U.S. patent application number 10/418087 was filed with the patent office on 2004-02-05 for filling apparatus.
Invention is credited to Damen, Frans, Hendrickx, Paul, Stewart, Paul.
Application Number | 20040020558 10/418087 |
Document ID | / |
Family ID | 32908350 |
Filed Date | 2004-02-05 |
United States Patent
Application |
20040020558 |
Kind Code |
A1 |
Stewart, Paul ; et
al. |
February 5, 2004 |
Filling apparatus
Abstract
An apparatus for filling pharmaceutical containers in a
substantially sterile environment may include an upright wall
dividing the apparatus into a substantially contamination free
sterile zone and a non-sterile zone and an enclosure cooperating
with the upright wall to define the sterile zone. The apparatus may
also include a transfer apparatus that receives empty containers
from a point outside the sterile zone and a transport at least
partially disposed within the sterile zone that moves the
containers through the sterile zone. The apparatus may include a
filling apparatus that fills the containers with pharmaceuticals in
the sterile zone as the containers are moved through the sterile
zone. The filling apparatus may include at least one dispenser
disposed within the sterile zone and a drive disposed in the
non-sterile zone. The filling apparatus may extend through a sealed
opening in the upright wall generally between the filling apparatus
dispenser in the sterile zone and the drive in the non-sterile
zone. The apparatus may also include a device movable with the at
least one dispenser and configured and positioned to control flow
of pharmaceuticals from the at least one dispenser. The at least
one dispenser may be movable into and out of filling engagement
with the containers.
Inventors: |
Stewart, Paul; (Youngstown,
NY) ; Hendrickx, Paul; (Baarie-Nassau, NL) ;
Damen, Frans; (Langeweg, NL) |
Correspondence
Address: |
Finnegan, Henderson, Farabow
Garrett & Dunner, L.L.P.
1300 I Street, N.W.
Washington
DC
20005-3315
US
|
Family ID: |
32908350 |
Appl. No.: |
10/418087 |
Filed: |
April 18, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10418087 |
Apr 18, 2003 |
|
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|
10179675 |
Jun 25, 2002 |
|
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|
60311823 |
Aug 14, 2001 |
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Current U.S.
Class: |
141/250 ; 53/167;
53/282 |
Current CPC
Class: |
B65B 3/003 20130101;
B65B 55/025 20130101 |
Class at
Publication: |
141/250 ; 53/282;
53/167 |
International
Class: |
B65B 001/00; B65B
005/00 |
Claims
What is claimed is:
1. An apparatus for filling containers in a substantially sterile
environment, the apparatus comprising: an upright wall dividing the
apparatus into a substantially contamination free sterile zone and
a non-sterile zone, said zones at least partially disposed in
side-by-side relation; an enclosure cooperating with said upright
wall to define one of said sterile zone and said non-sterile zone;
a transfer apparatus that receives empty containers from a point
outside said sterile zone; a transport at least partially disposed
within said sterile zone that moves the containers through said
sterile zone; a filling apparatus that fills the containers with
pharmaceuticals in said sterile zone as the containers are moved
through said sterile zone, said filling apparatus comprising at
least one dispenser disposed within said sterile zone and
comprising a drive disposed in said non-sterile zone, said filling
apparatus extending through a sealed opening in said upright wall
generally between said filling apparatus dispenser in said sterile
zone and said drive in said non-sterile zone; and a device
configured and positioned to control flow of pharmaceuticals from
said at least one dispenser, said device being movable with said at
least one dispenser, and said at least one dispenser being
reciprocally movable at least one of vertically and horizontally
into and out of filling engagement with said containers.
2. The apparatus for filling containers according to claim 1,
further comprising a transport that moves the containers through
said sterile zone.
3. The apparatus for filling containers according to claim 1,
further comprising a frame that supports said upright wall and said
enclosure.
4. The apparatus for filling containers according to claim 1,
further comprising connecting apparatus between said drive and said
filling apparatus dispenser, said connecting apparatus extending
through said sealed opening in said upright wall.
5. The apparatus for filling containers according to claim 1,
further comprising a plurality of operating apparatus, including
said filling apparatus, disposed in sequential relation, each of
said operating apparatus comprising at least a portion disposed
within said sterile zone and a drive disposed within said
non-sterile zone, a given operation being performed with respect to
the containers at each of said operating apparatus; and each of
said operating apparatus extending through said sealed opening in
said upright wall generally between said portion in said sterile
zone and said drive in said non-sterile zone.
6. The apparatus for filling containers according to claim 5,
wherein said plurality of operating apparatus comprises a closure
apparatus.
