The design of pharmaceutical water systems has always been part science and part alchemy, and unfortunately, it is not likely to change in the near future. Daily rhetoric is rife with statements from informed and intelligent people alleging design requirements that do not actually exist.
The problem is that if you do not have documentation from a reliable source that supports or contradicts these statements, they are nearly impossible to refute. As a result, they are often incorporated into system design.
Take, for example, the use of bacteria-retentive filtration in a water system. For years, variants of the following alleged statement have circulated verbally: "FDA doesn't allow filters because it considers them to be band-aids on a badly designed system." As a result, many systems were designed without filters, rooted in a fear that the US Food and Drug Administration would disapprove. Meltzer et al., after researching this very subject, wrote that current FDA staffers indicated they would not disapprove a system simply because it contained these filters (1). Was this statement ever really made?
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