Manufacturer declaration - FDA VEGABAR 53 p Process pressure/ Hydrostatic In general 1 In general FDA stands for Food and Drug Administration, a U.S. authority. Amongst others, this authority issues a regultion for the use of materials with product contact in the pharmaceutical, food and beverage and cosmetics industry (Code of Federal Regulations CFR). Use a suitable, FDA approved process seal. The seal supplied by default must not be used. 32548-EN-070611 2 VEGABAR 53 Manufacturer declaration 2 Manufacturer declaration We herewith declare that the material composition of the wetted parts of the following versions VEGABAR 53 meet the requirements of the Food and Drug Administration. Thread BR53.**GC****** BR53.**GF****** BR53.**GN****** BR53.**GV****** Flange BR53.**ES****** Clamp BR53.**CA****** BR53.**CC****** Cone BR53.**KC****** BR53.**KD****** Bolting BR53.**RA****** BR53.**RE****** Aseptic fitting with compression nut in conjunction with EPDM, FKM and Fluoraz seal BR53.**LA****** BR53.**LB****** BR53.**LD****** Tuchenhagen Varivent BR53.**TA****** BR53.**TB****** Neumo Bioconnect BR53.**BS****** 32548-EN-070611 DRD BR53.**AA****** This declaration is based on the following certificates: VEGABAR 53 3 Manufacturer declaration l l Opinion letter to the used stainless steels of the Public Health Service of the Food and Drug Administration, College Park, MD 20740 of November 22, 2004 The explanations of our suppliers to conformity of the fill fluid with requirements according to FDA 21 CFR 172.878 as well as 178.3620 Furthermore the operator has to guarantee the compliance with further food and process-specific requirements. 32548-EN-070611 4 VEGABAR 53 32548-EN-070611 Manufacturer declaration VEGABAR 53 5 Manufacturer declaration 32548-EN-070611 6 VEGABAR 53 32548-EN-070611 Manufacturer declaration VEGABAR 53 7 VEGA Grieshaber KG Am Hohenstein 113 77761 Schiltach Germany Phone +49 7836 50-0 Fax +49 7836 50-201 E-mail: [email protected] www.vega.com ISO 9001 All statements concerning scope of delivery, application, practical use and operating conditions of the sensors and processing systems correspond to the information available at the time of printing. © VEGA Grieshaber KG, Schiltach/Germany 2007 Subject to change without prior notice 32548-EN-070611
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