Method of transferring articles, transfer pocket and enclosure

Method of transferring articles (1) contained in a closed transfer pocket (4) into an enclosure, wherein a part S of the wall of the closed transfer pocket (4) is stuck onto a part of the enclosure, there is cut out in the said part S, and from the inside of the enclosure, an opening of sufficient area to allow the passage of the said articles (1), the periphery of the opening of the transfer pocket (4) remaining stuck to the enclosure, and a corresponding opening (13) is made in the enclosure and the said articles (1) are then transferred into the enclosure through the said openings, pocket and enclosure for sterile transfer in particular.

The present invention relates to a method of transferring articles, a 
pocket specially designed for making this transfer and an enclosure also 
specially designed for making the said transfer. 
In many cases, it is desirable to transfer articles from one place to 
another, without the latter being subjected to the action of the 
atmosphere or of the environment though which they pass. An example of 
such a transfer of particular interest is the transfer of sterilized 
objects into a sterile enclosure; another example is the transfer of 
articles in a certain gaseous atmosphere, for example nitrogen or argon, 
into an enclosure containing nitrogen or argon, whilst passing through a 
normal atmosphere. 
A method of transferring articles is always being sought which guarantees 
absolute protection of these articles from the atmospheres through which 
they pass. This method should preferably be simple and inexpensive. 
A known transfer technique is for example the one described in EP-A-0 505 
269 which consists, in order to transfer products from a contaminated 
enclosure into a second enclosure without contaminating the latter, in 
bringing alongside the contaminated enclosure a transport container in 
which there is placed an empty transfer pot. 
With regard to safety systems designed for such transfers, EP-A-0 586 307 
may also be quoted which describes a centralized control mechanism with 
built-in safety arrangements designed for a device with a double door for 
sealed transfer between two closed volumes. 
However, this system does not provide entire protection from contamination 
during the transfer, because of the section of the joints of the double 
door, previously exposed to the non-sterile environment, or because of the 
section of the joints fatigued by the repeated sterilizations of the 
transfer container. 
EP-A-0 537 117 describes an equipment for forming a temporary connection 
for the transfer of objects between discontinuous confined volumes and a 
method in which there is applied a connector provided with a special 
membrane over a window which is also provided with a special membrane 
installed on a compressible ring, the said window comprising a cutting 
annular structure. However, the transfer chamber has a rather complex 
structure at the level of the connector. Furthermore, after use, the 
connector becomes useless unless it is reconditioned (replacement of the 
cut membrane, re-sterilization, . . . . 
That is why the subject of the present invention is a method of 
transferring articles contained in a closed pocket called the "transfer" 
pocket into an enclosure, characterized in that a part S of the wall of 
the closed transfer pocket is stuck onto a rigid part of the enclosure, in 
that there is cut out in the said part S from the outside or preferably 
from the inside of the enclosure, an opening of sufficient area to allow 
the passage of the said articles, the periphery of the opening of the 
transfer pocket remaining stuck to the enclosure, in that a corresponding 
opening is made in the enclosure and in that the said articles are then 
transferred into the enclosure through the said openings. 
The articles to be transferred can be of any nature, and for example can be 
sterile medical equipment, high precision equipment protected from 
particles and more particularly components of the packaging of a medicine, 
such a pumps, bottles, phials, syringes, etc. . . . 
"Pocket" refers to a flexible or semi-rigid bag essentially formed from an 
envelope. 
The transfer pocket can be of any nature adapted to protect the articles to 
be transferred from the action of the atmosphere or atmospheres which the 
latter have to pass through. The more particularly chosen pockets are 
those whose nature is such that they can be traversed by gamma radiation 
for the purpose of obtaining the sterility of the contents of the said 
pocket whilst protecting the said articles from contamination after the 
action of the radiation. Pockets are also chosen whose nature is permeable 
to the action of ethylene oxide. The transfer pocket is preferably made 
from a plastic material like those used for example for packaging sterile 
articles such as probes, syringes, needles, etc. . . and which are 
particularly suitable for sterilization by gamma radiation, in particular 
a plastic material which easily melts when heated. 
