BI Nutraceuticals Emphasizes Importance of Kill-Step Validation, Supply Chain Transparency at Natural Products Expo West


Nutritional Outlook spoke with a representative from BI about how the company’s Protexx HP Green Steam botanical sterilization process can provide manufacturers a “safety net” for botanical ingredients, and why kill-step validation and adequate testing methods are now an industry imperative.

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The botanical ingredients industry has certainly seen its share of negative press on contamination and adulteration. With this in mind, at the recent Natural Products Expo West trade show, BI Nutraceuticals (Long Beach, CA) highlighted the importance of validation methods that it said can ensure that bad actors in the botanicals industry are weeded out and that consumers are purchasing products with proven-safe ingredients. Nutritional Outlook spoke with a company representative about why BI’s Protexx HP Green Steam botanical sterilization process can provide manufacturers a “safety net” for validated ingredients, and why kill-step validation and other test methods are now an industry imperative.

Randall Kreienbrink, vice president of marketing, BI, explained that product-specific kill-step validation is an important aspect of the botanical ingredient extraction process. Kill steps are stages in the manufacturing process at which pathogens like E. coli, Salmonella, and Listeria are eradicated from the ingredient. Kreienbrink said that product-specific kill-steps are crucial because different types of products-food, botanicals, and spices, for example-have different safety standards.  

United States Pharmacopeia (USP) standards indicate that a 5-log reduction (lowering the number of microorganisms in an ingredient 100,000-fold) is sufficient to kill harmful pathogens, but Kreienbrink said that sometimes further reduction is necessary depending on the ingredient in question. He said that BI currently works with over 400 different botanical species and that each one has specific sterilization needs.

BI’s purpose-built machinery, he said, allows the company to sterilize raw material specific to a botanical ingredient’s particular needs in order to maintain the color, flavor, and bioactives found in that botanical. Here’s how the technology works: “[Our sterilization] process [uses] dry, hot steam with pressure that helps to do a several-log reduction,” he said. “It’s validated, it’s standardized, and we make sure that we get it to safe levels that meet USP standards and industry standards for 5-log reduction.”

“It’s cleaner, it’s safer, and it doesn’t destroy the integrity of the botanical,” he said. “If [our process] was a harsh steam, it would totally destroy the color, some of the oils, the vitamins. It’s just like overcooking something. If you overcook your vegetables, you just kind of ruin it-there’s no taste.”

He added that the sterilization technology is trademarked Green Steam because BI doesn’t use any chemicals in the process, and uses as little steam as is needed in order for the cleaning process to be effective. Though several other companies use similar steam sterilization methods, he claims that BI’s Green Steam system is the industry’s only species-specific, organic steam system with a validated kill step.

He added that even with other similar steam sterilization methods, if the steam is too harsh, or the temperature too high, the bacteria and pathogens may be effectively killed, but the color and flavor of the ingredient are altered as well. “Especially if it’s going into a food product,” he said, “you want to keep the flavor and some of the actives intact, as you would also in supplements.”

Kreienbrink stated that although there are a few unscrupulous players in the botanicals industry hoping to make a quick buck, “that’s small-picture thinking.” Adopting standards for kill-step validation and testing to verify identity can help the good players in the industry move forward.

Undertaking adequate safety and validation measures on the front-end of the manufacturing process can save companies a lot of trouble down the line, Kreienbrink said. “You don’t ever want to be on that food and drug recall list. You don’t want that bad press. Because once you get on that recall list, it’s just a brand killer.”

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