U.S. patent application number 15/513917 was filed with the patent office on 2019-08-01 for storage and transportation tray with cooling means.
The applicant listed for this patent is SANOFI-AVENTIS DEUTSCHLAND GMBH. Invention is credited to Jasmin Groeschke, Sven Hilke, Jan Huesch, Hanno Juhnke, Katrin Kinkel, Jan Moritz Maas, Matthias Scharf, Michael Schrack, Jan-Peter Spengler, Claudio Trankalis.
Application Number | 20190234681 15/513917 |
Document ID | / |
Family ID | 51661926 |
Filed Date | 2019-08-01 |
![](/patent/app/20190234681/US20190234681A1-20190801-D00000.png)
![](/patent/app/20190234681/US20190234681A1-20190801-D00001.png)
![](/patent/app/20190234681/US20190234681A1-20190801-D00002.png)
![](/patent/app/20190234681/US20190234681A1-20190801-D00003.png)
![](/patent/app/20190234681/US20190234681A1-20190801-D00004.png)
![](/patent/app/20190234681/US20190234681A1-20190801-D00005.png)
![](/patent/app/20190234681/US20190234681A1-20190801-D00006.png)
United States Patent
Application |
20190234681 |
Kind Code |
A1 |
Spengler; Jan-Peter ; et
al. |
August 1, 2019 |
STORAGE AND TRANSPORTATION TRAY WITH COOLING MEANS
Abstract
Embodiments may relate to a storage and transportation tray for
a manifold of cartridges filled with a liquid medicament. The tray
comprises a planar bottom and at least one side wall at an outer
edge of the bottom to form a storage volume with the bottom. The
storage volume will accommodate the manifold of cartridges. The
storage volume is accessible through an access opening formed by an
upper edge of the at least one side wall. At least one cooling
member or several cooling members may be thermally coupled with at
least one of bottom; side wall and access opening. to keep the
cartridges located in the storage volume refrigerated.
Inventors: |
Spengler; Jan-Peter;
(Frankfurt am Main, DE) ; Scharf; Matthias;
(Frankfurt am Main, DE) ; Groeschke; Jasmin;
(Frankfurt am Main, DE) ; Trankalis; Claudio;
(Frankfurt am Main, DE) ; Juhnke; Hanno;
(Frankfurt am Main, DE) ; Kinkel; Katrin;
(Frankfurt am Main, DE) ; Hilke; Sven; (Frankfurt
am Main, DE) ; Maas; Jan Moritz; (Frankfurt am Main,
DE) ; Schrack; Michael; (Frankfurt am Main, DE)
; Huesch; Jan; (Pliezhausen, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SANOFI-AVENTIS DEUTSCHLAND GMBH |
Frankfurt am Main |
|
DE |
|
|
Family ID: |
51661926 |
Appl. No.: |
15/513917 |
Filed: |
September 29, 2015 |
PCT Filed: |
September 29, 2015 |
PCT NO: |
PCT/EP2015/072313 |
371 Date: |
March 23, 2017 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
F25D 3/08 20130101; F25D
3/06 20130101; F25D 25/005 20130101 |
International
Class: |
F25D 25/00 20060101
F25D025/00; F25D 3/08 20060101 F25D003/08 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 2, 2014 |
EP |
14187502.1 |
Claims
1-14. (canceled)
15. A storage and transportation tray for a manifold of cartridges
filled with a liquid medicament, the storage and transportation
tray comprising: a planar bottom and at least one side wall at an
outer edge of the bottom to form a storage volume with the bottom
to accommodate the manifold of cartridges, wherein the storage
volume is accessible through an access opening formed by an upper
edge of the at least one side wall, at least one cooling member
thermally coupled with at least one of the bottom, the side wall
and the access opening to keep the cartridges located in the
storage volume refrigerated, wherein at least one of the at least
one side wall and the bottom comprises a fastening structure to
releasably engage with a corresponding fastening structure of a
cooling member filled with a coolant medium.
