The Company

Fibres are the most common cause of particulate contamination on manufacturing sites and can potentially originate from many sources such as the use of PP filter fibres, Centrifuge bag filter, brushes, Lint-free cloth fibres or several other items used in the cleaning process. A batch of pharmaceutical API was observed to contain fibres during the quality control inspection. The batch was rejected for the commercial market but was investigated to determine the source of the contamination.

The solution

The collected samples were dissolved in a suitable solvent and filtered using 0.2 micro filters. Isolated fibres are examined microscopically. Optical microscopy was used to determine fibre colour, and SEM to explore fibre diameter, longitudinal characteristics and surface morphology. Chemical information was recorded using EDAX/EDS. The fibres were also compared to a range of potential sources including PP filter fibres, Centrifuge bag filter, brushes and Lint-free cloth fibres.

The benefit delivered to the client

The costs incurred by the client to reject even a single batch were big as it was an antiviral API. The client needed to identify the source of the fibre and reliable counsel to mitigate the problem. Our investigation and analysis revealed the source of contamination to be PP filter fibres that were shedding the fibrous particulates into the product. As a result, the client was able to isolate the root cause of the problem and replace the PP filters to avoid this in subsequent batches.