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The deve\u00adlo\u00adp\u00adment and manu\u00adfac\u00adture of products used in highly sensi\u00adtive areas such as food produc\u00adtion is also stan\u00addard for us. Examp\u00adles include screw convey\u00adors, pistons, housings and meter\u00ading need\u00adles. With the intro\u00adduc\u00adtion of our FG product range, we respon\u00added very early to the requi\u00adre\u00adments arising from Regu\u00adla\u00adti\u00adons (EC) 1935\/2004 and (EU) 10\/2011.<\/p>\n
We offer a wide range of mate\u00adri\u00adals that meet the requi\u00adre\u00adments of EU Regu\u00adla\u00adtion 10\/2011 as well as the US FDA Regu\u00adla\u00adtion. The basic aim of both regu\u00adla\u00adti\u00adons is to prevent subs\u00adtances from migra\u00adting from the plas\u00adtic mate\u00adrial into the product.<\/p>\n
When orde\u00adring, we require the indi\u00adca\u00adtion that the product is to be manu\u00adfac\u00adtu\u00adred in accordance with the requi\u00adre\u00adments of EU Regu\u00adla\u00adtion 10\/2011. Our process then begins with item crea\u00adtion, order entry and mate\u00adrial allo\u00adca\u00adtion and conti\u00adnues through the entire manu\u00adfac\u00adtu\u00adring process. All process and manu\u00adfac\u00adtu\u00adring steps at our company and, if appli\u00adca\u00adble, also at our suppli\u00aders are control\u00adled, docu\u00admen\u00adted and carried out within the frame\u00adwork of Regu\u00adla\u00adtion (EC) No. 2023\/2006 \u2013 Good Manu\u00adfac\u00adtu\u00adring Prac\u00adtice (GMP).<\/p>\n
You will receive a certi\u00adfi\u00adcate with all TEPLAST FG products upon deli\u00advery. This lists the mate\u00adrial-speci\u00adfic migra\u00adtion values (OML and SML) and data on the manu\u00adfac\u00adtu\u00adring process and tracea\u00adbi\u00adlity. TEPLAST FG products are ther\u00ade\u00adfore 100 percent legally compli\u00adant and EU-compli\u00adant. If the EU 10\/2011 requi\u00adre\u00adment is only brought to our atten\u00adtion after deli\u00advery, certi\u00adfi\u00adca\u00adtion is usually no longer possible.<\/p>\n
FDA-compli\u00adant plas\u00adtics are clas\u00adsi\u00adfied as compli\u00adant by the semi-finis\u00adhed product manu\u00adfac\u00adtu\u00adrer over a longer period of time. So if you choose an FDA compli\u00adant plas\u00adtic for your product, we can also issue the FDA decla\u00adra\u00adtion of compli\u00adance after\u00adwards. Tracea\u00adbi\u00adlity is not a manda\u00adtory part of FDA.<\/p>\n
The data sheets for this mate\u00adrial and other mate\u00adri\u00adals can be found in our down\u00adload center.<\/p>\n<\/div>