HIRSCHEL, Jürg,HOSTETTLER, Patrick,SCHEURER, Simon
申请号：
IBIB2018/050143
公开号：
WO2018/130944A1
申请日:
2018.01.10
申请国别(地区):
IB
年份:
2018
代理人:
摘要：
A method for sterilizing a fluid path unit (25) for an injection device comprising the steps of: a) providing an empty cartridge (26) having a glass barrel (125) and a septum (27) connected to the distal end of the glass barrel (125) using a crimp (27a), b) providing a fluid path comprising a spike (31) adapted for piercing the septum of the cartridge (126) and a needle (36) adapted for piercing the skin of a patient, the spike (31) and needle (36) being interconnected preferably by a tubing (43). The fluid path unit (25) furthermore has a first cavity (127) encapsulating the spike (31) and the needle (36) and a second cavity (128) adapted to receive the distal end of the cartridge (126), the first and second cavity being connected to each other and having a passage (130) there between adapted to receive the spike (31) of the fluid path. The following steps are also part of the sterilization method: c) inserting the empty cartridge (26) into the second cavity (128) of the fluid path unit (25), d) fixating the empty cartridge (26) to the fluid path unit (25), e) sterilizing the first cavity (127) of the fluid path unit, and the method is characterized by that the empty cartridge (26) having a glass barrel (125) and a septum (27) connected to the distal end is provided with a sterile interface (126) between the glass barrel (125) and the septum (27) and that in step f) the empty cartridge (126) is filled with a medicament (134) after step e).La présente invention concerne un procédé de stérilisation d'une unité de trajet de fluide (25) pour un dispositif d'injection comprenant les étapes consistant à : a) utiliser une cartouche vide (26) comprenant un cylindre en verre (125) et un septum (27) relié à l'extrémité distale du cylindre en verre (125) à l'aide d'un sertissage (27a), b) utiliser un trajet de fluide comprenant un perforateur (31) conçu pour percer le septum de la cartouche (126) et une aiguille (36) conçue pour percer la peau d'un patient, le perforateur (31
