U.S. patent application number 10/566256 was filed with the patent office on 2008-09-04 for process for sterile packaging of containers with drop-dispensers, and means for actuating the process.
This patent application is currently assigned to BORMIOLI ROCCO & FIGLIO S.P.A.. Invention is credited to Emilio Morini.
Application Number | 20080209857 10/566256 |
Document ID | / |
Family ID | 34960442 |
Filed Date | 2008-09-04 |
United States Patent
Application |
20080209857 |
Kind Code |
A1 |
Morini; Emilio |
September 4, 2008 |
Process For Sterile Packaging of Containers With Drop-Dispensers,
and Means For Actuating the Process
Abstract
The process includes a stage of sterilisation of the flagon, the
drop-dispenser and the closure cap making up the container, which
is preceded by a stage in which the cap and the drop-dispenser are
removably anchored together. In a subsequent stage the flagon and
the drop-dispenser-cap group are placed in an aseptic environment,
and the flagon is filled before the pre-assembled
drop-dispenser-cap group is inserted on the flagon. The means for
actuating the above process comprise a flagon (1), a drop-dispenser
(2) which is pressure-inserted in the flagon (1) and a closure cap
(3) which is screwed onto the drop-dispenser before the
drop-dispenser (2) is inserted on the flagon (1)
Inventors: |
Morini; Emilio; (Parma,
IT) |
Correspondence
Address: |
YOUNG & THOMPSON
209 Madison Street, Suite 500
ALEXANDRIA
VA
22314
US
|
Assignee: |
BORMIOLI ROCCO & FIGLIO
S.P.A.
PARMA
IT
|
Family ID: |
34960442 |
Appl. No.: |
10/566256 |
Filed: |
January 13, 2005 |
PCT Filed: |
January 13, 2005 |
PCT NO: |
PCT/IT05/00012 |
371 Date: |
January 30, 2006 |
Current U.S.
Class: |
53/281 ; 53/426;
53/471 |
Current CPC
Class: |
B65D 47/18 20130101;
B65D 41/3428 20130101; B65B 55/08 20130101; B65B 55/04
20130101 |
Class at
Publication: |
53/281 ; 53/426;
53/471 |
International
Class: |
B65B 55/12 20060101
B65B055/12; B65B 7/28 20060101 B65B007/28; B65B 3/04 20060101
B65B003/04 |
Claims
1). A process for sterile packaging of containers with
drop-dispensers, comprising stages of: sterilisation of components
of the container comprising a flagon, a drop-dispenser and a
closure cap; introduction of the components into an aseptic
environment; filling of the flagon in the aseptic environment,
insertion of the drop-dispenser on the flagon and closure of the
flagon with the closure cap; wherein the process comprises a
removable anchoring stage of the closure cap on the drop-dispenser,
performed in non-sterile conditions, in order solidly and removably
to constrain the cap to the drop-dispenser and to obtain a
pre-assembled group comprising the drop-dispenser and the cap which
is configured to be directly connected to the flagon; the process
further comprises a stage of sterilisation of the pre-assembled
drop-dispenser-cap group; the process further comprises an
introduction stage of the drop-dispenser-cap group into an aseptic
environment; the process further comprises an insertion stage of
the pre-assembled drop-dispenser-cap group onto the flagon.
2). The process of claim 1, wherein the anchoring stage of the
closure cap onto the drop-dispenser is performed by means of a
screw-coupling between an outside of the drop-dispenser and an
inside of the cap.
3). The process of claim 1, wherein the stage of insertion of the
pre-assembled drop-dispenser-cap group on the flagon is performed
by pressure-insertion of the drop-dispenser-cap group on the mouth
of the flagon.
4). The process of claim 1, wherein the stage of sterilisation of
the pre-assembled drop-dispenser-cap group is performed by
inserting a plurality of the pre-assembled drop-dispenser-cap
groups into a closed package and treating the closed package with
gamma rays.
