CIP Systems For Process Development And Clinical Production, Part 4

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•Application Note: CIP Systems For Process Development And Clinical Production, Part 4

Part four of four

Two brains are not always better than one

The control and monitoring of a CIP system involves the need for a local controller and data logging system. A CIP system typically includes a dedicated PLC controller to store recipes and operate the system. As such, the CIP recipe allows automation of the cleaning process, and is not dependent upon human operators, other than the initial manual set-up, allowing the process to be highly reproducible.

In some process development facilities, CIP systems are purchased and intended to be dedicated to cleaning a limited number of systems. For example, a portable CIP cart can be optimized in design and footprint when intended to clean a bioreactor, or a number of similar size bioreactors. If planned in advance, it is possible to reduce cost and complexity by having the CIP system "intelligence" built into the digital controller of the bioreactor(s). The portable CIP cart (now deemed a "dumb" system) interfaces directly with the bioreactor through a cable hook-up to coordinate operation between the two units.

Besides a local controller, the bioreactor and CIP system need to have the proper level of automation to verify that the CIP process operated as intended. This automation can be installed as part of the bioreactor or can be installed as part of the CIP system itself. For example, many bioreactors used in process development include addition arrays with manual valves. To assure that the addition paths get cleaned an automatic valve is needed in each CIP flowpath to allow cleaning solution to be cycled through the addition array. The automated valve(s) can be built into the portable CIP cart, and controlled by the local controller. A feedback signal from the automated valve, proximity switches and flow detectors are commonly used to verify and document that each step in the CIP process operated as intended.

SOURCE: Sartorius Stedim Biotech

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•Application Note: CIP Systems For Process Development And Clinical Production, Part 4