Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
SYSTEMS AND METHODS FOR AUTOMATED PELLET PRESSING
AND VIALING
FIELD
[0001] The present disclosure generally relates systems and methods
for
manufacturing vialed pellets; and in particular to systems and methods for
automatically
pressing and vialing of implantable pellets.
BACKGROUND
[0001] The manufacturing of implantable pellets, such as pellets
containing testosterone, require high manufacturing standards to ensure
compliance
with requirements related to proper pellet shape, pellet surface area, pellet
volume, and
pellet integrity. In the past, manual pellet presses have been used to
manufacture
pellets, which can be time consuming and potentially introduce variance in
pellet shape,
surface, area, volume and integrity during manufacturing. As such, automated
methods
for manufacturing pellets that meet the stringent standards of manufacturing
such
implantable pellets are desirable.
[0002] These implantable pellets are oftentimes stored and
distributed in
vials. A vial is generally understood as a plastic or glass vessel or bottle,
which may be
tube-shaped or cylindrical and used to store or protect a substance such as a
medicine,
perfume, chemical, and the like. A vial may also be referred to as a phial,
container,
bottle, or tube. Vials may include single-dose or multi-dose substances or
medications.
In some cases, vials are enclosed using a cap, stopper, cork, or other such
closure
mechanism. In addition, the process of manufacturing and vialing a plurality
of pellets
for individual storage, packaging and distribution may be better automated
into a more
time and cost effective process.
[0003] It is with these observations in mind, among others, that
various
aspects of the present disclosure were conceived and developed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] FIG. 1 is a simplified block diagram of a system for automated
pellet fabrication and vialing.
[0005] FIG. 2 is a simplified block diagram of a process flow
associated
with pellet fabrication and vialing.
1
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
[0006] FIG. 3 is a perspective view of an automated pellet press used
in
the system for the automated pellet fabrication and vialing of FIG. 1.
[0002] FIG. 4 is an exploded view of the automated pellet press of
FIG. 3.
[0003] FIG. 5 is a front view of the automated pellet press of FIG.
3.
[0004] FIG. 6 shows various illustrations of upper and lower punches
having different sizes and related dies that may be used with the automated
pellet
press of FIG. 3.
[0005] FIGS. 7A and 7B show before-and-after assembly of upper and
lower punches using a simplified front view of the automated pellet press of
FIG. 3.
[0006] FIGS. 8A and 8B illustrate before-and-after assembly of a face
plate and vacuum tubing using a simplified enlarged front view of the
automated pellet
press of FIG. 3.
[0007] FIGS. 9A and 9B illustrate before-and-after assembly of a feed
cup
and shaker lever in relation to a die using a simplified view of the automated
pellet
press of FIG. 3.
[0008] FIG. 10 illustrates an assembly of the feed cup and shaker
lever
shown in FIG. 9B in relation to an upper punch of the automated pellet press
of FIG. 3.
[0009] FIG. 11A illustrates the feed cup and shaker lever situated in
alignment when the die is in a "dispensing" position with the die being shown
in
phantom;
[0010] FIG. 11B illustrates the feed cup and shaker lever with an
elongated edge of the feed cup being out of alignment when the die is in a
"non-
dispensing" position;
[0011] FIG. 11C illustrates the feed cup and shaker lever with an
elongated edge of the feed cup being returned to a "dispensing" position and
moving
across the die, an operation which facilitates the "eject" function of the
automated pellet
press of FIG. 3.
[0012] FIG. 12 shows an illustration of the lifting cam of the
automated
pellet press of FIG. 3 defining an eccentric pathway formed along its face.
[0013] FIG. 13 is an image of one embodiment of the system of FIG. 1
for
automated pellet vialing.
[0014] FIG. 14 is a simplified block diagram depicting an exemplary
process including a decision tree associated with the pellet vialing framework
of FIG. 1.
2
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
[0015] FIG. 15 is a simplified block diagram showing an example of a
computing system that may implement various services, systems, and methods
discussed herein.
[0007] Corresponding reference characters indicate corresponding
elements among the view of the drawings. The headings used in the figures do
not limit
the scope of the claims.
DETAILED DESCRIPTION
[0008] The present disclosure relates to an automated pellet
fabrication
and vialing system and related method of manufacturing and vialing of
implantable
pellets. In particular, referring to the drawings, one embodiment of the
present system
of manufacturing pellets includes an automated pellet press for the automation
of
pharmaceutical pellet production and an automated pellet vialing and packaging
apparatus for the automation of transitioning raw pellets to a vialed and
labeled product,
is illustrated and generally indicated as 100 in FIGS. 1-15.