The enclosure into which the said articles are transferred is in particular 
any protected or decontaminated enclosure, such as a sterile enclosure, in 
particular an enclosure of Class 10 level (less than 300 particles per 
m.sup.3). This can be an enclosure containing a controlled atmosphere such 
as an enclosure containing an inert atmosphere such as nitrogen, argon, 
etc. . . . 
According to the invention, a part S of the wall of the closed transfer 
pocket enclosing the articles to be transferred is stuck onto a rigid part 
such as a wall of the enclosure. In order to facilitate close adhesion, it 
is understood that the part of the enclosure onto which the wall of the 
transfer pocket is stuck is substantially flat or at least free from 
pronounced reliefs. In the case in which the wall and the enclosure are 
stuck by gluing, this gluing can be in the shape of a disk or can for 
example be annular. 
Then there is cut out, in particular from the inside of the enclosure, an 
opening of sufficient area to allow the passage of the said articles, the 
periphery of the opening of the transfer pocket remaining stuck to the 
enclosure. 
Although the said cutout is produced in practice from the inside of the 
enclosure, given that the latter is generally of much greater size than 
the transfer pocket, there is nothing to prevent the opening from being 
produced from the inside of the transfer pocket, considering its 
flexibility. For example, the latter can enclose a cutting object which, 
because of the flexibility of the transfer pocket, can be grasped from the 
outside and which can then be used to produce the cutout. 
The rigid part of the enclosure on which a part of the wall of the transfer 
pocket must be stuck can be made from a material whose nature allows it to 
be cut, for example with the help of a cutting object; it is then possible 
to make an opening of the same size and at the same time in the wall of 
the transfer pocket and in that of the enclosure. 
However, in a preferred embodiment of the invention, the part S is stuck 
onto a rigid window formed in the enclosure and constituting the desired 
opening into the enclosure. 
In a preferred embodiment, the stuck part S entirely covers the window and 
at least its periphery over a certain width. As mentioned above, this 
stuck part can for example be disk-shaped or annular. 
This width can for example be greater than 0.5 cm, preferably greater than 
1 cm and generally of the order of 2 to 5 cm, even though there is no 
mandatory upper limit except for that determined by utility. 
In an especially preferred embodiment, the window itself comprises means 
for cutting the external wall of the transfer pocket. 
"Window" is understood to refer to an element of the enclosure, articulated 
or not articulated, capable of efficiently and hermetically obturating the 
corresponding opening for the purpose of constituting an effective barrier 
against the external atmosphere, in particular against microorganisms. 
These cutting means can be of any known type, for example a blade, 
particularly of circular shape, which is retracted at the time of sticking 
and which can, for example by means of pressure, be made to protrude from 
the said window in order to produce the cutout. 
In order to facilitate the latter, the said circular cutting blade can for 
example be capable of rotation. 
Instead of a circular blade, it is also possible to use a blade like that 
of a knife, a scalpel or any contusive means capable of operating in a 
continuous manner in a wall, in combination or not with any appropriate 
device allowing the said blade to be displaced, for example with a 
circular movement, in order to produce a corresponding cutout in the 
transfer pocket. 
In an especially preferred embodiment, the cutting means comprise a means 
capable of destroying pathogenic micro-organisms which may be present at 
the location of the cutting, such as a heating device; a heating blade is 
therefore used. The latter does not necessarily have to be cutting, if the 
nature of the transfer pocket makes it possible to produce the cutout by 
melting the material of the transfer pocket. 
Insofar as the periphery of the opening produced in the transfer pocket is 
stuck to the periphery of the window, cutting out in the way described 
above provides protection against any possible external contamination, 
including protection against any contamination coming from the melted 
circumference which is sterilized by the hot metal during the melting. 
It can therefore be seen that it is not necessary for the external surface 
of the enclosure on which the transfer pocket is stuck and the external 
surface S of the transfer pocket to be sterilized, which is a noteworthy 
advantage of the invention. It is on the other hand necessary for the 
opening to be produced within the continuity of the stuck zones. 
