U.S. patent application number 09/316165 was filed with the patent office on 2001-08-30 for system to form, fill and seal flexible bags.
Invention is credited to SICCARDI, ALBERTO.
Application Number | 20010017022 09/316165 |
Document ID | / |
Family ID | 11375271 |
Filed Date | 2001-08-30 |
United States Patent
Application |
20010017022 |
Kind Code |
A1 |
SICCARDI, ALBERTO |
August 30, 2001 |
SYSTEM TO FORM, FILL AND SEAL FLEXIBLE BAGS
Abstract
A system to form, fill and seal (FFS) flexible bags including
the steps of: a total printing of the film as it winds off the
supply reel; a dry cleaning; a gimballed aligning for the folding
of the printed and washed film; a hot-bar welding of the folded
film; a valve welding controlled by an algorithm; a humidification
treatment of the valve cavity; a shaping of the bags by hot tools
also controlled by an algorithm; and a high precision dosage of the
filling liquid.
Inventors: |
SICCARDI, ALBERTO; (CANTON
TICINO, CH) |
Correspondence
Address: |
MARK J BUONAIUTO ESQ
CORPORATE COUNSEL
BAXTER INTERNALTION INC
ONE BAXTER PARKWAY DF2-2E
DEERFIELD
IL
60015
|
Family ID: |
11375271 |
Appl. No.: |
09/316165 |
Filed: |
May 21, 1999 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09316165 |
May 21, 1999 |
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PCT/IB97/01458 |
Nov 18, 1997 |
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Current U.S.
Class: |
53/451 |
Current CPC
Class: |
B65B 55/02 20130101;
B65B 55/103 20130101; B65B 61/186 20130101 |
Class at
Publication: |
53/451 |
International
Class: |
B65B 009/00 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 22, 1996 |
IT |
MI 96A002451 |
Claims
1. A system for the forming and filling of flexible
plastic-material containers, in particular sterilizable bags
containing solutions for administration, infusion type solutions,
including at least the phases of:--feeding a film or pellicle,
preferably multilayer, from at least one reel;--printing, washing,
winding the said printed material;--aligning and folding the said
printed and washed film;--welding the film folded first in one
direction, typically longitudinally or vertically;--supplying and
applying valves onto the surface of the folded and welded
film;--filling the bag;--effecting a second welding in a second
direction, typically transverse or horizontal;--cooling and cutting
the bags for sending to overwrapping and sterilization; the system
being characterized by the fact that the number of steps or
abovementioned phases is reduced, carrying out in particular:--a
total printing (TP=total print) of the film as it winds off the
supplying reel(s);--a dry cleaning of the printed film;--a
gimballed aligning of the printed and washed film to be folded; --a
hot-bar longitudinal welding (vertical) of the folded
film;--application of the valve(s) by welding, controlling, by
means of algorithm, the speed and position of the welding head
during its approach to the anvil, the said valve(s) having
undergone a humidification treatment of the cavity;--shaping the
bags using algorithm-regulated hot tools; high precision dosage of
the filling liquid
2. System according to claim 1, characterized by the fact that to
subject the cavities (outside the bag and having no contact with
the filling solution) to humidification use was made of a means to
dose the liquid as a function of the cavity volumes themselves, and
tools (5b3) to ascertain the wetting taking place, making it
possible to sterilize the cavities of the valve(s) in times and
with procedures substantially equal to those of the bag
sterilization
3. System according to claim 2, characterized by the fact that the
wetting is effected downstream from a vibrator (5b1) associated
with feeding the valves to the station (5b) for their welding onto
the body of the bag, the means (5b3) for controlling the wetting of
the cavities of the said valves being placed downstream from the
wetting tools
4. System according to claims 2 and 3, characterized by the fact
that the wetting liquid is chosen from among distilled water,
physiological solutions and hydrogen peroxide
5. System according to claim 4, characterized by the fact that use
is made of hydrogen peroxide to sanitize and detect the electric
conductability in the cavities
6. System according to the preceding claims, characterized by the
fact that the humidification apparatus (5b2) includes, in addition
to the source of sterile liquid, a dosing valve (70) and a
flusstate (71), outside a means that includes a nozzle that is
moved by a double-effect piston controlled by a sensor, and that is
supplied with a lance for penetration into the valve cavities, the
