WO2009144559A2

WO2009144559A2 - Process for the manufacture of single-dose phials for fluid products of the medical, pharmaceutical, cosmetic type or the like, and a phial thus obtainable

Info

Publication number: WO2009144559A2
Application number: PCT/IB2009/005706
Authority: WO
Inventors: Antonio Fontana
Original assignee: Lameplast S.P.A.
Priority date: 2008-05-30
Filing date: 2009-05-25
Publication date: 2009-12-03
Also published as: WO2009144559A3; EP2293918A2; ITMO20080170A1

Abstract

The process for the manufacture of single-dose phials (1) for fluid products of the medical, pharmaceutical, cosmetic type or the like comprises the following phases: extruding at least a barrier layer of plastic material (2, 3, 4) to form a first substantially tubular semi-finished product (7) having a distal extremity (9) and a proximal extremity (8); blowing an expansion gas into the first semi-finished product (7) through the proximal extremity (8) inside a forming mould (11, 12) with the distal extremity (9) substantially closed, to form a second semi-finished product (13) ~~ having a dispensing spout at the distal extremity (9); removing the proximal extremity (8) from the second semi-finished product (13) to define an open bottom (15) for the introduction of a fluid product of the medical, pharmaceutical, cosmetic type or the like; drilling the distal extremity (9) to define an outlet opening for the fluid product and to form a single-dose phial having the open bottom, which is sealable after the filling of the phial with the fluid product, and the outlet opening obtained on the dispensing spout (14).

Description

PROCESS FOR THE MANUFACTURE OF SINGLE-DOSE PHIALS FOR FLUID PRODUCTS OF THE MEDICAL, PHARMACEUTICAL, COSMETIC TYPE OR THE LIKE, AND A PHIAL THUS OBTAINABLE

Technical Field The present invention relates to a process for the manufacture of single-dose phials for fluid products of the medical, pharmaceutical, cosmetic type or the like, and a phial thus obtainable.

Background Art

It is known that some types of the medical, pharmaceutical and cosmetic products require packing inside particular phials made of materials conventionally defined as "barrier".

Such definition stems from the fact that, while commonly used materials, such as traditional plastic or the like, remain at least in part permeable to external agents such as oxygen, gas and water vapour, the "barrier" materials oppose the transit of these agents and completely safeguard the products contained in them.

The traditional "barrier" materials can be of both the metal and the plastic type.

Some examples of "barrier" materials are the following:

- Aluminium, which acts as an obstacle to crossing by oxygen, air, humidity and light; - EVOH (ethylene vinyl alcohol), which acts as an obstacle to crossing by oxygen and other gases;

- LDPE (low density polyethylene), HDPE (high density polyethylene), LLDPE (linear low density polyethylene), which all act as an obstacle to crossing by water vapour. The walls of the traditional phials that require the barrier effect are usually made in the form of multiply, in which a layer of aluminium is usually coupled with one or more layers of plastic materials and then shaped to define the container for the fluid product. But while this system of manufacture is fairly practical for the production of bottles and/or tubes of fairly large size, it presents considerable complications if used to produce small single-dose phials, which normally have very small dimensions. It should also be noted that within the medical, pharmaceutical, cosmetic ambit and the like, the single-dose phials usually have a body intended to contain the fluid product that is made of aluminium and which at one extremity is welded to a dispensing spout in plastic material made separately, e.g., by injection moulding.

The need to envisage two separate component parts to be joined together considerably complicates the manufacturing process which is inconveniently not very practical and expensive. The mixing of plastic and metal materials, furthermore, results in considerable difficulties during disposal of already-used phials.

In this respect in fact, it should be remembered that in many countries of the world, waste has to be selected according to its nature before being disposed of, and the fact of having a part in metal and a part in plastic means the phial contains two different kinds of material that have to be disposed of separately. Object of the Invention

The main aim of the present invention is to provide a process for the manufacture of single-dose phials for fluid products of the medical, pharmaceutical, cosmetic type or the like, that allows manufacturing in a practical, easy and functional way single-dose phials which, once used, can be disposed of in a simple and practical way.

Another object of the present invention is to provide a process for the manufacture of single-dose phials for fluid products of the medical, pharmaceutical, cosmetic type or the like, that allows overcoming the mentioned drawbacks of the background art within the ambit of a simple and rational solution that is easy and effective to use and of low cost.

The above objects are achieved by the present process for the manufacture of single-dose phials for fluid products of the medical, pharmaceutical, cosmetic type or the like, characterized in that it comprises the following phases:

- extruding at least a barrier layer of plastic material to form at least a first substantially tubular semi-finished product having a distal extremity and a proximal extremity;

- blowing an expansion gas into said first semi-finished product through said proximal extremity inside a forming mould with said distal extremity substantially closed, to form a second semi-finished product having a dispensing spout at said distal extremity;

- removing said proximal extremity from said second semi-finished product to define an open bottom for the introduction of at least a fluid product of the medical, pharmaceutical, cosmetic type or the like;

- drilling said distal extremity to define an outlet opening for said fluid product and to form a single-dose phial having said open bottom, which is sealable after the filling of said phial with said fluid product, and said outlet opening obtained on said dispensing spout.

