Puretech Genesys purified water systems are designed and constructed to produce purified and highly purified water in full compliance with cGMP guidelines as per FDA and EMEA, EP, JP and USP requirements. Engineering and manufacturing practices follow ISO 9001 procedures, ASME BPE criteria, GAMP guidelines, etc. Design and construction meets the most stringent Regulations and Codes from Europe, USA and others concerning Safety and Pressure Vessels. To ensure the equipment meets your requirements, we work in partnership with you, a dedicated team follows your order as a unique project. We develop specific Quality Plans (DQ, IQ and OQ) and undertake factory acceptance testing (FAT) to give assurance of performance and quality.
Purified water is used as an excipient in the preparation of non sterile products and as a starting material in the preparation of water for injection and pure steam. It’s also used for rinsing purposes and in the preparation of cleaning solutions. Highly Purified water is used in the preparation of medicinal products where bacterial endotoxins need to be controlled, except where water for injection is required.
The pretreated (softened) water is passed through a filter housing (typically 5 µm) and analysed for free Chlorine prior to entering the RO feed tank. The filtered water then enters the stainless storage tank, if the tank is full the softened water is returned to the raw water tank to ensure constant movement to minimise the risk of bacterial proliferation. The softened water is then pumped at high pressure using a stainless steel multistage centrifugal pump, through the RO membranes.