Process For Sterile Filling Of Collyrium Flasks And The Like And Apparatus For Carrying Out Said Process

Abstract

A process for sterile filling of collyrium flasks and the like wherein a flask, a stopper and a filter-holder are placed and sterilized within a closed bag and manipulated from outside the bag in the proper sequence to allow the filling of the flask and the closure thereof prior to removing said flask from said bag.

Description

This invention relates to a process for sterile filling of collyrium flasks and the like as well as to apparatuses for carrying out said process. It is generally recognized and in numerous countries, it is even mandatory to fill up collyrium flasks in sterile conditions. The best method known heretofore to practically meet this requirement comprises sterilizing the flask, its stopper and a filter-holder with a bacteria filter in a sterilization bag suitable therefor, whereupon these elements are removed from the bag or bags to be manipulated with hand under UV-irradiation or not. This direct handling presents a hazard of smearing which cannot be completely excluded even with the said UV-irradiation.

The object of this invention is to allow a simple preparation of collyrium under quite sterile conditions.

For this purpose, there is suggested a process which comprises principally disposing the flask, its stopper and a filter-holder with a bacteria filter in a sterilization bag, closing said bag, sterilizing the bag with its content and, after the sterilization, by manipulating the closed bag from outside, namely by locally distorting it, bringing the flask against the outlet opening of the filter-holder provided that the latter has not been initially disposed on the flask, filling the flask from outside the bag via a syringe and, by manipulating from outside the bag, removing the filter-holder of the flask and bringing the stopper on the latter and then, opening the bag.

The said bag may be closed either by clamping its open end around the filter-holder with bacteria filter so that the inlet opening of the said filter-holder remains outside the bag, or normally in such a way that, before or after the sterilization, a clamping means is adapted outside the bag and around the filter-holder, thereby forming two chambers in the bag, one of said chambers containing the flask, the stopper and the outlet portion of the filter-holder, whereas the second chamber which comprises the inlet portion of the filter-holder, is opened before the injection.

By this way, the flask leaves the sterile bag or a sterile portion thereof immediately after having been filled up and after having been tightened with its drop-stopper. Then, it may be truly question of a quite sterile filling.

In order to carry out said process more easily and more particularly the said handlings, also in accordance with the invention, use may be advantageously made of an apparatus consisting at least of a holder for the flask, a holder for the drop-stopper and a connecting means between said two holders, so that relative turn over and/or translation movements between the flask and the stopper may be induced by manipulation.

Some embodiments of such apparatus will be described hereafter with more details by way of illustration and without any limitation, reference being made to the enclosed drawings in which :

FIG. 1 is a front view of an apparatus according to the invention in its two characteristic positions;

FIG. 2 shows another embodiment of an apparatus according to the invention;

FIG. 3 shows a longitudinal section of a third embodiment according to the invention;

FIG. 4 is a view taken according to arrow F4 of FIG. 2 and

FIG. 5 shows the apparatus according to FIGS. 3 and 4, immediately before the preparation of a collyrium.

The apparatus according to FIG. 1 comprises principally a holder 1 for the flask 2, a holder 3 for the drop-stopper 4 and, between said two holders, a connecting means 5. The latter is formed, on one hand, by two upright diametral strips 6-7 fixed to the holder 1 and, on the other hand, by two profiled arms 8-9 fixed to holder 3, whereby said strips 6-7 and arms 8-9 are pivotally connected to each other near their ends by means of rivets 10 and 11 respectively. Near their free ends, the said both arms 8-9 have a bent edge portion 12-13 respectively bearing agents the edges of the strips 6 and 7 when the holders 1 and 3 are disposed coaxially.

The two extreme positions of said apparatus are shown respectively on the left hand and on the right hand of FIG. 1.

In the embodiment according to FIG. 2, the connecting means 5 consists of an L-shaped plate 14 in which are provided two slots 15 and 16 at right angles to each other. Two sliders 17 and 18 respectively may be shifted along said slots. The flask-holder 1, under the form of a resilient clamp may be fastened on slider 17, whereas two similar clamps fastened on slider 18 are forming the drop-stopper holder 3.

On plate 14 and at one end of slot 15, is fixed a small bracket 19 with a ring 20. Around said ring 20, may be shifted the outlet side of a filter-holder 21 known per se, the latter being disposed coaxially with holder 1.

In the embodiment shown in FIGS. 3-5, the connecting means 5 is formed by a U-shaped plate 22 with a long leg 23 and a short leg 24, the latter being connected to each other through a cross-piece 25.

