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Water filtration, or for example reverse osmosis, has also its application in a pharmaceutical industry. Water is actually both an integral component and at the same time the most commonly used commodity of production cycle in the pharmaceutical industry. Water utilization is versatile as a part of the product basis, during the chemical synthesis, water is an integral part of the final product and it also serves as a cleaning agent for rinsing the used vessels and equipment. In the case when the necessary water tretment does not také place in the production process, there is a chance of possible contamination of the final product. This apply even in the case when the water is subsequently removed from the product during the production process.
According to the inlet water quality, different water treatment methods are used for the water purification e.g. ultrafiltration, ion exchange technology water treatment, reverse osmosis and its multi-level membrane technologies together with refining units, or possibly water electrodeionization-EDI.
Water treatment for so-called Aqua purificata, or exactly Aqua pro iniectione, Aqua purificata and Aqua valde purificata is used mainly in the pharmaceutical industry. Water quality is then defined by corresponding regulations – it has to correspond with the Decree no. 252/2004 Coll. together with quality regulation according to the ČL 2005. The decree distinguishes three different quality levels of the water used.
- Aqua pro iniectione with specific electrical conductivity max. 1,1 µS/cm at 20°C, max. total organic carbon 0,5mg/l and max. bacterial endotoxin content of 0,25 m.j. per 1ml.
- Aqua purificata with specific electrical conductivity max. 4,3 µS/cm at 20°C, max. total organic carbon 0,5mg/l and max. bacterial endotoxin content of 0,25 m.j. per 1ml.
- Aqua valde purificata with specific electrical conductivity max. 1,1 uS/cm at 20°C, max. total organic carbon 0,5mg/l and max. bacterial endotoxin content of 0,25 m.j. per 1ml.
According to customer requirements we at BKG take over the projecting and design of the equiment (basic design, detail design), together with an actual water treatment technology production, delivery, assembly, programming/automation and technology start-up for operations as water filtration, softening, desalination or reverse osmosis. We also provide all the documents (design as built), maintenance, service support, spare parts and operational parts delivery.