Download Clean-in-Place for the Biopharmaceutical Processes by Dale A. Seiberling PDF

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By Dale A. Seiberling

This advisor illustrates most sensible practices and profitable purposes of CIP in either pharmaceutical and biotechnology amenities. supplying reader-friendly descriptions of a number of the varieties of gear and fabrics present in common CIP approaches, Clean-In-Place For Biopharmaceutical techniques will take the guess-work out of CIP improvement, and illustrate all one must comprehend for the institution and optimum functioning of a CIP procedure.

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Special Cleaning Regimes A typical highly automated CIP skid may be used to clean nearly any combination of biopharmaceutical vessels and interconnecting piping, and much of the related process equipment. Ultrafiltration systems require special control of flow and pressure of their membranes in operation and in cleaning. In addition, special nonalkaline solutions may be required for membrane cleaning. Chromatography columns must be bypassed for CIP and cleaned and regenerated with special solutions.

All very important to the fine tuning of the CIPable process design. Layout of Process Facility for CIP CIP Skid Distance to Process Circuits The major reason for giving significant consideration to CIP early in the conceptual design process is to enable development of a facility layout favorable to minimum CIP S/R piping runs (Fig. 3). Water is the mostly costly ingredient in the CIP process, followed by time during which process equipment is unavailable for production, when being cleaned. Consider the following: 1.

The automated CIP procedure enables modern computer-based technology to be applied to document the performance of the cleaning process when compared with the requirement. 6. The properly engineered CIP-cleaned process will generally contribute to substantial reduction of product losses. The most effective and repeatable CIP operations are achieved by a high level of automation. Therefore, the highly automated process is generally more easily designed as a CIP-cleanable process when compared with processes which utilize manually operated pumps and valves, or considerable manually assembled product piping.

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