[0009] Referring to FIGS. 1 and 2, an exemplary system for automated
pellet fabrication, vialing and packaging (hereinafter "system") 10 is shown.
The
system 10 may include an automated pellet press 100 which is operable to
fabricate a
plurality of pellets 190, among other features as described herein. The system
10 may
further include a pellet vialing apparatus 200 operable for vialing the
plurality of pellets
190 into a plurality of vialed pellets 106 from the plurality of pellets 190
fabricated by the
automated pellet press 102. A more detailed description of the system 100 is
set for the
below.
Automated Pellet Press
[0016] Various embodiments of an automated pellet press are disclosed
herein. In some embodiments, the automated pellet press includes a frame
operatively
connected to a motor having a pulley arrangement that actuates an upper
plunger and
a lower plunger in alternating opposite axial directions such that an upper
punch and a
lower punch associated with the upper and lower plungers, respectively,
alternately
engage a die containing a pharmaceutical compound in powder form to produce an
implantable pellet. In some embodiments, the pellets produced by the automated
pellet
press have the same size, configuration, volume, and pellet integrity to be
inserted
subcutaneously within a patient for delayed release or release of the
pharmaceutical
3
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
substance overtime. Referring to the drawings, an embodiment of the automated
pellet
press is illustrated and generally indicated as 100 in FIGS. 3-12.
[0017] Referring to FIGS. 3 and 4, in some embodiments the automated
pellet press 100 is operable to manufacture a plurality of pellets made from a
pharmaceutical substance in an automated pressing operation. In one method of
manufacture using the automated pellet press 100 a pharmaceutical substance in
powder form is poured into a die 138 and then compressed into pellet form when
stamped by an upper punch 140 disposed partially within an upper plunger 117
and a
lower punch 141 partially disposed within a lower plunger 118 in which the
upper and
lower punches 140 and 141 are driven against the die 138 in alternating
sequence from
opposite axial directions. Once stamped, the formed pellet is then extracted
from the
die 138 for collection.
[0018] Referring to FIG. 4, the automated pellet press 100 includes a
frame 101 that provides a structure for assembling the components of the
automated
pellet press 100. In some embodiments, the frame 101 defines an upper mounting
portion 161 forming a pair of axially extending channels 163A and 163B as well
as a
lower mounting portion 162 forming a pair of axially extending channels 164A
and 164B
in respective alignment with the axially extending channels 163A and 163B. As
shown,
first and second shoulders 165 and 166 are defined above the upper mounting
portion
161 and form aligned respective first and second longitudinal channels 167 and
168
configured to receive a rotatable main shaft 115. In some embodiments, the
frame 101
may be secured or rest on a base plate 114 and/or reside within an enclosure
(not
shown) that prevents contaminants from contacting the pellet during
manufacture.
[0019] As shown in FIGS. 3-4, a motor 150 is operably coupled to a
first
pulley 152 which drives a belt 155 engaged between the first pulley 152 and a
second
pulley 153. The second pulley 153 is coupled to a rotatable main shaft 115
mounted
along the first shoulder 165 and a second shoulder 166 of frame 101. In some
embodiments, a hand wheel 160 is coupled to one of the end portions of the
main shaft
115 and is operable to manually operate the automated pellet press 100 by
manually
rotating the rotatable main shaft 115 when manual operation is desired.
[0020] In some embodiments, the rotatable main shaft 115 is coupled
to a
lifting rod 116 by a converter mechanism which converts a rotational motion
provided
by the main shaft 115 to an up-and-down reciprocating linear motion of the
lifting rod
116. One such embodiment of the converter mechanism is a lifting cam 104
defining an
4
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
eccentric pathway 172 (shown in FIG. 12) which is operatively coupled to the
lifting rod
116 through a laterally extending protrusion 123 defined by or coupled to the
lifting rod
116 that is engaged within and follows the eccentric pathway 172 as the
rotatable main
shaft 115 is rotated. As the laterally extending protrusion 123 follows the
path of the
eccentric pathway 172 as the main shaft 115 is rotated, the lifting rod 116 is
caused to
move up and down in opposite axial directions A and B shown in FIG. 5. In some
embodiments, a lifting block 143 is attached to the bottom portion of the
lifting rod 116
through an aperture 156 formed through the lifting block 143. The lifting
block 143
further defines a slot portion 157 configured to engage the lower plunger 118
such that
axial movement of the lifting rod 116 causes the lower plunger 118 to
concurrently
move in the same axial direction. In one embodiment, the lifting rod 116 is
disposed
through the aligned upper channel 163A and lower channel 164A of frame 101.
