Producing cold Water for Injection
Is there safety in producing WFI from Reverse Osmosis? 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 at least critical applications (cosmetics, healthcare, human food and animal feed, for example). So, our approach is really focused, with a wide range of specific knowledge.
We consider that every pharmaceutical facility needs “pure” water. First of all, the question is: what this word, “pure”, means? To answer this question it is necessary, in every sense, to go back to the source, analyzing water quality in-situ (the raw water employed), which is very different from place to place. Then, the task of the pre-treatment of water is just that: bring the particular water to a functional quality, according to the user requirements specification (URS).
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). Water treatment systems have the task of ensuring a constant quality to the water production, also through physical systems such as reverse osmosis. However, producing WFI from Reverse Osmosis systems requires special attention, since in RO there is not a water changing state (from liquid to vapor, a natural microbiological barrier).
Cold WFI from RO requires Ultrafiltration (UF)
In WFI production, RO system requires -unlike distillers- a correct downstream unit to prevent contaminations: the ultrafiltration (UF). This is the only one know system which allows the process validation. Naturally, it must be done a continuous control on RO efficiency, in terms of membrane degradation, biofilm prevention and microbial charges, with periodic sanitization. If there are no obstacles in ensuring this constant monitoring, the reverse osmosis system can offer a real advantage, reducing the energy needs and thus reducing production costs.
RO and Water Pretreatment Systems
As we have noted, any pharmaceutical water pretreatment system must be customized upon a thoroughful evaluation of feedwater quality using the customer’s water analysis. The raw water must be pre-treated to remove contaminants (such as particulates, calcium and magnesium salts, heavy metals, organics and bacteria) through a multiplicity of different steps (they can include softeners, UV reactors, deionisers, …)
Chemical dosing stations are added for many purposes such as water disinfection and/or chlorine neutralization. Pre-treated water quality is constantly monitored to ensure suitability to feed downstream water treatment equipments, such as the RO units to produce WFI.
BRAM-COR performs accurate simulations starting from raw water data to design and tailor the best suitable Pretreatment Plants for any specific condition. For an effective microbial control strategy to prevent biofilm formation and fight against severe contaminations by pseudomonas aeruginosa, BRAM-COR designs and supplies hot water sanitizable versions.