Contaminant identification is of great concern to the pharmaceutical and medical device industry. Therefore, it is critical to understand and find a potential contaminant’s origin quickly. Two contaminant identification case studies will be presented. The use of multiple analytical techniques is paramount to determining a contaminant’s identity. These case studies include analytical techniques such as Fourier Transform Infrared Spectroscopy (FT-IR), Scanning Electron Microscopy Energy Dispersive X Ray Spectroscopy (SEM/EDS), and Gas Chromatography Mass Spectrometry (GC/MS).
The first case study is a contaminant identification of a brown material present on a pharmaceutical tablet. This brown material was the source of a potential field recall of an entire lot of a drug product. After isolation and rush analysis, the contaminant was identified, it clearly came from an external source at the consumer end and a field recall was unnecessary for the product.
The second case study presented is material isolated during the cleaning validation of medical grade tubing. The yellow material observed was analyzed by FTIR and SEM/EDS in order to determine the bulk chemical identification. The material was determined to be consistent with polymeric material of the bulk tubing material that was causing issues to downstream processes. After identification, the material was quantified using Gel Permeation Chromatography (GPC). This allows the client to be able to monitor the cleaning procedure.
A pharmaceutical tablet was submitted for the analysis of a brown material present. The contaminant was the source of a potential field recall of an entire drug lot.
The prepared samples were analyzed by direct inject GC/MS and Solid Phase Microextraction (SPME) GC/MS.
A yellow waxy material was observed during a cleaning validation procedure. In order to identify the source and nature of the material FTIR and SEM/EDS were performed.
Additional samples were submitted for analysis using Gel Permeation Chromatography (GPC).
Contaminant identification is of great importance in the medical device and pharmaceutical industries. Identifying the source of the contaminant can help save time and money for the manufacturer. We’ve shown in these two case studies that specialized analytical techniques can help identify contamination.
Contact us today for your Contaminant identification needs at +1 800-366-3867 or please complete the form below to have an EAG expert contact you.
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