Manufacturing Excellence: Setting the Standard, Setting Us Apart

By David Baker

Talk of manufacturing facilities bring a few images to mind. You have the greasy, grinding gears of industry sending out sparks and soot, or Willy Wonka’s chocolate river flowing through a pastoral candy paradise. Fortunately, USANA’s in-house manufacturing facilities are neither industrial wasteland nor cartoonish wonderland.

Walking the path of a USANA product brings you through clean, sterile environments, past operators dressed in full regalia, and through impressive, shiny machinery. Every step of the journey—from the powders dumped into a room-sized cone mixer to the multi-layer tablet press machine-gunning out finished products—is designed to maximize quality. (See the video below to follow a product on its path from powder to pill.)

For years, USANA voluntarily adhered to pharmaceutical-level Good Manufacturing Practices (GMPs). Recently, USANA took another step and acquired U.S. Food and Drug Administration (FDA) Drug Establishment Registration. Now, USANA’s facility can be inspected under pharmaceutical guidelines—the FDA’s highest possible standard for manufacturers. No changes need to be made to USANA processes in order to comply with the increased FDA scrutiny.

Along with adhering to pharmaceutical-level GMPs, the manufacturing process for each product is fully validated.

“Our validation process ensures that we know how to manufacture a batch of tablets with tablet-to-tablet ingredient uniformity,” said Dr. John Cuomo, USANA’s executive director of research and development. “We know, for example, if we’re making Mega Antioxidant we not only match the labeled amount of ingredients in a bottle, but that each and every tablet in that batch has those ingredients at the labeled amount, with very little variation. I don’t think anybody else in the nutraceutical industry is doing that. Certainly not anybody who doesn’t do the production themselves.”

Validation means establishing checks throughout the system and testing at different points in the process. This also means mixing up anywhere from 600 to 1500 kilograms of different powders and putting them in a big blender and making tablets so you can test a representative sample of a full production run. Basically, process validation is a very big, very expensive experiment, Dr. Cuomo says. But it assures you are making a consistent product that contains the right ingredients, in the right quantities, uniformly through a batch.

The validation process is only done once or twice on a product to set up the parameters and procedures for making that product properly. However, every commercial batch of products made in USANA’s manufacturing facility go through weight uniformity testing, as well as a variety of tests on the final product. Since the process has been validated and there are checks established throughout the system, any problems can be recognized and dealt with immediately.

Knowing the proper processes and having control over every step from raw material to tablet gives USANA unmatched quality control, which shows in each and every product.

“I haven’t come across any of our direct competitors who have the same kind of facility and can manufacture their own products like we do,” said Dr. Mark Brown, USANA’s director of product development. “We took a good process and made continuous improvements to it over the next 20 years. We have a very solid operation and I think that’s the number-one key to assuring a quality product.”

This production of quality products has been a cornerstone of USANA since its founding in 1992.

“Quality manufacturing is important because we’re trying to provide products that actually do something for people,” Dr. Cuomo said. “We really believe in Dr. Wentz’ vision that you can provide people with the proper nutrients to help maintain optimal health. To do that, you’ve got to give them products that are proven and tested, and you’ve got to make sure that you’re getting the right material into the finished product, and nothing else.”

Tell us what you think about this Manufacturing Excellence series at usanatoday@us.usana.com.