7. The apparatus for filling containers according to claim 1,
wherein said enclosure comprises a bottom wall and a drain disposed
within said bottom wall.
8. The apparatus for filling containers according to claim 1,
wherein said upright wall comprises a substantially vertical wall
member.
9. An apparatus for filling containers in a substantially sterile
environment, the apparatus comprising: a frame; an upright wall
carried by said frame and dividing the apparatus into a
substantially contamination free sterile zone and a non-sterile
zone at least partially disposed in side-by-side relation; an
enclosure cooperating with said upright wall to define said sterile
zone; a transfer apparatus that receives empty containers from a
point outside said sterile zone; a transport at least partially
disposed within said sterile zone that moves the containers through
said sterile zone; a filling station that fills containers with
pharmaceuticals as they are moved through said sterile zone by said
transport, said filling station being disposed in said sterile
zone; a drive in operable communication with said filling station,
said drive being disposed within said non-sterile zone; connecting
apparatus between said drive and said filling station, said
connecting apparatus extending through a sealed opening in said
upright wall; at least one dispenser associated with the filling
station; and a device configured and positioned to control flow of
pharmaceuticals from said at least one dispenser, said device being
movable with said at least one dispenser, and said at least one
dispenser being movable into and out of filling engagement with
said containers.
10. The apparatus for filling containers according to claim 9,
wherein said enclosure comprises a bottom wall and a drain disposed
within said bottom wall.
11. The apparatus for filling containers according to claim 9,
wherein said upright wall comprises a substantially vertical wall
member.
12. The apparatus for filling containers according to claim 11,
wherein said substantially vertical wall member and said enclosure
comprise stainless steel.
13. The apparatus for filling containers according to claim 9,
wherein said transport comprises: first and second drive wheels
disposed in opposed relation, each of said drive wheels being
disposed for rotation about a substantially horizontal axis; an
endless conveyor belt encircling said first and second drive wheels
and defining upper and lower flights; and a plurality of container
carrying members secured to the endless conveyor belt in spaced
relation.
14. The apparatus for filling containers according to claim 13,
wherein each of said container carrying members is disposed in
overlying relation to the outer face of the endless conveyor
belt.
15. The apparatus for filling containers according to claim 14,
wherein the width of each container carrying member substantially
corresponds to the width of the endless conveyor belt.
16. The apparatus for filling containers according to claim 15,
wherein each of said container carrying members defines a platform
sized and configured to receive and supportably carry one of said
containers.
17. The apparatus for filling containers according to claim 16,
wherein each of said container carrying members further comprises a
V-shaped laterally opening recess disposed over said platform for
providing lateral support to containers of differing size.
18. The apparatus for filling containers according to claim 9,
wherein said filling station comprises a plurality of dispensers
disposed in a substantially linear relation.
19. Apparatus for filling containers in a substantially sterile
environment, comprising: frame means; upright wall means carried by
the frame means and dividing the apparatus into a substantially
contamination free sterile zone and a non-sterile zone at least
partially disposed in side-by-side relation; enclosure means
carried by the frame means and cooperating with the upright wall
means to define said sterile zone; transport means at least
partially disposed within said sterile zone for transporting
containers through said sterile zone; container transfer means for
transferring empty containers from a point outside said sterile
zone to said transport means in said sterile zone; means for
filling containers with pharmaceuticals as they are moved through
the sterile zone by the transport means, the means for filling
containers being disposed in said sterile zone; drive means
disposed within said non-sterile zone for actuating said means for
filling containers; connection means for operably connecting the
drive means with the means for filling containers, the connection
means extending through a sealed opening in said upright wall
means; at least one dispenser associated with said means for
filling; and a device configured and positioned to control flow of
pharmaceuticals from said at least one dispenser, said device being
movable with said at least one dispenser, and said at least one
dispenser being movable into and out of filling engagement with
said containers.
20. An apparatus for filling pharmaceutical containers in a
substantially sterile environment, the apparatus comprising: an
upright wall dividing the apparatus into a substantially
contamination free sterile zone and a non-sterile zone, said zones
being at least partially disposed in side-by-side relation; an
enclosure cooperating with said upright wall to define said sterile
zone; a transfer apparatus that receives empty pharmaceutical
containers from a point outside said sterile zone; a plurality of
operating apparatus disposed in sequential relation, each of said
operating apparatus comprising at least a portion disposed within
said sterile zone and a drive disposed within said non-sterile
zone, a given operation being performed with respect to the
pharmaceutical containers at each of said operating apparatus, each
of said operating apparatus extending through a sealed opening in
said upright wall generally between said portion in said sterile
zone and said drive in said non-sterile zone; a transport at least
partially disposed within said sterile zone that moves the
pharmaceutical containers through said plurality of operating
apparatus; at least one dispenser structured and arranged to direct
flow of pharmaceuticals into said pharmaceutical containers; and a
device configured and positioned to control flow of pharmaceuticals
from said at least one dispenser, said device being movable with
said at least one dispenser, and said at least one dispenser being
movable into and out of filling engagement with said
containers.
