Document krjR7RzBagRNZ2gJmkbkzJ0B

g$raooaricn The BFGoodrich Company Geon Vinyl Division 6100 Oak Tree Boulevard Cleveland, Ohio 44131 216-447-6000 December 15, 1992 /M^73 -7 - - '' ,/ Susan Banovic Nalge 75 Panaroma Creek Rochester, NY 14625 SUBJECT: GEON 102EP Dear Ms. Banovic: Geon 102EP is a homopolymer polyvinyl chloride (PVC) resin. Polyvinyl Chloride is prior sanctioned for use in general food contact applications, both flexible and rigid. The prior sanction is based on an article by A. J. Lehman, from the fda, published in the Journal of the Association of Food and Drug Officials. July, 1951. The current Food Manufacturing Practice (GMP) specifications for prior sanctioned PVC are a maximum volatility of 3.0% (1 hour at 105 C) and an inherent viscosity of not less than 0.35 by ASTM D-1243-79. Geon 102EP meets the GMP specifications for prior sanctioned PVC and therefore meets the current FDA requirements for general food contact applications. i PVC is also listed as an acceptable ingredient of food contact articles under 21CFR: 175.105 175.300 176.180 177.1010 177.1200 177.2250 179.45 I am enclosing a technical data sheet on Geon 102EP. If you have any questions, please contact me at (216) 447-7831. Sincerely, THE BFGOODRICH COMPANY CLfriytU-.o V/' Q-JjUtr*--' Connie N. Dillon Regulatory and Data System Specialist 1215-1/jp Enclosure 21677001 BFG15981 Geori 102 EP General Description Type Polymerization Process Appearance Polyvinyl Chloride Homopolymer Resin Suspension White, free flowing powder Features & Uses Flexible compounds Electrical wire coating High tensile strength flexible products Typical Properties ASTM Classification Specific Gravity Inherent Viscosity Specific Viscosity Relative Viscosity "K" Value Heat Loss, % (maximum) Particle Size-Sonic Sifter % thru 40 mesh % thru 140 mesh Powder Mix Time (seconds) Electrical Volume Resistivity Ohms/cm @ 95C (minimum) Flow Time (seconds) Porosity cc/gram G P-6-15443 1.4 1.13 1.59 2.59 74 0.3 100 15 300 2.0 x 10'2 20 .34 Test Procedures ASTM-D-1243 1 % Cyclohexanone @ 30C 1% Cyclohexanone @ 30C 1% Cyclohexanone @ 30C BFG 793-F BFG 812-G BFG 488-H ASTM-D-257-66 BFG 692-E BFG-1094A | BFGoodrich The BFGoodrich Company, Geon Vinyl Division/6100 Oak Tree Blvd., Cleveland, Ohio 44131 lIPGoodrich Geon Vinyl Division The information contained herein is believed to be re liable, but no representations, guarantees or warranties of any kind are made as to its accuracy, suitability for particular applications or the results to be obtained therelrom. The information is based on laboratory work with small-scale equipment and does not necessarily indicate end product performance Because of the variations in methods, con ditions and equipment used commercially in processing these materials, no warranties or guarantees are made as to Ihe suitability ol Ihe products for the application dis closed. Full-scale testing and end product performance are Ihe responsibility of the user. BFGoodrich shall not be liable lor and Ihe customer assumes all risk and liability of any use or handling of any material beyond BFGoodrich's direct control. The SELLER MAKES NO WARRANTIES. EXPRESS OR IMPLIED. INCLUDING, BUT NOT LIMITED TO. THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Nothing contained herein is to be considered as permission, rec ommendation, nor as an inducement to practice any pat ented invention without permission of Ihe patent owner. Printed in U.S.A. February 1987 BFG15982 2167700Z