Purified water must be prepared using potable water as feed water. Purified water is used as an excipient in the production of pharmaceutical products and for cleaning equipment, especially surfaces in contact with non-sterile chemicals. The types of purification used to produce this water include deionization, distillation, ion exchange, reverse osmosis, and filtration. Purified water must meet ionic and microbial organic chemical requirements. The components that produce, store and circulate purified water must be disinfected and monitored frequently to avoid biofilm formation. 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 high biological quality water is required. HPI must meet the same quality standards as water for injection (WFI), including the limit for endotoxins, but generation systems are not as reliable as distillation. HPI can be prepared by combinations of methods such as reverse osmosis, ultrafiltration, and deionization. Water for Injections (WFI) Water for Injections (WFI) should be prepared from potable water such as feed water of minimum quality. WFI is used as an excipient in the production of potentials and for cleaning equipment, 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 multi-column distillation. Water must meet ionic, organic chemical, microbial and endotoxin requirements. Systems that produce, store, and circulate distilled water (WFI) should be controlled through circulation, frequent sanitization, and monitoring to avoid factors such as microbial contamination and endotoxins. Bacteriostatic water for injections Bacteria... in the center of the paper... now has two circuits which have led to a decrease in the performance of the generation system due to increased demand. There are two storage tanks for purified water, TK-310 and TK-253. Currently, in the existing system, TK-310 requires water from TK-253. This interface will be made redundant. For the new storage and distribution system, the TK-253 system will require water from the TK-310 distribution circuit. This will require a new POU (point of use) valve assembly on the TK-310 distribution circuit. The control system was obsolete. Another purpose of the investment was to upgrade the current control system used to operate the generation system. The existing control system included operating valves with a distribution pump, a filling tank and a sanitization circuit. The second circuit (Synthroid) has a new control system with its own storage tank, pump distribution circuit and sanitization system.
tags