The closed transfer pocket containing the articles is itself preferably 
contained inside another pocket which is also closed. The advantage of 
this is additional safety ensuring that the opening of this sterile bag 
makes it possible to deliver into the sterile enclosure products which are 
perfectly free from all forms of contamination: microbial, chemical, 
particulate, or others. 
The articles to be transferred may themselves be contained in a closed 
pocket, called an "internal pocket", which is itself contained inside the 
closed transfer pocket intended to be stuck to the enclosure. 
The sticking of the transfer pocket to the enclosure can be carried out as 
follows: 
In a first variant in which the sticking is a gluing, the window and its 
periphery are treated with an adhesive product, then a part S of the wall 
of the transfer pocket is stuck onto this part. 
It is then possible to provide a certain protection of this zone, which in 
maintained in a laminar flow for example. 
It is also possible to produce the sterility of the latter and to protect 
it by means of a protective film. The latter will in particular be applied 
onto the bag coated with adhesive before producing the sterility of the 
film-adhesive surface assembly. 
In a preferred embodiment, the adhesive is applied onto the transfer 
pocket. As above, it is possible to treat the wall of the transfer pocket 
using an adhesive, or the transfer pocket can originally include an 
adhesive section, preferably protected by a protective film. 
In a particularly preferred embodiment, a flat rigid frame is installed 
inside the transfer pocket before it is closed. This makes it possible to 
produce a flat surface on the transfer pocket, like a drum, which is easy 
to stick onto a flat surface of the enclosure. 
In a particularly preferred embodiment, the flat frame is provided with a 
peripheral groove, making it possible to stretch the part S of the wall of 
the transfer pocket, like the skin of a drum, for example by using a tie, 
preferably elastic, installed in the said groove. 
Thus, and at any time, even when the transfer pocket is already closed, it 
is possible to press the frame against a part of the wall of the transfer 
pocket, to stretch the latter over the frame, and to install around the 
periphery of the latter an elastic or non-elastic tie, provided or not 
provided with a mechanical tightener, in order to produce a kind of 
tambourine. 
If the transfer pocket comprises a pre-existing adhesive surface, protected 
or not protected by a protective film, this operation is carried out where 
the adhesive is. It is also possible, once this kind of tambourine has 
been obtained, to treat its surface with an adhesive which is possibly, 
and preferably, protected with a protective film which can be sterilized 
if desired, either as it is or after it has been installed in another 
pocket called the "external pocket". 
The sticking can also be obtained by other means, in particular by magnetic 
means. In this case, the part of the enclosure on which the pocket is 
stuck and the transfer pocket are provided with magnetic means. It is 
possible for example to place a magnetic disk or a concentric disk and 
ring inside the pocket, whilst the corresponding part of the enclosure is 
made of a magnetic metal such as steel, or a disk made of magnetic metal 
or of magnetic plastic material can be placed inside the pocket, whilst 
attraction means, a magnet or an electromagnet, are provided on the 
enclosure. 
It is of course possible to combine gluing and magnetic attraction when it 
is desired to strengthen the adhesion between the pocket and the 
enclosure. 
The invention also relates to a transfer pocket specially designed for 
using the transfer method as defined above, characterized in that it 
comprises a rigid flat frame provided with a peripheral groove, a part S 
of the wall of the transfer pocket being stretched over this frame like a 
drum skin with the help of a tie, preferably elastic, installed in the 
said groove. 
In a preferred embodiment, the said flat frame has an oval or preferably 
circular shape. Any other shape, such as square, rectangular or polygonal, 
can be used but in this case it is preferable to avoid the use of sharp 
corners and because of this the corners are preferably rounded. 
In another preferred embodiment of the transfer pocket, the flat frame is 
extended towards the inside, for example it extends towards the centre if 
this frame is circular, in order to constitute a barrier to a contusive 
means of opening or to a heating means such as a laser beam, preventing 
the propagation of the latter into the transfer pocket containing the 
objects to be transferred. 
Preferred transfer pockets according to the invention comprise a part S 
which is adhesive or which is rendered adhesive, preferably protected with 
a protective film. 
