The prevention of cross contamination is an essential component of any GMP program and is necessary to ensure the safety of drugs, biologics and medical devices used in human or veterinary applications. A major source of contamination risk to these products is in the form of carryover of compounds and cleaning agent residues from the previous manufactured product or cleaning process. Properly designed and executed cleaning validation studies ensure that the process removes product and cleaning agent residues from product contact surfaces to an acceptable limit.

ProPharma Group has the expertise to guide you through the cleaning validation process.

We are experienced at developing and executing validation master plans and protocols abreast with current industry standards. We provide a hands-on group of professionals that can guide you through the details of establishing a cleaning master plan, setting residue acceptance criteria, preparing a comprehensive sampling plan and validating and utilizing appropriate analytical methods with sufficient sensitivity for those unique processes and equipment.