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Cleanable API Processing Equipment and Systems 293
It is the usual practice that CIP solutions not be recycled to acentral system.
The concern is that potent compounds could be redistributed to other areas ofthe
facility, greatly complicating the task of proving asystem is clean.
There isalso asafety concern of returning fluids that contain flammable
solvents back to acentralized system located in an area not designed for solvents.
The other complicating factor is that most API facilities serve multiproduct
or multipurpose functions. They are constantly being reconfigured to run new
products. To accomplish this, most companies employ some sort of solvent, water,
waste, and process manifold systems.
Experience has shown that these manifold systems can be designed to serve
both the process and CIP functions, but careful attention should be paid during the
design phases with regard to physical size, accommodation of automated valves,
and drainability. Atypical system is shown in Figure 8. The boxes represent arrays
of valves to control flow.
In this system, organic solvents and process water is directed to process
vessels through amanifold system for both process and CIP purposes. Acid–base
wash solutions are prepared/conditioned and distributed in the same piping. The
solutions can be applied to the process systems in the once-through mode or they
can be recirculated.
Many API facilities utilize process manifolds to provide interconnectability
between various pieces of equipment. These process manifolds can be set up with
automated valves so that process transfers can be made from system to system and
recirculation for cleaning purposes can be established.
Reactor system
and
cleaning circuits
Solvent distribution
center
Recirculation Recirculation
Recirculation
or
waste
Fresh solvent/process water
Process manifold
Waste
Waste
Recirculation
or
waste
FIGURE 8 CIP fluid/waste distribution, active pharmaceutical ingredient facility.
Isolation system
and
cleaning circuits