title: Cleaning validation 2: development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent.
abstract: A cleaning validation method, ion chromatographic method with conductivity detection was developed and validated for the determination of traces of a clean-in-place (CIP) detergent. It was shown to be linear with a squared correlation coefficient (r(2)) of 0.9999 and average recoveries of 71.4% (area response factor) from stainless steel surfaces and 101% from cotton. The repeatability was found to be 2.17% and an intermediate precision of 1.88% across the range. The method was also shown to be sensitive with a detection limit (DL) of 0.13 ppm and a quantitation limit (QL) of 0.39 ppm for EDTA, which translates to less than 1 microL of CIP diluted in 100mL of diluent in both cases. The EDTA signal was well resolved from typical ions encountered in water samples or any other interference presented from swabs and surfaces. The method could be applied to cleaning validation samples. The validated method could be included as a suitable one for rapid and reliable cleaning validation program.
authors.affiliation: Department of Chemistry, University of Puerto Rico-Cayey, Antonio R. Barceló Ave. Cayey, PR 00736, USA.
authors.forename: Wilfredo
authors.initials: W
authors.lastname: Resto
authors.forename: Darimar
authors.initials: D
authors.lastname: Hernández
authors.forename: Rosamil
authors.initials: R
authors.lastname: Rey
authors.forename: Héctor
authors.initials: H
authors.lastname: Colón
authors.forename: José
authors.initials: J
authors.lastname: Zayas
mesh_terms: D002138:Calibration; D002614:Chelating Agents / Q000737:chemistry; D002852:Chromatography, Ion Exchange / Q000379:methods*; D003666:Decontamination / Q000379:methods*; D003902:Detergents / Q000032:analysis*; D003976:Diazinon; D004492:Edetic Acid / Q000737:chemistry; D004866:Equipment Contamination / Q000517:prevention & control; D005278:Fenitrothion; D003368:Gossypium / Q000737:chemistry; D016014:Linear Models; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013193:Stainless Steel / Q000737:chemistry; D013678:Technology, Pharmaceutical
chemical_list: D002614:Chelating Agents; D003902:Detergents; D013193:Stainless Steel; D004492:Edetic Acid; D005278:Fenitrothion; D003976:Diazinon