PHARMACEUTICAL PLUG, PISTON OD. DGL. AND METHOD FOR PRODUCING PHARMACEUTICAL PLUGS, PISTON OD. DGL.

摘要

1. A method for producing a pharmaceutical stopper, piston or similar seal (2-2f) which consists essentially of rubber or a similar elastomeric material and serves to close or subdivide a bottle (1), a barrel (22) of a syringe, or a similar container, the stopper, piston or the like having in a sealing area facing the interior (6) of the container a coating of a fluorinated polymer film (8) or similar inert film only partly surrounding said sealing area of the stopper at the side thereof facing the wall of the container opening, so that a further part of the uncoated sealing area of the stopper sealingly butts against the container opening (3), characterized in that the stopper or the like is produced in several working steps, in the first step an unvulcanized rubber sheet (46) together with a fluorinated polymer film or similar inert film (8) is initially pressed into a calibre plate (41) of a first moulding tool (45) and then corresponding portions of the polymer film or the like (8) and of the rubber sheet (46) assume the outer contour corresponding to the hollow mould(s) (47) provided in the calibre plate (41), polymer film or the like (8) resting against the wall of the hollow mould (47) being inseparably connected under the influence of heat to the part of the rubber sheet (46) lying within and being vulcanized to form in each case one inner sealing part (46a) of the stopper (2), that in the next working step the inner sealing parts (46a) of the stopper (2) which have thus been formed and are coated with the fluorinated polymer or the like (8) are removed from the first moulding tool (45) and in the next working step are punched out of the coated rubber sheet (46) in such a manner that the upper edge (52) of each inner rubber sealing part (46a) protrudes somewhat radially with a diameter (D2) beyond the diameter (D1) given by the hollow mould (47), that in the next working step in which the inner sealing part (46a) is placed in the hollow mould(s) (47a) of a second moulding tool (48, 48a) said protruding upper edge (52) upwardly (at 51) seals said hollow mould(s) in such a way as to prevent that in the next working step, when the inner sealing part (46a) is joined to an outer part (5) of the stopper, unvulcanized rubber material of the subsequent outer part of the stopper enters the area between fluorinated polymer film or the like (8) and the wall of the hollow mould (47a, 47b) of the second moulding tool (48, 48a).