Process for the preparation in a series of self-injectable syringes in a sealed container, for lyophilized medications, and device for the implementation of said process

Claim 1

Process for the preparation in a series of self-injectable syringes for lyophilized medications, arranged in a sealed tube, each of said syringes comprising a tubular body whose lower end is adapted to accommodate an injection needle and a plunger comprising a shaft, whose lower end is provided with a part having an enlarged section capable of sliding with friction inside said tubular body and whose upper end comprises an enlarged end forming a pusher, said process comprising: sealing the lower ends of said tubular bodies using movable seal means; vertically disposing multiple seal tubes on an appropriate support, which holds them so that their upper open ends are essentially at the same level, the said seal tubes being large enough so that they can contain the syringe-plunger assembly; vertically disposing a syringe body in each seal tube; maintaining the said syringe body in a manner such that the seal tube and the syringe body which it contains are arranged in an essentially coaxial manner; introducing a single dose of the medication in solution in a solvent in each tubular body thus arranged; disposing a plunger suspended by its pusher in each seal tube, above the syringe body, in a movable manner, at the lower end of a stopper which can adapt to said seal tube, so that said plunger is essentially in the axis of the syringe body and the lower end of said plunger is located above the upper end of the syringe body, with said stopper being held in a position so that said seal tube is not blocked or is not entirely blocked, so as to obtain an assembly comprising an open system in which the internal space, in the seal tubes and above said solution in the syringe bodies, communicates with the outside of the system; introducing said system into a lyophilized device; effecting a lyophilization operation; introducing an inert gas into the lyophilization device at a predetermined pressure which is lower than atmospheric pressure; applying a downward vertical pressure to said stoppers, so that said stoppers completely block the seal tubes while said plungers fastened to said stoppers, are introduced into said tubular bodies until a predetermined maximum insertion position is reached; and subsequently, introducing said inert gas into the lyophilized device until the pressure reaches atmospheric pressure.