Highly Purified Water (HPI)
Highly Purified Water should be prepared using potable water as feed water. It is intended for use in the preparation of products where water of high biological quality is needed. HPI must meet the same quality standard as water for injections (WFI) including the limit for endotoxins, but the generation systems are not as reliable as distillation. HPI may be prepared by combinations of methods such as reverse osmosis, ultrafiltration and deionisation.
Water For Injections (WFI)
Water for Injections (WFI) should be prepared from potable water as a minimum quality feed water. WFI is used as excipients in manufacturing of potentials and for equipment cleaning especially product contact surfaces of sterile products. It is prepared using purified water as feed water. The method used for the preparation of WFI is multicolumn distillation. The water must meet ionic, organic chemical, microbial and endotoxins requirements. The systems that produce, store and circulate WFI should be controlled by circulation, frequent sanitisation and monitoring to avoid factors like microbial contamination and endotoxins.
Bacteriostatic Water for Injections
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...now has two loops which led to a decrease in the performance of the generation system due to the added demand.
There are two storage tanks for purified water, TK-310 and TK-253. Currently, in the existing system, TK-310 requests water from TK-253. This interface will be made redundant. For the new storage and distribution system, The TK-253 system will request water from the TK-310 distribution loop. This will require a new POU (Point of Use) valve assembly on the TK-310 distribution loop.
Control system was outdated
Another purpose for the investment was to update the current control system used to run the generation system. The existing control system included running valves with a distribution pump, a filling tank and a sanitisation loop. Second loop (Synthroid) has a new control system with its own storage tank, pump distribution loop and sanitisation system.
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