21. The apparatus for filling containers according to claim 20,
further comprising a transport that moves the containers through
said sterile zone.
22. The apparatus for filling containers according to claim 20,
further comprising a frame that supports said upright wall and said
enclosure.
23. The apparatus for filling containers according to claim 20,
further comprising a plurality of drives in operable communication
with corresponding first portions of said plurality of operating
apparatus, said drives being disposed within said non-sterile
zone.
24. The apparatus for filling containers according to claim 23,
further comprising a plurality of connecting apparatus between each
of said plurality of drives and said corresponding first portions
of said plurality of operating apparatus, said connecting apparatus
extending through said sealed opening in said upright wall.
25. The apparatus for filling containers according to claim 20,
wherein said plurality of operating apparatus comprises a filling
apparatus and a closure apparatus.
26. The apparatus for filling containers according to claim 20,
wherein said enclosure comprises a bottom wall and a drain disposed
within said bottom wall.
27. The apparatus for filling containers according to claim 20,
wherein said upright wall comprises a substantially vertical wall
member.
28. The apparatus for filling containers according to claim 20,
further comprising sealed access for intervention during operation
of the apparatus from outside said sterile zone into said sterile
zone.
29. The apparatus for filling containers according to claim 28,
wherein sealed access includes glove ports.
Description
RELATED APPLICATION
[0001] This application is a continuation-in-part of prior
application Ser. No. 10/179,575, filed Jun. 25, 2002, which claims
the right to priority based on Provisional Patent Application No.
60/311,823, filed Aug. 14, 2001, each of which are incorporated
herein by reference.
TECHNICAL FIELD
[0002] The invention relates generally to a filling apparatus and,
more particularly, to an improved filling apparatus configured to
fill containers, for example, vials, with liquid products, for
example, pharmaceuticals and the like.
BACKGROUND
[0003] In the pharmaceutical industry, many preparations, for
example, injectable drugs and medicines, are packaged in containers
such as vials, which are often small in size. In-line filling
machines, or in-line fillers, are often used to package these
pharmaceutical preparations to high standards of sterility.
[0004] The in-line fillers may be "isolated" so as to maintain a
high level of sterility. Isolated in-line fillers may define a
clean and sterile area for packaging the preparations by coupling
an enclosure to a horizontal or substantially horizontal table or
by coupling an enclosure to a vertical wall. In the case of a
table, components of the filling system are mounted to the table
such that only the necessary components for packaging the
preparation are located in the sterile area. The drive mechanisms
and other components that are difficult to maintain to a high
degree of sterility are below the table.
[0005] In the case of a vertical wall filler, such as disclosed in
U.S. Pat. No. 5,673,535, the components of the filling system are
mounted to the wall such that only the necessary components for
packaging the preparation are located in the sterile area. The
drive mechanisms and other components that are difficult to
maintain to a high degree of sterility are on an opposite side of
the wall from the sterile area.
[0006] Alternatively, in-line fillers could be used without an
enclosure that defines a sterile zone. These types of fillers are
kept in a "clean room" where the entire room is maintained to the
necessary high degree of sterility. Optionally, in a clean room
application, the filling system may include an enclosure for
enclosing mechanical drives and other components, thereby confining
these components to a non-sterile zone.
[0007] Conventional fillers may include a filling system, for
example, a pump-activated filling system or a time and pressure
filling system. In a time and pressure system, a liquid product may
be fed from a stationary pressurized manifold through a plurality
of flexible supply lines to a corresponding plurality of
dispensers, for example, filling needles, nozzles, or the like. A
valve may be associated with each flexible supply line in either
type of filling system.
[0008] The quantity of liquid dispensed may be controlled by the
valves. In order to dispense a desired quantity, the valves may be
opened for a certain period of time dependent upon, among other
things, the pressure and temperature of the liquid product. The
valves may be configured as pinch valves that pinch the flexible
supply line to stop the flow of liquid and lessen the pinch to
start the flow. When the valves open, the liquid product may be
dispensed from the dispensers into a corresponding plurality of
vials.
