FDA - Insatech A/S

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.
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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******
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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.
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VEGABAR 53
32548-EN-070611
Manufacturer declaration
VEGABAR 53
5
Manufacturer declaration
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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
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