Intertek ASG Laboratory, Manchester, UK

Case Study:

Batch Contamination - Fine Chemicals

A major Fine Chemicals customer who manufactures drug intermediates and API's to the highest regulatory standards and controls at several sites in the UK recently encountered a significant contamination problem in a batch of high value product. The local manufacturing support team identified correctly the likely cause of the problem, but urgently needed help to confirm the hypothesis, exclude other possibilities and quantify the extent and nature of contamination to meet regulatory concerns.

An ASG emergency response project team was set up in partnership with the business. The project team involved experts in problem solving across materials science, inorganic analysis and polymer chemistry and with technique expertise in XRF, ICP, MS, pyrolysis GC-MS, vibrational spectroscopy and liquid chromatography.

Over a period of a few days the nature of the contamination was fully characterised and the basis for low level quantitative methods established. The quantitative methods were subsequently verified for use in mobilising batches free from contamination.

The project highlighted ASG's ability to work in multi-disciplinary teams to problem solve in diverse situations and the commitment and ability of staff to meet the demanding needs of customers in the healthcare sector.