Medical Device Components | #Polyisoprene molded medical components


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Polyisoprene molded medical components

Medical Device Components | #Polyisoprene molded medical components

USP <381> compliant polyisoprene materials for molded medical components meets stringent Type I requirements for elastomeric closures in medical devices and drug delivery septa


Especificaciones técnicas

  • Cumplimiento con especificaciones: USP Class VI, USP <381>, FDA Regulation 21CFR177.2600,
  • Materiales de fabricación: IIR
  • Industria: Healthcare & Life Sciences, Medical, Bioprocessing & Biopharma
  • Marca: Parker
  • División: Composite Sealing Systems Division

Información del artículo

Parker's synthetic polyisoprene compounds meet or exceed USP <381> Type I requirements for elastomeric closures. In addition, the new polyisoprene elastomers demonstrate exceptional self-sealing capabilities, even with needles as large as 16-gauge. Closures have survived 20 pierce/vacuum test cycles with no trace of leaks. Requiring minimal force for piercing, the new formulations improve both septum performance and user safety, while still offering the strength and other physical/ mechanical properties of traditional polyisoprenes.

 

Product Benefits:

  • Meets USP <381>, ISO 8871, JP 7.03 and EP 3.2.9. guidelines
  • Very low UV absorbance (0.1 to 0.2) 
  • More than two times higher resistance to reducing substances than traditional polyisoprene compounds
  • Improves needle safety for caregivers and their patients with its easy needle penetration: just 3.5% of force limit set by USP <381> 
  • Excellent self-sealing and non-coring even with needles as large as 16-gauge 
  • Tested to withstand 20 piercing/vacuum test cycles without leakage — ideal for multiple-dose or multiple-sample containers
  • No visible fragmentation after penetration which greatly reduces risk of contamination and leakage


Medical Device Application Uses:

  • Pierceable septa for drug delivery
  • Closure seals for diagnostic sampling
  • Duckbill valve seals
  • Catheter port seals

 

Contact us to discuss molded medical component manufacturing utilizing Parker’s USP <381> polyisoprene materials for medical device closures and drug delivery septa.

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Latin American Group Headquarters

Parker Hannifin Ind. e Com. Ltda.

Estrada Municipal Joel de Paula, 900

São José dos Campos

SP

Brasil

12247-015

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