16. The storage and transportation tray according to claim 15,
wherein at least one of the cooling members forms at least one of
the at least one side wall and the bottom and comprises a hollow
shell filled with a coolant medium.
17. The storage and transportation tray according to claim 15,
wherein the cooling member comprises a planar cooling pad to cover
the access opening and further comprises at least one cooling
lamella extending into the storage volume to thermally couple with
at least some of the manifold of cartridges.
18. The storage and transportation tray according to claim 15,
wherein the cooling member comprises a cooling line extending along
or inside of at least one of the bottom and the at least one side
wall.
19. The storage and transportation tray according to claim 18,
wherein the cooling line is in flow communication with a feed line
extending into at least one of the bottom and the side wall and is
further in flow communication with a discharge line extending out
of at least one of the bottom and the side wall.
20. The storage and transportation tray according to claim 15,
wherein the cooling member comprises a refrigerating machine
arranged inside at least one of the bottom, the at least one side
wall and the storage volume and which is further coupled with a
temperature sensor and a controller to keep the temperature inside
the storage volume at a predefined level.
21. The storage and transportation tray according to claim 15,
wherein an upper edge of the side wall comprises a first stacking
structure and wherein a lower edge of the side wall comprises a
second stacking structure mating with the first stacking structure
to form a stack of trays.
22. A system comprising: an arrangement of at least two storage and
transportation trays, each of the at least two storage and
transportation trays comprising a planar bottom and at least one
side wall at an outer edge of the bottom to form a storage volume
with the bottom to accommodate the manifold of cartridges, wherein
the storage volume is accessible through an access opening formed
by an upper edge of the at least one side wall, at least one
cooling member thermally coupled with at least one of the bottom,
the at least one side wall and the access opening to keep the
cartridges located in the storage volume refrigerated, wherein the
at least one cooling member is arranged at least one of below,
above and around the arrangement of storage and transport
trays.
23. The system according to claim 22, wherein the at least one
cooling member is arranged between adjacently arranged storage and
transportation trays.
24. The system according to claim 22, wherein the cooling member is
connectable with a cooling supply.
25. The storage and transportation tray according to claim 15,
wherein at least one of the at least one side wall and the bottom
comprises a fastening structure to releasably engage with a
corresponding fastening structure of a cooling member filled with a
coolant medium.
26. The storage and transportation tray according to claim 15,
wherein the cooling member comprises a refrigerating machine and is
further coupled with a temperature sensor and a controller to keep
the temperature inside the storage volume at a predefined
level.
27. The storage and transportation tray according to claim 15
wherein the cooling member comprises a planar cooling pad to cover
the access opening and further comprises at least one cooling
lamella extending into the storage volume to thermally couple with
at least some of the manifold of cartridges.
28. A cooling system to refrigerate an arrangement of storage and
transportation trays, the cooling system comprising: a carriage to
carry a support for an arrangement of trays; and at least one
cooling member to thermally couple with at least one of the support
and the arrangement of trays.
29. The cooling system according to claim 28, wherein the cooling
member forms an enclosure to receive the carriage with an
arrangement of trays located on the carriage.
30. The cooling system according to claim 28, wherein the cooling
member comprises a cooling layer arranged between the support and
the carriage or between the support and a lowermost tray, wherein
the cooling layer is connectable with a cooling supply.
31. The cooling system according to claim 30, wherein the cooling
layer is configured to receive a coolant from the cooling supply
that is embedded in the cooling system or is provided on site.
32. The cooling system according to claim 28, wherein the cooling
member comprises a liftable and lowerable cooling bell to
accommodate the arrangement of trays.
33. The cooling system of claim 28, wherein the cooling system is
engagable to at least one of a side wall, access opening, and
bottom of a tray of the arrangement of trays.
34. The cooling system of claim 28, wherein the cooling system
includes: a refrigeration machine; a temperature sensor; and a
controller configured to control a cooling strength of the
refrigeration machine based on input from the temperature sensor.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a U.S. national stage application under
35 USC .sctn. 371 of International Application No.
PCT/EP2015/072313, filed on Sep. 29, 2015, which claims priority to
European Patent Application No. 14187502.1 filed on Oct. 2, 2014,
the entire contents of which are incorporated herein by
reference.
