Improving Yield: Pharmaceuticals
Improved batch yield to increase plant throughput rate by 64% in three months
Chemicals and Pharmaceuticals - Active Pharmaceutical Ingredients
Increase output by 50% without CapEx
3 months - 2 consultants
- Increased throughput by 64% in three months through batch yield and execution improvement.
- Sufficient new plant time created for an additional API campaign and an extra €3 million contribution.
Why did this Pharmaceuticals manufacturer join forces with Chartwell?
The Active Pharmaceutical Ingredient manufacturer needed to increase the capacity of one of their blockbuster drugs by at least 50 %. Investment in capital expenditure was not viable as the drug patent would expire before the end of the payback period.
Internal improvement resources had lifted the plant performance as far as they could but the shortfall in capacity was still losing the company sales.
"We thought we were at full capacity and had exhausted all options. In fact, we dsicovered the improvement potential was huge." - Process Team Leader
Simplified Production Process
Key Project Workstreams
Each API batch would typically take 65 hours on the bottleneck process - with little variation in bottleneck time between batches. It was a common belief that maximum throughput was being achieved.
A closer analysis was carried out of the variation in the 243 individual phase steps that make up the bottleneck batch time. The aggregate of the best of each phase step would have taken 25 hours for one batch – i.e. 63 % of the bottleneck time was spent on avoidable delays or yield loss.
- The single largest cause of lost throughput was the variation in batch yield. Some batches were achieving their theoretical maximum of 200kg of finished product, many others were as much as 32% less.
- Improving the yield required a root cause analysis of the source of the yield losses.
- Following a structured problem solving process led the team to look at the Filtration stage. Carefully designed trials showed that low yield batches corresponded with product in the filtrate waste.
- The root cause was a loss of temperature control in the previous stage. Product would be delivered at -5oC, and if this was filtered immediately a good batch yield of 200kg would be achieved. If the product was delayed for any reason, the product would warm and some of the product would re-dissolve back into the filtrate and pass through the filter as waste.
- To ensure that that the filtration step was carried out immediately, and time at the bottleneck was not being lost during other steps, the team implemented improved production visibility and monitoring tools - creating a quick feedback loop to eliminate time losses and prevent results from backsliding of performance over time.
- Together with the yield workstream above, the combined impact of these two approaches was to increase throughout rate by 64%