[0021] As further shown, the main shaft 115 is coupled to the upper
plunger 117 by a second converter mechanism which converts the rotational
motion
provided by the main shaft 115 to a repetitive up and down linear motion of
the upper
plunger 117 in opposite axial directions A and B. The second converter
mechanism
may be embodied as an eccentric sheave 102 coupled to the main shaft 115,
wherein
the eccentric sheave 102 is coaxially engaged within an eccentric strap 103
coupled to
an upper plunger eyebolt 120 through an eyebolt pin 122. The upper plunger
eyebolt
120 is also coupled to the upper plunger 117 using an eyebolt nut 121. In one
embodiment, the upper plunger 117 is disposed through the upper channel 163B
defined by the frame 101. In operation, as the main shaft 115 is rotated, the
eccentric
sheave 102 produces an up and down axial motion that is imparted to the upper
plunger 117 through the upper plunger eyebolt 122 and eccentric strap 190. As
such,
movement of the upper plunger 117 in an up and down axial motion along axial
directions A and B is caused by rotation of the eccentric sheave 102 by the
main shaft
115 is rotated, while movement of the lower plunger 118 in a similar up and
down axial
motion along axial directions A and B that alternates with the up and down
motion of
the upper plunger 117 is caused by rotation of the lifting cam 104 by the main
shaft 115
as described above. The upper punch 140 is disposed within the upper plunger
117
and secured in place using an upper plunger nut 131.
[0022] In some embodiments, the lower plunger 118 is disposed through
the lower channel 164B of frame 101. As shown, the lower plunger 118 is
operatively
coupled with a lower adjusting nut 111 which is rotated to adjust the height
of the lower
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
punch 141 relative to the lower plunger 118 and therefore control the size of
the pellet
(e.g., the length of the pellet). In addition, an upper adjusting nut 110 is
provided to
control the flushness of the lower punch 141 relative to the die 138. As
shown, the
combination of an adjusting nut collar 132, adjusting nut clip 133 and
adjusting nut clip
screw 134 engages the upper and lower adjusting nuts 110 and 111 to the lower
plunger 118 for adjustment of the lower punch 141. A lower plunger bushing 119
is
coupled to the bottom end of the lower plunger 118.
[0023] As shown, the main shaft 115 is also engaged to a swivel cam
105
that defines an eccentric pathway (not shown) configured to receive a shaker
roller pin
128, wherein the shaker roller pin 128 is in operative engagement with a
swivel lever
roller arm 129 defined by the swivel lever 107. The swivel lever roller arm
129 imparts a
back and forth or rocking motion to the swivel lever 107 as the swivel lever
roller arm
129 travels along the eccentric pathway defined by the swivel cam 105 as the
main
shaft 115 rotates. In addition, the swivel lever 107 is configured to receive
a spring 108
and a swivel lever fulcrum pin 130 which is attachable to the frame 101 and
collectively
facilitate the back and forth motion of the swivel lever 107 imparted by the
swivel cam
105 as the main shaft 115 rotates. In some embodiments, a tensioner pin 106
may be
provided that ensures the top of the spring 108 is maintained at the
appropriate location
relative to the swivel lever 107. In some embodiments, a collar 136 is
disposed through
the swivel cam 105 for engagement with the main shaft 115.
[0024] As shown in FIGS. 9A-9B and 10, the swivel lever 107 is in
operative engagement with a feed cup 109 that is operable to deposit a
predetermined
amount of a pharmaceutical substance in powder form into the die 138 for
formation of
a pellet in the stamping operation. In some embodiments, the feed cup 109 may
be in
operative association with a hopper 151 (FIG. 4) that is configured to provide
a storage
conduit for supplying the pharmaceutical substance in powder form to the feed
cup 109,
although in other embodiments the feed cup 109 may be configured to store and
dispense the pharmaceutical substance without a hopper 151. In some
embodiments,
the feed cup 109 may further include an elongated edge 109A positioned above
the die
138 and below the upper punch 140. The feed cup 109 may also define a forked
end
109B on the opposite side, wherein the forked end 109B is operable to capture
the
swivel lever 107, as shown in FIG. 9B. In one embodiment, the forked end 109B
of the
feed cup 109 couples the swivel lever 107 to the feed cup 109 such that the
feed cup
109 is operable to swivel between a supply position wherein the hopper 151
supplies
6
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
an amount of pharmaceutical substance into the feed cup 109 and a dispensing
position wherein the feed cup 109 is aligned directly over the die 138 and
dispenses an
amount of pharmaceutical substance in powder form to the die 138 when shaken
by the
back and forth operation of the swivel lever 107 before the feed cup 109
swivels to the
non-dispensing position, where the feed cup 109 is no longer positioned
directly over
the die 138. During this swiveling operation, the elongated edge 109A swivels
across
an upper side of the die 138, an operation which will facilitate the ejection
of the formed
pellet. This swiveling operation of the feed cup 109 between non-dispensing
and
dispensing positions is repeated for the formation of each individual pellet.
