At the firm of Fertin Pharma, SILHORKO-EUROWATER has supplied, installed and commissioned a water treatment plant for purified water production used for cleaning purposes and for manufacturing of medicated chewing gum. After this expansion of the production capacity, the new plant can deliver 3,000 l/h of purified water. The facilities meet all current GMP* requirements from the US Food and Drug Administration (FDA) and the EU, all regulatory requirements for external environment and work environment, the EU Machinery Directive as well as current versions of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (Ph. Eur).
* = Good Manufacturing Practice
The water treatment plant is designed for nonstop operation (365 days). Chemicals for sanitizing can be employed.
In the outlet of the RO system, the stainless steel in contact with media is AISI 316L. Surface roughness is better than Ra < 0.8 µm, welds < 1.6 µm. All welds are documented in a welding log.
The compact pharma unit (CU:PHARMA) is equipped with water-saving technology. The RO system is of the type RO-PLUS with a water recovery of approx. 90 % – without compromising on either operational reliability or water quality.
- Flow: 3.000 l/h
- Conductivity: <0.1 µs/cm at 15°C
- TOC: <500 ppb
- CFU: <100 CFU pr. ml
Units in plant
- Pressure boosting pump.
- Softening plant type SMP 362 with Testomat analysis unit for hardness monitoring.
- CU:PHARMA compact unit comprising RO-PLUS system, EDI system, mixing tank, CIP unit as well as central control board with PLC and HMI.