The invention also relates to an enclosure designed for the use of the 
method described above, characterized in that it comprises a flat window 
with coplanar framing, the said window being able to be provided with at 
least one means of cutting the part S of the wall of the transfer pocket, 
without necessitating the opening of the said window. 
The means of cutting the part S of the wall of the transfer pocket are in 
particular those mentioned above but they are preferably localized on the 
outer rim of the opening. Cutting means are preferred which are heating 
means, protruding through the widow, and in particular producing the 
cutout by melting. 
In order to facilitate the placing of the part S of the transfer pocket on 
the window and better adhesion, an enclosure is preferred which is 
characterized in that the window furthermore comprises means of 
strengthening the adhesion, preferably suction means or magnetic 
attraction means, possibly as well as the framing of the window, allowing 
good adhesion of the part S of the wall of the transfer pocket to the 
enclosure at the level of the window. 
Furthermore, latches can be provided around the window, for example 3, 4 or 
5 of them, making it possible to lock, and also preferably to centre, the 
tambourine with respect to the window. These latches strengthen the 
adhesion of the transfer pocket to the enclosure. They can also serve as 
safety arrangements in the sense that as long as they are not closed over 
the tambourine, it is impossible to open the window. These safety 
arrangements can for example be obtained by electrical contacts made when 
the latches are closed. 
One means of implementing the invention is as follows in the case of 
transferring sterile objects into a sterile enclosure. 
The articles to be sterilized are placed in a first pocket called the 
"internal pocket" which is closed and, if desired, provided with a 
sterilization indicator. In the transfer pocket there is placed, on the 
one hand, the internal pocket containing the articles and, on the other 
hand, a flat circular frame provided with a peripheral groove. This 
transfer pocket is then closed and the surface of a part of the said 
transfer pocket is stretched over the frame, and this part is kept 
stretched by means of an elastic band placed in the peripheral groove. An 
adhesive is then placed on this part and it is provided with a protective 
film. If desired, this pocket is also provided with a sterilization 
indicator. Preferably, the assembly is then placed in another pocket, 
called the "external pocket" and the whole is subjected to sterilization 
by gamma radiation. 
The assembly of three pockets is then transported to the enclosure in which 
the articles must be placed. The external pocket is then opened and, if 
desired, it is checked, by means of the indicator or indicators, that the 
sterilization has been carried out correctly. The part S of the transfer 
pocket is placed opposite the window and, after having withdrawn the 
protective film, this part is stuck to the window after having started up 
the suction device with which the latter is provided. Preferably, the 
enclosure is provided with guides making it possible to correctly position 
the frame opposite the window. Thus the transfer pocket is perfectly stuck 
to the window of the enclosure. The cutting out of an opening in the part 
S of the transfer pocket is then carried out by pushing a handle with 
which the window is provided on its internal side which causes cutting and 
heating blades to protrude outside the window and at the same time makes 
an electrical contact allowing the said device to be heated up 
sufficiently to melt the wall of the transfer pocket. Thus, at the same 
time as the cutout is being produced, the microorganisms which may be 
present at the level of the said cutout are destroyed; the other 
microorganisms are blocked or killed by the glue, given that the wall of 
the transfer pocket is stuck up to the edge of the window. It is then 
possible to proceed with the opening of the window, and with the transfer 
of the articles. The opening of the window and the transfer of the 
articles can be carried out for example by using sleeves with which the 
enclosure is provided, allowing the manipulator's arms to be inserted in 
these sleeves in order to carry out the desired manipulations. Such 
enclosures are for example of the type used for caring for immunodepressed 
persons who must be placed in a sterile atmosphere or for carrying out 
dangerous manipulations or manipulations of toxic substances, in 
particular when handling microorganisms or toxins. 
Once the transfer is completed, the window can be closed and then the 
transfer pocket which was used for the transfer can be removed by tearing 
off the part stuck to the window and which is integral with the frame. 
The pocket and the method according to the present invention also have 
other advantages which will be seen below. 
