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Clean Approach Saves Global Pharmaceutical Drug Manufacturer Time, Money

by Janet Jacobsen

Mallinckrodt Facility Image

The cleaning procedure at Mallinckrodt Pharmaceuticals’ salts facility in St. Louis, Mo., was hindered by significant bottlenecks. The fill, boil, and drain method, used to clean the five 2,000-gallon production tanks, was highly inefficient, resulting in rework and reducing capacity.

In fact, production in this building had been on back order for more than a year; with an average change-over time between products of nearly three days, and a clean-out failure rate over 50 percent.

Company leaders set out to identify ways to improve the efficiency of the process.


Case Study At a Glance . . .

Clean Approach Saves Global Pharmaceutical Drug Manufacturer Time, Money

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-A team-based Lean Six Sigma project aimed to reduce equipment cleaning time.

-Using a variety of quality tools, including process mapping, brainstorming, and root-cause analysis, the team created a new cleaning procedure.

-Meeting all objectives, the project resulted in significant annual cost savings for the company.

Download the entire case study (PDF) or continue reading below for project highlights. 

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Mallinckrodt Case Study Highlights

About Mallinckrodt

Mallinckrodt Pharmaceuticals Logo

Mallinckrodt is a global specialty pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. The company’s Specialty Pharmaceuticals segment includes branded and specialty generic drugs and active pharmaceutical ingredients, and the Global Medical Imaging segment includes contrast media and nuclear imaging agents. Mallinckrodt has approximately 5,500 employees worldwide and commercial presence in roughly 70 countries. The company’s fiscal 2013 revenue totaled $2.2 billion.

Selecting the project

The proposed project focused on procedures for cleaning equipment after one product was made and before employees could start manufacturing a different product. The process was so time consuming and ineffective that it was viewed as low-hanging fruit. “Any improvement in the process would shorten the timeline and allow additional time for manufacture of actual product,” said Lead Validation Engineer Cindy Duhigg, “which is profit rather than time wasted.”

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Video demonstration of a sprayball (Gamajet spray machine)

Completing such an improvement project would achieve the following organizational goals, key performance indicators, and deployment strategies:

  1. Significant cost savings
  2. 20 percent waste reduction/five years
  3. No negative audit findings
  4. 10 percent cost-of-poor-quality reduction
  5. 20 percent increase in schedule attainment
  6. 75 percent decrease in backorders
  7. Promote zero defect culture

Using quality tools to improve

The first step in developing an effective improvement strategy involved pinpointing issues in the current process. Some of the quality tools used to accomplish this task are highlighted in the table below. Of these tools, root-cause analysis identified key drivers for the first-time right issues and revealed a 62 percent cleanout failure rate the team needed to address.

Quality tool usedWhat data was analyzedHow analysis was performed
Process mapFlow chart of entire process including cycle timesVisual observation to detect excessive complexity
Waste walkFacility and process were observed during operationTeam documented areas of waste, prompted by a standardized form
BrainstormingGroup knowledge and experienceTeam and technical subject-matter experts met to identify potential improvements
BenchmarkingIndustry standards and practicesSubject-matter experts provided insight into most current solutions
Root-cause analysisProcess history and flowchartCausal relationships between inputs and outputs identified

Developing strategies 

To bring greater focus to possible improvement actions, three evaluation methods were used: value stream mapping, screening experiments, and benchmarking. The maps clarified the steps needed to achieve the project’s objectives. They also verified the location of the bottlenecks in the process and where non-value added waste was occurring, such as the time needed to clean out the tanks.

The value-stream mapping for the current process allowed the team to determine that an entirely new procedure was necessary to satisfy the project’s objectives. Team members developed a five-part strategy, which consisted of the following changes:

  • Converting from a batch process where each tank was filled and dumped sequentially to a continuous process where tanks could be jet-sprayed with a tank cleaning machine (from Gamajet).
  • Externalizing process tasks such as using a heat exchanger to provide hot water, instead of filling the tanks, then heating the entire volume; and draining the tanks continuously while cleaning, instead of having to wait until agitation was complete before draining.
  • Separating sample collections.
  • Utilizing other water sources.
  • Standardizing the process, labeling the lines, and providing more detailed batch records.

Screening experiments for different tank cleaning machines plotted the cleaning efficacy against time to determine whether a specific sprayball could achieve the required objectives. The data collected from these experiments prompted the purchase of multiple sprayballs and manways (used to access the tanks). Finally, benchmarking activities allowed team members to learn about past successes to create a foundation for determining the best solutions to decrease the clean-out cycle time.

Mallinckrodt Improvement Team 

Mallinckrodt Project Team


The reduced change-over time helped the Mallinckrodt focus factory to introduce an additional product, not originally produced on this line. This added $700,000 in increased absorption, or new product manufactured.

The results had a direct impact on organizational goals as the improvements reduced the number of cleaning failures nearly to zero, eliminating as many as two to three cleaning reworks per month. The project goal of promoting a zero-defect culture with a first-time right measure of 100 percent was reached, showing a 62 percent improvement. Also, nearly $2 million in backorders were completely eliminated at this focus factory.

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