[0009] The dispensers may be associated with a structure that
follows the motion of the vials as they progress along a conveyor
system through the filling system. In the case of needle-type
filling dispensers, the structure may be referred to as a needle
bridge. Because the liquid supply lines are flexible, the
dispensers may move while the product supply manifold remains
stationary. Since the valves in conventional fillers are also
stationary, the dispensers may move relative to their corresponding
valves. This relative motion may cause the flexible supply lines to
change shape, which in turn causes a change in internal volume. As
a result, the accuracy of the filling system may be
compromised.
[0010] In addition, the measurement of temperature and pressure of
the liquid product is conventionally performed in the product
supply manifold. The measurement of temperature remote from the
dispensers can introduce filling errors if the fluid flow
properties are temperature sensitive.
SUMMARY OF THE INVENTION
[0011] According to one aspect of the invention, an improved
apparatus is provided for filling pharmaceutical containers in a
substantially clean and sterile environment. The apparatus may
include an upright wall dividing the apparatus into a substantially
contamination free sterile zone and a non-sterile zone and an
enclosure cooperating with the upright wall to define the sterile
zone or, alternatively, the non-sterile zone. The apparatus may
also include a transfer apparatus that receives empty containers
from a point outside the sterile zone and a transport at least
partially disposed within the sterile zone that moves the
containers through the sterile zone. The apparatus may include a
filling apparatus that fills the containers with pharmaceuticals in
the sterile zone as the containers are moved through the sterile
zone. The filling apparatus may include at least one dispenser
disposed within the sterile zone and a drive mechanism disposed in
the non-sterile zone. The filling apparatus may extend through a
sealed opening in the upright wall generally between the filling
apparatus dispenser in the sterile zone and the drive mechanism in
the non-sterile zone. The apparatus may also include a device
movable with the at least one dispenser and configured and
positioned to control flow of pharmaceuticals from the at least one
dispenser. The at least one dispenser may be movable into and out
of filling engagement with the containers.
[0012] According to another aspect of the invention, an apparatus
for filling containers in a substantially sterile environment may
comprise a frame, an upright wall carried by the frame and dividing
the apparatus into a substantially contamination free sterile zone
and a non-sterile zone at least partially disposed in side-by-side
relation, and an enclosure cooperating with the upright wall to
define the sterile zone. The apparatus may also include a transfer
apparatus that receives empty containers from a point outside the
sterile zone, a transport at least partially disposed within the
sterile zone that moves the containers through the sterile zone,
and a filling station that fills containers with pharmaceuticals as
they are moved through the sterile zone by the transport. The
filling station may be disposed in the sterile zone. The apparatus
may also include a drive mechanism in operable communication with
the filling station and disposed within the non-sterile zone and
connecting apparatus between the drive mechanism and the filling
station. The connecting apparatus may extend through a sealed
opening in the upright wall. The apparatus may include at least one
dispenser associated with the filling station and a device
configured and positioned to control flow of pharmaceuticals from
the at least one dispenser. The device may be movable with the at
least one dispenser, and the at least one dispenser being movable
into and out of filling engagement with the containers.
[0013] According to yet another aspect of the invention, an
apparatus for filling containers in a substantially sterile
environment may comprising frame means, upright wall means carried
by the frame means and dividing the apparatus into a substantially
contamination free sterile zone and a non-sterile zone at least
partially disposed in side-by-side relation, and enclosure means
carried by the frame means and cooperating with the upright wall
means to define the sterile zone. The apparatus may include
transport means at least partially disposed within the sterile zone
for transporting containers through the sterile zone, container
transfer means for transferring empty containers from a point
outside the sterile zone to the transport means in the sterile
zone, and means for filling containers with pharmaceuticals as they
are moved through the sterile zone by the transport means. The
means for filling containers may be disposed in the sterile zone.
The apparatus may also include drive means disposed within the
non-sterile zone for operating the means for filling containers and
connection means for operably connecting the drive means with the
means for filling containers. The connection means may extend
through a sealed opening in the upright wall means. The apparatus
may include at least one dispenser associated with the filling
means and a device configured and positioned to control flow of
pharmaceuticals from the at least one dispenser. The device may be
movable with the at least one dispenser, and the at least one
dispenser may be movable into and out of filling engagement with
the containers.
