Good Manufacturing Practices require that the cleaning of drug manufacturing equipment be
validated. Common analytical techniques used in the validation process include HPLC …

Cleaning validation is the process of assuring that cleaning procedures effectively remove
residue from manufacturing equipment/facilities below a predetermined level This is …

For cleaning validation purposes, the combination of swab sampling and the total organic
carbon (TOC) test method provides a useful mechanism to monitor the cleanliness of …

Discussion As stated in the article on visual inspection, the selection of methods for
assessing cleaning should be science-based and risk-based. Key considerations for the risk …

Background 21 CFR 211.67 states,“Equipment and utensils shall be cleaned, maintained,
and sanitized at appropriate intervals to prevent malfunctions or contamination that would …

Cleaning validation is the process of assuring that cleaning procedures effectively remove
the residue from manufacturing equipment/facilities below a predetermined level. This is …

The total organic carbon (TOC) test is a fast and effective analytical technique to evaluate
the cleaning of biopharmaceutical manufacturing equipment. This technique can help …

Abstract A Total Organic Carbon (TOC) based analytical method to quantitate trace residues
of clean-in-place (CIP) detergents CIP100® and CIP200® on the surfaces of pharmaceutical …

This paper presents a useful method using total organic carbon analyzers employing both
combustion and wet oxidation for validating equipment cleaning procedures and verifying …

Cleaning verification is a critical process for patient safety in pharmaceutical manufacturing
in order to keep cross-contamination below acceptable limits. A common cleaning …