Importance of Clean-in-Place Design Planning Emphasized

Interphex2007, New York, NY (Apr. 25)-As manufacturers prepare for processing more-potent compounds, they seek effective clean-in-place (CIP) and wash-in-place (WIP) design systems.

 “They key to success for implementing an integrated CIP or WIP system is to plan, design, execute, and test,” said Tim Hoover, business development manager, pharmaceutical/biotech at Niro Inc. (Columbia, MD, www.niroinc.com). A review of CIP and WIP processes, design, and validation issues were part of a presentation titled “Advances in the Integration of CIP/WIP in Solid Dosage Manufacturing” during Wednesday’s session of Interphex2007 Conference and Exhibition.

Hoover emphasized the importance of incorporating temperature, action (mechanical engineering), chemicals (commonly known at TACT), and time in controllable CIP parameters. Although automated CIP processes are higher in cost and have more complex designs, many companies have chosen to implement these systems because they enable the practical use of programmable logic controllers, which means they are reliable and repeatable and reduce the dependence of manual standard operating procedures, noted Hoover. In addition, automated CIP systems reduced the chance of a sterility breach.

One of the most common applications of CIP is for process tanks, a task that presents several challenges. “A tank is never easy to clean because it often has domes, shadow areas, or sumps. Therefore, one spray device often is not enough to clean a tank,” say Hoover.

There are several CIP devices, with spray balls being the most common. The advantages of spray balls are that they are simple, inexpensive, have no moving parts, small, and require low pressure feeds (approximately 2 bar). The disadvantages include that high CIP supply volumes are required and they are easily blocked.

However, implementing a CIP design takes a lot of upfront consideration. “A CIP design are not add on,” said Hoover. “They need to be considered and incorporated from day one. This includes cleanability audits of equipment, interconnect ducts, and so forth. CIP circuits need to be designed with the process, not as an after-thought.”