[0014] According to still another optional aspect of the invention,
an apparatus for filling pharmaceutical containers in a
substantially sterile environment may include an upright wall
dividing the apparatus into a substantially contamination free
sterile zone and a non-sterile zone. The zones may be at least
partially disposed in side-by-side relation. The apparatus may also
include an enclosure cooperating with the upright wall to define
the sterile zone, a transfer apparatus that receives empty
pharmaceutical containers from a point outside the sterile zone,
and a plurality of operating apparatus disposed in sequential
relation. Each of the operating apparatus may comprise at least a
portion disposed within the sterile zone and a drive disposed
within the non-sterile zone, wherein a given operation may be
performed with respect to the pharmaceutical containers at each of
the operating apparatus. Each of the operating apparatus may extend
through a sealed opening in the upright wall generally between the
portion in the sterile zone and the drive in the non-sterile zone.
The apparatus may also include a transport at least partially
disposed within the sterile zone that moves the pharmaceutical
containers through the plurality of operating apparatus, at least
one dispenser structured and arranged to direct flow of
pharmaceuticals into the pharmaceutical containers, and a device
configured and positioned to control flow of pharmaceuticals from
the at least one dispenser. The device may be movable with the at
least one dispenser, and the at least one dispenser may be movable
into and out of filling engagement with the containers.
[0015] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of the invention, as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate exemplary
embodiments of the invention and, together with the description,
serve to explain the principles of the invention. In the
drawings,
[0017] FIG. 1 is a schematic representation of a conventional
container filling apparatus modified in accordance with some
aspects of the present invention;
[0018] FIG. 2 is a top plan view of the modified container filling
apparatus of FIG. 1;
[0019] FIG. 3 is a transverse section view of the modified
container filling apparatus taken along line III-III of FIG. 2;
[0020] FIG. 4 is a cross-sectional view of a filling apparatus in
accordance with an embodiment of the present invention;
[0021] FIG. 5 is a cross-sectional view of a portion of the filling
apparatus shown in FIG. 4;
[0022] FIG. 6 is a partial perspective view of a known exemplary
vertical container conveyor that could be used with the container
filling apparatus in accordance with the invention;
[0023] FIG. 7 is a partial perspective view of a known exemplary
horizontal container conveyor that could be used with the container
filling apparatus in accordance with the invention; and
[0024] FIG. 8 is a cross-sectional view of the exemplary horizontal
container conveyor taken along line VIII-VIII of FIG. 7.
DETAILED DESCRIPTION
[0025] Reference will now be made in detail to embodiments of the
invention, examples of which are illustrated in the accompanying
drawings. In accordance with the present invention, a filling
apparatus is provided. The filling apparatus may be used, for
example, to fill containers, for example, vials, with fluid.
[0026] Referring to FIGS. 1-3, a vial filling apparatus embodying
the invention is represented generally by the numeral 41 and is
disclosed generally in U.S. Pat. No. 5,673,535, except for the
modifications and improvements discussed in detail herein. The
apparatus 41 is intended for use in the sequential filling of
continuously fed vials for injectable drugs, but the invention
contemplates the filling of any type of container in a clean and
sterile environment.
[0027] With particular reference to FIG. 2, apparatus 41 includes a
sterilized infeed enclosure 42 through which vials 14 pass on a
conveyor 48. Infeed enclosure 42 represents the inlet to a sterile
zone, discussed below, and it is essential that the vials 14
entering at this point be in a sterilized condition. To that end,
enclosure 42 is connected to a conventional vial washer/sterilizing
tunnel 50 that receives unsterilized vials, performs a multiple
step procedure that sterilizes the vials, generally including
depyrogenization, and delivers sterilized vials to the conveyor 48
of sterilized infeed enclosure 42. At this point, the sterilized
vials are transferred to an oscillating belt infeed station 43 that
moves the vials to a transfer star wheel 44, which sequentially
loads the vials 14 onto a principal container conveyor 45 or 45'.
Although a vertical conveyor 45 is depicted in FIGS. 1-3, an
improved horizontal conveyor 45', as shown and described with
respect to FIGS. 7 and 8, may be used.
[0028] Conveyor 45, 45' sequentially moves the vials 14 to a
pre-fill check weigh station 46 that randomly removes a vial to
establish a reference pre-fill weight. The vials are then carried
by conveyor 45, 45' through a filling station 47 which comprises a
filling device 414, including a plurality of nozzles 49, described
in further detail below.
[0029] After filling, the vials 14 are moved by conveyor 45, 45'
past a post-fill check weigh station 52, which removes each of the
randomly selected empty vials previously weighed at pre-fill check
weigh station 46. This comparative weighing ensures that the
specific amount of pharmaceutical preparation has been metered and
dispensed into each vial. The weigh stations may include contact or
non-contact weighing devices.