TECHNICAL FIELD
[0002] The present disclosure relates to the field of storage and
transportation trays for a manifold of cartridges filled with a
liquid medicament. Additional aspects further relate to an
arrangement of at least two storage and transportation trays and
further to a cooling system to refrigerate an arrangement of at
least two storage and transportation trays as they are commonly
used for mass manufacturing of drug delivery devices equipped with
such cartridges.
BACKGROUND
[0003] Drug delivery devices for setting and dispensing a single or
multiple doses of a liquid medicament are as such well-known in the
art. Generally, such devices have substantially a similar purpose
as that of an ordinary syringe.
[0004] Drug delivery devices, in particular pen-type injectors have
to meet a number of user-specific requirements. For instance, with
patient's suffering chronic diseases, such like diabetes, the
patient may be physically infirm and may also have impaired vision.
Suitable drug delivery devices especially intended for home
medication therefore need to be robust in construction and should
be easy to use. Furthermore, manipulation and general handling of
the device and its components should be intelligible and easy
understandable. Moreover, a dose setting as well as a dose
dispensing procedure must be easy to operate and has to be
unambiguous.
[0005] Typically, such devices comprise a housing or a particular
cartridge holder, adapted to receive a cartridge at least partially
filled with the medicament to be dispensed. The device further
comprises a drive mechanism, usually having a displaceable piston
rod which is adapted to operably engage with a piston of the
cartridge. By means of the drive mechanism and its piston rod, the
piston of the cartridge is displaceable in a distal or dispensing
direction and may therefore expel a predefined amount of the
medicament via a piercing assembly, which is to be releasably
coupled with a distal end section of the housing of the drug
delivery device.
[0006] The medicament to be dispensed by the drug delivery device
is provided and contained in a multi-dose cartridge. Such
cartridges typically comprise a vitreous barrel sealed in distal
direction by means of a pierceable seal and being further sealed in
proximal direction by the piston. With reusable drug delivery
devices an empty cartridge is replaceable by a new one. In contrast
to that, drug delivery devices of disposable type are to be
entirely discarded when the medicament in the cartridge has been
completely dispensed or used-up.
[0007] Disposable drug delivery devices, such like pen injectors
are initially equipped with a cartridge filled with a liquid
medicament. Typically, the medicament and hence the cartridge
requires cooling or refrigerating during storage. Assembling of
disposable drug delivery devices and in particular assembling of
the cartridge inside the delivery device is fully automated and is
implemented in a mass manufacturing process. Manufacturing of a
large number of delivery devices within a comparatively short time
interval requires a constant supply of a large amount of such
cartridges. In the production and assembly environment, the final
assembly of the cartridge into the drug delivery device takes place
at room temperature. For not affecting the medicament and in order
to provide a high quality standard the time interval for which such
cartridges are exposed to room temperature should be as short as
possible. These demands impose rather sophisticated restrictions
and constrictions regarding the supply of cartridges in the mass
manufacturing process.
[0008] Typically, cartridges filled with a medicament and to be
assembled into a drug delivery device are stored and transported in
storage and transportation trays, in which the cartridges are
densely packed. Every storage and transportation tray therefore
represents a batch of cartridges that has to be supplied in the
manufacturing process and hence to an assembly line.
[0009] The batch-wise processing of cartridges may have a further
negative influence on the temperature stability of the medicament
contained therein during the mass manufacturing process. Cartridges
taken last from such a storage and transportation tray might be
exposed to room temperature for a longer time than those cartridges
that are processed first from such storage and transportation
trays.
SUMMARY
[0010] A first aspect the invention relates to a storage and
transportation tray for a manifold of cartridges that are filled
with a liquid medicament. The storage and transportation tray
comprises a planar bottom and at least one sidewall arranged at an
outer edge of the bottom to form a storage volume with the bottom.
