Abstract
Water for Injection abbreviated as “WFI” is allowed to be produced by distillation or membrane filtration of RO and/or UF even in the 16th Japanese pharmacopoeia.
The distillation has most widely been applied in the injections for practical use from the dawn of the injection up to the present, and water stills are usually divided into single effect type, thermo compression type, and multi-effect type.
Especially, the multi-effect water still hereinafter abbreviated as “MWS” was originally developed in a Finnish maker in 1970's, and various kinds of improvement has been introduced by several still manufacturers since then.
Some types of MWS are used with either downward-filmy flow effect or natural water circulation effect each of which is adopted as evaporation system.
Herein, a highly efficient MWS, which adopts a vertical filmy water-flow system, is introduced because it is characterized as short time startup into operation with little holding water. This type of MWS should meet the latest international GMP, ICH/Q9 (quality risk management), ASME-BPE (Bioprocess Equipment of the American Society of Mechanical Engineers), and any pharmaceutical manufacturing guidelines.
Consequently, the new MWS considered with an optimum mechanism has now been developed to function as a next generation type devised by a risk-based approach.