[0030] Conveyor 45, 45' then moves the vials through a stoppering
station 53 at which each of the filled vials is closed and sealed
with a stopper. Vials 14 then move into an eject and outfeed
station 54, where the vials are removed from conveyor 45, 45' and
carried by means not shown to a packing station.
[0031] With reference to FIG. 3, apparatus 41 comprises an
elongated frame, certain components of which are shown in this
transverse sectional view. These include vertical leg members 55, a
cross rail member 56, a mounting plate 57 and a vertical frame
support member 58 that extends between the cross rail member 56 and
plate 57, at an intermediate point between the vertical leg members
55. It is will be understood that the various components 55-58
repeat over the length of the apparatus frame.
[0032] A vertically disposed mounting plate 59 is secured to the
several frame support members 58, extending longitudinally over the
length of the apparatus 41 (see also FIG. 2). A portion of vertical
mounting plate 59 extends above the mounting plate 57. A thin
stainless steel sheet 61 corresponding in size to vertical mounting
plate 59 is mounted thereto in spaced relation. The stainless steel
sheet 61 defines the elongated barrier or back plate of a stainless
steel cabinet bearing general reference numeral 63, which in turn
defines an internal sterile zone 64. The area outside cabinet 63
(i.e., that portion on the left side of barrier plate 61 as viewed
in FIG. 3) constitutes a non-sterile zone bearing the general
reference numeral 70.
[0033] With continued reference to FIGS. 1 and 3, sterile cabinet
63 further comprises a front plate 65 that is shown as
corresponding generally in size to the back plate 61 in the
schematic representation of FIG. 1. However, and as shown in FIG.
2, the front plate 65 includes several outward steps to accommodate
various of the components described above. Referring again to FIG.
1, a cabinet top 66 and cabinet bottom 67 interconnect the back
plate 61 and front plate 65, and the cabinet ends are enclosed by
end plates 68, 69.
[0034] As shown in FIG. 2, the primary inlet to sterile zone 64 is
the sterile tunnel 42 as discussed above. The stoppering station 53
also includes a stopper inlet or docking port 53a through which
sterilized stoppers are admitted in a sterile manner as is known in
the art. The sole outlet from sterile zone 64 is the eject and
outfeed station 54, which may, for example, comprise a plurality of
conventional star wheels, the first of which is disposed within
sterile zone 64 and the second of which is disposed outside the
sterile zone 64. Vials 14 are transferred between these first and
second star wheels through a small opening in cabinet 63. Sterile
zone 64 may be maintained at a pressure higher than that of the
ambient surroundings to cause an outflow of air through the vial
outlet between the star wheels, thus resisting contaminant entry.
The means for maintaining such pressure, which is not shown, is
conventional and typically includes a supply of air that is
filtered to remove contaminants.
[0035] In an embodiment, cabinet 63 includes a plurality of
conventional glove ports 80 or other conventional means for
permitting sealed access to the sterile zone 64. Preferably, glove
ports 80 are disposed at spaced points to permit operators of the
apparatus 41 to have access at all points along the line of vial
movement.
[0036] With reference to FIG. 1, a drain portion 71 of the cabinet
63 projects downwardly below the filling station 47. The respective
bottom portions 67 adjacent the drain portion 71 are inclined
downwardly toward the drain portion 71. The bottom of drain portion
71 defines a plurality collecting drain pans 71A-C which
respectively lead to drains 72A-C. Each of the drains 72A-C is
connected through a sealed coupling 73 to a common drain pipe 74.
The purpose of these drain components is discussed in further
detail below.
[0037] Referring now to FIGS. 4 and 5, the filling apparatus may
include the filling station 47, a product supply manifold 411, at
least one supply line 412, and a filler configured to fill
containers, for example, a vial filling device 414. The product
supply manifold may be positioned in the sterile zone 64 or in the
non-sterile zone 70. Each supply line 412 may be disposed between
the product supply manifold 411 and the vial filling device 414.
Each supply line 412 may be configured as a conduit, at least a
portion 413 of which may be elastically deformable. The vial
filling device 414 may include at least one dispenser 49. It should
be appreciated that one supply line 412 may be provided for and
associated with each dispenser 49. The dispensers 49 may be
configured, for example, as filling needles, nozzles, or the like.
Optionally, the dispensers 49 may be provided with mechanical,
electrical, or electro-mechanical out-of-position sensors 417.
[0038] The filling apparatus may further comprise at least one
valve 418. The valve 418 may comprise, for example, a pinch valve
provided for and associated with each supply line 412 and dispenser
49. Accordingly, there may be a one-to-one-to-one correspondence
between the number of supply lines 412, dispensers 49, and valves
418. A portion 420 of the supply line 412 between the valve 418 and
the dispenser 49 may be rigid, or at least semi-rigid.
