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Cleanable API Processing Equipment and Systems 295
of the solid surface to accept or donate electrons, the speed of the flowing fluid, and
the conductivity of the solid.
Little charge is generated by apolar liquid flowing through highly conductive
pipes (i.e., water flowing in stainless steel). However,large potentials (thousands of
volts) can be generated by nonpolar solvents flowing through insulated systems
such as Teflon-lined pipe.
Charge can build up on the flowing liquid, insulating solids, and isolated
conductors. This charge is sufficient to ignite flammable solvents if oxygen in
sufficient quantities is present. It can also damage piping and glass-lined equipment
if no steps are taken to dissipate this charge.
The charge buildup can be instigated by the proper grounding of conductive
components and the use of conductive piping elements to dissipate charges from
flowing liquids.
CONCLUSION
The recent trends toward more potent API compounds have spurred increased
interest in the design of bulk chemical synthesis facilities designed for CIP.
Numerous systems have been built or revamped, incorporating the philosophies
addressed in this chapter.
The author believes that the need for automated, repeatable cleaning methods
will only increase in the future driven by regulatory issues. The challenges for this
improvement are currently being taken up by the manufacturers of equipment,
piping, and the designers of API facilities. The API manufacturing process has
needs for defining fabrication criteria for awide variety of equipment including
pumps, mixers, vessels, heat exchangers, etc.
Fortunately, even as this chapter is being written, the Steering Committee of
Pharmaceutical 3-A Standards has begun development of P3-A Standards to allow
equipment manufacturers to better understand the specialized needs of the API
sector. This work has started with three coordinated efforts including the development
of adocument for pumps, and the development of aglossary document and
another document for materials. The P3-A efforts are focused on supporting
equipment designs for manufacturing of APIs. All three of these documents are
being reviewed by aconsensus body as part of the ANSI standards development
procedures (1).
REFERENCE
1. 3-A Sanitary Standards Inc., 1451 Dolley Madison Boulevard, Suite 210, McLean, Virginia
22101–3850, U.S.A., Phone: 703-790-0295, Fax: 703-761-6284 (Accessed January 8, 2007 at
www.3-a.org).