Textbook – An Introduction to Six Sigma & Process Improvement 2e
By James R. Evans and William M. Lindsay
Banner Pharmacaps specializes in the research, development, manufacturing, and distribution of innovative soft-gelatin dosage forms of health care products. In 1992, Banner developed and patented a gelatin coating for tablets and caplets or cores, as they refer to themfor ease of swallowing. Fish oil soft gels, which are made using Banners proprietary enteric technology, EnteriCare, are the star product in its line of direct-to-market nutritional supplements. The company employs 499 people at its facility in High Point, North Carolina.
Because the active pharmaceutical ingredient (API) in some products is very expensive, multiple attempts to produce the right blend of ingredients for the same batch can be extremely costly. Banner sought a tool that would aid earlier submissions of product to the Food and Drug Administration (FDA). Shorter cycle times were needed to make the company more competitive. Banner was also inter-ested in continuing to build a workforce of problem-solvers.
The company trained employees and champions in Lean Six Sigma concepts to help minimize variability, decrease cycle times, and help build a work force empowered to focus on root cause methodology. By incorporating the LSS philosophy, one team was able to increase the Soflet gelcap yield for one of their products from 94.15 percent to 98.3 percent. Even more importantly, employees are now challenged to improve. They look at the data, make recommendations, and lead initiatives.
Six Sigma principles are not used only in Banners manufacturing processes. A senior scientist in research and development who earned a Green Belt applied a design of experiment (DOE) approach to an Rx product in the development pipe-line. Even when developing a generic pharmaceutical product, development and registration of the product with the FDA is a time-consuming and arduous pro-cess. Producing a registration batch that meets all the criteria necessary for a physi-cally and chemically stable product in comparison to the branded product could take 18 months or more. The project mission was to reduce the product formula-tion time from 18 months to 15 months. The DMADV approach was used to deter-mine optimal settings for the registration batch, while simultaneously ensuring a robust process and quality product. The result was that the design project sur-passed its goal significantly and allows earlier submissions to the FDA. Depending on the timing of FDA approval and commercial launch, this project has the poten-tial to increase this products earnings by more than twice the initial forecast. The company realized $650,000 in cost savings, increased yield from 94.15 percent to 98.3 percent, and reduced formulation time from 18 months to 15 months.