Brief Description of the Drawings

Other characteristics and advantages of the present invention will become more evident from the description of a form of preferred, but not sole, embodiment, of a process for the manufacture of single-dose phials for fluid products of the medical, pharmaceutical, cosmetic type or the like, illustrated purely as an example but not limited to the annexed drawings in which: figure 1 is an exploded section view of some barrier layers superimposed the one on the other used in the process according to the invention; figure 2 is a section view of a first phase of the process according to the invention; figure 3 is a section view of a second phase of the process according to the invention; figure 4 is a side view of a third phase of the process according to the invention; figure 5 is a axonometric view of a fourth phase of the process according to the invention; figure 6 is a section view of a fifth phase of the process according to the invention.

Embodiments of the Invention

With particular reference to such illustrations, a single-dose phial for fluid products of the medical, pharmaceutical, cosmetic type or the like, obtainable with the process according to the invention, has been globally indicated by 1. The walls of the single-dose phial 1 are made by means of at least a barrier layer 2, 3, 4 of plastic material in which, e.g., the barrier layer 2, 3, 4 is chosen from the list comprising: LDPE (low density polyethylene), HDPE (high density polyethylene), LLDPE (linear low density polyethylene), EVOH (ethylene vinyl alcohol) and the like.

In the particular embodiment of the invention shown in the illustrations, e.g., the walls of the single-dose phial 1 consist in a series of barrier layers 2, 3, 4 in plastic material, superimposed the one on the other, of which an outer layer 2 in LDPE (thickness 0.1-0.2 mm), an intermediate layer 3 in EVOH (thickness 0.02-0.04 mm), and an inner layer 4 in LDPE (thickness 0.1-0.2 mm).

Furthermore, between one barrier layer 2, 3, 4 and another a layer of adhesive material 5 is interposed.

Alternative embodiments of the present invention cannot however be ruled out in which a different number of barrier layers 2, 3, 4 is used. The process according to the invention comprises a first phase I which consists in extruding the barrier layers 2, 3, 4 through a extruder die 6 to form a first semi-finished product 7 with tubular shape having a proximal extremity 8 and a distal extremity 9, in which the adjectives proximal and distal are used with reference to the distance from the extruder die 6. The second phase II of the process consists in blowing an expansion gas 10 inside the first semi-finished product through the proximal extremity 8. During this phase, the first semi-finished product 7 is closed inside a forming mould 11, 12 which has a first half-shell 11 and a second half-shell 12. The half-shells 11, 12 are shaped so that, during the blowing, the distal extremity 9 of the first semi-finished product 7 is closed; the filling with the expansion gas 10, therefore, causes the deformation of the walls of the first semi-finished product 7 and their crushing against the inner walls of the half- shells 11, 12, leading to the formation of a second semi-finished product 13. For this purpose, the forming mould 11, 12 is shaped so as to give the second semi-finished product 13 a substantially axial-symmetric and elongated shape along a longitudinal direction that extends between the proximal extremity 8 and the distal extremity 9; other embodiments cannot however be ruled out. Furthermore, the second semi-finished product 13 obtained at the exit from the forming mould 11, 12, has a dispensing spout 14, obtained at the distal extremity 9, while the proximal extremity 8 of same consists in a deformed waste portion (feedhead). The third phase III of the process consists in removing the proximal extremity 8 from the second semi-finished product 13 to define an open bottom 15 for the introduction of a fluid product, of the medical, pharmaceutical, cosmetic type or the like. The removal phase is defined by the performance of a cutting-off operation (with cutting-off machine, circular saws or similar tools), or cutting (e.g., by laser or other cutting tools), or shearing (with shearing units or the like). The process according to the invention further comprises a fourth phase IV that consists in drilling the distal extremity 9 to define an outlet opening 16 for the fluid product. Usefully, the outlet opening 16 is made in a substantially axial position at the extremity of the dispensing spout 14 by means of an operation of punching of the distal extremity 9 by means of a substantially pointed punching element 17. Usefully, the punching element 17 is first of all heated to favour the penetration of same through the second semi-finished product 13. At the end of the fourth phase IV of the process, the second semi-finished product 13 appears modified to form the single-dose phial 1 having the open bottom 15, which is sealable after the filling of the phial itself with the fluid product, the dispensing spout 14 arranged on the opposite side with respect to the open bottom 15, and the outlet opening 16 obtained on the dispensing spout 14.

