Particle Technology Labs
based in Downers Grove, ILLINOIS (USA)
Concurrent with the U.S. Food and Drug Administration’s final rule establishing regulations to require current good manufacturing practices (cGMPs) for dietary supplements, PTL can offer cGMP services to all supplement manufacturers. PTL has sustained its FDA registration since 1994, which involves rigorous inspections by FDA every 2 years or sooner. According to the final rule, proper controls must be in place for dietary supplements to be produced in a consistent manner for identity, purity, strength, and composition. PTL’s particle characterization tests can be conducted following FDA regulations. Valuable testing such as particle size and shape, image analysis, B.E.T. surface area, pore volume and pore size can be analyzed under cGMP compliance. These analyses can give insight into absorption, strength, and composition of the material being processed.