On leg 23, is fastened the flask-holder 1 under the form of a resilient clamp.

Practically, with collyrium flasks, a drop-stopper consists of a dropper 4a which may be screwed on the neck of the flask, and of a stopper proper 4b. When using the described apparatus, the dropper 4a is permanently mounted upon flask 2.

In that case, the stoppper-holder 3 consists of a firstly conical and then cylindrical bore passing through the cross-piece 25 and in which the stopper 4b is pushed. The stopper may be tightened in this pushed position by means of a screw 26.

Under the stopper-holder 3, the cross-piece 25 has a bore 27 in which the end of the dropper 4a may be pushed.

The free end of leg 24 has two diverging guide flanges 28 and 29 bent in the direction of leg 23. In addition, the plate 22 is provided with a bore and a bearing piece 30-31 respectively so that an outlet needle 32 of the filter-holder 21 projects also through said bore 27.

When carrying out the process according to the invention by means of any of the above described apparatuses, the flask 2 and the stopper 4 (4b) are firstly fitted in holders 1 and 3 respectively. The filter-holder 21 loaded with a bacteria filter 33 remains either disengaged from the apparatus (FIG. 1) or is mounted on the apparatus (FIGS. 2, 3, 5).

The apparatus and the filter are then pushed in a sterilization bag 34 known per se, said bag being then closed. Before or after the sterilization, the bag is adapted around the filter-holder 21, e.g. by means of a resilient ring 35, thereby forming two chambers 36-37 respectively in the bag. Chamber 36 comprises the loaded apparatus and the outlet end of the filter-holder 21, whereas chamber 37 comprises only the inlet end of the filter-holder.

After the sterilization, chamber 37 is opened by cutting or tearing the bag.

By manipulating the bag from outside, the flask is brought against the outlet opening of the filter-holder by shifting either the whole apparatus (FIG. 1, right position) or the slider 17 (FIG. 2) towards the filter-holder. Of course, the above mentioned opening of chamber 37 could just occur at that point.

With the apparatus according to FIGS. 3-5, this shifting of the flask towards the filter-holder is not necessary.

Then, the flask may be filled up with liquid via the filter-holder and the filter by means of a syringe.

The flask is then removed from the filter-holder (by shifting the whole apparatus (FIG. 1), by shifting the slider 17 (FIG. 2) or by axially shifting the flask (FIGS. 3-5).

The flask and the stopper are then almost coaxially disposed by pivoting the connecting means 5 (FIG. 1) or by shifting the slider 18 (FIG. 2) or by tilting the flask (FIGS. 3-5). The flask is then shifted towards the stopper and screwed therein.

All these handlings have been thus carried out within the still closed sterile chamber 36. The latter may be then closed.

The above mentioned sterilization may of course be carried out with dry heat, steam, radiation and sterilizing gases.

Of course, as regards the apparatus, the invention is not limited to the above described embodiments. For instance, it could be possible to modify the apparatus according to FIGS. 3-5 so that the flask and the stopper are kept normally and substantially coaxial, the needle 32 being thereby resiliently distorted to penetrate the dropper.

The described apparatuses may be also adapted in accordance with the nature and the shape of the used drop-stoppers.

This invention covers also an equipment considered as a new industrial product and consisting of at least a sterilization bag, an apparatus of the above described type and a clamping means intended to divide the said bag into two chambers.

Claims

What I claim is:

1. A process for sterile filling of collyrium flasks and the like, characterized in that it comprises principally disposing the flask, its stopper and a filter-holder with a bacteria filter in a sterilization bag, closing said bag, sterilizing the bag with its content and, after the sterilization, by manipulating the closed bag from outside, namely by locally distorting it, bringing the flask against the outlet opening of the filter-holder provided that the latter has not been initially disposed on the flask, filling the flask from outside the bag via a syringe and, by manipulating from outside the bag, removing the filter-holder of the flask and bringing the stopper on the latter and then opening the bag.

2. A process according to claim 1, characterized in that the said bag is closed by clamping its open end around the filter-holder with a bacteria filter, the inlet opening of said filter-holder remaining thereby outside the bag.

3. A process according to claim 1, characterized in that the said bag is normally closed whereby before or after the sterilization, a clamping means is applied outside the bag and around the filter-holder thereby forming two chambers in the bag so that one of said chambers comprises the flask, the stopper and the outlet portion of the filter-holder, whereas the second chamber, which comprises the inlet portion of the filter-holder, is opened before the injection.