Cleaning Validation Services

Cleaning Validation is the documented process of demonstrating that equipment cleaning procedures consistently remove product residues, cleaning agents, and contaminants to predetermined acceptable levels.

Maximum Allowable Carryover (MACO) is the maximum amount of product residue permitted to remain on manufacturing equipment following cleaning before the next product is manufactured.

Swab sampling directly evaluates residue remaining on equipment surfaces, while rinse sampling measures residues removed during the final rinse. Both methods may be used depending on equipment design and validation strategy.

Yes. We provide validation support for both Clean-in-Place (CIP) and Steam-in-Place (SIP) systems, including protocol development, execution, performance verification, and lifecycle support.

Absolutely. We assist organizations with cleaning validation remediation, acceptance criteria updates, risk assessments, lifecycle improvements, and responses to regulatory observations.