Beyond Ingredients: Suppliers Providing Intermediate Steps

by Shaheen Majeed

Contract manufacturing in todays tighter regulatory environment and challenging economy has created unique opportunities for suppliers and their customers to work together more closely than ever before. Often intermediate steps are required before the finished product is made, incurring the additional cost of shipping raw material for intermediate processing before it goes to the manufacturing facility. A well-equipped supplier may be able to handle those steps, negating the need for an intermediate processes vendor.

Many finished product manufacturers have encapsulation or tableting machines, and just focus on punching out tablets and filling capsules; but, blending may be a technology they cant easily do in-house. When a supplier handles this intermediate step, it can simplify procurement, warehousing, sampling and handling. It can be extremely difficult from the analysis point of view, but a company with good internal labs and well-trained staff will be able to meet the customers validation needs.

Among other intermediate steps companies may require is granulation. When manufacturers purchase inexpensive raw material, more processing may be needed before making a finished form such as capsules or tablets. Good granulation provided by an ingredient supplier can assist manufacturers in cost-effectively producing a quality capsule or tablet, especially since not all contract manufacturing companies have granulation facilities. Although a number of DC-grade (directly compressible) raw materials and excipients are now available, which require only blending before tablet compression, not every ingredient is available in DC form. These materials can be granulated by an appropriately equipped supplier, then blended with readily available DC material and directly compressed into tablets. The benefits include batch-to-batch consistency, and minimal quantity of water or other solvents needed, aiding good microbial control.

Look for a supplier with the capability to address different granulation requirements. Granulation is a good solution for content uniformity problems. Material loss is less, as granular material does not create as much dust as fine powders. Bulk densities of materials has been a growing area where customers need help. When asked to provide formulation assistance, one of the leading indicators that should be considered is bulk density on all the ingredients going into the final form. That determination may lead to increasing the bulk density in many cases to help fit into a capsule better. Bulk density can be increased either by roller compaction followed by milling back to desired particle size, or via high-shear granulation (rapid mixer granulator). Granulation in low shear (fluid bed processor) will improve the flow property.

Another service that may be desirable is small-scale production capabilities to make relatively small batches of finished product. Ingredient suppliers with proprietary ingredients that have been the subject of clinical studies may have this capability already in order to provide capsules and tablets to research institutions for clinical studies using their ingredients. Helping start-up companies go all the way to the final bottle complete with the FDA/FTC-compliant mock label in batches as small as 200 bottles used to test, trial or sample may well result in large ingredient orders down the line.

Although not technically processing, HACCP certification is another extra the savvy ingredient supplier should offer. Internationally, many countries do not recognize dietary supplements as a separate category; they are instead recognized as food. For those countries, HACCP controls should be in place.

By providing additional services, a well-equipped ingredients provider can be positioned as a partner in facilitating customers manufacturing processes. When coupled with high-quality, proprietary ingredients backed by intellectual property and science, this makes the supplier an even more valuable partner to their customers.

Shaheen Majeed is the marketing director at Sabinsa Corp ., which offers a variety of ingredients, including proprietary branded offerings, as well as contract manufacturing services; the company holds International Foods Standards Certification (IFS) from DNV, which includes an annual physical audit for HACCP and other critical functions.