Operating Instructions
Contents
1. Declaration FDA VEGAFLEX 83 BH Document ID 43113 1 General information VEGA 1 General information 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 Always use a suitable FDA approved process seal The USP United States Pharmacopeia is an official authority issuing the quality standards for drugs and medical products USP checks and documents also food additives as well as materials and their ef fect on living tissue Regulation EC No 1935 2004 of 27 10 2004 aims at securing a protective level for human health and the consumer of objects and materials coming into contact with foodstuffs The main focus of the regulation is ensuring that good manufacturing practices are main tained For us the first aspect of good manufacturing means realizing the goal of ensuring that components potentially coming into contact with foodstuffs are designed so that under foreseeable conditions a migration of constituent substances is largely avoided or does not oc cur in quantities that endanger human health or cause unacceptable changes in the composition or organoleptic properties of the material We fulfill these general requirements by purchasing components delivered with proof of compliance with FDA requirements an2. d when it comes to materials not subject to explicit FDA requirements by obtaining a No Objection Letter from the Public Health Service of the Food and Drug Administration as well as requesting the expert opinion of independent accredited laboratories and organizations 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 VEGAFLEX 83 e VLLOVIL NA EL LED 43113 EN 140114 2 Manufacturer declaration 2 Manufacturer declaration We hereby declare that the materials of the product contacting parts of the following versions of VEGAFLEX 83 meet the requirements of the Food and Drug Administration Furthermore the wetted plastics and elastomers of the following ver sions of VEGAFLEX 83 meet in their composition the requirements according to USP Class VI For the following versions of VEGAFLEX 83 the goals of directive EC No 1935 2004 of 27 10 2004 are fulfilled Versions Listing VEGAFLEX 83 foodstuffs FX83 Brerrmea Ex83 peer FX83 F were Exa Hee FXB3 genre EXga A This declaration is based on the following certificates e The official statement of the Public Health Service of the Food and Drug Administration on the implemented stainless st
3. eels College Park MD 20740 of 22 11 2004 e The official statement of the supplier of the isolating sleeve of PEEK LSG and the O rings of FKM FFKM PPE and EPDM on conformity with FDA as well as USP Class VI regulations 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 43113 is explicitly shown on the type label or the accompa nying documentation VEGAFLEX 83 e 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 43113 EN 140114 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
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