[0039] The vial filling device 414 may further include a structure
426, for example, a walking beam, with which the dispensers 49 and
valves 418 are associated. The structure 426 may be configured to
follow the motion of the vials 14 as they progress along the
conveyor 45, 45' through the vial filling device 414 during the
filling process.
[0040] The dispensers 49 and valves 418 may be associated with the
structure 426 such that there is substantially no relative motion
between the dispensers 49 and valves 418 as the structure 426
moves. In the case of needle-type filling dispensers, the structure
426 may be a needle bridge walking beam.
[0041] The filling apparatus may include a drive 151 (FIG. 2), for
example, a drive pulley, operatively connected to the vial filling
device 414 via a mechanism 434 that passes from the non-aseptic
zone 70 to the aseptic zone 64 via a sealed opening 436. The
mechanism 434 may carry the structure 426, including a housing 438.
Referring to FIG. 5, the housing 438 may contain valve actuators
440. The housing 438 may provide a seal between a surrounding
aseptic zone 64 and an interior, non-sterile or non-aseptic zone
433. The mechanism 434 may also be hollow to provide a non-sterile
or non-aseptic zone 435, including an enclosed path 442
communicating with the non-aseptic zone 70 for filler operation
and/or drive utilities 150, for example, the drive 151, a power
supply, motion and actuation control, and the like, that support
the actuation and operation of the valves 418. The valve actuators
440 may be separated from the valves 418 by a flexible diaphragm
444, which provides a seal between aseptic and non-aseptic zones
64, 433.
[0042] Additionally, a temperature sensor 446 may be positioned at
or proximate to the dispenser 49. Thus, the temperature of the
liquid product may be measured proximate the dispenser 49 rather
than in a more distally-located product supply manifold 411. As a
result, filling errors associated with temperature-sensitive fluid
flow properties of a product may be reduced.
[0043] With reference to FIGS. 2, 3, and 6, the vertical container
conveyor 45 may include a conveyor belt 87 having a row of sprocket
holes 88 disposed along each edge. Conveyor belt 87 may be
endlessly driven by a pair of opposed sprocket wheels 89, 90 (only
sprocket wheel 89 is shown in FIG. 6). The sprocket wheels 89, 90
may rotate about a horizontal axis as shown by reference numeral 91
in FIG. 3. For purposes of simplicity in FIG. 3, the horizontal
shafts upon which drive sprocket wheels 89 rotate are not shown.
Such shafts extend through appropriate seals in the stainless steel
sheet 61 and mounting plate 59 and are driven as discussed below.
With such a configuration, the width of conveyor 45 may be
significantly reduced. Further, since the drive for conveyor 45 may
be located outside sterile cabinet 63 as discussed below, cabinet
63 and sterile zone 64 may be significantly reduced in size from
the standpoint of width.
[0044] Referring now to FIG. 7, in a preferred embodiment, an
improved horizontal container conveyor 45' for transporting the
vials may be configured with drive sprocket wheels or the like 89'
that rotate about vertical axes. For example, as shown in FIGS. 7
and 8, the horizontal conveyor 45' may include one or more conveyor
belts 87' configured to move upper container holders 800 and lower
container holders 802 through a conveyor path. The lower container
holders 802 may support the containers 14, and the upper container
holders 800 may separate the containers 14 from one another and
hold them substantially still relative to one another. The distance
between adjacent upper container holders 800 may be adjustable so
as to accommodate different sized container 14. With such a
conveyor 45', the containers may be carried to the side of a
conveyor belt rather than above the belt 87 as discussed above.
Therefore, although such an alternative configuration of the
conveyor 45' may increase the width of the cabinet 63 and sterile
zone 64, the conveyor belt 87' may be less susceptible to
contamination in the alternative configuration than in the
configuration that carries the containers above the belt 87.
[0045] With reference to FIG. 2, each of the operating stations
disposed within the sterile zone 64 may be driven by an actuating
means, for example, a drive, that is disposed outside the sterile
zone 64 (i.e., within the nonsterile zone 70). These various
actuating means, although separate, may be interrelatably driven
because the various operations performed within sterile zone 64
must be synchronous. An electric motor 131 serves as the primary
drive means for the various actuating means. Separate servomotors
are used for other actuating means as described below, which are
operated in synchronous relation to primary drive motor 131.
[0046] The motor 131 includes a drive pulley 133 at at least one
end. Drive pulley 133 is connected through a drive belt 136 to a
driven pulley 137, which in turn is mounted to a common drive shaft
bearing the general reference numeral 138. Drive shaft 138
comprises a plurality of interconnected drive shaft segments
138A-E.