The storage volume is adapted and designed to accommodate the
manifold of cartridges, typically in a densely-packed
configuration, wherein adjacently located cartridges directly touch
in order to exploit the storage volume in a most effective way. The
side walls and the bottom form a void space that equals the storage
volume which is densely packable by the manifold of cartridges.
[0011] The storage and transportation tray typically comprises
numerous sidewalls, e.g. four sidewalls that are arranged in a
rectangular fashion so as to form a box-shaped storage and
transportation tray. The storage and transportation tray may be of
cubic shape. Alternatively, it is conceivable, that the tray only
comprises a single sidewall, entirely surrounding the outer
circumference or the outer edge of the bottom. A single sidewall
may constitute a storage and transportation tray of e.g.
cylindrical or oval cross-section.
[0012] In general, the storage volume formed by at least the planar
bottom and the sidewall is accessible from the top through an
access opening formed by an upper edge of the at least one
sidewall. Typically, the sidewall extends substantially
perpendicular to the planar bottom. A lower edge of the sidewall is
typically connected to the outer edge of the bottom so that the
upper edge of the at least one sidewall forms a kind of a free end
or free edge, thereby defining the access opening. In typical
embodiments the storage and transportation tray is lidless; hence
the access opening is not covered by a lid but its storage volume
readily accessible from above.
[0013] The storage and transportation tray further comprises at
least one cooling member that is thermally coupled with at least
one of bottom, sidewall and access opening to keep the cartridges
located inside the storage volume refrigerated. The storage and
transportation try may also comprise or may be equipped with
several cooling members. By providing the storage and
transportation tray with at least one cooling member, the critical
time interval during which the tray equipped with cartridges can be
kept at room temperature can be prolonged. The cooling member may
help to keep the cartridges cool and refrigerated even when the
storage and transportation tray is exposed to an elevated
temperature, such like room temperature. The cooling member can be
implemented in many different ways. It may be implemented as a
passive cooling member to store thermal, hence cooling energy, e.g.
in a refrigerated environment and to absorb thermal energy, e.g. in
form of heat, from a heated environment or at room temperature in
order to prevent a premature heating of the cartridges and the
medicament above a critical temperature, at which the medicament
could be affected.
[0014] By means of the at least one cooling member the storage and
transportation tray can be kept for a comparatively long time at
room temperature, e.g. during assembly of drug delivery devices
without running into danger that the medicament stored therein
could be affected due to thermal treatment. In this way, a batch of
cartridges can be stored and kept for a much longer time interval
in the vicinity of an assembly line without running into danger,
that the medicament is warmed up to or above a critical
temperature.
[0015] In addition, at least one of the bottom and the at least one
sidewall comprises a fastening structure to releasably engage or to
detachably engage with a corresponding fastening structure of a
cooling member, wherein said cooling member is filled with a
coolant medium. The cooling member may be provided as a separate
thermal pack that can be attached and assembled to the tray. In the
same way the thermal pack could be released and disassembled from
the tray.
[0016] The separate thermal pack or cooling member can be kept in a
refrigerated environment in order to store thermal energy, in
particular to store cooling energy. The fastening structures of
cooling member and tray mutually mate in such a way, that a rather
easy and intuitive assembly and disassembly thereof is provided.
Typically, the mutually engaging fastening structures of cooling
member and tray may positively or frictionally engage. For this
purpose, the mutually corresponding fastening structures may
comprise male and female fastening elements, such like protrusions
and recesses.
[0017] It may of particular benefit, when the tray's fastening
structure is arranged at an outside-facing sidewall portion or at
an outside-facing portion of the planar bottom. In this way, the
releasable attachment of the cooling member to the tray does not
influence and does not decrease the effective storage volume of the
storage and transportation tray. The tray's fastening structure may
also be arranged at an inside-facing side of the sidewall portion
or of the bottom. Then, a thermal coupling between the cooling
member or members and the cartridges located in the storage volume
of the tray can be improved.
