Description:

The Saline Manufacturing portion of Fresenius houses a multi-phase process combining full automation with LCD touch screen controls and lean manufacturing principles. Sterile manufacturing for peritoneal
dialysis drugs and saline fl uid requires multiple classes of clean rooms (1,000 to 100,000). The main components are as follows:

Solution formulation requires class 10,000 clean rooms to house its 4 DCI 36000 liter single shell vertical storage systems and agitator mix tanks.

A 16,000 SF class 10,000 clean room is required for the fi lling area, with a class 1,000 portion over the manufacturing equipment in the Fill Rooms. Each of the 4,800 SF Fill Rooms utilize sterile laminar fl ow
technology to provide the utmost protection for the production of the 1 and 5 liter saline bags. This area also includes sterile packaging, and inspection in class 100,000.

The third element is sterilization, which requires 4 steam-sterilization autoclave systems. This portion is 24,000 SF, including loading, sterilizing, packaging, staging, and clean warehouse.