The Challenge

A pharmaceutical liquid sample was observed to contain multiple particulate contaminants. Contact parts can be a common source of contamination at manufacturing sites. Our team of experts inspected the manufacturing site. Liquid samples, alongside a few other samples of contact parts, were collected for further investigation.

The Solution

The collected liquid samples were filtered using 0.2 microfilters. Isolated particulates were examined microscopically. Optical microscopy was used to determine the colour. SEM was used to explore the other characteristics and surface morphology of the particulates. Chemical information was collected using EDAX/EDS. Other samples collected were subjected to FTIR and a few more modes of analysis

The Benefit conveyed to our client

We adopted a non-destructive technique for this case, which allowed for the extraction of qualitative information to identify the chemical nature of the particulate contaminants. In the present case, the inner parts of the production vessel, particularly Gasket’s and Silicone’s integrity was compromised due to the use of an abrasive stirring. The particles were imaged and separately examined for elemental composition using EDAX. Details of the same are given in Figure 1A is a particle with stainless steel composition. Figure 1B is a particle from the gasket (Figure 1).