In fact, the system described above of a flexible pocket containing or not 
containing a frame also makes it possible, at the end of the operation, 
after the transfer of the articles originally present, to transfer or to 
re-transfer, in particular in a perfectly sterile manner, articles, and in 
particular sterile articles, from the enclosure into the pocket whilst it 
is still stuck to the enclosure. 
Once these latter articles have been placed inside the pocket (for example 
objects like the waste material produced by cutting, empty bags or other 
materials), it is possible to close the door again and it is also possible 
to close the pocket again, for example by fitting on the latter a 
conventional tying means known in the prior art, such as a cord, an 
adhesive tightening tape, a sliding ring with a non-return system, etc. . 
. . The pocket can then be detached from the enclosure. 
Depending on the case it is then possible, if the materials to be discarded 
have been put in before the tying operation, to remove the latter whilst 
retaining the materials to be protected which are placed in the pocket but 
after the tying. It is also possible to use the same pocket several times 
for transferring the articles it contains for example into another 
enclosure provided with a device such as described above whilst avoiding 
manipulations. The said articles can, for example, be the original but 
modified products, or other articles having nothing in common with the 
previous ones except for being present in the enclosure. As many 
operations of this type as desired can be carried out provided that the 
available surface of the pocket is still sufficient. 
The present application also relates to a method such as defined above, 
characterized in that, furthermore, after the transfer of the original 
articles into the enclosure, other articles or the same articles possibly 
after modification are placed in the transfer pocket, the pocket is tied 
between the said articles and the enclosure and a new transfer is carried 
out. 
As those skilled in the art will realise immediately, for certain functions 
the frame and the enclosure have symmetrical roles. For example, means of 
cutting by heating can be provided on the frame and not on the outer rim 
of the opening as shown in the figures: in this case, the cutout is 
produced from the outside and not from the inside of the enclosure. 
The application therefore also relates to a frame such as referred to above 
and provided with cutting means as described above. 
Those skilled in the art will also realise that it is possible to make a 
transfer in a similar manner between two enclosures by using a pocket 
provided for example with two frames, or a transfer between two pockets by 
using an intermediate enclosure provided with two entrances, such as two 
windows.

In FIG. 1 it is possible to observe the articles to be transferred, in this 
case bottles 1 enclosed in an internal pocket 2 whose opening 3 has been 
obturated. This pocket 2 enclosing the articles 1 is itself placed in the 
closed transfer pocket 4 whose opening 5 has been obturated and provided 
with a sterilization indicator. In the top part of the drawing there can 
be seen the frame 6 determining a plane at its top and provided with a 
peripheral groove 7 in which a part of the wall of the closed transfer 
pocket 4 is retained by means of an elastic band 8. Thus the structure of 
a diametral cross-section of a frame has the general shape of a "U" of 
which one of the sides is shorter than the other. On the part S of the 
transfer pocket held by the frame there is placed an adhesive 9 protected 
by a protective film 10 provided with a tab 11. The frame and the articles 
enclosed in the internal pocket were of course placed inside the closed 
transfer pocket before it was closed. The said two pockets have themselves 
been placed inside a pocket called the "external" pocket 12, which is 
itself closed. This pocket 12, like the others, may be provided with a 
sterilization indicator and with identification devices such as bar codes. 
On the left hand side of FIG. 2 there can be seen an enclosure according to 
the invention. The latter comprises a special zone, used for receiving the 
adhesive part S of the transfer pocket. In this special flat zone can be 
seen the window itself 13 and latches 14 used for fixing the frame against 
the enclosure. 
In this figure it can also be seen that the external pocket 12 has been 
opened in order to place the surface S of the transfer pocket 4 opposite 
the window 13 of the enclosure. 
In FIG. 3 it can be seen that the window 13 has been opened, allowing the 
transfer of the internal pocket 2 containing the articles 1 from the 
closed transfer pocket 4 into the enclosure. 
In this figure it can be seen that the latches 14 have been moved in such a 
way as to lock the frame 6 against the framing of the window. There can 
also be seen at this point the remainder of the wall 4 of the transfer 
pocket, of which a part 4' has remained stuck against the window 13. The 
wall 4 slightly overlaps the window towards the inside and remains stuck 
over the whole periphery of the latter. 
