Surface Cleaning Validation Using Mass Spectrometric Analysis

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2015-CHOO-67146
In many areas of industry, such as production of pharmaceutical products, there is a strong possibility of batch contamination from residual active ingredients, cleaning agents, microorganisms, dust, and particulates. Cleaning validation is important given it shows that the cleaning process used will prevent any contamination that affects the safety, efficacy, purity, and quality of manufactured products. Currently, surface cleaning validation is lengthy, costly, and requires cumbersome sample preparations. In the rinsing approach, the reactor is rinsed with large volumes of solvents and then collected and diluted before analysis. In the swabbing approach, a small sample area is swabbed and then the swabs stand in a solution for 20 minutes before analysis. Another common analysis is done via chromatographic analysis coupled with mass spectrometry, which is known as ultraviolet-visible spectroscopy (UV-Vis).

To simplify the surface cleaning validation technique, researchers at Purdue University have developed a method for ambient surface cleaning and sampling using real-time mass spectrometric analysis. It is both a continuous and noncontinuous analysis. This technology incorporates a surface interface member that has a portion designed to receive and retain porous material that absorbs the sample from the surface. This is connected to a transfer member, which is then connected to a mass spectrometry probe. This technology uses vacuum pressure to help transfer the absorbed sample through the transfer line to the mass spectrometry probe and then used for analysis. This technology is advantageous because it is direct and real-time. Sample preparation or sample pretreatment is not required; the entire process can be done within one to two minutes. Hence, this technology is a cost-effective and efficient method of surface cleaning validation that can be incorporated in industry.

Advantages:
-Real-time data collection
-Direct analysis of samples
-Cost effective and faster

Potential Applications:
-Industrial laboratories
-Pharmaceutical industry
Oct 6, 2017
Utility Patent
United States
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Oct 6, 2016
Provisional-Patent
United States
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Purdue Office of Technology Commercialization
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