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160<br />

CIP Philosophy<br />

The production process must be designed to incorporate a selected cleaning<br />

philosophy from its inception. Design criteria may include separation of CIP<br />

circuits by functional process areas, common CIP supply and return piping for<br />

a variety of vessel sizes, and integration of process piping for conveying<br />

CIP fluids.<br />

CIPable Design<br />

All equipment in this process must be designed to be CIPable or easily removed for<br />

manual cleaning. The sprays must be designed giving consideration not only to just<br />

minimum coverage requirements, but also maintenance of adequate velocities in all<br />

vessel CIP-related piping. The vessel outlet valves and outlet piping must be given<br />

consideration not only just for process flow rate, but also the generally higher CIP<br />

flow requirement. And, the individual equipment components in the process must<br />

be cleanable by spray methods. Vessels are the major item of equipment in most<br />

processes and this chapter will discuss vessel CIP. Figures 1and 2inChapter 1<br />

illustrate atypical vessel and define the CIP issues of concern.<br />

CIP Programs<br />

The cleaning flush, wash, and rinse solutions and the cleaning regime,<br />

i.e., combination of time, solution temperature, and chemical concentration must<br />

be capable of loosening and suspending the soil for subsequent removal.<br />

Other chapters of this book provide detailed information on the above and<br />

related subjects.<br />

TYPES OF SPRAY DEVICES<br />

Franks and Seiberling<br />

Thereare two basic types of spray devices utilized in this industry,those being fixed<br />

type and rotating type. Rotating sprays, especially those designed to provide<br />

physical impact on all surfaces, are less suitable for permanent installation in<br />

these types of applications, but areoften applied in other industrial and commercial<br />

applications. Fixed sprays devices are by far the more prominent in both<br />

biopharmaceutical and pharmaceutical processes. The advantages and disadvantages<br />

of each are reviewed below.<br />

Rotating Spray Devices<br />

Rotating or “dynamic” spray devices areavailable in two types, single axis and dual<br />

axis. The single-axis type is sometimes described as “spinners.” Most rotating spray<br />

devices of either type claim the use of impact or impingement as the means of<br />

accelerating the cleaning process, and using less water and solution. Rotating<br />

sprays by definition have moving components and bearing surfaces. Their inherent<br />

design makes them susceptible to wear (a validation concern) and potential internal<br />

cleanability issues. Foreign particles in recycled wash solutions may make them<br />

susceptible to failure due to lack of rotation. Rotation sensors are sometimes<br />

employed to assure arotating spray is indeed rotating but that adds additional<br />

complexity to the entire process. Rotating sprays can be constructed of stainless<br />

steel, hastelloy, orother alloys, or polytetrafluoroethylene and often include some<br />

nonmetallic type bearing surface in the design. Most single-axis rotating sprays

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