The frame 6 can be made of magnetic metal whilst attraction means, 
electromagnetic for example, are provided on the framing of the window 13. 
In FIG. 4 it can be seen that, after opening the internal pocket 2, the 
articles have been transferred into the enclosure and the internal pocket 
has been replaced in the transfer pocket 4. The latches 14 have been 
opened in order to release the frame 6 and to allow the transfer pocket 4 
to be withdrawn. Previously, the window 13 was re-closed in order to 
maintain the sterility of the enclosure. It is then possible to remove 
possible traces of adhesive remaining on the window as well as the 
remainder 4' of the transfer pocket 4. Thus the enclosure and its window 
are ready for use again. Similarly, the frame 6 and the elastic band 8 can 
be retrieved to be used again with a new transfer pocket 4. 
FIG. 5 shows details of various elements at the level of the part of the 
enclosure designed for receiving a transfer pocket according to the 
invention. Firstly, there can be seen the pocket 4 held in a groove of the 
frame 6 by means of an elastic band 8. The part S of the transfer pocket 4 
is pressed over the whole surface of the window 13 and beyond. The window 
13 comprises a chassis 15 provided with suction holes 16 emerging on the 
outside of the enclosure. These suction holes are connected together and, 
towards the inside, form additional suction pipes 17 which are connected 
with the main suction pipes 18 going to the suction device 19 which can be 
located outside of the enclosure in order to avoid the undesired intake of 
gas, and/or can be provided, for example, with one or more sterilizing 
filters. There are also additional suction holes 20 and additional suction 
pipes 21 on the framing of the window. In this case the suction pipe is 
common to both the framing of the window and the window itself, but it is 
entirely conceivable to have separate suction pipes and devices. 
The rear of the chassis of the window is provided with a handle 22 having a 
special function. This handle is capable of moving or of being moved from 
the inside towards the outside of the enclosure in such a way as to cause 
the springing out of heating blades 23 capable of protruding with respect 
to the surface of the window and of the framing. This protrusion is 
obtained by pressing on the handle which is mounted on the elastic devices 
represented here by springs 24. Thus, a pressure on the handle 22 makes it 
possible, on the one hand, to obtain an electrical contact causing the 
heating up of the heating blades and, at the same time, the protrusion of 
the latter. 
In this figure there can also be seen a latch 14 in the articulated open 
position, which can be closed again in order to lock the frame 6 against 
the surround of the window. This latch 14 is provided with an electrical 
contact 25 capable of cooperating, after closing, with another electrical 
contact 26 located on the surround of the window, thus constituting a 
safety arrangement. If a latch (or the latches) are not closed, it becomes 
impossible to activate the heating blades and, furthermore, it preferably 
becomes impossible to open the window. 
In FIG. 6, in which the latch 14 is in the closed position, the formation 
of an electrical circuit according to the invention can be observed 
better. In this figure, an electrical contact has been made between the 
electrical contacts 25 and 26. Electrical continuity has therefore been 
able to be established so that the pressure on the handle 22 of the window 
has caused the protrusion of the heating blades 23 beyond the surface of 
the chassis 15 of the window and thus the cutting out by melting of an 
opening in the surface S of the transfer pocket 4. The heating up has been 
obtained by cooperation between an electrical contact 27, with which the 
heating blade or its support is provided, and another electrical contact 
28, with which the chassis of the window is provided, establishing 
electrical continuity. It can also be seen that the edge of the transfer 
pocket 4, after cutting, overlaps toward the inside of the opening of the 
window. 
In FIG. 7, the opening phase of the window and of the transfer pocket can 
be seen. It can be seen that the window 13 has carried away with it a part 
S of the wall of the transfer pocket 4 which has been cut out at the level 
of the heating blades 23. Continuity is thus established between the 
inside of the transfer pocket 4 and the inside of the enclosure, allowing 
the transfer of articles from the transfer pocket 4 into the said 
enclosure.