISO 7 of 260 square meters in total and ISO 5 of 10 square meters. Its own laboratories, outfitted with modern equipment for chemical, microbiological, biological (diagnostic) and physical analysis, allow to hold a constant high level of products quality control. More than that, this production unit has its own water supply with capacity of 140.000 liters per day.
This facility is GMP certified by Anvisa and ISO 13485 as well as ISO 9001 certified by TÜV SUD, which enables the plant to operate according to all regulatory requirements.