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Flexible Tubing, Transfer Panels, or Automated Valves
Flexible tubing provides the maximum flexibility for making process and CIP
connections but lacks ameans of organizing and verifying connections. Flexible
tubing is also less capable of meeting the CIP requirement for drainability.Flex-lines
should be limited to use for temporary connections for liquid ingredient additions,
or final transfer to aportable tank.
U-Bend transfer panels and/or automatically controlled valves are the
preferred components to be used in aCIPable process design for either product
development work or full-scale production.
HISTORICAL DEVELOPMENT
Seiberling
Chapter 1 provided historical references to CIP as applied in dairy, brewing,
beverages, and food processing by the mid-1970s. These processes shared a
unique operating requirement in that many large tanks contained product for
extended periods of time, and required connections to piping and process systems
that generally ran less than 14 to 16 hours. Atraditional practice was to clean all
piping after each period of use, and clean vessels whenever they were emptied
(with restriction on maximum period of use). This operating requirement led to the
development of extensive CIP supply/return (CIPS/R) piping systems to facilitate
connections to establish alarge number of CIP circuits.
Chapter 1also defined the typical pharmaceutical/biopharmaceutical process
as being comprised of atrain of vessels, and as the product moved from vessel to
vessel the soiled equipment generally consisted of the empty vessel and aportion of
transfer piping and associated components. Seiberling therefore suggested in 1986
(1) and 1987 (2) the consideration of “Integrated piping system design for product
and CIP solution use.” This concept was further reviewed by Seiberling in 1992 (3)
and Seiberling and Ratz in 1995 (4). The concepts first described in those
publications are the basis of the generic concepts to be described in the remainder
of this chapter. Marks further explained other aspects of the “integrated approach”
in 2001 (5). Chrzanowski, Crissman, and Odum published atreatise on valve
assembly use in 2001 (6) that further explains the means of achieving the functional
capability suggested in some figures of this chapter. The use of CIP transfer panels
as described by Shnayder and Khanina (7) is more typical of the dairy,brewery,and
beverage facility applications from 1960 onwards, but applicable to some product
development facilities that may favor flexibility over automation.
TYPICAL PROCESS APPLICATIONS
AGeneric Process Train with U-Bend Transfer Panels
Figure 1illustrates abasic concept applicable to almost all multi-tank process trains.
The vessels could be variable in volumes, and as many as are required for a
complete process can be organized in this manner. The indicated valves must be
automated to achieve validatable CIP.
Mixproof valves are shown for CIPS only. U-Bend transfer panels are the
suggested method of configuring flow paths for all other process and CIP/SIP
requirements. Whereas the generic process train discussed in Chapter 1used a
single panel at the bottom of the tank, this concept shows high-level and low-level
panels. Apreferred approach for multiple vessels serving acommon function,
i.e., media prep, fermentation, or buffer prep, would combine all upper level