5). Means for actuating the process of claim 1, which means
comprise a container which in turn comprises a flagon (1) for
containing a product to be packaged, provided with a drop-dispenser
(2) and closed by a closure cap (3), wherein: the flagon (1) is
provided with a mouth (1a) in which an annular end (2a) of the
drop-dispenser (2) is pressure-inserted; the drop-dispenser
comprises an appendix (2b) for dosing the product, which appendix
(2b) projects externally of the flagon (1), and a skirt (2c),
external of and concentric to the annular end (2a), which skirt
(2c) together with the annular end (2a) defines an annular cavity
in which the mouth (1a) of the flagon (1) joints; means for
fastening being located on an external surface of the skirt (2c)
for removably fastening the closure cap (3) to the drop-dispenser
(2).
6). The means of claim 5, wherein: the cap (3) comprises a
bell-shaped zone (3a) which covers the skirt (2c) of the
drop-dispenser; the means for fastening comprise a screw-coupling
(4) made partly on an external surface of the skirt (2c) and partly
on an internal surface of the bell (3a).
7). The means of claim 6, wherein the cap (3) comprises an annular
security strip (3b) connected to the bell-shaped zone (3a) by
easy-break ribs.
8). The means of claim 5, wherein the appendix (2b) for dosing of
the drop-dispenser (2) comprises, on an external surface thereof,
at least an annular cavity (5) in which an annular relief (6) is
inserted when the cap (3) is connected to the drop-dispenser (2);
the annular relief (6) being made on an internal surface of the cap
(3).
Description
TECHNICAL FIELD
[0001] The invention relates to a process for sterile packing of
containers with drop dispensers and means for actuating the
process.
BACKGROUND ART
[0002] The prior art teaches containers with drop-counting
dispensers closed by caps, often having a security strip, which
containers must be packaged in sterile surroundings given the
nature of their contents. These containers are used, for example,
in the pharmaceutical field, and in particular in the field of
ophthalmology, for containing eye-drops, for sterile cleaning
liquids, and the like. Generally these containers comprise a
flagon, made of glass or a plastic material, which is provided with
a drop dispenser and closed by a cap made of plastic. The invention
relates in particular to the latter type of container, with
drop-dispenser and plastic cap.
[0003] At present the sterile packaging of these containers which
obviously takes place in sterile surroundings, is performed in the
following way.
[0004] The packaging companies, which are generally pharmaceutical
industries, receive the various pieces making up the container in
closed packages containing a high number of units; in particular,
packages containing the flagons, the drop-dispensers and the caps
are separately delivered.
[0005] The packages arrive at the pharmaceutical packagers with
their internal parts already sterile, or they can be sterilised
after arriving; the sterilisation thereof is done, with the
packages closed, by gamma ray bombardment which sterilises the
insides of the packages without any need to open them.
[0006] Using various lines and systems, of known type, these
packages are introduced into a sterile environment and are opened
while there, so that the sterility thereof is not compromised. The
various sterile parts which exit are sent on to machines, located
in the sterile environment, which position and predispose the
various pieces for the filling and closing stages of the
containers.
[0007] During this packaging stage, which as has been mentioned is
done in a sterile environment and in general using continuous
automatic machines, the flagon is filled with the product in a work
station; in a following work station, the drop-dispenser is
inserted on the flagon by press-fit; and in a further work station
the flagon-drop dispenser assembly is completed by screwing on the
cap, at which point the container exits the sterile environment and
is ready to be put up for sale. This packaging process involves
considerable expense, primarily for sterilisation of the parts of
the container; gamma ray sterilisation includes costs that are
calculated in terms of "occupied volume", i.e. the number of
objects to be sterilised, which, in the described process, is a
very high number even though the volume consists mostly of empty
space, being the inside of the containers, the drop-dispensers and
the closure caps which are hollow elements. Secondly, the high
costs are due to the presence, internally of the sterile machines
where the packaging takes place, of a high number of infeeding
lines of the single components and a large number of work stations,
which, apart from the cost of these specific lines and stations,
lead to the need to keep a fairly large space under sterile
conditions.
[0008] A further drawback in the known processes is the difficulty
of regulating the torque in the cap-dispenser coupling.
