Upcoming Issue Highlights

Taking a Spotless Approach to Sanitation

From eliminating pathogens to keeping dust out of the manufacturing process, ingredient suppliers make a clean sweep.

The good manufacturing practices (GMPs) for dietary supplements now in effect for all manufacturers don’t just state that clean living is a must. The GMPs make the point again and again. In a fact sheet summarizing the requirements, the Food and Drug Administration (FDA) says that, among other requirements, manufacturers are obligated to “hold and distribute dietary supplements and materials used to manufacture dietary supplements under appropriate conditions of temperature, humidity, light and sanitation so that the quality of the dietary supplement is not affected.” 

Even without an FDA mandate, though, scrupulous attention to sanitation throughout the production process has long been a concern for conscientious suppliers and manufacturers. Since this priority informs all aspects of the sourcing and production cycle, it’s not surprising that supplement companies have devised a variety of methods to address sanitation.

Aloecorp, for example, deploys what it calls the TTS (time, temperature and sanitation) process from harvesting the aloe plants through drying of the leaves. “The overall timing of TTS production phases [is] extremely critical And numerous clinical and pre-clinical studies with our product have validated the success of this methodology,” according to the Washington-based ingredient supplier.

“Timing and sanitation begin with early morning harvesting and careful removal of the leaf from the mother plant,” according to Aloecorp. Proper extraction of the leaf assures that the base of the leaf is “intact and sealed from possible introduction of microbes. Microbial contamination can significantly degrade the vital components of aloe that must be retained for maximum benefit in a finished product.” 

The other major source of microbial contamination, said Aloecorp, comes from the rind of the leaf. “To prevent contamination during processing, the leaves are handled very carefully to prevent puncture of the rind and soaked in a food grade sanitizer, which effectively reduces microbial levels in preparation for the next step in aloe processing.” 

The next phase involves pasteurization, with Aloecorp noting that “biological activity remains essentially intact when aloe is pasteurized by the high temperature short time (HTST) method. This method is similar to that used in the pasteurization of the milk. Extended periods or higher temperatures will result in greatly reduced quality.” 

Next comes concentration. “The product obtained using the harvesting, sanitation and pasteurization methods can be concentrated under vacuum without the loss of quality,” according to the company. “The concentration operation must be conducted at temperatures below 50 degrees Celcius with continuous flow. Higher vacuums and temperatures will cause activity loss, as will extended concentration times.” 

Picking Up Steam 

Last year, California-based Ingredients by Nature introduced a new technology that employs steam to sanitize and sterilize ingredients. Known as Steam By Nature, it’s said to minimize color change and degradation of vital nutrients, while eliminating clumping and maintaining the powder’s flowability.

“This is a needed service in our industry and for our customers as there is a limited number of steam sterilization systems out there,” Ingredients By Nature CEO Robert Brewster said when the technology was introduced. Because virtually all ingredients by their nature require sterilization before reaching the end user, “steam is by far the cleanest way of accomplishing this task.” He added that with more consumers becoming concerned about the excessive use of chemicals to process supplements, goods and beverages, products made with steam-sanitized ingredients would be looked upon favorably.

Described as gentle to the product, the Steam By Nature process is continuous, according to the company. It blends the material during sterilization, providing formulation flexibility—i.e. multiple ingredients maybe steamed simultaneously—and also eliminates the need to blend out hot spots. In addition, Steam by Nature is certified for organic processing.

“Steam sanitation/sterilization is a way to naturally bring down microbials found in botanical and natural extract powders,” said Brewster. “The use of gamma irradiation was a fail-proof sterilization method used in our industry many years ago that is no longer allowed; therefore, alternative, natural ways to sterilize microbial issues (total plate count, yeast and mold, etc., which are found naturally in these powdered ingredients) was needed. The industry, including our company, had responded with dry heat sterilization. But we have found that use of dry heat is harsher on the ingredients and their vital actives than steam, which is why we set about to invest heavily into being the premier service supplier of steam sanitization.” 

Attention to sanitation can be a happy consequence of addressing a larger priority. Triarco Industries in New Jersey, for instance, in 2011 received halal certification for its patented enzyme system, Aminogen, from the Islamic Food and Nutrition Council of America. While the certification mainly allowed greater flexibility on the part of manufacturers using Aminogen, and on the part of consumers in choosing halal supplements, it also paid off in terms of complying with Islamic law, which requires specific sanitation procedures to be followed when obtaining and processing foods and ingredients, while also prohibiting the use of certain substances, such as pork, pork by-products, intoxicants and some synthetic substances.

Food safety is another area of concern for consumers, and Marylandbased Brassica Protection Products employs a litany of GMP and hazard Analysis and critical control point (HACCP) programs, FDA-designated seed sanitation and “hold for release” testing, requiring these to be applied uniformly across all facilities producing BroccoSprouts through its network of licensees. “The Brassica Pathogen Reduction and HACCP Program is based on a series of widely accepted systems that have been developed over the years to ensure that food production facilities, processes and ingredients are safe and wholesome,” according to Brassica.

The company said the requirement for sanitation standard operating procedures (SOPs) in Brassica’s Pathogen Reduction and HACCP program is “one element of the strategy to modernize the sprouting industry and to reduce the risk of pathogens on sprout products. Brassica growers must have written sanitation SOPs and HACCP programs to show how they meet these requirements on a daily basis.”

The company licenses only a limited number of growers that can meet its food safety requirements. “Third-party auditors, such as the American Institute of Bakers (AIB), inspect BPP growers on an announced and unannounced basis to ensure compliance,” Brassica said.

Contract manufacturer ProTab Laboratories in California prides itself on its adherence to SOPs to ensure both product quality and sanitation. For example, it employs isolated rooms for each phase of the manufacturing operation. “These rooms allow for a higher degree of quality checks, sanitation and prevents cross contamination of material within the manufacturing process,” according to the company.

Additionally, all manufacturing equipment and contact surfaces are stainless steel “to maintain efficient and thorough cleaning standards,” ProTab stated. “Each room’s floors are specially coated and floorboards and wall coverings are designed to provide for efficient and thorough maintenance of the cleaning standards.” Moreover, ProTab employs a specialized dust collection system “to prevent migration of material from one workstation to another, as well as helping ensure that we meet our SOPs for cleanliness and sanitation.”