discharged sterile liquid being detected by a circuit with electric
bridging
7. System according to claim 1, characterized by the fact that the
total stamp (total print, TP) in line on the film as it unwinds
from the feeding reel(s) is made with a hot printer that uses as
the impression means a hot press, depositing onto the bag, due to a
pigmented film, the characters put on a clich
8. System according to claims 1 and 7, characterized by the fact
that the film, stamped/printed in line, is dry cleaned with
purified air and, after accumulation, undergoes a gimballed
alignment
9. System according to claim 7, characterized by the fact that a
ring for suspension is welded onto the bag or, as an alternative, a
suspension hole (FOS) is made
10. System according to the preceding claims, characterized by the
fact that the liquid filling the bag is dosed with great precision
in a station that includes in the inlet a contribution regulation
valve (51), a constant pressure valve (52), a turbine flowmeter
(53), that feeds the valve (54) a with true and proper washing of
the solution inside the bag, still not welded transversely, the
said valve having a double electropneumatic boost and the control
being carried out by the number of impulses coming from a lobed
flowmeter of Hall effect.
11. System according to at least one of the preceding claims,
characterized by the fact that contemporary shaping at the
transversal welding of the bags is carried out with two mobile bars
heated by electric resistances of high output with temperature
control on many points, preferably twelve interconnecting points,
the cooling being effected by two mobile cold bars that, as well as
cooling and blocking the folding process of the welding, contain
means for the cutting and separation of the bags
12. System according to at least one of the preceding claims,
characterized by the fact that the blocking of the valve welding is
done with a means that includes substantially a transducer of
position, a cylinder, a slide, a sonotrode and a piezoelectric
transducer.
Description
FIELD OF THE INVENTION
[0001] The present invention concerns a system to form, fill and
seal (F.F.S.) containers of flexible plastic materials, in
particular sterilizable bags containing solutions for
administration, types of infusion solutions including at least
phases consisting of:
[0002] feeding from at least one reel B a plastic and flexible
material in the form of a film or pellicle F, preferably
multilayer, forming the bag;
[0003] printing the said material pulled from the said reel;
[0004] winding the said printed material FSI;
[0005] washing the printed material;
[0006] aligning and folding the said printed and washed film
FSTL;
[0007] welding the folded film in a first direction;
[0008] feeding and applying valves on the surface of the folded and
welded film;
[0009] making a second welding in a second direction;
[0010] cooling and cutting the bags to send to them for
overwrapping and sterilizing.
STATEMENT OF THE PRIOR ART
[0011] Numerous systems for manufacturing flexible containers and
filling them with liquids material of three laminated layers, a
specific type of valve and a very generic "form and fill" system.
However only in the U.S. Pat. No. 4,456,813 (corresponding to the
European patent N.sup.o 142,758) of the Applicant is there
described a first efficient system, substantially automatic, for
the industrial production of bags with valves, comprising the
phases described in the introduction of this description and in the
preamble of claim 1. This system has, for quite some time,
permitted the achievement of large industrial targets;
nevertheless, with all its merits, it has shown some limits or
wrinkles. For example present day demands and the even more severe
requirements imposed by the Health Authorities call for several
further means such as the application of a means for bag
suspension, the fixing of complex valves of the last generation,
single or double (twin-valve) (e.g. of the type called VEM or
EMO-LUER). These and other valves can have zones difficult to
access, e.g. cavities that would require extremely long
sterilization times for safe sterilization, compared with those
needed to sterilize the bag: though, for example, this latter can
be done satisfactorily in about 10 minutes in an autoclave at
120.degree. C., that of the valves requires much longer times that
are not industrially acceptable. In fact the water would reach the
cavities either through permeability of the bag wall on which the
valve is welded, or through the external surfaces of the valve
itself. If the volume of the cavity is small the danger is small
but if the volume is big the danger is prohibitive.
