WFI Water For Injection with Full automation managed through GAMP-compliant hardware and software

Product Name:WFI Water For Injection with Full automation managed through GAMP-compliant hardware and software

Processes such as softening, decalcification, pre-filtration, degassing, nano-filtration, electro-deionisation, ozonation, UV treatment and microfiltration, can be considered in relation to feed water’s quality. In turn, water’s quality has to be compliant to the pharmacopeia’s quality levels if, for example, the water has to be used for the production of WFI.

Nevertheless, the WFI production with reversed osmosis systems require particular attention, unless the feed water is truly excellent, since RO does not include a change in the state of the substance (e.g. from liquid to gas, i.e. a natural microbiological barrier). Through the availability of technological membranes which are more advanced in ultrafiltration, we are still able to provide WFI in cold water, a process which enables to fulfil the range of required parameters (USP, EP, JP…).

Our RO + ultrafiltration systems reach an excellent WFI quality; nevertheless, once produced, any RO system requires constant monitoring related to the degradation of the membrane, in function of preventing the creation of eventual biofilm or micro charges, which is possible through disinfection and periodical validations. If there are no roadblocks which undermine a constant monitoring, which should also concern the distribution circuits, the reversed osmosis systems can offer a significant advantage, reducing energy expenditure and, hence, production costs.