American Small Manufacturers Coalition

Member Resources

Login

Follow us on Twitter View our YouTube

Password

Forgot your password? Contact us: carrie@smallmanufacturers.org

  • Who We Are
    • About Us
    • Staff
    • Members
    • Industry Data
    • Board of Directors & Committees
    • Supporters
    • Manufacturers & Friends of MEP
  • Success Stories
  • News
  • Events
  • Contact

Find Members

Search for Manufacturing Extension Partnership (MEP) members by state

 
 

GeorgiaGeorgia Manufacturing Extension Partnership

Success Story:PQ Corporation
Improved inventory accuracy by 100 percent

 
US Map KY OH PA NY CT RI MA VT NH ME DE NJ MD WV VA NC SC GA FL PR HI AL MS TN MI IN WI IL LA TX AK NM AZ CA NV UT CO OK AR MO KS IA MN ND SD NE WY MT ID OR WA

Hill Day 2020

Save the date! March 3-4, 2020
The American Small Manufacturers Coalition (ASMC) members and client companies gather once...

More

Success Stories

Find Success Stories by State

MEP Member

North Carolina Manufacturing Extension Partnership

Story Title

At Banner Pharmacaps, Inc., the Active Ingredient is Lean Six Sigma

Client Profile

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.

Situation

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.

Solution

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.

 Results

  • 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.

Testimonial

“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

 

How To Help
How to submit written testimony
for the Congressional record
How to Write To The
Committee Directly

Stay Connected to ASMC

Follow us on Twitter View our YouTube channel

Receive news and updates about ASMC

American Small
Manufacturers Coalition (ASMC)


PO Box 15289
Washington, D.C. 20003
P: 202-341-7066
F: 202-315-3906
Carrie.Hines@SmallManufacturers.org

Home
Success Stories
News
Events
Contact

Who We Are
Staff
Member List
Industry Data
Board of Directors & Committees
Supporters & Friends of MEP Manufacturers & Friends of MEP

© 2023 • American Small Manufacturers Coalition • All rights reserved

website design and development by Imagemakers