[0047] Drive shaft segment 138A is connected through a right angle
gear drive 139 to a pulley/timing belt configuration. A drive
connection 142 extends through a sealed opening 139 of the wall of
cabinet 63, connecting the pulley/timing belt 141 to the
oscillating belt infeed station 43.
[0048] Drive shaft segment 138A is connected to shaft segment 138B
through a right angle drive 144. A right angle drive 145 is
connected between drive shaft segments 138B-C, the purpose of which
is to drive the star wheel 44 through a pulley/belt configuration
146 and a drive connection 147. Drive connection 147 extends
through mounting plate 59 of cabinet 63 through a seal of the same
type as seal 143.
[0049] Drive shaft segment 138C is connected through a pulley/belt
configuration 148 to a right gear drive 149 having a drive pulley
151 (see also FIG. 3). Drive pulley 151 is connected to drive the
walking beam 426 through at least one actuator 86, each of which
extends through the mounting plate 59 through a seal similar to
seal 143.
[0050] The pre-fill check weigh station 46 and post-fill check
weigh station 52 may be separately driven by servomotors (not shown
for purposes of clarity), which are operated in synchronous
relation to the primary drive motor 131. Pre-fill check weigh
apparatus 46 includes a drive connection 152, and post-fill check
weigh apparatus 52 includes a drive connection 153.
[0051] Shaft drive segment 138D is connected through a pulley/belt
configuration 154 to a right angle gear drive 155 which in turn
drives a pulley/belt configuration 156. This, in turn, is connected
to a drive connection 157 that actuates a portion of the stoppering
station 53. Other components of the stoppering station are driven
by a separate variable speed motor.
[0052] Shaft drive segment 138D is also connected through a gear
drive 158 that drives a pulley/belt configuration 159. A drive
connection 161 interconnects the configuration 159 through a seal,
similar to seal 143, to the eject and outfeed station 54.
[0053] Shaft drive segment 138E is connected to a right angle gear
drive 162 which in turn drives a pulley/belt configuration 163. A
drive connection 164 extends through a seal and mounting plate 59
and connects configuration 163 with drive sprocket wheel 89.
Sprocket wheel 90 is a driven wheel and does not include a direct
drive.
[0054] With particular reference to FIGS. 1 and 3, the sterile zone
64 within the sterile cabinet 63 can be periodically cleaned and
sterilized by techniques utilizing steam and/or a disinfecting
liquid wash with all of the internal components in place. As a
result, clean zone 64 may be effectively sterilized and
decontaminated on a periodic basis in a manner which is far easier
than decontaminating an entire room or much larger zone. This also
results in a significant decrease in the cost of operating and
maintaining the apparatus 41.
[0055] In operation, a liquid product may be fed from a product
supply manifold 411 located in the aseptic zone 64 through one or
more supply lines 412 to corresponding dispensers 49. The valves
418 may control the quantity of liquid dispensed from the
dispensers 49.
[0056] In order to dispense a desired quantity, the valves 418 may
be opened for a certain period of time dependent upon, for example,
the pressure and temperature of the liquid product proximate the
dispensers 49. As shown in FIG. 5, the valves 418 may be configured
as pinch valves that pinch an elastically-deformable portion 413 of
the supply lines 412 to stop the flow of liquid and lessen the
pinching force to start the flow. When the valves 418 open, the
liquid product may be dispensed from the dispensers 49 into a
corresponding plurality of vials.
[0057] The conveyor 45 or 45' transports vials 14 past the vial
filling device 414. The structure 426 may follow the motion of the
vials 14 as they progress along the conveyor system 422 past the
vial filling device 414. Because the portion 413 of the supply
lines 412 is flexible, the dispensers 49 may move to engage the
vials 14, such as by a combined translation and reciprocal
movement, while the product supply manifold 411 remains stationary.
Since the valves 418 and dispensers 49 may move with the structure
426, the internal configuration or flow geometry of the portion 420
of the supply lines 412 between the dispensers 49 and the valves
418 remains substantially unchanged during movement of the
structure 426 during the filling process. As a result, the accuracy
of the filling apparatus may not be compromised.
[0058] It will be apparent to those skilled in the art that various
modifications and variations can be made to the filling apparatus
without departing from the scope or spirit of the invention. Other
embodiments of the invention will be apparent to those skilled in
the art from consideration of the specification and practice of the
invention disclosed herein. It is intended that the specification
and examples be considered as exemplary only.
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