North Carolina Manufacturing Extension Partnership
At Banner Pharmacaps, Inc., the Active Ingredient is Lean Six Sigma
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 them, for ease of swallowing. Fish oil soft gels which are made using Banner’s 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 of 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 interested in continuing to build a workforce of problem-solvers. The company contacted the North Carolina Manufacturing Extension Partnership (NC MEP), a NIST MEP network affiliate.
NC MEP provided assistance with red belt, green belt and champion training to help minimize variability, decrease cycle times and help build a work force empowered to focus on root cause methodology. By incorporating the Lean Six Sigma 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 only used in Banner’s manufacturing processes. Newly certified green belt, Dr. Mervin Williams, senior scientist in research and development, applied a design of experiment (DOE) approach to an Rx product in the development pipeline. Even when developing a generic pharmaceutical product, development and registration of the product with the FDA is a time consuming and arduous process. Producing a registration batch that meets all the criteria necessary for a physically and chemically stable product in comparison to the branded product could take 18 months or more. Williams’ green belt project mission was to reduce the product formulation time from 18 months to 15 months. He utilized a DOE approach of 1) define, 2) measure, 3) analyze 4) design, and 5) verify (DMADV) to determine optimal settings for the registration batch, while simultaneously ensuring a robust process and quality product. The result of Williams’ design project surpassed its goal significantly and will allow an earlier submission to the FDA. Dependent upon the timing of FDA approval and commercial launch, this project has the potential to increase this product’s earnings by more than twice their initial forecast.
- Realized $650,000 in cost savings.
- Increased yield from 94.15 percent to 98.3 percent.
- Reduced formulation time from 18 months to 15 months.
“Lean Six Sigma opened it up to looking at the problem more holistically. Collecting statistical data encourages the hows and whys to be addressed allowing access to the root cause.”
Joseph Coleman, Chief Encapsulation Manager