Issue link: https://www.e-digitaleditions.com/i/701238
32D July 2016 Tablets & Capsules Our strategy for built-in quality At Sabinsa, procuring high-quality raw materials starts with cultivation that follows good agricultural practices. This includes determining how well the soil was treated, with or without pesticides or fertilizers, and documenting what chemicals were used, how much, and how often. Additionally, we check for the presence of heavy metals and assess the risk of cross-contamination to determine the starting level of any likely contaminant. That's how we begin to build in quality. Next comes the processing stage, when plants undergo extraction to enrich the bioactive markers to standardized levels. This process should be monitored to ensure that the assay levels are correct and that any residual solvents are washed away, leaving the purest extracts possible. During this stage, the ingredi- ent manufacturer can, in many cases, also further reduce or eliminate any detectable pesticides to deliver products that comply with the limits set by regulatory bodies such as US Pharmacopeia. Extraction technologies have improved in the last few years, with some of the best ingredient companies opting for continuous extraction to increase output over traditional methods that use extraction vessels. Continuous extraction also reduces solvent consumption and lowers costs. With all that processing power and with in-process qual- ity checks performed at the site and during extraction, you would think it's redundant to test again, but that's exactly what should happen. Each batch of raw material should undergo a series of analytical, chemical, and microbiologi- cal checks to ensure maximum safety and efficacy, and the findings must be documented. It's these documents and processes that the FDA and other global regulatory govern- ing bodies will look for in an audit, and it's these audits that build consumer trust. The nutraceutical market used to deal in smaller quanti- ties because there were fewer customers, and at that time batch manufacturing dominated. As demand increased, however, and as standardized natural extracts gained acceptance, continuous extraction has grown. In the early days of Sabinsa, we processed a 1.5-ton batch of our Curcumin C3 Complex. Today, we use continuous extrac- tion and process 30 tons of raw material daily while reduc- ing our consumption of solvents by almost half compared to the batch operation. Another important component of sourcing raw materials is planning how to protect the farmlands and the harvest. This helps ensure material is available season after season. Traceability of such plants and extracts is also crucial, and vertically integrated companies like Sabinsa—with its seed- to-shelf approach—are well positioned to provide cus- tomers with ingredients that can be traced through the chain of custody. We've found that maximiz- ing output, minimizing solvent use, and being ready for audits anytime are necessary steps for making high-quality ingredients. You want to have a robust extraction process that yields the best output for your ingredients. As previously stated, using technologies like continuous extraction systems, can minimize solvent con- sumption while increasing output. The importance of auditing It's not enough to say you test your products during cultivation and extraction, you must show proof, and there is no better way to do that than third-party certifi- cation. Sabinsa has chosen National Accreditation Board for Testing and Calibration Laboratories (NABL) as our third-party certifier. NABL has agreements with the International Laboratory Accreditation Conference (ILAC) and Asia Pacific Laboratory Accreditation Cooperation (APLAC) that provide international recog- nition and mutual acceptance of test results. In other words, NABL accreditation has worldwide acceptance. You must also validate the testing methods for each product that goes through your lab, and they must be "fit for purpose." Basic components you should test for include identity, purity, assay, bulk density heavy metals, and pesticides. See Table 1. US customers that sell products in California have to comply with Proposition 65, which requires any product sold in the state to include a warning if the product includes trace amounts of lead. The European and Japanese govern- ments also have very strict standards regarding pesticides and heavy metals that must be followed or the product will be rejected. You should have comprehensive testing and documentation in place to support customers' claims of compliance with these and other standards. Here's an example of how a widely successful ingredient can fail without the proper quality safeguards. Curcumin (turmeric roots) is a popular ingredient in the dietary sup- plement industry, yet, in a few cases curcumin was synthe- sized and mixed into batches of the true raw material. Table 1 Basic components of raw ingredient testing • Identity • Solubility • Loss on drying • Ash content • Bulk density • Sieve test Determining the identity and quality of botanicals can be difficult. In one case it was necessary to add C14 radio carbon testing. • Assay • Purity • Microbiological profile • Heavy metal content • Solvent residue • Pesticide residue • Shelf-life (stability)