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Water for the CIP System 43
FIGURE 2 Dual water softener system. Source: Courtesy of Lonza Biologics, Portsmouth, New
Hampshire, U.S.A.
low molecular-weight organic materials before itisfinally purified by reverse
osmosis and/or distillation.
If USP purified, reverse osmosis/deionizing (RO/DI), or highly purified
water is your compendial process water, aRO filter system with aDIfilter bed is
the most common way to meet the USP monographs for conductivity, pH, total
organic carbon (TOC), and bioburden. These grades of water are generated and
distributed around the facility at ambient temperature.
With WFI there are two distillation options that are dominant in the industry
now: vapor compression still directly after the carbon bed (Fig. 1) or multieffect still
fed by purified water.Both stills can produce water that meet the USP monographs
for conductivity, pH, TOC, bioburden, and endotoxins. However, with the use of
vapor compression technology,the retentate water that is lost during the filtration of
the still’s feedwater,isnow conserved (Fig. 3).Some facilities areproducing WFI or
highly purified water by filtration alone in lieu of distillation. WFI is generated and
distributed around the facility hot (65–80 8 C), chilled (20–258 C), or ambient
temperature. Each one is acceptable for CIP but hot WFI is preferred because it
does not require much heat to be added by the CIP skid.
For more information on compendial waters, when to use them, how to pipe
them throughout the facility, and what validation and testing is required the
designer can refer to the latest editions of the USP, ASME BPE, or the International
Society for Pharmaceutical Engineering baseline guides. This chapter limits the
discussion of these systems to their design as they relate to the CIP systems and
their design for efficiency.