Purified and injection water storage and distribution systems

  It is a well-known fact that water is one of the key substances used in pharmaceutical and biotech industry. The water treatment equipment used in this process has a direct influence on the quality of the original product and, therefore, should be validated.

  The water treatment system in a pharmaceutical industry consists of 2 parts:

• The source (a system designed for producing purified water).

• The purified and injection water storage and distribution system. The function of the source can be carried out by a reverse osmosis installation, which includes, but not necessarily, the use of the electrodeionization technology, as well as by multistage distillation units. The Storage and distribution system consists of circulation circuit which includes a storage tank with purified water.

  We offer our customers a process water system, realized in accordance with the basic instructions provided by the International Society for Pharmaceutical Engineering (ISPE). The chemical and bacteriological purity of the water, depending on the needs of the client, can be reduced to the standards of the American, European or Japanese Pharmacopoeia. As a source of purified water, we offer the installations provided by GDN (Italy), a recognized manufacturer of water treatment systems.

  The process water storage and distribution systems are manufactured by our company. In their production process we follow the standards introduced by the US biopharmaceutical industry (ASME BPE), as well as by the European Hygienic Engineering & Design Group (EHEDG). Welding operations are performed by personnel certified in accordance with requirements of the German Technical Inspections Organization (TUV), are carried out on a calibrated orbital welding machines manufactured by MK Products (USA). The documentation that accompanies the products contains a full set of certificates: for materials, for the calibration of orbital welding machine, quality of the surface passivation certificate etc. Upon customer request we perform design qualification (DQ), installation qualification (IQ) and operation qualification (OQ).