[0018] Moreover, since the cooling member is detachable from the
tray it can be cooled down to a much larger degree than the
cartridges filled with the liquid medicament. While the cartridges
may have to be kept at a temperature of e.g. around 5.degree. C.
the cooling member or a manifold of cooling members can be kept at
much lower temperatures before they are attached to the tray via
the mutually mating fastening structures. In this way, a cooling
efficiency of the cooling member can be further enhanced.
[0019] The at least one cooling member that comprises a fastening
structure may be of passive or of active type. When implemented as
an active cooling member, the cooling member is configured to
generate a cooling effect and to lower temperature in its close
vicinity. It is then configured to convert electrical or chemical
energy into a cooling effect. When implemented as an active cooling
member, it may comprise for instance a Peltier element to provide a
cooling via the thermoelectric effect. It may also comprise a
refrigerating machine that is operable to remove heat from a liquid
via a vapor-compression cycle or via an absorption refrigeration
cycle.
[0020] According to another embodiment the cooling member or at
least one of the cooling members, forms at least one of the at
least one sidewall and the bottom and comprises a hollow shell
filled with a coolant medium. With this embodiment, at least parts
of the tray itself may act as a cooling member. The coolant medium
typically comprises a comparatively large heat capacity. The
coolant medium contained inside the hollow structure of sidewall
and/or bottom may be subject to a cooling when the storage and
transportation tray equipped with cartridges is kept in a
refrigerated environment before it is provided to the assembly
line.
[0021] By having the coolant medium at least inside a sidewall or
inside the bottom of the storage and transportation tray, the
cartridges arranged inside the storage volume of the tray can be
kept at a refrigerated temperature even when the storage and
transportation tray should be exposed to room temperature. In this
way, the critical time interval during which the cartridges and the
medicament are kept out of a refrigerator can be effectively
prolonged. In effect, a larger amount of storage and transportation
trays can be temporally stored and provided to a manufacturing line
at an elevated temperature compared to the critical temperature. In
this way, the logistic and material flow for a mass production
process can be simplified and optimized without affecting or even
by improving a required quality- and/or safety standard.
[0022] According to another embodiment the cooling member or at
least one of the cooling members comprises a planar cooling pad to
cover the access opening. The cooling member then further comprises
at least one cooling lamella extending into the storage volume to
thermally couple with at least some of the manifold of cartridges.
Typically, the cooling lamella or a series of cooling lamellas are
integrally formed or attached to the planar cooling pad. The
cooling lamella may extend substantially perpendicular to the plane
of the cooling pad. Typically, the cooling lamella extends from a
downward-facing surface portion of the cooling pad in order to get
in direct mechanical and thermal contact with at least some of the
cartridges stored in the storage volume. The cooling pad as well as
the cooling lamellas may also be filled with a coolant medium. By
means of the cooling pad the access opening of the storage and
transportation tray can be effectively closed so as to insulate the
storage volume against the environment and to prevent or to
counteract ingress of heat or thermal energy into the storage
volume via the access opening.
[0023] The cooling lamellas may comprise a structure matching with
a densely-packed or predefined configuration of the cartridges when
stored and arranged inside the storage and transportation tray. The
cooling lamellas may extend from above and in between
adjacently-located cartridges.
[0024] The lamellas and/or the cooling pad are typically flexible
in order to snuggle to individual cartridges and in order to
improve cooling efficiency. The cooling pad as well as the cooling
lamellas may comprise a flexible pouch or bag filled with a coolant
medium. The coolant medium typically comprises a comparatively
large thermal heat capacity or cooling capacity. It is even
conceivable, that the coolant medium in general comprises a cold
storage medium that is adapted to release cooling energy due to a
phase transition. It is in particular conceivable, that the coolant
medium undergoes a phase transition, such like a melting and
withdraws heat of fusion or latent heat from the environment,
thereby providing an effective cooling effect to the
surrounding.