[0009] The main aim of the present invention is to provide a
process for sterile packaging of containers having drop-dispensing
mechanisms, and the means for realising the process, which process
and means reduce the drawbacks in the prior art, and in particular
reduce the costs and wastage during the packaging process.
[0010] An advantage of the invention is that container packaging
times are reduced.
[0011] A further advantage of the invention is that containers are
obtained which are safer and easier for a consumer to use.
[0012] These aims and advantages are achieved by the invention, as
it is characterised in the appended claims.
DISCLOSURE OF INVENTION
[0013] Further characteristics and advantages of the present
invention will better emerge from the detailed description that
follows of a possible actuation of the process, and a possible
embodiment of the means for realising the process, illustrated
purely by way of non-limiting example in the accompanying FIG. 1,
which shows a section in vertical elevation of a flagon group,
drop-dispenser and cap which make up the means for actuating the
process of the invention.
[0014] The sterile packaging process is applied on containers used
in particular in the pharmaceutical field for containing products
such as medicinal drops, sterile cleaning liquids and the like,
which containers comprise a flagon 1, made preferably of a plastic
material, on which after filling with the product they are destined
to contain, a drop-dispenser 2 and a closure cap 3 are to be
fitted, the cap 3 closing the package but which can be removed to
enable use of the product, and replaced to close the flagon before
further use; both the drop-dispenser 2 and the cap 3 are made of a
plastic material, and preferably by injection moulding.
[0015] The process includes, as with known processes, a
sterilisation stage of the flagon, the drop-dispenser and the
closure cap.
[0016] While the sterilisation of the flagon is done using known
processes, for sterilising the drop-dispenser and the cap the
process of the invention includes a preparation stage of removably
anchoring the closure cap on the drop-dispenser; this anchoring
stage is done under conditions of perfect cleanliness but not
necessarily sterility, generally by the manufacturer of the
drop-dispenser and the cap; during this stage the cap and the
drop-dispenser are solidly constrained to one another and a
pre-assembled group is obtained, which is already configured to be
directly connected to the flagon. This anchoring stage, however,
produces a connection between the drop-dispenser and the cap which
can be resolved at moment of use of the package; for this purpose
the anchoring stage of the cap on the drop-dispenser is achieved by
a threaded coupling between an outside of the drop-dispenser and an
inside of the cap, which easily enables, at moment of use, the
anchored state between the drop-dispenser and the cap to be removed
and replaced, i.e. the container can easily be opened and
closed.
[0017] Once assembled, the drop-dispenser-cap groups are packed in
a packaging, which contains a considerable number of units, which
is sent on to a successive stage of sterilisation of the
pre-assembled groups; this sterilisation stage is performed, with
the packagings closed, by bombardment of gamma rays which, in a
known process, sterilise the inside of the packaging and the
contents thereof with no need for opening the packaging.
[0018] With respect to known processes, this stage of
sterilisation, the economic cost of which depends on the volume of
the packaging, is much less expensive because the volume occupied
by the drop-dispenser-cap groups is much smaller (with the
drop-dispenser-cap groups proposed for actuating the process of the
invention, as shall be seen herein below, the volume is about half)
than the totality of the volumes occupied by the drop-dispenser and
cap when considered separately; in other words, with the
sterilisation of the volume represented, in known processes, by the
packaging containing the caps, sterilisation can be performed of
both the cap and the drop-dispenser.
[0019] This stage of sterilisation can be performed by the
packaging company or, as frequently occurs, by an external company,
which sends the packaging company the packages containing the
drop-dispenser-cap groups already sterilised.
[0020] The drop-dispenser-cap groups are then placed in an aseptic
environment represented by the plant performing the filling and
closing of the packages; the flagons are also placed in the aseptic
environment. The flagons are then filled in this aseptic
environment, following known processes.
[0021] Once the flagon is filled the pre-assembled
drop-dispenser-cap group is inserted, so that in a single operation
at a single work-station the package is provided with the
drop-dispenser and the cap destined to close the container.
