Lean Six Sigma in Pharmaceuticals & Biotechnology Industry
As per the industry classification benchmark, this industry sector includes the following subsectors –
Biotechnology – Companies engaged in research into and development of biological substances for the purposes of drug discovery and diagnostic development, and which derive the majority of their revenue from either the sale or licensing of these drugs and diagnostic tools.
Pharmaceuticals – Manufacturers of prescription or over-the-counter drugs, such as aspirin, cold remedies and birth control pills. Includes vaccine producers.
- Case Study Description
In the process of growing amino-acids, multiple batches were found to contain contaminates.
As the process took place in a reactor system which was closed to the atmosphere, the only possible source of contamination was the entry points. These entry points were used for nutrients, stabilizers etc to be pushed into the reactor. Chemical analysis of the ingredients showed traces of bacterial activity which was well within safety limits, repeated studies provided the same results and baffled the team. It was finally concluded that the failure of multiple batches was either the result of sabotage or a rare “bacterial quorum” phenomenon. Through designed experiments where traces of identified contaminants were treated to reactor conditions, it was found that multiple combinations resulted in “bacterial quorum”. Bacterial interactions were resulting in contamination levels far greater than sum of the parts.
Various alternative solutions were considered including reduction in reactor time, increasing concentration of certain ingredients, change in certain ingredients, etc. Through multiple trials, an ideal solution was developed and implemented leading to smooth functioning and increased business from the pharma clients.
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