2012 Volume 14 Issue 1 Pages 16-41
A jointly sponsored USP/ISPE survey of the pharmaceutical industry is presented and analyzed on the topic of the potential to use alternative methods of production (other than distillation) as the final purification process in the preparation of Water for Injection (WFI). The survey was prepared by USP Expert Committee members. It was reviewed, supported, and administered by the ISPE Critical Utilities Community of Practice (CU COP) leadership to the CU COP, and the results were collected and analyzed. The purpose of the survey was not only to acquire data related to the design, maintenance, and reliability of alternative non-distillation approaches for making WFI-quality water, but also to collect viable data from engineering end users so that the discussion could be removed from private unpublished anecdotes and brought to light-for better or worse-for eventual public dialogue among the industry, compendia, and regulatory groups.
Typically, past discussions centered about the topic of “distillation vs Reverse Osmosis (RO) and/or UltraFiltration (UF)” as the final step and arbiter of microbiological and endotoxin control in WFI production. The current survey asked a series of different questions. Instead of focusing on the final purification step, the entire water system design, its operation and control strategies, and testing data was studied.
Of the non-distillation systems that met all of the testing attributes of WFI, though validated as another type of water system, the analysis of the results shows a fascinating variability in the number and types of purification system designs, distribution designs, and sanitization strategies. The analysis also demonstrates that the goals of the survey were met, which were: 1. to expand the discussion to consider the entire water system and 2. achieve a meaningful dialogue based on data of real water systems.
