Verfahren zur Herstellung eines Stopfens mit Septum für Medizinischen Behälter, Stopfen und Polymerzusammensetzung für das Septum

Details

Veröffentlichungs-Nr.

EP4523883

Aktenzeichen

EP24200223

Anmeldetag

13. September 2024

Veröffentlichung

19. März 2025

Rechtsraum

EP

IPC

B29C45/16A61J1/14B65D51/00// B29L31/56

Abstract

The present invention provides a manufacturing method for a stopper (7) used in medical containers, the stopper (7) having a septum (3b) and a housing (6) supporting the septum (3b) , the manufacturing method comprising firstly creating the septum (3b) using a first molding process with a thermoplastic elastomer composition; then creating the housing (6) using a second molding process with a plastic composition, by the second molding process the septum (3b) being pre-compressed in a radial direction perpendicular to a needle penetration direction of the septum (3b); and subjecting the stopper (7) to a steam sterilization, wherein after the septum (3b) experiences the steam sterilization, the septum (3b) exhibits a residual pre-compression level of 12% to 30% in the radial direction compared to when the septum (3b) is uncompressed, and the residual pre-compression level is measured based on a thickness or average diameter of the septum (3b).

Anmelder

Firma

TSRC Corporation

Land

🇹🇼 Taiwan

Fachgebiete