CIP Systems For Process Development And Clinical Production, Part 2

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•Application Note: Developing a Clean In Place Process

Part two of four

As a starting point for development of a CIP process, process development personnel often work with a specialist in pharmaceutical cleaning to develop and optimize cleaning parameters within their processing equipment. Some companies contract with a specialist in chemical based pharmaceutical cleaning. Cleaning studies are performed using samples of the various cell suspensions (or similar suspensions) for testing. Stainless steel coupons are dipped into the cell suspension and allowed to dry. The coupons are repeatedly dipped until they form a product build up matching the conditions inside the bioreactor. From those dirtied coupon samples, the CIP specialists determine the type and concentration of chemicals needed to dissolve the cell suspension, as well as the optimum time and temperature of the cleaning agents needed to do the job. Some cleaning specialists test the coupons with both spray ball and impingement type spray devices to determine the optimum desired CIP flow rate and pressure.

The intent of the testing is to mimic actual worse case conditions. For example, the culture residue remaining in a bioreactor might be easy to remove when active, however, cells and cell debris can sit in the bioreactors for weeks at a time, particularly if used as part of a seed train within a scale-up process. Even after decontamination, the material
- a combination of protein and fat content - can dry to become a hard crust.
The method selected to clean the reactors must generate sufficient turbulence
to loosen this material.

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•Application Note: Developing a Clean In Place Process

SOURCE: Sartorius Stedim Biotech