STILL
Principle
According to pharmaceutical standards and by definition, water for injection (WFI) is water required for manufacturing medicines for parenteral administration. The Centec multi effect distillation system STILL is designed for the production of sterile, pyrogen-free WFI. The unit consists of a series of interconnected columns. Pre-treated feedwater enters into the first column. Using external energy, a significant proportion of it evaporates in the first tubular heat exchanger. In order to separate any water droplets that might harbour contaminants like particles and pyrogens, the column contains an expansion chamber. While the steam moves further upwards in the chamber, the water droplets fall into its lower section by gravity, thus separating from the steam. The non-evaporated water flows into the next column, where it is again heated in a heat exchanger using steam produced in the previous stage. While another portion of the water evaporates, some steam condenses into WFI. This process is repeated in each column. To condense the steam produced in the final column, cooling water is used. The WFI is at 80 °C and needs to be kept at this temperature to prevent the growth of microorganisms.
Characteristic
·Application Specific and Energy Efficient optimized gravitational separation method WFI storage and loop on demand
· Modular Design with Standard PLC skid mounted for easy installation and start-up
· In Compliance with USP, ASME, GMP, FDA, ISPE
· Completely Qualified (DQ, IQ, OQ)
· Low Operating and Maintenance Costs
Technical Data
Capacity 0 - 20 m3/h
Number of Columns Up to 8
WFI Temperature 80 °C (lower on request)
Total Bacteria < 10 CFU/100ml
Endotoxin < 0.25 EU/ml
Residual Conductivity < 1.1 mS/cm (20°C)
Material 1.4404/1.4435/… AISI 316L/… electropolishing possible
Surface Finish Ra < 0,4 possible
Ferrite Content < 1 % possible
PLC SIMATIC S7
Options Water pre-treatment WFI storage & distribution