Declaration of conformity VEGAPULS 64 Antenna versions PTFE VO (EG) 1935/2004 and VO (EU) 10/2011 as well as acc. to FDA 21 CFR 177.1550 and USP Class VI as well as ADI-free Document ID: 53317
Editing status: 2019-02-06 2
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 27.10.2004 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 22.12.2006, 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 14001. 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 2011. 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 VEGAPULS 64 3
first contact with the foodstuff. In the process, damages on the seal represent a hygienic risk. To avoid this, the seals must be checked regularly on damages and appropriate measures must be taken (e.g. exchange), if necessary. 4 VEGAPULS 64
Issue date: 20.09.2018 Issued by: VEGA Grieshaber KG Am Hohenstein 113 77761 Schiltach We herewith declare that the wetted parts of the hygienic fitting versions with encapsulated antenna system of PTFE of VEGAPULS 64 listed in the following table 1 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 177.1550 or stainless steel alloys (such as e.g. 316L) proven over years in the pharmaceutical and food processing industry. PS64(*).**[H/I]**[I/J/T/U/V]******[M] consisting of: Feature in the type code [H/I] ** I/J T/U/V Wetted materials 316/316L PTFE T - PTFE/FKKM Kalrez (6230) U - PTFE/FKM (75.5/VA75F) V - PTFE/EPDM (70.10-02) Migration tests in accordance with VO (EU) 10/2011 have shown that PTFE TFM 1600 is suitable for all types of foodstuffs under the following test conditions Test conditions: 1 x 10 ppb screening with 95 % ethanol for 24 h with reflux 1 x global migration with 95 % ethanol for 24 h with reflux 1 x global migration with 3 % acetic acid for 30 minutes at 130 C (sterilization conditions) and 10 days (storage conditions) at 60 C 10 ppb screening: Limit value for non-valuated substances 20 µg/kg Global migration: Limit value with global migration 10 mg/dm 2 Organoleptic test: The proof of the organoleptic requirements according to DIN 10955 was provided for drinking water at 100 C for a test period of 30 minutes. The evaluations are based on a surface/volume ratio of 6 dm 3 per kg of food under the stated test conditions. Other conditions may require recalculation and evaluation. The supplier of the raw material has provided the statement that the material is ADI-free (BSE/TSE) and the statement on USP Class VI at 70 C. The following table lists the conformity statements of our seal suppliers for the optional seal versions. Seal feature in the type code VEGAPULS 64 Sealing material Standard T FKKM Kalrez (6230) FDA 21 CFR 177.2600 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) 121 C EC 1935/2004 5
Seal feature in the type code Sealing material Standard U FKM (75.5/VA FDA 21 CFR 177.2600 (a-f) V EPDM (70.10-02) EC 1935/2004 USP XXXII Ed. 2009 Class VI <88>, 70 ADI free resp. TSE/BSE related substances GB 4806.11-2016 National standards for food safety Rubber materials and articles for food contact FDA 21 CFR 177.2600 (a-f) 3-A Standard 18-03 Class 2 NSF (Standard 51) for food till 100 C USP class VI, <87>; and <88> (121 C) ADI free resp. TSE/BSE related substances 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 VEGAPULS 64
Issued by: VEGA Grieshaber KG Am Hohenstein 113 77761 Schiltach We herewith declare that the wetted parts of the versions with encapsulated antenna system of PTFE of VEGAPULS 64 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 177.1550 or stainless steel alloy (such as e.g. 316L) proven over years in the pharmaceutical and food processing industry. PS64(*).**[F/G]**[I/J]******[M]: Feature in the type code [F/G] ** [I/J/K/L] Wetted materials 316/316L PTFE Migration test in accordance with VO (EU) 10/2011 has shown that PTFE Inoflon M290 is suitable for all types of foodstuffs under the following test conditions. Test conditions: 1 x 10 ppb screening with 95 % ethanol for 24 h with reflux 1 x global migration with 95 % ethanol for 24 h with reflux 1 x global migration with 3 % acetic acid for 30 minutes at 130 C (sterilization conditions) and 10 days (storage conditions) at 60 C 10 ppb screening: Limit value for non-valuated substances 20 µg/kg Global migration: Limit value with global migration 10 mg/dm 2 The evaluations of the migration tests are based on a surface/volume ratio of 6 dm 3 per kg of food under the stated test conditions. Organoleptic test: Proof of compliance with the organoleptic requirements was provided with drinking water at a surface/volume ratio of 0.5 dm 2 /1 l and a test duration of 5 minutes at 100 C in accordance with DIN 10955. Furthermore the supplier of the raw material has provided the statement that the material is ADI-free (BSE/TSE) and the statement on USP Class VI at 70 C. 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. VEGAPULS 64 7
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 2019 VEGA Grieshaber KG Am Hohenstein 113 77761 Schiltach Germany Phone +49 7836 50-0 Fax +49 7836 50-201 E-mail: info.de@vega.com www.vega.com