FDA Testing

Polyhedron – FDA Testing
Polyhedron Laboratories performs U.S. Food and Drug Administration (FDA) testing to CFR standards; a list of these tests are given below:

1. • FDA-CFR-177.1310, Extractions in Stainless Steel Cells in a High Pressure Reactor/2 hours
2. • FDA-CFR-176.170 Water Extractables 250 Degrees Fahrenheit/2 hours
3. • FDA-CFR-176.170 Heptane Extractables 150 Degrees Fahrenheit/2 hours
4. • FDA-CFR-176.170 Heptane Soluble Extractables
5. • FDA-CFR-176.170 Water Soluble Extractables
6. • FDA-CFR-176.170 8% Alcohol Extractables
7. • FDA-CFR-176.170 50% Alcohol Extractables
8. • FDA-CFR-177.1520 % Hexane Extractables at 50 Degrees Centigrade
9. • FDA-CFR.177.1520 % Xylene Extractables at 25 Degrees Centigrade

FDA Extraction by ASTM D4754 (at 160 Degrees Fahrenheit/2 hours)
ASTM D4754-98 - Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell - This test procedure outlines the use of the FDA migration cell in the extraction of components and permits quantitation of individual migrants from plastic materials by appropriate extracting of liquids, including food-stimulating solvents and liquid foods. This test routine allows for a two-sided, liquid extraction test for plastic materials that can be formed into disks, sheet, or film. Additionally, this test procedure has been applied to a variety of migrant/polymer systems in contact with numerous food stimulants and foods. This test routine has been shown to yield reproducible results under the conditions for migration tests requested by the FDA.
Additional testing performed by Polyhedron includes % Hexane Extractables by Soxhlet Extraction (24 hours), and % Heptane Extractables by Soxhlet Extraction (24 hours).