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Pharmaceutical RO EDI Plant
Purified Water (PW) Treatment Plants (RO-EDI Plants) generates High Purity water for pharmaceutical, Biotech, Semiconductor and Ã¢â‚¬ËœFood & Beverages Industry.
Sterinox Purified Water Treatment plants are designed and optimised for hassle free low maintenance operation. The entire system utilises best instruments and equipments ensuring solid performance and reliability. Sterinox Purified Water Treatment Plants are skid based and designed to accommodate in minimum footprint.
· The final output quality complies with USFDA, MHRA, WHO, EU 8L other international pharmacopeia's and standards Plants are manufactured as per cGMP guidelines and complies with ASME BPE Standard.
· PLC based fully automated plant complies with 21 CFR Part 11 8t GAMP 5. Hence low maintenance and minimum human interference required.
· Designed for minimum dead leg criterion of < 1.5 D. Also 100% drainability can be achieved by maintaining the minimum slope of 1:100
· Complete inter connecting piping is semi seamless tubes as per ASTM A270.
· All contact parts are AISI 316L Stainless Steel and Non-Contact parts are A151 304 Stainless Steel.
· All contact parts surface is electro polished to less than 0.4 Ra surface finish, All interconnecting piping are orbital welded using High Purity (99.99%) argon gas and welding joints can be inspected by boroscopy machine.
· Complete set of documentation and certificates to ensure compliance with regulatory authority. We provide DQ, OQ, IQ, FAT 81 SAT. Also assist client to develop PQ.