Evaluation of swab and rinse sampling procedures and recovery rate determination in cleaning validation considering various surfaces, amount and nature of the residues and contaminants

Document Type: Research article

Authors

1 Department of Analytical Chemistry, Faculty of Chemistry, Islamic Azad University, North Tehran Branch, Iran

2 Department of Pharmaceutics, Faculty of Pharmacy, Islamic Azad University of Pharmaceutical Sciences Branch, Tehran, Iran.

Abstract

A cleaning validation for a family of compounds utilizing swab sampling and rinse solution procedures, and high performance liquid chromatography for separation and detection of the analytes was performed.
The parameters affecting the recovery of pharmaceutical residues and contaminants including sampling method, characteristics of swab, solvent, swabbing technique, and material substance of product contact surfaces within the manufacturing equipment namely, Stainless Steel, PVC, Plexiglas for swab sampling and PVC, Polyester for rinse sampling, quantitative cleaning verification method development, and active pharmaceutical ingredient (API) level and nature have been studied.
The limit of detection and the limit of quantitation for the HPLC method were determined to be 0.0198 µg/ml, and 0.0495 µg/ml of the analyte respectively. The linearity on replicate injections of the standard prepared in the range of 0.78, 1.55, 3.1, 6.2 µg/ml, and relative standard deviation (R.S.D.) found to be 1.2, 1.0, 0.9, 0.6 respectively with correlation coefficient of R2 =0.9999. Recovery coverage for each type of surface was acceptable, ranging from 63.88% for swab sampling of stainless steel to 97.85% for rinse sampling of PVC. The acceptance criteria for precision on replicate injections of the analyte prepared in three concentration levels covering the specified range of 50, 100, 200% was successfully accomplished R.S.D. lower than 15% for recovery results.
Thus choosing the appropriate sampling method, swab type, and surface condition can affect and increase recovery rate determination efficiency.

Graphical Abstract

Evaluation of swab and rinse sampling procedures and recovery rate determination in cleaning validation considering various surfaces, amount and nature of the residues and contaminants

Keywords