Fluent material handling – with receiver or receiver coacting mea – Processes – Gas or variation of gaseous condition in receiver
Patent
1986-01-10
1987-11-03
Bell, Jr., Houston S.
Fluent material handling, with receiver or receiver coacting mea
Processes
Gas or variation of gaseous condition in receiver
141 11, 141 83, 141 95, 141350, 141 70, B67C 700
Patent
active
047037814
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a method for manufacturing a prefilled single-dose syringe, comprising on one hand an ampoule open at one end, provided with a neck of contricted section for containing a medicine to be injected, and on the other hand an injector composed of a capsule adaptable to the ampoule neck and a piston-valve solid with the capsule and adapted for insertion into the ampoule, wherein the ampoule containing the medicine to be injected and the injector are conveyed via two separate paths to the same assembling station, these two components are positioned above one another and brought together for assembly, and wherein gassing of the ampoule or of the ampoule and of the injector is effected prior to assembly of these components, in said assembling station.
It likewise relates to an installation for manufacturing a prefilled single-dose syringe, for carrying out said method, comprising means for gassing the ampoule or the ampoule and the injector, before or during assembly of these two components.
There are numerous known automatic installations for assembling disposable syringes which generally consist of a syringe body and a piston engaged in this body. These installations are generally of conventional design, the precautions to be taken to avoid contamination of the components as well as to control the assembly are well known and the means for their implementation are relatively simple.
It is quite different in the case of prefilled syringes of the single-dose type having components which must be mechanically manipulated with particular precision and care and where new operations such as filling of the ampoules take place in the course of assembly.
The requirements with regard to filling are extremely strict, given that the objective to be achieved consists in introducing the medicine into the syringe and in hermetically sealing the latter, in such a manner that the atmosphere above the medicine in the syringe consists exclusively of a gas selected as a function of the medicine, for example a neutral gas, that is to say it should be free of solid particles, of contaminants, of oxygen or oxygenous substances.
To meet these requirements, one could of course use the well known techniques consisting in mounting the installation in a room with a controlled neutral atmosphere. Due to the installation's costs and the important technical means for its implementation, the choice of such a solution constitutes a serious handicap for the widespread use of prefilled single-dose syringes.
Another technique has been utilized to effect gassing of the ampoule after it has been filled and during mounting of the piston in certain prefilled syringes comprising an ampoule which in fact constitutes the body of the syringe and a piston which closes off one of the extremities of this body. This technique consists in squeezing the piston between two jaws so as to reduce its diameter, and in injecting a selected gas between the inner wall of the syringe body and the piston, on one side of the latter, in such a manner that the gas may escape on the other side.
Such a procedure does not ensure that the gas does not drive solid particles or oxygen towards the interior of the syringe body and does not permit an overpressure of the gas to be built up within the syringe.
Moreover, the present techniques do not allow this ampoule gassing operation to be controlled qualitatively, nor quantitatively, and consequently to stop production in case defects are observed.
Another requirement imposed on the method is that of controlling the manufactured products. It is known that the sealed ampoules presently containing most medicines intended for injection, are subjected to an optical control which permits in principle to verify the absence of solid particles, and a control of airtightness called "blue bath control" which consists in immersing the ampoule in a coloured liquid bath and in verifying each ampoule individually to detect the possible presence of coloured liquid in the medicine ampoule.
Needless to say this control
REFERENCES:
patent: 4457877 (1984-07-01), Love et al.
Howald Ernst
Meyer Gabriel
Bell, Jr. Houston S.
Cosmonor S.A.
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