BRAM-COR is committed to providing a clear answer to every need of water treatment to produce pharmaceutical waters (i.e. PW or WFI) or compendial water for other critical applications (cosmetics, healthcare, human food and animal feed, for example). Our approach is really focused, with a wide range of specific knowledge. BRAM-COR CROS Sanitary Reverse Osmosis Systems, in particular, are designed to produce compendial purified (PW) and also Water for Injection (WFI), through several water treatment steps, according to any specific feed water quality and production need.
The treatment steps, necessary to separate the water from organic substances, high and medium molecular weight ions and from bacteria / pyrogenes, may include:
PW is usually obtained through:
WFI is usually obtained through an Ultrafiltration (UF) system located downstream.
In each RO stage, water is processed through thin film composite RO membranes, offering the highest rejection of contaminants.
Two different flows are generated by the RO system: permeate water, corresponding to PW specification, and RO concentrate, which is recycled in the system in order to obtain a higher recovery with a lower consumption of inlet water. An additional devoted RO step might also be added to reduce the amount of concetrate water to be wasted.
BRAM-COR CROS equipment offer range of PERMEATE capacity spanning from 100 up to 20.000 lph, complying with cGMP and FDA regulations, including
Techniques such as water softening, descaling, pre filtration, degasification, nanofiltration, electro-deionisation, ozonation, UV treatment and micro-filtration should all be considered, in relation to the feed water quality. Subsequently, the water quality must correspond to the quality levels of the pharmacopoeia required, if it should use, for example, for the production of Water for Injection (infusional bags or bottles, and so on).
However, producing WFI with Reverse Osmosis systems requires special attention, unless the feed water is really excellent, since in RO there is not a water changing state (from liquid to vapor, that is a natural microbiological barrier). With the availability of more technologically advanced membranes UF, we can get cold WFI. So, the WFI meets all the parameters required (USP, EP, JP, …). Our RO Systems + UF achieve an optimal WFI quality; however, once in production, any RO system requires a continuous control on its efficiency, in terms of membrane degradation, biofilm prevention and microbial charges, with periodic sanitization and validation. If there are no obstacles in ensuring this constant monitoring, which must also concern distribution loops, the reverse osmosis system can offer a real and meaningful advantage, reducing the energy needs and thus reducing production costs.