[0025] As noted above, the upper plunger 117 is engaged to the upper
punch 140 to drive the upper punch 140 in an axial direction A and then axial
direction
B, while the lower plunger 118 is engaged to a lower punch 141 to drive the
lower
punch 141 in an opposite axial direction B and then axial direction A as
illustrated in
FIGS. 3-5. In this arrangement, the upper punch 140 and lower punch 141 are
driven
into contact with the die 138 in alternating sequence against the die 138 in
an
automated stamping operation as the upper plunger 117 and lower plunger 118
are
actuated by operation of the motor 150 in alternating sequence relative to the
die 138
as the main shaft 115 is rotated.
[0026] In some embodiments, as shown in FIG. 4 one or more oil cups
112 may be provided to supply a lubricant along the moving components of the
automated pellet press 100. For example, a respective oil cup 112 may supply
lubricant
along the eccentric strap 103 as well as first and second channels 167 and 168
of
respective first and second shoulders 165 and 166 of frame 101. In some
embodiments, an oil cup 113 defining an elbow may provide a lubricant to the
upper
plunger eyebolt 120.
[0027] Referring to FIG. 6, embodiments of the upper and lower
punches
140 and 141 and the die 138 are illustrated. In some embodiments, the upper
punch
140 has a shorter length than the lower punch 141 and each may have a 3 mm 0r4
mm width. Similarly, a die 138A may be configured to receive the 3 mm upper
and
lower punches 140/141 or a die 138B may be continued to receive the 4 mm upper
and
lower punches 140/141 in an alternate embodiment. In one aspect, the upper and
lower
punches 140/141 may have different sizes to comport with the size of the die
138 used
to form the pellets of a particular shape and size during the stamping
operation.
7
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
[0028] Referring to FIGS. 7A and 7B as noted above, the upper punch
140 is in operative engagement with the upper plunger 117 and the lower punch
141 is
in operative engagement with the lower plunger 118. Upon assembly, the upper
punch
140 is inserted into the upper plunger 117 and the lower punch 141 is inserted
into the
lower plunger 118. Upon assembly, the die 138 is inserted into the lower
channel 164B.
Referring to FIGS. 8A and 8B, in some embodiments a vacuum tubing 124 is in
operative association with the die 138 such that suction is provided by the
vacuum
tubing 124 to facilitate the deposition of powder into the die 138. As shown
in FIG. 8B,
some embodiments of the lower mounting portion 162 of the frame 102 may have a
face plate 170 affixed to the lower mounting portion 162 for protection.
Referring to FIG.
9A, a top plate 171 is mounted onto the lower mounting portion 162 and secured
to the
face plate 170. Referring to FIG. 4, the feed cup 109 may be mounted to the
top plate
by the feed cup bolt 125, wherein the feed cup bolt 125 is sheathed by the
feed cup
spring 126 and secured by the feed cup nut 127. As noted above, the feed cup
109 is
coupled to the swivel lever 107 by a forked end 109B of the feed cup 109 such
that the
feed cup 109 is operable to swivel between a dispensing position and a non-
dispensing
position.
[0029] The dispensing position, as shown in FIG. 11A, involves
swiveling
the elongated end 109A of the feed cup 109 over the die 138 such that an
amount of
powdered material is dispensed into the die 138. The elongated end 109A of the
feed
cup 109 is then swiveled into a non-dispensing position away from the die, as
shown in
FIG. 11B. While the feed cup 109 is in the non-dispensing position, the upper
and lower
punches 140/141 contact the die 138 in alternating sequence and stamp the
powdered
material into a pellet. The feed cup 109 is then returned to the dispensing
position,
however, as shown in FIG. 9C, the lower punch 141 lifts the pellet out of the
die 138
and the elongated edge 109A of the feed cup 109 contacts and expels the pellet
out of
the die 138 and into a repository (not shown), thus ejecting the pellet from
the die 138
in time to fill the die 138 with more powdered material for forming another
pellet.