[0022] The insertion stage of the pre-assembled drop-dispenser-cap
group is performed by a simple pressure-insertion of the
drop-dispenser-cap group on the neck of the flagon. This stage is
much simpler and more reliable than known processes, which include
a pressure insertion of the drop-dispenser on the flagon followed
by the screwing-on of the cap on the neck of the flagon. The
screwing-on of the cap is indeed rather a delicate operation and
must be done most carefully in order not to subject the cap to
erroneous torques which might lead to an imperfect insertion of the
cap, or even a breakage of the cap. In the process of the
invention, the screw-on stage, which is generally done after the
realisation of the drop dispenser and the cap, is made especially
easy because the screw-coupling is effected partly on the cap and
partly on the drop-dispenser, which are both obtainable by
injection moulding and thus with a very high forming precision:
also, the assembly of the drop-dispenser-cap group is performed in
much easier conditions, as although the realisation and
manipulation of the various components is always done in perfectly
clean conditions (hygienic ambience) the assembly thereof does not
necessarily have to be done in a sterile environment. The
above-described process also offers considerable advantages for
transport and storage of the components of the package (the overall
shipping volume of the drop-dispenser and the caps is halved).
Control is also easier, as only one drop dispenser-cap group
control is needed instead of the two required when the components
are separate.
[0023] To actuate the above-described process means are used which
comprise a container which in turn comprises a flagon 1, of which
only the upper part is shown in the figure of the drawing, which
flagon 1 is destined to contain the product to be packaged; an
annular end 2a of a drop-dispenser 2 is press-fitted on the mouth
1a of the flagon 1, the drop-dispenser 2 being superiorly provided
with an appendix 2b which doses the contents and which projects
externally of the flagon 1 when the drop-dispenser is inserted in
the mouth 1a. The drop-dispenser comprises a skirt 2c which is
arranged externally of and concentrically to the annular end 2a. An
annular cavity is defined between the skirt 2c and the end 2a, in
which cavity the mouth 1a of the flagon is jointed when the
drop-dispenser 2 is press-inserted on the flagon 1. To guarantee a
solid joint of the drop-dispenser 2 on the flagon 1, there is an
annular relief 2d internally on the skirt 2c, which lodges in a
corresponding annular cavity 1b on the mouth of the flagon 1.
[0024] The means for realising the process further comprise a
closure cap 3 having the function of closing the container and
enabling it to be re-opened, so that the product in the container
can be dosed by the drop-dispenser, and then closed. The cap 3
comprises a bell-shaped zone 3a which covers the skirt 2c of the
drop-dispenser 2, and imitates the shape thereof, when the cap 3 is
placed on the container to close it. Preferably the cap 3 also
comprises a security strip arranged inferiorly of the cap and
connected thereto, in a known way, by easy-break ribs. The strip is
to evidence when a container has been opened. Also included are
means for fastening which enable the cap 3 to be fastened removably
to the drop-dispenser 2. The means for fastening comprise a
screw-coupling 4 which is partly made on the external surface of
the skirt 2c of the drop-dispenser 2 and partly on the internal
surface of the bell 3a of the cap 3.
[0025] The screw-coupling 4 enables an easy and efficacious
coupling between the drop-dispenser and the cap, usable for
realising the previously-described process; also, thanks to the
conformation of the drop-dispenser and the cap, and by means of the
said coupling, a drop-dispenser-cap group is obtained which
exhibits a volume equal to that of the cap alone, inasmuch as once
the coupling is achieved the drop-dispenser is entirely contained
inside the cap.
[0026] Preferably the appendix 2b for dosing on the drop-dispenser
comprises, on an external surface thereof, one or two (as shown in
the figure) annular cavities 5, in each of which, when the cap 3 is
connected to the drop-dispenser 2, an annular relief 6 is inserted
which annular relief 6 is made on the internal surface of the cap
3. This guarantees an excellent seal of the closed container.
[0027] The flagon 1, the drop-dispenser and the cap described
define together means for actuating the process of the invention in
a way which is easy and rapid. The process could however be
actuated with different drop-dispensers and caps from those
described, such as ones using a press-fitting, or having seal rings
instead of the described annular cavities 5 and the annular reliefs
6; or even having different systems for identifying when the
container has been first opened.
* * * * *