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

By Dale A. Seiberling

This consultant illustrates most sensible practices and profitable purposes of CIP in either pharmaceutical and biotechnology amenities. supplying reader-friendly descriptions of a few of the varieties of apparatus and fabrics present in ordinary CIP procedures, Clean-In-Place For Biopharmaceutical techniques will take the guess-work out of CIP improvement, and illustrate all one must recognize for the institution and optimum functioning of a CIP approach.

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Prior experience may provide the best guide to establishment of a starting point. Cleaning trials and tests should be conducted if CIP technology is to be applied to a process used for a new, unfamiliar, product or new and challenging to clean equipment. Other chapters of this book fully address issues such as cycle development, the impact of hot rinses on protein residues, and the occasional need to cool a vessel following a hot rinse before starting the next batch. Automation Perhaps one of the most important and difficult decisions to be made during conceptual design is the degree of automation to be applied to both the process and the CIP system.

Components of the equipment which were not designed to be cleaned in place are removed from the equipment to be manually cleaned. 2 Manual (COP) cleaning. Removal of soil when the equipment is partially or totally disassembled. Soil removal is effected with chemical solutions and water rinses with the assistance of one or a combination of brushes, nonmetallic scouring pads and scrapers, and high- or low-pressure hoses, with cleaning aids manipulated by hand, or wash tank(s) which may be fitted with recirculating pump(s).

Flushing, washing, rinsing, and (optional) sanitizing solutions are brought into immediate contact with all product contact surfaces under controlled conditions of time, temperature, and concentration, and continuously replenished. Vessels and filter housings are sprayed and piping is pressure washed. Steam-in-place (SIP) is the next logical step following CIP. The objective is to reduce the microbiological content in the equipment. Depending on the process requirements, SIP means to “sanitize” or “sterilize” the equipment.

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