[0012] In addition to long times there would always be uncertainty
about the effectiveness of the treatment. Furthermore in the
conventional system there were several difficulties in the
sanitation of the various mechanisms, for example that of dosing.
To dose the quantity of solution to fill the bag needed time that
was certainly not short and was without adequate precision.
SUMMARY OF THE INVENTION
[0013] The first aim of the present invention is to provide a very
advanced system (of the last generation) that does not have the
disadvantages of previous systems and is characterized by high
efficiency, reliability, hygiene security and maximum precision.
Another aim of the invention is to provide the previous system with
more efficient, less expensive and more compact treatment means.
These and other aims are obtained in the system with the present
invention, whose main characteristics are stated in the claims
below, to which the reader is referred.
BRIEF SUMMARY OF THE DRAWINGS
[0014] The different aspects and advantages of the invention will
be seen better in the following description of the forms of
realization (illustrative and not limiting) shown in the
accompanying figures, where:
[0015] FIG. 1 is a block diagram of the process at the base of the
system;
[0016] FIG. 2 is a planar representation of a first kinematics
scheme of the realization of the process of FIG. 1;
[0017] FIG. 2A is the enlarged representation of a variant of a
portion of FIG. 2;
[0018] FIGS. 2B and 2C are two views in partial and schematic
perspective of a dry cleaning means;
[0019] FIG. 3 is a schematic and partial axonometric view that
shows a preferred arrangement of the stages and means for the
realization of the process in FIG. 1;
[0020] FIGS. 4 and 5 are two frontal views, partially in section,
of two valves;
[0021] FIGS. 6 and 7 are schematic top views of bags with the
valves of FIGS. 4 and 5 and with a ring AS in the suspension hole
FOS;
[0022] FIG. 8 is a partially cross-sectioned view of a means of
humidifying the valves of the bags;
[0023] FIG. 9 is the scheme of a high precision liquid dosing
means;
[0024] FIG. 10 is a lateral schematic view of the filling portion
of the actuating machine, incorporating the said dosing means of
FIG. 9;
[0025] FIG. 11 is a lateral view of an arrangement of the total
print station (2);
[0026] FIG. 12 is an axonometric view of the valve welding station
5b;
[0027] FIG. 13 is an axonometric view of the final welding and
molding block 5d, 5e.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0028] With reference to FIGS. 1 and 2 the system according to the
invention is substantially representable with at least 5 stations,
each involving one or more treatments.
[0029] In particular block 1 shows the stage, respectively the
supplying station for the feeding of the film F from a reel B; the
dashed rectangles show the possibility of placing in station 1 at
least a second reel B' in parallel to the first reel B and of the
same width as that, or else a reel B" of a width n times the width
of B or B'. Associated with the unwinding reel RS is a means for
tension adjustment bearing a braking means DF.
[0030] According to another aspect of the invention block 2 shows a
station of total printing TP on line (2a) followed by the
accumulation (2b) of the thus completely printed film on line. The
TP station now includes a hot printer that uses a hot-press as the
impression means and that lays on the bag, from a pigmented film,
the characters placed on a clich. The station TP is preset to
obtain the printing of the prescription, the lot number and the
data of the daily production. Furthermore through the print menu it
is possible to set up the bag format (from 50 cc to 5,000 cc), the
temperature and speed and all the numerous parameters needed for
the printing of the bag itself.
