3rd Party Testing
We do, on occasion, utilize contract laboratories to perform specialized testing that we cannot conduct ourselves or as a means to corroborate or “validate” critical testing results. As a general rule however, we perform all our own raw material, intermediate and final product testing “in-house”.
As an internationally recognized manufacturer of FDA regulated products, we must perform all our operations, including analytical testing, in accordance with strict Federal Regulations (21 CFR , Parts 111, 210 and 211). We are routinely inspected by the agency and all our Quality Assurance, Manufacturing and QC testing capabilities are closely scrutinized for compliance with these regulations. Our Quality Control (QC) laboratory is required to meet the identical quality and operating standards that companies providing contract laboratory services must meet and by law, must function separately from all our other operations, e.g. serve as an “independent” testing entity.
We currently have two state-of-the-art QC laboratories supporting our manufacturing operations in Irvine, CA and Colorado Springs, CO. Our laboratory in Colorado Springs, for example, is equipped with multiple High Performance Liquid Chromatographs (HPLCs) and an Inductively Coupled Plasma with Atomic Emission Spectrometer (ICP-AES) for the analysis of vitamins, minerals, and other active ingredients in raw materials and in-process or finished nutraceutical and pharmaceutical products. In addition, disintegration and dissolution testers are available for determining the release profiles of various product ingredients.
Other instrumentation includes a Gas Chromatograph with flame ionization detector (GC/FID) and headspace analyzer, Gas Chromatograph with a Mass selective detector (GC/MS), Total Organic Carbon Analyzer (TOC), Fourier Transform Infrared Spectrometer (FTIR), Ultraviolet and Visible Spectrometer (UV/ VIS), Thin Layer Chromatography (TLC), Microwave Digestion System, ICP-MS (Inductively Coupled Plasma Mass Spectrophotometer) and a Capillary Electrophoresis (CE) system. Our standard laboratory facilities also allow for wet chemical testing of materials and we possess a fully functional microbiological laboratory with Petri-film, agar, and automated methods for assessments of total aerobic bacterial counts, yeasts and molds, coliforms, E.Coli, Enterobacteriacae, Salmonella, S.Aureus, Lactobacillus, and Pseudomonas. Stability chambers, both ambient and accelerated, are located in-house for “Best By” (dietary supplements) and expiration (pharmaceutical) dating and stability studies.