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

By Dale A. Seiberling

This consultant illustrates most sensible practices and winning 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 standard CIP procedures, Clean-In-Place For Biopharmaceutical methods will take the guess-work out of CIP improvement, and illustrate all one must comprehend for the institution and optimum functioning of a CIP method.

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Personal Correspondence, 1994. 5. Grimes TL, Fonner DE, Griffin JC, Pauli WA, Schadewald FH. An automated system for cleaning tanks and parts used in the processing of pharmaceuticals. Bull Parenter Drug Assoc 1977; 31(4):179–86. 6. Seiberling DA. Clean-in-place and sterilize-in-place applications in the parenteral solutions process. Pharm Eng 1986; 6(6):30–5. 7. Seiberling DA. Clean-in-place/sterilize-in-place (CIP/SIP). In: Olson WP, Groves MJ, eds. Aseptic Pharmaceutical Manufacturing. 1st ed.

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).

Postwash Rinse Following the solution wash, a minimum of softened water will be used to flush the soil and alkaline solution from the equipment surfaces. Neither sodium hydroxide nor potassium hydroxide is free rinsing, however, and whereas the simple check of conductivity at the discharge to drain may suggest that the alkaline material has been removed early in the rinse, sampling of the equipment surface may reveal a considerable alkali residual. 0 (just slightly on the acid side of neutral). This solution, recirculated at the water supply temperature (no additional heating), will neutralize all traces of alkali residual on the equipment surfaces.

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