[0031] Block 3 shows the washing station phase that now consists of
a single dry washing stage, there being no contact with liquids and
supports. One of the preferred washing means is represented in
FIGS. 2B and 2C. It is formed by two superimposed chambers 101 and
102 with a central slot for the printed film FST that is suspended
and subjected to filtered air AF flowing in from three nozzles 103,
104 and 105, the said air flowing out through nozzles 106, 107 and
108 after having flowed over, and hence washed, particles and
impurities from the printed film FST as shown in FIG. 2C. In the
case of using more reels B, B' etc. of equal length, or a reel B"
of a width n times greater than the previous ones, the stations 2
and 3 are able to operate contemporarily on film plurality.
[0032] Block 4 shows the treatment of the printed film on line and
dry washed, FTSL, in only four subphases that now foresee:
accumulation (4b) of FSTL, gimballing alignment (4d), folding (4e),
and towing (4f).
[0033] In the system according to the present invention there has
been the advantageous elimination of not only the drying phase (4a)
(due to dry washing) but also the phase (4c) of sterilization with
ultraviolet rays UVA of the U.S. Pat. No. 4,456,813. As can now be
seen the station is extremely more compact, efficient and reliable.
The few means for performing these operations are thus the rollers
(4b), (4d), (4e, 4e' with the folding prism PR) and (4f), there
having been eliminated the old squeezing rollers (4a) and the UV
plate (4c) associated with the rollers.
[0034] The functioning of the alignment rollers (4b), the folding
prism PR inserted between the rollers (4e) and (4e') and, lastly,
the towing roller (4f) cooperating with the second folding roller
(4e') is now faster and safer (also because there are no stops and
interruptions in the new, only four-phase, station 4). Station 5
can now be considered "revolutionized" compared with that of our
previous U.S. Pat. No. 4,656,813. In fact in station 5, bag
formation by vertical and horizontal welding and application of
valve(s) and suspension rings, there are now found only substations
of longitudinal (vertical) welding (5a) and valve application
(5b).
[0035] FIGS. 4 and 5 show two valve structures of the types
EMO-LUER and TWIN VALVE. They consist of a cap T, a valve core CV,
a rubber plug GP and two cavities CA1 and CA2. In the "TWIN" valve
TO indicates the part to be removed at the moment of using the
product, guaranteeing the sterility of the product contained
within, ZF indicates the twist-off fracture zone. The EMO-LUER
valve of FIG. 5 consists of the valve core EPO-L, the rubber plug
GP, the cap TT, the perforator P and the warranty seal SG that will
be broken at the moment of use; OR indicates the sealing gasket.
These valves are in themselves already known for example from the
Applicant's U.S. Pat. No. 4,467,003. Shown in FIG. 6 is a bag SA
with a TWIN-VALVE valve TV at a transverse extremity, and a
suspension hole in the opposite wall. Shown in FIG. 7 is a bag SA
with an EMO-LUER valve (VEM) on the longitudinal side and with a
suspension ring AS on the other longitudinal side.
[0036] Characteristically station 5 now also comprises: x) a
vibrator (5b1) for feeding the valves and, according to the most
notable aspect of the invention y) a spray wetting-means (5b2) for
valve cavities; z) a means (5b3) for the detection and control of
the wetting; j) a means (5c) for making a bag suspension hole; and
w) a means (5f) for the application of a suspension ring (in
addition to, or as an alternative to, the said hole), including
also a vibrator (5f1) for the supplying of the said ring.
[0037] According to an aspect of the invention the valve welder is
an ultrasound one with open ring control of position and approach
speed. For such a purpose the original welding system according for
example to the U.S. Pat. No. 4,656,813 has been greatly improved by
the introduction of a continuous checking of the position and speed
of the welding head (5b) ("sonotrode") during its approach to the
anvil (represented by dashes). FIG. 12 shows the relative block
(5b) comprising a position transducer (81), a cylinder (82), a
slide (83), the sonotrode (84), and a transducer (85). With an
algorithm of the PID type sampled to a thousandth of a second, an
optimization was carried out of the speed and the acceleration
(deceleration) of the sonotrode.backslash.anvil impact, the aim
being to make the whole welding operation as soft as possible (and
hence reliable).
