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|Discover the Versatility of EVOPRENE
Evoprene G is ideal for personal hygiene items, baby products and kids toys, and medical devices. Some features:
Hardness range: 10A to 95A
Available clear, translucent, or opaque
Bonds excellent with PP, good with PE
Service temp -50 to +130 deg. C
If recovery properties are important, we recommend Evoprene Super G.
For recommendations, data sheets, etc., please contact us:
978-537-8071 (main number)
FREQUENTLY ASKED QUESTIONS
Are EVOPRENE compounds suitable for food contact applications? Is it recognized by the FDA and in the EU?
Certain EVOPRENE compounds are formulated with additives sanctioned by the US FDA in Title 21 CFR for indirect food contact. In Europe, certain EVOPRENE compounds are based on ingredients approved for use in food contact applications under 2002/72/EC and meeting basic migration requirements.
As formulated thermoplastic compounds, EVOPRENE products are not directly sanctioned by the US FDA. Under US food law (i.e., Food, Drug & Cosmetic Act), FDA recognition is based on the status of the additives. Furthermore, the overall finished article must meet appropriate extraction tests as defined in 21 CFR 176.170 (c).
In Europe, the EU focuses on potential levels of migration to food and adequacy of safety data to support these levels. This is covered under EC 2002/72 and its subsequent amendments as well as under National law in several Member States. We select raw materials only from suppliers who can demonstrate the safety of their products in contact with food. However, it is the responsibility of the end user to satisfy themselves with respect to the overall or global migration into the foodstuffs into which the compound is expected to come in contact.
Do any EVOPRENE grades pass Class VI Biocompatibility testing?
Yes, certain Evoprene compounds are formulated to pass Class VI testing. In fact, various Evoprene compounds have been successfully tested to meet both Class VI and ISO 10993. Our Regulatory Manager can provide information specific to the compound being utilized.
Can EVOPRENE compounds be sterilized / repeat boiled?
We have tested various Evoprene materials to ETO and gamma sterilization and found no adverse affects with typical sterilization methods. Please note that for gamma sterilization, we recommend up to 15 Kilo Grays (1.5 Mrads); some yellowing can occur at higher levels although the physical properties are not affected. We have tested certain grades with repeat boiling and autoclaving (up to 135C / 275F) with the same results. After repeat boiling, certain Evoprene compounds maintain a good, clean, translucent finish and do not distort.
Which fluids can Evoprene compounds be used in contact with?
Evoprene G grades have excellent resistance to water (hot and cold), alcohols, acids (except very strong oxidizing acids such as fuming nitric) and alkalis.
Performance is application dependent so we encourage our customers to test thoroughly in the intended conditions to verify suitability as we are not qualified to make this determination.
Will EVOPRENE re-seal after needle puncture?
Yes, both softer grades of Evoprene Super G and unfilled Evoprene G are being successfully used in applications which require re-sealing after puncture with a needle. Evoprene Super G grades are better when higher sterilization temperatures are used, and they have superior molding capabilities.
How is the clarity of EVOPRENE compounds?
We have both clear and translucent grades. We're happy to supply representative sample plaques upon request. After repeat boiling, many Evoprene compounds have been found to maintain their translucency and show minimal distortion.
Have EVOPRENE compounds been used for baby products?
Yes, quite successfully especially for the one-trip market. Specific Evoprene grades are tested to ensure compliance with the EN14350 Child Use and Care Articles (Drinking Equipment) European Standard. These grades have also been proven to contain zero or certainly less than 1 part per billion of nitrosamines and nitrosatable amines, and there have been no known cases of allergenic reaction to SEBS-based Evoprene compounds.
Can Evoprene compounds be used for tubing?
Yes, certain grades are formulated for tubing applications. Kink resistance can be improved by using special extrusion techniques.
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