Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities.

Cleaning validation acceptance criteria in multiproduct facilities are established using maximum allowable carryover calculations. Carryover calculations incorporate the shared equipment surface area between two products to ensure that an acceptable limit for residue from the previously manufactured product to the subsequent product is determined. The shared surface area can be limited to areas where carryover presents the highest risk to product quality or patient safety.