This article compares the technical performances of several different commercially available
swabbing materials for the purpose of cleaning verification. A steel surface was soiled with …

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 manufacture of pharmaceuticals requires clean processing. Wipers are used to remove
contaminants, such as chemical films, microbiological entities, and nonbiological particles …

A swab-sampling method was developed for cleaning validation of a residual active
pharmaceutical ingredient in samples collected after cleaning the sampling suite. A …

This paper presents the development of a new technique using the dry-swabbing method for
monitoring the contamination of pharmaceutical equipment. Black polyester wipes were …

Small swabs are often dampened with a solvent when used to clean surfaces. Cotton swabs
of the type sold in drug stores contain stearic acid, probably used as a lubricant during …

The purpose of this study was to qualify the MicroWorks, Inc. Swab Sampling System
(MSSS™) swab kit for use in sampling cleanroom surfaces for bioburden. A six-part study …

WHAT IS CLEANING VALIDATION? The US Food and Drug Administration (FDA) issued its
Guide to Inspections—Validation of Cleaning Process1 in 1993. Since that time, the …

Design-of-experiment (DoE) techniques (specifically, a Plackett-Burman design) were used
to assess the robustness of the sampling procedure. The study was performed alongside the …

Cleaning validation is one of the key elements of the validation program of an active
pharmaceutical ingredient (API) manufacturer. One of the most important aspects of cleaning …