Contract Manufacturing and Formulating with Whole Foods and Botanicals - Nutraceuticals World, October 2002
It seems odd to be discussing manufacturing and formulating with whole foods in an industry that was founded on natural foods and natural health. Many of us remember when supplementing with vitamin B meant we were eating brewer’s yeast; or supplementing with vitamin E, A or C meant we were eating wheat germ oil, cod liver oil and rose hips respectively. In the last couple decades, isolated, synthesized nutrients have replaced many of the nutrient-dense foods that were once used as supplements. However, we are now closing the circle and returning to an appreciation of the synergistic value of whole food. Scientific research supports the conclusion that whole foods are superior to isolated nutrients, and consumers are increasingly demanding organic, food-based supplements and functional foods. The bottom line is that people who choose natural food lifestyles want natural, whole food, and companies are seeking ways to adjust their formulas in response to that demand.
Manufacturers began using fine chemicals instead of foods for numerous reasons, the primary one being that isolates are an easier medium with which to work. Foods and botanicals are inconsistent by nature ~ their appearance, color and volume vary, the potencies vary, and the macronutrient chemical composition can vary from one batch to the next. Moreover, foods require scrupulous handling, as they are far more susceptible to microbial or chemical residue contaminations. Handling a vitamin C-rich food is very different than handling a USP ascorbic acid that arrives in-house with a zero microbial plate count. For the above reasons, many contract manufacturers in the nutraceutical industry won’t accept food projects, and as a result, expertise in contract manufacturing and formulating with foods and botanicals is not widespread.
We have been manufacturing with whole foods and botanicals since our inception and, in that time, we have learned a great deal about the nuances of working with these materials. To successfully include whole foods or botanicals in your finished product, you must consider both the manufacturing facility and your raw materials. The finest manufacturing processes in the world cannot compensate for poor quality raw materials, so we always begin with a thorough evaluation of the proposed ingredients. We have learned that it is essential to have stringent quality controls in place that ensure a material is clean and has complete documentation. This cannot be emphasized enough — one contaminated raw material can jeopardize an entire formula. We consistently see high microbiological counts that must be rejected, and were it not for our insistence upon third party testing and thorough documentation, these contaminated ingredients would slip by undetected.
When evaluating an ingredient, we consider many things, all of which have a direct and immediate impact on the safety, potency and efficacy of the finished product.
How is the material grown? In most cases, organic certification is ideal, as it helps to eliminate a host of potential concerns. However, it is important to note that if manure is used in the compost material, it can lead to high microbial counts. The growing location is also important. Ingredients grown or wildcrafted roadside or near industrial and urban areas can have high heavy metal or radioactive residues. As a matter of course, we require documented testing for heavy metals and radioactive residues of any material that may be at risk. If the material is not organic, pesticide residues must be evaluated. Genetically engineered (GE) status must also be determined and any non-GE or organic certification claims must be documented. It is also necessary to confirm that the organic certifying agency is NOP (National Organics Program) approved.
How is the material handled after harvest? All botanicals begin to lose potency as soon as they are harvested, and microbes and molds begin to breed. It is often essential that botanicals and food ingredients be chilled immediately after harvest until they are processed. How is the material processed? If it was extracted or concentrated, what temperatures and solvents were used? If it was dried, what methods and temperatures were used? This affects both the preservation of nutrients and active constituents, as well as the final moisture content of the ingredient. Proper moisture content is critical to the safety of a final product — small amounts of excess moisture can create a breeding ground for microbes. It is also important to determine what carriers are used and their percentage of the final material. Be aware that many commonly used carriers are GE materials. We always inquire whether material has been irradiated or autoclaved, as often suppliers do not reveal this information. We always require documentation and verification of a suppliers microbial testing.
How is the material packaged and stored? Naturally occurring nutrients and phytonutrients are easily destroyed by exposure to heat, light, moisture and oxygen. Foods are much more susceptible to microbial growth after processing than fine chemicals. For both these reasons, it is critical that food and botanical ingredients be protected with sealed, air-tight bulk packaging, and where appropriate, nitrogen purged.
What are the physical characteristics of the material? To avoid problems in production, determine a material’s mesh size, bulk densities, moisture content, color and flow in advance. These characteristics can vary substantially from lot to lot due to the inherent variability of foods and botanicals.
