The key element here is that the product is to be used in a solid oral dosage form. What is the possibility that an oral pathogen has gotten into the product, i.e. natural origin product. Many organisms will survive in a low water environment. They will no grow but will survive. A classic example is the survival of Salmonella in Thyroid Tablets for up to a year. The Salmonella came in through the thyroid glands, survived the drying process and was incorporated into the tablet. If the wax is a synthetically manufactured product the chance of an oral pathogen is probably low. The heat that is supplied during sample preparation will kill most oral pathogens. I think a rationale can be developed to exclude this product from testing. Terry E. Munson KMI/Parexel ------------------ The PMFList (http://microbiol.org/pmf.htm) is operated from The Microbiology Network (http://microbiol.org) and supported by our sponsors (http://microbiol.org/sponsor.htm) as a service to the scientific community.