Declaration of conformity VEGAFLEX 83

Transcription

1 Declaration of conformity VEGAFLEX 83 acc. to VO (EG) 1935/2004 and VO (EU) 10/2011 as well as acc. to FDA 21 CFR and USP Class VI as well as ADI-free Document ID: 53455

2 Editing status:

3 CFR 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 beverage and cosmetics industries (Code of Federal Regulations CFR). We meet these basic requirements by implementing sensor variants made of materials whose composition corresponds to the relevant 21 CFR's 177. For materials for which 21 CFR's 177 are not applicable, we refer to the current state of knowledge of independent experts from the pharmaceutical and food sectors or to statements of the Public Health Service of the Food and Drug Administration. EG 1935/2004 Regulation (EC) No. 1935/2004 of is aimed at ensuring a high level of protection of human health as well as the safety of consumers, respecting articles and materials intended to come into contact with food. Along with this regulation, individual measures can be implemented. For plastics, this is for example regulation (EU) no. 10/2011. The special focus of the regulation is on compliance with good manufacturing practice. We understand the principal aspect of good manufacturing 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. GMP EG 2023/2006 Under the second aspect of good manufacturing practice (GMP) acc. to EG 2023/2006 of , 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 management system according to ISO 9001 and ISO USP The USP (US Pharmacopial Convention) is a non-commercial organisation for development and formulation of requirements and standards for the identity, quality and purity of drugs as well as food components and supplements. If confirmations of the supplier for plastics or elastomers on USP Class VI are available, the we confirm this for the respective concerned versions. ADI-free (BSE/TSE) Free from substances with animal origin or substances associated with TSE (Transmissible Spongioform Encephalopathy) or BSE (Bovine Spongioform Encephalopathy). This can also mean the risk assessment of the manufacturer in the case of possible unintentionally introduced ingredients of animal origin and the elimination of ingredients of animal origin by longterm processing temperatures above 200 C, e.g. according to EMEA/410/01 of July If confirmations of the supplier are available that plastics or elastomers are ADI-free, then we refer to this for confirmation for the concerned versions. Notes on proper use The conformity declaration contains no information on additional hygienic aspects or cleanability, e.g. absence of gaps and undercuts, surface quality. If hygienic design is required, we recommend our instrument versions, for which conformity with "3A or EHEDG" is also confirmed. To ensure that there is no unintentional contamination to the process through transport, installation or mounting, a rinsing with a suitable cleaning medium (e.g. drinking water) is required before the VEGAFLEX 83 3

4 first contact with the foodstuff. 4 VEGAFLEX 83

5 Issue date: Issued by: VEGA Grieshaber KG Am Hohenstein Schiltach We herewith declare that the wetted parts of VEGAFLEX 83 listed in the following table are made of materials meeting in the composition with regulation VO (EC) No. 1935/2004 and VO (EU) 10/2011 as well as FDA 21 CFR or stainless steel alloys (such as e.g. 316L) proven over years in the pharmaceutical and food processing industry. FX83(*).**[F/H/G/I]**[C/T/E]***M Feature in the type code F/G/H/I Process fitting C/T/E Wetted materials (BN) (BN) PEEK LSG In conjunction with seal: C - Freudenberg EPDM 291 T - FEPM (602 Extreme-EPT, COG) E - FFKM (Kalrez 6221) Migration test in accordance with VO (EU) 10/2011 on a PEEK LSG component have shown that PEEK LSG is suitable for all types of foodstuffs under the following test conditions. Criterions for the plastic in contact with the media "PEEK LSG" Test conditions: Test on total migration (OML): Organoleptic test: The test for total migration and specific migration on PEEK LSG test samples was performed under the following test conditions: 3 x 4 h at reflux temperature in 3 % acetic acid (simulant B), in 10 % ethanol (simulant A) according to EN and 4 x for 2 h at 175 C in olive oil (simulant D2) according to EN A contact area of 0.9 dm 2 was compared with a simulant volume of 100 ml. Compliance with the limit value for total migration 10 mg/dm 3 has been proven The proof of the organoleptic requirements according to DIN was provided for food-grade oil at 175 C for a test period of 30 minutes. The following substances were tested on the specific limit value (SML): Substance 4.4'-difluoronbenzophenone dihydroxybenzene 0.6 Component A (subject to secrecy) 3 Component B (subject to secrecy) 0.05 SML [mg/kg] Result: Compliance with the SML has been proven for all substances. The PEEK LSG is therefore suitable for contact with all types of food under the test conditions mentioned. Furthermore, the supplier of the PEEK LSG semi-finished product confirms: Safety with regard to BSE and TSE based on the requirements of EMEA/410/01 Rev. 03, July 2011 VEGAFLEX 83 5

6 USP Class VI Chapter <88> (In Vivo) C The following table lists the conformity statements of our seal suppliers for the optional seal versions. Seal feature in the type code C T Sealing material Freudenberg 70 EP- DM 291 FEPM (602 Extreme- ETP, COG) Standard (EG) No. 1935/2004 FDA 21 CFR A Sanitary Standards Class II USP class VI, Chapter <87> (In Vitro) and Chapter <88> (In Vivo) C NSF 51 ADI-free FDA 21 CFR USP Class VI up to +121 C (EG) No. 1935/2004 CIP, SIP and WFI-tested Resistance in use with animal and vegetable fats ADI-free E FFKM (Kalrez 6221) FDA 21 CFR EG VO No. 1935/2004 (only on FDA basis and EG 2023/2006) USP class VI, Chapter <87> (In Vitro) and Chapter <88> (In Vivo) C USP class VI, <87>; and <88> (121 C) Note: The supplier does not confirm that the Kalrez 6221 is ADIfree! The traceability of the wetted parts and materials according to VO (EG) 2023/2006/GMP is guaranteed by our QM system from procurement to production and assembly up to placing on the market. 6 VEGAFLEX 83

7 Notes VEGAFLEX 83 7

8 Printing date: 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. Subject to change without prior notice VEGA Grieshaber KG, Schiltach/Germany 2018 VEGA Grieshaber KG Am Hohenstein Schiltach Germany Phone Fax