What is Cleaning in Place (CIP)?
Clean in place (CIP) is a common cleaning method for removing process residues from bioreactors, fermenters, and other equipment used in biopharmaceutical, pharmaceutical, and food and beverage manufacturing. The residue is removed through a combination of heat, chemical action, and turbulent flow. Manufacturers must validate repeatable, reliable, and effective cleaning processes. The Code of Federal Regulations 21 CFR 211.67 states “Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements.” 21 CFR 211.67 is one of the most often cited regulations in FDA warning letters.
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It is essential that the right chemicals be employed in CIP systems. Manufacturers choose from either commodity chemicals, formulated detergents, or a combination of the two. The choice of chemistry is largely dependent on the type of soil to be removed along with other factors. Basic chemicals such as Sodium Hydroxide and Phosphoric Acid are often preferred in the biopharmaceutical industry due to the ease of solubility of the soils as well as the simplicity in developing test methods to verify clearance of cleaning chemicals from process vessels. Whether formulated detergents or commodity chemistry is the chosen cleaning chemistry, manufacturers should strongly consider utilizing chemicals that are blended in a cGMP compliant, FDA registered and ISO 9001 certified facility.