[0030] One method of manufacturing pellets using the automated pellet
press 100 as disclosed herein shall be discussed. As noted above, a
predetermined
amount of a powdered material, such as a pharmaceutical substance, is first
deposited
into the die 138 by feed cup 109. Once the powdered material is deposited into
the die
138, the feed cup 109 swivels away from the dispensing position and the lower
plunger
118 is actuated in axial direction B such that the lower punch 141 contacts
the die 138
8
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
and sets the powdered material within the die 138. After the die 138 is
contacted by the
lower punch 141, the upper plunger 117 then drives the upper punch 140 into
contact
the die 138 from opposite axial direction A to fully form the pellet within
the die 138 from
the deposited powder material. The lower plunger 118 then subsequently drives
the
lower punch 141 into contact with the die 138 again from axial direction B to
extract and
remove the formed pellet from the die 138, lifting the formed pellet in an
axial direction
B out of the die. After the lower punch 141 lifts the formed pellet from the
die 138, the
feed cup 109 swivels back into the dispensing position again to dispense
another
amount of powdered substance into the die 138 for formation of another pellet
by the
upper and lower punches 140 and 141 in the stamping operation. During the
swiveling
operation of the feed cup 109 shown in FIG. 11C, the elongated edge 109A of
the feed
cup 109 concurrently knocks the formed pellet having been lifted by the lower
punch
141 out of alignment with the die 138 for collection. As such, the three step
stamping
operation of the upper and lower punches 140 and 141 set, form, and extract
each
pellet from the die 138.
[0031] In
some embodiments, as shown in FIG. 8B, vacuum tubing 124 is
in communication with the die 138 to apply a vacuum or suction to the interior
portion of
the die 138 to facilitate the formation of the deposited powder material
within the die
138 prior to the stamping operation between the upper and lower punches 140
and
141.
[0032] In
some embodiments as shown in FIG. 4, the rotatable main shaft
115 defines a first key 146 for preventing slippage of the lifting cam 104
from the
rotatable main shaft 115, a second key 145 for preventing slippage of the
eccentric
sheave 102 from the rotatable main shaft 115, and a third key 147 for
preventing
slippage of the swivel cam 105 from the rotatable main shaft 115.
Automated Pellet Vialing and Labeling
[0033] As shown in FIG. 13, the automated pellet press 100 and
the pellet vialing apparatus 200 may be in operable communication with one
another
and collectively form a fabrication line 300 for pellet production and
vialing, operable for
the automation of transitioning the pellets 190 to a finished (vialed) product
which may
be labeled as described herein. In some embodiments, the fabrication line 300
may
generally include at least a ramp 306 for transporting the pellets 190 from
the
9
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
automated pellet press 100, and a repository 308 where pellets 190 may be
collected
and stored prior to vialing. In some embodiments the fabrication line also
includes a
weight and length station 310 where pellets 190 may be checked for quality
assurance
for meeting one or more manufacturing standards and at least one of a routing
arm 312
as well as a belt conveyance 314 for transporting the pellets 190 between
modules. In
the present disclosure, the fabrication line also includes a vialing module
316 where
pellets 190 may be vialed into vials 106 containing the pellets 190. The
vialing module
316 includes pre-vialing cavities 318 of a tray 321 where pellets 190 may be
sorted,
and a capping module 324 wherein vials 106 are capped, as depicted and further
described herein.
[0034] In
some embodiments, the fabrication line 300 may be in operable
communication with a computing device 302, executing an application 304. The
computing device 700 may include a server workstation with at least one
server, a
controller, a personal computer, a terminal, a workstation, a portable
computer, a
mobile device, a tablet, a mainframe, or other such computing device. The
computing
device 700 may be configured, by virtue of the application 304, to send and
receive
information and to send instructions to either of the automated pellet press
100 or the
pellet vialing apparatus 200, via a network (which may include the Internet,
an intranet,
a virtual private network (VPN), and the like. In some embodiments, a cloud
(not
shown) may be implemented to execute one or more components of the computing
device 302. In addition, aspects of either of the computing device 700 or the
application 304 may be provided using platform as a service (PaaS), and/or
software as
a service (SaaS) using e.g., Amazon Web Services, or other distributed
systems.
[0035]
Referring to FIG. 14, a process flow 400 is depicted for automated
vialing and labeling of the pellets 190. The pellets 190 are initially formed
using the
automated pellet press 100. In block 402, each of the pellets 190 enters the
repository
308 of the pellet vialing apparatus 104 via the ramp 306. The ramp 306 may
define a
generally planar surface such that the pellets 190 slide freely along the ramp
306 from
the automated pellet press 100 to the pellet vialing apparatus 200 (as a
change in
orientation of the ramp 306 may increase the transfer speed). The ramp 306 may
be
angled from the automated pellet press 100 to the pellet vialing apparatus 100
in any
predetermined manner suitable for transferring the pellets 190 as described.
