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Improving Yield: Pharmaceuticals

"We thought we were at full capacity and had exhausted all options. In fact the improvement potential is huge." - Process Team Leader


Industry

Chemicals and Pharmaceuticals - Active Pharmaceutical Ingredients

Support Level

2 Consultants, 3 months

Objective

Increase output by 50 % without CAPEX

Results

In three months the throughput rate increased by 64 %.  This created sufficient new plant time 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.

Results of the 3 month project

  • Solving the filtration yield problem and twenty or so other problems increased the throughput by 64 %
  • The line time created was used to produce an additional API campaign and add an extra €3 million to the business
 

Examples of Project work 

What was the biggest lever in realising the improvements?

FOCUS AREA:

Each API batch would typically take 65 hours on the bottleneck process, there was little batch to batch variation and 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 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.


PROBLEM:

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.

What were the results of eliminating this problem?

RESULTS:

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.