Application of Online SFE-SFC-PDA for Cleaning Validation

Introduction

Cleaning validation is a process step that is extremely important for ensuring high quality and safety at pharmaceutical manufacturing sites. Cloth used for surface wiping, called a swab, is used to wipe a given part of a piece of manufacturing equipment, and analysis of the wiped area of the swab is performed by using high-performance liquid chromatography (HPLC) or a total organic carbon analysis (TOC). Evaluations using HPLC have been increasingly used in recent years because HPLC enables determination of individual compounds. Prior to analysis, an extraction procedure must be performed on the swab. Using supercritical fluid extraction (SFE) as the pretreatment method allows for simple and quick target component extraction. Using supercritical fluid chromatography (SFC) after SFE also means that analysis results can be obtained simply by preparing the sample for SFE, which unifies the work flow from pretreatment to analysis. Please see Application News L496 for an overview of online SFE- SFC. This article describes the process of column selection using the Nexera-UC Chiral Screening System as the first step in analysis of the target compound alkylbenzenesulfonate.

February 12, 2016 GMT