The fifth phase V of the process consists in seal capping the outlet opening 16 with a closing element 18 of the type of a cap or the like. In the particular embodiment shown in the illustrations, the closing element 18 comprises a cap 19 that can be fitted around the dispensing spout 14 and a shutter body 20 obtained inside the cap 19 and which can be seal fitted in the outlet opening 16. Once the single-dose phial 1 has been capped, the process according to the invention envisages a subsequent phase, not shown in the illustrations, which consists in checking the seal of the closing element 18 through the outlet opening 16.

This checking phase is performed by means of the carrying out of a seal test such as, e.g., a high-pressure test, a low-pressure test, a steam test, an electrical conductivity test or similar methods.

The subsequent phases of the process according to the invention are not shown in the illustrations and consist in filling the single-dose phial 1 with the fluid product, making the product pass through the open bottom 15, and in sealing the open bottom 15, e.g., by edge sealing.

Finally, the single-dose phial 1 thus obtained can, if necessary, be blister packed and packaged in order to be subsequently introduced onto the market and distributed to consumers.

It has in fact been found how the described invention achieves the proposed objects.

The invention thus conceived is susceptible to numerous modifications and variations, all of which falling within the scope of the inventive concept.

Furthermore all the details can be replaced with others that are technically equivalent. In practice, the materials used, as well as the contingent shapes and dimensions, may be any according to requirements without because of this moving outside the protection scope of the following claims.

Claims

1) Process for the manufacture of single-dose phials for fluid products of the medical, pharmaceutical, cosmetic type or the like, characterized in that it comprises the following phases: - extruding at least a barrier layer of plastic material to form at least a first substantially tubular semi-finished product having a distal extremity and a proximal extremity;

- removing said proximal extremity from said second semi- finished product to define an open bottom for the introduction of at least a fluid product of the medical, pharmaceutical, cosmetic type or the like; - drilling said distal extremity to define an outlet opening for said fluid product and to form a single-dose phial having said open bottom, which is sealable after the filling of said phial with said fluid product, and said outlet opening obtained on said dispensing spout.

2) Process according to claim 1, characterized in that said barrier layer is chosen from the list comprising: LDPE₅ HDPE, LLDPE, EVOH and the like.

3) Process according to one or more of the preceding claims, characterized in that said extruding comprises extruding at least two of said barrier layers superimposed the one on the other.

4) Process according to claim 3, characterized in that at least a layer of adhesive material is interposed between said barrier layers.

5) Process according to one or more of the preceding claims, characterized in that said forming mould is shaped so as to give said second semi-finished product a substantially axial-symmetric and elongated shape along a longitudinal direction that extends between said proximal extremity and said distal extremity.

6) Process according to one or more of the preceding claims, characterized in that said removing comprises performing an operation chosen from the list comprising: cutting-off, cutting, shearing.

7) Process according to one or more of the preceding claims, characterized in that said drilling comprises making said outlet opening in a substantially axial position. 8) Process according to one or more of the preceding claims, characterized in that said drilling comprises punching said distal extremity by means of a substantially pointed punching element.

9) Process according to one or more of the preceding claims, characterized in that said drilling comprises heating said punching element. 10) Process according to one or more of the preceding claims, characterized in that it comprises seal capping said outlet opening with at least a closing element.

11) Process according to one or more of the preceding claims, characterized in that said closing element comprises at least a cap that can be fitted around said dispensing spout and at least a shutter body obtained inside said cap and which can be fitted in said outlet opening.

12) Process according to one or more of the preceding claims, characterized in that it comprises checking the seal of said closing element through said outlet opening. 13) Process according to one or more of the preceding claims, characterized in that said checking comprises carrying out a seal test chosen from the list comprising: a high-pressure test, a low-pressure test, a steam test, an electrical conductivity test.

14) Process according to one or more of the preceding claims, characterized in that it comprises filling said phial with said fluid product through said open bottom.

15) Process according to one or more of the preceding claims, characterized in that it comprises sealing said open bottom.

16) Process according to one or more of the preceding claims, characterized in that said sealing comprises sealing the edge of said open bottom.

17) Single-dose phial for fluid products, particularly medical, pharmaceutical, cosmetic products or the like, obtainable with the process according to one or more of the claims from 1 to 16, characterized in that it is made of at least a barrier layer of plastic material and comprises at least an open bottom sealable after the filling with at least a fluid product, at least a dispensing spout arranged on the opposite side with respect to said open bottom, and at least an outlet opening of said fluid product obtained on said dispensing spout.

18) Phial according to claim 17, characterized in that said barrier layer is chosen from the list comprising: LDPE, HDPE, LLDPE, EVOH and the like.

19) Phial according to one or more of the claims 17 and 18, characterized in that it is made with at least two of said barrier layers superimposed the one on the other.

20) Phial according to claim 19, characterized in that at least a layer of adhesive material is interposed between said barrier layers.