In some
embodiments, the ramp 306 defines an angled stainless steel ramp.
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
[0036] As indicated in block 404, the repository 308 may define a
weight
and/or count threshold, and it is determined whether this threshold has been
met. The
threshold may be predetermined by pellet strength and a required sample size
intra-
batch per quantity produced. In some embodiments, aspects of this production
quality
assurance may be measured and monitored by the application 304.
[0037] As indicated in block 406, an applicable number of the pellets
190
may then be transported to the weight and length station 310 via the routing
arm 312
and the belt conveyance 314 for quality control. As indicated in decision
blocks 408
and 410, weight and length of the pellets 190 is measured at the weight and
length
station 310, which may include an embedded scale for weight measurement, and
an
embedded micrometer device for length measurement. In some embodiments, a
signal
light (which may be yellow or other colors) may be included with the
fabrication line 300
and may be illuminated to indicate that the intra-batch segment is on hold
until
acceptable measurements are achieved. As indicated in block 412, if an intra-
batch
segment of the pellets 190 does not meet certain predefined measurements
(weight
and length), the process may pause and/or a technician troubleshoot and
manually
review offline.
[0038] Referring to blocks 414 and 416, pellets 190 that satisfy the
weight
and length measurement thresholds are routed to the vialing module 316 and
sorted
into the pre-vialing cavities 318. Signal lights may be implemented to
indicate that the
pellets 190 have satisfied the measurement thresholds. The pre-vialing
cavities 318 of
the fabrication line 400 may be substantially equal to or equivalent to the
size of the
individual pellets 190, and be angled at a predetermined decline to
accommodate
transition of the pellets 190 into respective vials 320. In some embodiments,
the pre-
vialing cavities 318 are defined within the tray 321 and positioned over a
sliding solid
base 322.
[0039] Referring to block 418, the pellets 190 positioned within the
pre-
vialing cavities 318 may be transitioned into respective vials 320. Below the
sliding
base 322, vials 320 are loaded directly under the pre-vialing cavities 318 and
may be in
direct alignment with the pre-vialing cavities 318 above accounting for the
angled
decline. The tray 321 may then be triggered to retract, which may be initiated
upon
sensors verifying the presence of mass in the pre-vialing cavities 318, such
that the
pellets 190 slide into the vials 320, thereby fabricating vialed pellets 190,
as indicated in
FIG. 2. The tray 321 then returns into an original position.
11
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
[0040] Referring to blocks 420 and 422, the vials 106 containing
pellets
190 may then be routed to the capping module 324. In this manner, the vials
106
containing pellets 190, which may remain in the tray 321 to accommodate
alignment,
can then be migrated to the capping platform 326 which is aligned to the
capping grid
328 above and transitions down and applies a cap 330 to each of the vials 106
containing pellets 190, with a twisting motion.
[0041] Referring to block 424, the vials 106 containing pellets 190
with
caps 330 applied to the vials 106 are then routed to the labeling module 332.
Referring
to blocks 426, 428, and 430, the vials 106 are removed from the tray 321 and
placed
into a linear feed of the labeling module 332 that consists of a conveyor belt
and fitted
side walls. The labeling module 332 introduces vials 106 one by one into a
labeling
mechanism that applies labels (not shown) with a perforated line directly in
between the
cap 330 and the top end of the vial container. In some embodiments, prior to
total
passage through the labeling module 332, pre-labeled images may be taken using
a
camera (not shown). In some embodiments, once the labels are applied to the
vials
106 a robotic arm of the labeling module 332 applies an e-beam indicator.
[0042] Referring to block 432, the vials 106 with labels applied or
otherwise having been transitioned through the labeling module 332 are
transferred to a
boxing module 340. Referring to blocks 436 and 434, a robotic arm of the
boxing
module 340 is implemented to descend and move vials 106 containing pellets 190
into
a box or other container. In some embodiments, the box may be a foam insert
box in
accordance with e-beam dose map validation configuration. The box is then
loaded
into an exit chamber and made available to quality assurance prior to storage
in
quarantine awaiting sterilization results.
[0043] In some embodiments, the finished vials 106 may have the
pellets
190 enclosed within a small glass container, which may be cylindrical defining
a screw
threading portion for engaging with the caps 330. The vials 106 may comprise
glass or
plastic and may define an amber color for protecting the pellets 190 against
ambient
light or other environmental contaminants.
[0044] In other embodiments, the vials 106 may further include an
insert
positioned within each vial 106 proximate to or in direct contact with the
pellets 190.