How is the material’s identity and potency verified? It is absolutely essential to obtain verifiable documentation regarding identity and potency claims.
Unique Manufacturing Challenges
As we mentioned earlier, working with fine chemicals and USP nutrients is pretty straightforward. They tend to be consistent, as well as resistant to degradation and microbial contamination. This is not the case with food. Nature doesn’t produce anything with cookie cutters. Thus every botanical or food is a slight variation on a theme, and this necessitates continual adjustment, refinement and checks to ensure the quality of the finished product.
Particular attention must be focused on tightly controlling the manufacturing processes and on selecting packaging that will both protect the ingredients and finished product from contamination, as well as protect their fragile, naturally occurring active constituents and nutrients from degradation. The first step in providing this protection is to control the ambient environment. All production and warehouse areas must be carefully climate controlled to maintain cool temperatures and low humidity. Air and water quality must also be controlled. People often overlook the importance of filtered air and purified water in a nutraceutical production facility. As soon as the bulk packaging of a raw material is breached, the contents will be exposed to whatever might be present in the external environment, so it is crucial that the environment be as sterile as possible.
Every incoming material should be quarantined in climate-controlled storage. During quarantine, we take samples for third party testing and for retention. An organoliptic review is also mandatory. After third party testing confirms the documentation provided by the supplier, the material can then be cleared out of quarantine. When production of the finished product begins, the materials should, once again, be verified when they arrive in the production area.
Very often, mesh sizes of food or botanical ingredients will be inconsistent, and this makes the choice of blenders an important consideration. Only careful blending will prevent stratification or settling. Ribbon blenders work well for single ingredients or ingredients that are all the same weight and size. However, if you are mixing a variety of ingredients this is not usually the case. For example, blending herbs and fine chemicals in a ribbon blender can result in the heavier, fine chemicals settling to the bottom unless the load size is carefully controlled. This will not occur in a V blender. The tumbling action combined with an intensifier bar guards against any settling or stratification. V blenders can also accommodate wet granulation. Other blending methods may be considered as well.
Storage & Transport
After blending, the blended material must be placed in properly labeled containers for transport to other production areas or intermediate storage. If the blended material is being stored, it may be appropriate to nitrogen flush the container to prevent oxidation, and all containers must be properly sealed and placed in a climate-controlled area. Prior to tableting, encapsulating or powder filling, the properties of the blended material must be evaluated for their flow characteristics, as they can differ substantially from one lot to the next, due to the natural variations of food. When working with food nutraceuticals, we always try to avoid the use of excipients such as binders, lubricants and flow agents. With patience, it is possible to use the inherent properties of foods to create ideal tableting or flow for encapsulation or powder filling. In this way, potentially questionable ingredients can be avoided in products that are marketed as “natural”. Additionally, tablets that are excipient-free are softer and easier for the body to digest and utilize.
The Science of Package & Bottle Selection
For the long-term viability of your product, bottling and packaging choices are of the utmost importance. If you are making the extra effort to offer the full-spectrum benefits of foods and botanicals, it is wise to select packaging that will offer the greatest protection to the active constituents in the foods and botanicals. There is real science in selecting the most appropriate bottling or packaging materials that will protect your product from moisture, odors, light and oxygen transmission. Not only must the materials in the product be considered, but also the desired shelf life and environment in which the product will be stored. Induction sealed, amber glass bottles still offer the best protection from oxygen. However, pouching and blister packs have become quite sophisticated and can provide good results in many applications. Whichever packaging materials are used, creating an oxygen-free, low moisture environment is essential. This can be accomplished through a combination of nitrogen flushing, oxygen absorbers, vacuum packing and dessicants. A manufacturer experienced in working with whole food nutraceuticals can offer invaluable guidance in selecting the most efficacious packaging and inserts.
In the End…
Producing nutracueticals that contain foods and botanicals requires a great deal of expertise and planning. Everything from the selection of ingredients to choosing the most appropriate processes and packaging must be carefully considered and tightly controlled. But something more than expertise and experience is required. Integrity and an unshakeable commitment to natural ingredients and processes form the foundation on which a quality product is built. Without that foundation, it is too easy to justify exceptions that will compromise the effectiveness and safety of the finished product.
David Tannen, Sales and Support
Elizabeth Cate, Customer Service