No need for Bisphenol A

Since spring 2011 it has also in Germany no longer been allowed to sell articles for babies like soothers and feeding bottles containing suspicious softeners like Bisphenol A (BPA). A. Hopf GmbH Kunststoffverarbeitung have given proof of designing alternative 3-way Stopcocks in BPA-free material and to deliver them by serial production.
Due to safety measures, driven by the French Government and the Danish Government in Europe, the European Commission has published the Commission Directive 2011/8/EU. The European Union put pressure on the industry to remove nonconforming feeding bottles from commerce and supermarket shelves according to the European Commission’s Directive 2011/8/EU of Jan. 28th 2011 as regards the restriction of use of Bisphenol A in plastic infant feeding bottles, amending the Directive 2002/72/EEC.

The European Union responded to numerous scientific studies proving the influence of the softener Bisphenol A on the human endocrine system, especially on babies. Polycarbonate is one of the resins produced on the base of BPA. Because of the contact of suspicious softeners, especially Bisphenol A (BPA) with nutrition or food for babies, a heating of the related plastics can lead to the consumption of small amounts of BPA within the feeding. A. Hopf GmbH Kunststoffverarbeitung in Zirndorf Germany, a company specialized in the field of the design and production of medical devices for enteral nutrition and parenteral (I.V.) applications, has already – because of these facts – started to design and develop alternative 3-way Stopcocks in BPA-free material for two years now and is also ready to deliver them by serial production. Sales director Alexander Hopf states, “already at Compamed 2010 we were able to show Stopcocks and Y-Connectors ready to market and production.” 

Describing the features of the related above-mentioned products, A. Hopf emphasizes “good clarity, good chemical properties like lipid resistance and welding with tube systems, a high shape and colour stability upon ETO and gamma sterilization and a good heat resistance.” It is expected that, especially in the enteral field, which use predominately liquids containing lipid sources, a shift to BPA-free materials will happen, because these liquids increasingly tend to absorb softeners like BPA from plastics. Further limitations of established materials might be taken into consideration by Directives, regulations and standards. Additionally Hopf offers BPA-free 3-way stopcocks and y-connectors which are secure from mix-ups between enteral and parenteral applicatons. 

Applications for these innovative products are – besides enteral nutrition – the use with cytostatics in cancer therapy and in the area of Infusion and transfusion therapy (e.g. blood therapy). Relating on the used raw material the demands of USP Class VI and FDA/ISO 10993 are fulfilled. It is the responsibility of the system integrator to evaluate its final product under actual end-users’ requirements. 

German Summary
Seit dem Frühjahr 2011 dürfen u.a. in Deutschland bei Babyartikeln wie Schnuller oder Babyflaschen fragwürdige Weichmacher wie Bisphenol-A (BPA) nicht mehr enthalten sein. Dass es möglich ist, marktreife und produktionsfertige BPA-freie 3-Wege Hähne und Y-Konnektoren herzustellen, zeigt die A.Hopf GmbH. Der deutschsprachige Beitrag ist nachzulesen auf www.meditec-international.com/medi0611bpa

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