The insert may be comprised of glass or plastic similar to the vials 320 and
may be
useful for maintaining the pellets 190 within a fixed position relative to the
vials 106.
12
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
[0045] Referring to FIG. 2, a process flow 500 related to the
aforementioned pellet vialing framework is indicated. In block 502 a
fabrication line
300 is provided including the automated pellet press 100 and the pellet
vialing
apparatus 200. In block 504, a plurality of pellets 190 are formed using the
automated
pellet press 100, and in block 506, the plurality of pellets 190 are
transitioned to the
pellet vialing apparatus 200. In block 508, it is determined whether the
plurality of
pellets 190 satisfies predetermined measurement thresholds associated with
weight
and length related to manufacturing standards. In block 510, each of the
plurality of
pellets 190 is sorted into respective cavities of a tray. In block 512, the
tray is
repositioned, or tipped to pass the plurality of pellets 190 to within a
plurality of
respective vials 106. In block 514, the vials 106 are capped and may then be
labeled,
boxed, and stored.
[0046] FIG. 15 is an example schematic diagram of a computing device
700 that may implement various methodologies discussed herein. For example,
the
computing device 700 may comprise the computing device 302 executing aspects
of
the application 304. The computing device 700 includes a bus 701 (i.e.,
interconnect),
at least one processor 702 or other computing element, at least one
communication
port 703, a main memory 704, a removable storage media 705, a read-only memory
706, and a mass storage device 707. Processor(s) 702 can be any known
processor,
such as, but not limited to, an Intel Itanium or ltanium 2 processor(s),
AMD
Opteron or Athlon MP processor(s), or Motorola lines of processors.
Communication port 703 can be any of an RS-232 port for use with a modem based
dial-up connection, a 10/100 Ethernet port, a Gigabit port using copper or
fiber, or a
USB port. Communication port(s) 703 may be chosen depending on a network such
as
a Local Area Network (LAN), a Wide Area Network (WAN), or any network to which
the
computer device 700 connects. Computing device may further include a transport
and/or transit network 755, a display screen 760, an I/O port 740, and an
input device
745 such as a mouse or keyboard.
[0047] Main memory 704 can be Random Access Memory (RAM) or any
other dynamic storage device(s) commonly known in the art. Read-only memory
706
can be any static storage device(s) such as Programmable Read-Only Memory
(PROM) chips for storing static information such as instructions for processor
702.
Mass storage device 707 can be used to store information and instructions. For
example, hard disks such as the Adaptec family of Small Computer Serial
Interface
13
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
(SCSI) drives, an optical disc, an array of disks such as Redundant Array of
Independent Disks (RAID), such as the Adaptec family of RAID drives, or any
other
mass storage devices, may be used.
[0048] Bus 701 communicatively couples processor(s) 702 with the
other
memory, storage, and communications blocks. Bus 701 can be a PCI / PCI-X,
SCSI, or
Universal Serial Bus (US B) based system bus (or other) depending on the
storage
devices used. Removable storage media 705 can be any kind of external hard
drives,
thumb drives, Compact Disc ¨ Read Only Memory (CD-ROM), Compact Disc ¨ Re-
Writable (CD-RW), Digital Video Disk ¨ Read Only Memory (DVD-ROM), etc.
[0049] Embodiments herein may be provided as a computer program
product, which may include an apparatus-readable medium having stored thereon
instructions which may be used to program a computer (or other electronic
devices) to
perform a process. The apparatus-readable medium may include, but is not
limited to
optical discs, CD-ROMs, magneto-optical disks, ROMs, RAMs, erasable
programmable
read-only memories (EPROMs), electrically erasable programmable read-only
memories (EEPROMs), magnetic or optical cards, flash memory, or other type of
media/apparatus-readable medium suitable for storing electronic instructions.
Moreover, embodiments herein may also be downloaded as a computer program
product, wherein the program may be transferred from a remote computer to a
requesting computer by way of data signals embodied in a carrier wave or other
propagation medium via a communication link (e.g., modem or network
connection).
[0050] As shown, main memory 704 may be encoded with the application
304 that supports functionality discussed above. In other words, aspects of
the
application 304 (and/or other resources as described herein) can be embodied
as
software code such as data and/or logic instructions (e.g., code stored in the
memory or
on another computer readable medium such as a disk) that supports processing
functionality according to different embodiments described herein. During
operation of
one embodiment, processor(s) 702 accesses main memory 704 via the use of bus
701
in order to launch, run, execute, interpret, or otherwise perform processes,
such as
through logic instructions, executing on the processor 702 and based on the
application
304 stored in main memory or otherwise tangibly stored.
