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Project Planning for CIPable Facility 23
& Organized approaches to commissioning and qualification
& Design/build as aproject delivery method
& Process simulation as a method of confirming the design will achieve
objectives
& The use of atechnical program document to save time and meet budget and
end result objectives
Odum (1999) provided “A Unique Look at Some Lessons Learned” (3) in a
highly detailed review of asignificant project, but mentioned only that “Process
information regarding package equipment such as cleaning cycles or utility service
requirements must be communicated to the equipment group. ”
The CIP Equipment Designer/Supplier Concern
The review of asmaller number of more general articles about CIP in the same
pharmaceutical engineering archive provided information about CIP system
design, biopharmaceutical equipment design for CIP/sterilize-in-place (SIP),
transfer panel design, and CIP cycle development. Each writer is focused on
specific features rather than on the integration of the required components and
technology in the overall process.
There islittle recognition that successful validated CIP is less affected by the
selection of the type of the spray device, CIP skid, or chemical cleaning agent, than it
is by the design of acleanable process .Areport produced for the Joint Service P2
Technical Library (4), totally unrelated to pharmaceutical or biopharmaceutical
applications, properly stated “CIP is more ofadesign method than acleaning
process. The CIP method works ‘automatically’ by eliminating the places where
residue can accumulate.”
ANeed for aCIP Expert
Aprobable reason for the above findings is that there are few truly knowledgeable
“CIP Experts” available; specifically individuals who understand the production
process and operations, the fluid flow and hydraulics’ issues of acomplex CIP
circuit, the mechanical attributes of the pumps and valves in the process, and the
chemical and biological issues involved in the cleaning and sterilization or sanitizing
processes, in sufficient depth to contribute fully to the basis of the design of the
modern computer-based control system used for both production and CIP processes.
Failure to fully recognize the CIP needs up front can lead to costly start-up delays.
After the fact remedies may include the need to modify waste systems, increased
water or chemical usage, and expensive computer software modifications.
The remainder of this chapter will define the attention that must be given to
CIP,inall phases of the project, for the life cycle of the project. Various aspects of CIP
design criteria will also be emphasized.
LARGE-SCALE FACILITY PROJECT LIFE CYCLE
Figure 1illustrates the life cycle of atypical biopharmaceutical/pharmaceutical
facility. The project duration before the facility becomes operational may vary from
three to four years or more. This chapter will discuss only those activities following
the feasibility study and site selection activities. The availability of water, in
adequate quantity and quality, and the disposal of waste, however, are important
considerations for site selection.