Operating Instructions
Contents
1. Declaration FDA VEGAWAVE 63 BH Document ID 36199 1 General information VEGA 1 General information Foodstuffs Pharmaceutical FDA stands for Food and Drug Administration a U S authority Among other things this authority issues a regulation on the use of product contacting materials in the pharmaceutical food and bever age and cosmetics industries Code of Federal Regulations CFR Regulation EC No 1935 2004 of 27 10 2004 is aimed at ensuring a high level of protection of human health as well as the safety of com sumer articles and materials intended to come into contact with food The special focus of the regulation is on compliance with good manu facturing practice We understand the principal aspect of good manu facturing practice to be making sure that parts with potential food contact are designed so that at least under foreseeable conditions the migration of constituent substances is largely avoided or does not occur in quantities that would endanger human health or bring about unacceptable changes in composition or organoleptic properties We meet these general requirements by purchasing parts and materials that will potentially come into contact with food with proof of compliance with FDA requirements or in cases where there are no explicit FDA requirements with a No Objection Letter from the Public Health Service of the Food and Drug Administration or by obtaining the expert opinion of indepe2. lth Service of the Food and Drug Administration on the implemented stainless steels College Park MD 20740 of 22 11 2004 Furthermore it is the responsibility of the operator to ensure compli ance with any additional food and process specific requirements Note This declaration is valid for instruments on which the document number 36199 is explicitly shown on the type label or the accompa nying documentation VEGAWAVE 63 Printing date VEGA All statements concerning scope of delivery application practical use and operat ing conditions of the sensors and processing systems correspond to the information available at the time of printing Subject to change without prior notice C 36199 EN 140527 O VEGA Grieshaber KG Schiltach Germany 2014 VEGA Grieshaber KG Phone 49 7836 50 0 Am Hohenstein 113 Fax 49 7836 50 201 77761 Schiltach E mail info de vega com Germany www vega com
3. ndent accredited laboratories and organizations in cases where uncertainties still exist Under the second aspect of good manufacturing practice we understand ensuring the traceability of components and products potentially coming into contact with foodstuffs throughout all stages of manufacturing and sales This is guaranteed by our quality manage ment system according to ISO 9001 und ISO 14001 Generally use a suitable process seal meeting the product specific requirements VEGAWAVE 63 Z S0v L N3 6619 36199 EN 140527 2 Manufacturer declaration 2 Manufacturer declaration We hereby declare that the materials of the product contacting parts of the following versions of VEGAWAVE 63 meet the requirements of the Food and Drug Administration Furthermore we confirm that the following versions of VEGAWAVE 63 fulfil the safety objectives of Regulation EC No 1935 2004 of 27 10 2004 Process fittings Thread WE63 GD WE63 ND Flange WE63 9p WE63 3F WE63 AU WE63 BU WE63 CU WE63 EF WE63 EK WE63 HA WE63 HE WE63 1A WE63 JAt WE63 KE WE63 MF WE63 OA WE63 OE WE63 OF WE63 PA WE63 Qp WE63 SA WE63 UA WE63 ZF Clamp WE63 CA This declaration is based on the following certificates e Opinion letter of the Public Hea
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