[0051] The description above includes example systems, methods,
techniques, instruction sequences, and/or computer program products that
embody
techniques of the present disclosure. However, it is understood that the
described
14
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
disclosure may be practiced without these specific details. In the present
disclosure,
the methods disclosed may be implemented as sets of instructions or software
readable
by a device. Further, it is understood that the specific order or hierarchy of
steps in the
methods disclosed are instances of example approaches. Based upon design
preferences, it is understood that the specific order or hierarchy of steps in
the method
can be rearranged while remaining within the disclosed subject matter. The
accompanying method claims present elements of the various steps in a sample
order,
and are not necessarily meant to be limited to the specific order or hierarchy
presented.
[0052] The described disclosure may be provided as a computer program
product, or software, that may include an apparatus-readable medium having
stored
thereon instructions, which may be used to program a computer system (or other
electronic devices) to perform a process according to the present disclosure.
A
apparatus-readable medium includes any mechanism for storing information in a
form
(e.g., software, processing application) readable by an apparatus (e.g., a
computer).
The apparatus-readable medium may include, but is not limited to optical
storage
medium (e.g., CD-ROM); magneto-optical storage medium, read only memory (ROM);
random access memory (RAM); erasable programmable memory (e.g., EPROM and
EEPROM), flash memory; or other types of medium suitable for storing
electronic
instructions.
[0053] Certain embodiments are described herein as including one or
more modules. Such modules are hardware-implemented, and thus include at least
one tangible unit capable of performing certain operations and may be
configured or
arranged in a certain manner. For example, a hardware-implemented module may
comprise dedicated circuitry that is permanently configured (e.g., as a
special-purpose
processor, such as a field-programmable gate array (FPGA) or an application-
specific
integrated circuit (ASIC)) to perform certain operations. A hardware-
implemented
module may also comprise programmable circuitry (e.g., as encompassed within a
general-purpose processor or other programmable processor) that is temporarily
configured by software or firmware to perform certain operations. In some
example
embodiments, one or more computer systems (e.g., a standalone system, a client
and/or server computer system, or a peer-to-peer computer system) or one or
more
processors may be configured by software (e.g., an application or application
portion)
as a hardware-implemented module that operates to perform certain operations
as
described herein.
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
[0054] Accordingly, the term "hardware-implemented module" or
"module"
encompasses a tangible entity, be that an entity that is physically
constructed,
permanently configured (e.g., hardwired), or temporarily configured (e.g.,
programmed)
to operate in a certain manner and/or to perform certain operations described
herein.
Considering embodiments in which hardware-implemented modules are temporarily
configured (e.g., programmed), each of the hardware-implemented modules need
not
be configured or instantiated at any one instance in time. For example, where
the
hardware-implemented modules comprise a general-purpose processor configured
using software, the general-purpose processor may be configured as respective
different hardware-implemented modules at different times. Software may
accordingly
configure a processor, for example, to constitute a particular hardware-
implemented
module at one instance of time and to constitute a different hardware-
implemented
module at a different instance of time.
[0055] Hardware-implemented modules may provide information to,
and/or receive information from, other hardware-implemented modules.
Accordingly,
the described hardware-implemented modules may be regarded as being
communicatively coupled. Where multiple of such hardware-implemented modules
exist contemporaneously, communications may be achieved through signal
transmission (e.g., over appropriate circuits and buses) that connect the
hardware-
implemented modules. In embodiments in which multiple hardware-implemented
modules are configured or instantiated at different times, communications
between
such hardware-implemented modules may be achieved, for example, through the
storage and retrieval of information in memory structures to which the
multiple
hardware-implemented modules have access. For example, one hardware-
implemented module may perform an operation, and may store the output of that
operation in a memory device to which it is communicatively coupled. A further
hardware-implemented module may then, at a later time, access the memory
device to
retrieve and process the stored output. Hardware-implemented modules may also
initiate communications with input or output devices.
[0056] It is believed that the present disclosure and many of its
attendant
advantages should be understood by the foregoing description, and it should be
apparent that various changes may be made in the form, construction, and
arrangement of the components without departing from the disclosed subject
matter or
without sacrificing all of its material advantages. The form described is
merely
16
CA 03121530 2021-05-28
WO 2020/123831
PCT/US2019/066018
explanatory, and it is the intention of the following claims to encompass and
include
such changes.
[0057] It should be understood from the foregoing that, while
particular
embodiments have been illustrated and described, various modifications can be
made
thereto without departing from the spirit and scope of the invention as will
be apparent
to those skilled in the art. Such changes and modifications are within the
scope and
teachings of this invention as defined in the claims appended hereto.
17
