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Project Planning for CIPable Facility 29
Cleaning Cycles or Programs
Atypical CIP cycle is asequential series of groups of events that can be controlled to
achieve different cleaning or process objectives. The range of different cycles may
include rinse only, a full CIP program only, a full CIP program plus steam
sanitization, or a full CIP program plus steam sterilization. If the process
equipment remains unused for longer than the validated clean hold time, a rinse
followed by sanitization or sterilization or repeat of the full CIP cycle may precede
its use. Atypical cleaning cycle will start with prerinses of city water, distalled
water (DI), reverse osmosis (RO) water, ambient water for injection (AWFI), or hot
water-for-injection (HWFI) to drain.
The chemical wash, generally an alkaline solution, is preferably recirculated
to minimize requirements for water, heat, and chemicals. Single pass chemical
washes may be employed for systems that are used to process avariety of different
products, to avoid the possibility of cross-contamination through development of
residues of a specific soil throughout the system. Once-through cleaning is
generally limited to circuits that can be cleaned at less than 50 gpm (190 Lpm)
and chemical wash times of not more than five minutes.
Apost-wash rinse with water may then precede either an acid wash or rinse.
Evaluation of the final rinse discharge either by instrumentation or sampling and
laboratory analysis will be applied to confirm removal of all traces of product and
chemical agents.
Some process systems, i.e., water soluble buffer prep vessels, may requireonly
awater rinse, followed perhaps by sanitization or sterilization.
The key in conceptual CIP engineering of cleaning cycles is to make good
assumptions for time, water,and chemical needs for CIP cycles. These assumptions
should be conservative enough to allow for potential extension of cleaning cycles as
well as increased water and chemical use.
Cleaning Program Variables
The efficacy of CIP is well recognized to depend upon the control of time,
temperature, and concentration. Prior experience may provide the best guide to
establishment of astarting point. Cleaning trials and tests should be conducted if
CIP technology is to be applied to aprocess used for anew, unfamiliar, product or
new and challenging to clean equipment. Other chapters of this book fully address
issues such as cycle development, the impact of hot rinses on protein residues, and
the occasional need to cool a vessel following a hot rinse before starting the
next batch.
Automation
Perhaps one of the most important and difficult decisions to be made during
conceptual design is the degree of automation to be applied to both the process and
the CIP system. High-volume production processes benefit from full process
automation. Product development and clinical manufacturing facilities may be
more flexible if the process is more dependent on human interaction; i.e., moving
U-bends on a transfer panel to change the process configuration, orestablish
production transfer paths and CIP circuits. Fully automated CIP may be applied
to either concept.