[0038] In a further aspect of the invention the dosing of the
filling liquid RIEM is done with very great precision due to a
station SP, substantially automatic, comprising at least
electropneumatic valves (60) and (62) fed by (61) and a processing
switchboard (63). The dosing valve has a double electropneumatic
thrust and permits the operating (opening/closing) of the dosage
means in a time of 3 to 5 thousandths of a second, allowing a
precision of +/-1 cc per dosage quantity.
[0039] In the preferred embodiment the means is controlled by the
number of impulses coming from a lobed flowmeter with Halls effect.
FIG. 10 shows the arrival point AIC of the tubular feeding
connection from the solution (not represented), the dosing valves
of FIG. 9, the broadened extremity EA of the supply tube TE within
a bag SA in the filling phase, followed by the next bag SAC (also
not yet sealed at the top, still to be filled).
[0040] Still another characteristic of the invention lies in the
shaping of the bags (contemporarily with horizontal welding),
through the regulation and control of the temperature of two mobile
bars (71), (73) (FIG. 13) that are heated by highly efficient
electric heating elements, and able to compress, weld and
thermoform the bags, eliminating any possible ears. Besides the hot
vulcanized bar (71), the means of FIG. 13 includes a cold bar
contrasting the cutting edge (72), the second hot forward bar (73),
a cutting edge support (74) and a cold support bar of the cutting
edge (75).
[0041] Again use is made of a PID (Proportional, Integral
Derivative) type algorithm, ad hoc modified to optimize temperature
control, for example on twelve interlaced points. The cooling of
the welding follows immediately through the action of cooled bars
(e.g. of the type 72, 75 of FIG. 13) that, besides cooling and
blocking the welding folding process, cuts the bags themselves to
measure.
[0042] As a notable aspect of the invention the humidification of
the cavities CA1 CA2 of either the EMO-LUER or TWIN VALVE of FIGS.
4 and 5 can be carried out in various ways, for example with the
means of FIG. 8, comprising a valve V1, a fluxstate FLU, a
nebulization nozzle US, a piston PA to move the US served by a
sensor SEP, a bridging circuit for the observation of the electric
conductability in the already wet cavity for the controlling of the
correct humidification, and a discharge channel for the wetting
liquid CSLB.
[0043] Even though the invention has been described with reference
to the embodiment forms represented in the accompanying drawings it
is obvious that it is not limited to these embodiments but is
susceptible to all the variants, modifications, substitutions and
such like that, being within the reach of the person skilled in the
art, fall naturally within the spirit and scope of the following
claims. In fact the described means of dry washing, total printing,
humidification etc. can be substituted by equivalent commercial
means. Furthermore the system according to the invention foresees
the possibility not only of welding one or more valves onto the
same bag but also of working on two series of bags (odds and evens)
and of applying a type of valve, a ring or a suspension hole on the
odd and even bags alternatively. The film and pellicle F (FIG. 1)
forming the bags (SA with valves and suspension means) are
preferably multilayer, consisting of (co)polymers of laminated
olefins, amides, esters etc. (U.S. Pat. No. 4,326,574), but better
still coextruded, particularly those according to the Applicant's
demands for European patent N.sup.o0658421 and International patent
WO 95/16565.
[0044] Indeed optimal results have been obtained with coextruded
film based on two external layers (homogeneous chemically) of
ethylene copolymers (PE)--propylene (PP) that themselves differ
only in the PE content, or of two chemically diverse layers e.g.,
polyethylene/polypropylene. The adhesion of the two layers is
ensured by an appropriate coextruded binding, also polyolefinic. By
cautiously choosing the composition of the external layers, the
binding and hence the adhesion between the said layers, and any
possible temperature difference between the welding bars etc. bags
can be obtained with optimal values of welding resistance,
resistance to shocks particularly dropping, transparency,
sterilizability etc., etc. The coextruded films can have additional
layers, these also being coextruded or even laminated onto
three-layer film (two external layers and that of the binding).
* * * * *