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d-Davidsonart_16-19_Masters 12/31/13 9:53 AM Page 17 January 2014 17 Tablets & Capsules Implementing Quality by Design Pioneered by Joseph M. Juran and based on the foundation of Six Sigma methodologies, Quality by Design asserts that quality can be planned and that any problems that arise during manufacture are related to how you made and followed the plan. When applying this concept to encapsulation productivity, the first and perhaps most important consideration is matching the dosing method of the capsule filler to the characteristics of your product. The same can be said about formulating the product: Match it to the dosing style of the machine you intend to use in commercial production. Consider, for example, the difficulty of achieving consistent weight control when you attempt to fill a difficultto-compress powder into capsules using a tamping-style machine. Only by accounting for the bulk density, lubricity, and other product characteristics during formulation can you maximize your success across the range of dosing styles. An early focus on manufacturing efficiency leads to better profitability, which reaches its maximum potential only when you recognize how the formulation, equipment, and capsule interact. By employing this kind of thinking during development, you're better positioned to avert pitfalls and cost inefficiencies. matching the formulation to the capsule and the capsule filler. Also, preventive maintenance is a must. Don't wait for trouble. All three areas of potential improvement can generate savings. In a recent review of more than 30 case studies, we quantified the efficiency improvements that my company's technical service engineers were able to perform by focusing on these three areas: • Increased speed. The average increase was 14,000 capsules per hour, and changes in this area contributed 61 percent to overall savings. • Higher yield. The average increase was 6.7 percent, and changes in this area accounted for 17 percent of overall savings. • Less downtime. The average reduction was 58 minutes per 8-hour shift, and improvements in this area accounted for 22 percent of overall savings. The combined savings of the 30 case studies was about $2.747 million, which averages $91,560 per company. Figure 1 illustrates how speed, yield, and downtime contributed to these savings. The combined savings of 30 case studies was about $2.747 million, an average of $91,560 per company. Capsule filling efficiency: Speed, yield, downtime Identifying the right combination of formulation, equipment, and capsule can cut costs by maximizing production speed and improving yield while minimizing downtime. These three cost drivers—speed, yield, and downtime—are often intertwined, and an improvement in one area usually leads to an improvement in the others. Speed. Time is money, and all things being equal, the faster your machine operates, the less products cost to make. Manufacturing costs also decrease as the number of different products that you make using the same equipment and staff increases. These include the costs of amortization, utilities, rent, and insurance. Yield. The fill material, not the empty capsule, accounts for most of a product's cost. Thus, you can generate big savings by improving yields, which means reducing the loss of starting materials. Better yields also reduce the time and energy your staff wastes filling capsules that cannot be sold. Even a small improvement in yield can have a significant financial impact, and that explains why boosting yields has been the most common target when companies seek to improve their capsule filling operation. Downtime. The longer production is halted—be it due to mechanical issues, cleaning, or troubleshooting— the more it costs to produce. You can reduce downtime dramatically by adopting a "fit-for-formulation" approach in the early stages of the project. That means, again, Snapshots of improvements and savings Below are examples of how our technical service engineers identified and resolved customers' problems. Increased speed for $365,000 in annual savings. An inspection determined that Company A was running its capsule filling machine below the rated speed. The limiting factor was the non-separation of capsules at higher speeds, a problem that stemmed from a vacuum pump that was not adequately sized. Once that was replaced, Figure 1 Contributions of speed, yield, and downtime to savings of $2.7 million for 30 capsule filling operations