[0025] According to another embodiment the cooling member or at
least one of the cooling members comprises a cooling line or a
cooling tube extending along or inside of at least one of the
bottom and the at least one sidewall. The cooling member may
comprise a cooling coil extending in a meander-like geometry across
or through the bottom and/or the at least one sidewall of the
storage and transportation tray. The cooling member may be supplied
with a coolant, e.g. via a coolant supply that does not belong to
the storage and transportation tray but which is provided in the
vicinity of the manufacturing line. With such an embodiment, the
storage and transportation tray does not have to be equipped with a
coolant medium but can be selectively supplied with a coolant
medium on request and as required.
[0026] According to a further embodiment the cooling line is in
flow communication with a feed line extending into at least one of
the bottom and the sidewall and wherein the cooling line is further
in flow communication with a discharge line extending out of at
least one of the bottom and the sidewall. Typically, feed line
and/or discharge line are connectable to a coolant medium supply.
It is particularly conceivable, that the production side is
equipped with a coolant supply, such like a cool water port. Then,
the cooling line could be connected to the coolant supply via the
feed line and a respective coolant, such like cooling water could
flow through the cooling line in order to keep at least one of the
sidewall and the bottom of the storage and transportation tray at a
predefined temperature or in order to prevent an inadmissible
heating thereof.
[0027] Typically, the feed line and/or the discharge line comprise
standardized couplings or standardized connectors so that the
environment of the storage and transportation tray and hence the
manufacturing environment is not contaminated with the coolant. A
standardized coupling or connector is also beneficial in order to
connect and disconnect the mobile storage and transportation tray
to an immobile cooling supply installed with the assembly or
manufacturing line. It is also conceivable that the connectors of
the feed line and the discharge line are mutually connectable. In
this way the cooling lines of several adjacently arranged tray can
be connected in series or parallel, so that a connection of a
series of storage and transportation trays can be easily coupled
and connected with an external coolant supply.
[0028] According to another embodiment the cooling member or at
least one of the cooling members comprises a refrigerating machine
arranged inside at least one of the bottom, the at least one
sidewall and the storage volume. The cooling member is further
equipped with a temperature sensor and a control, both connected
and coupled with the refrigerating machine in order to keep the
temperature inside the storage volume at a predefined level.
Temperature sensor, control and refrigerating machine may be
arranged in a control loop in order to provide a well-defined
amount of cooling energy just on demand. The refrigerating machine
may be based on various refrigerating principles. It may be based
on the Joule-Thomson effect. Like conventional fridges or air
conditioning apparatuses it may comprise a coolant circulation by
way of which a compressor, a condenser, an expansion valve and an
evaporator are coupled.
[0029] Alternatively, it is conceivable, that the refrigerating
machine is based on the Peltier effect. Hence, simply by supplying
electrical energy to the refrigerating machine, a respective
cooling effect could be generated inside the storage and
transportation tray.
[0030] Typically, a heat generating portion of the refrigerating
machine is thermally coupled to the exterior of the storage and
transportation tray while a refrigerating portion of the
refrigerating machine is thermally coupled to the storage
volume.
[0031] With these embodiments it may be of further benefit, when
the access opening is closed by a lid and that the sidewalls, the
lid as well as the bottom comprise an insulating material, such
like polystyrene or comparable heat insulating materials in order
to keep the electrical power consumption of the refrigerating
machine at a moderate level.
[0032] According to another embodiment the storage and
transportation tray comprises a first stacking structure and a
second stacking structure that mutually mate to form a stack of
trays, wherein a first tray is arranged on top of a second tray.
Typically, an upper edge of the sidewall of the storage and
transportation tray comprises the first stacking structure and a
lower edge of the sidewall and/or an outer edge of the bottom
comprises a second stacking structure. First and second stacking
structures mutually mate in order to allow stacking of a
multiplicity of equally-shaped storage and transportation trays on
top of each other. First and second stacking structures may
positively engage. The first stacking structure may comprise male
stacking elements while the second stacking structure comprises
female stacking elements that are adapted to receive the male
stacking elements of the first stacking structure. It is even
conceivable, that both first and second stacking structures each
comprise male and female stacking elements. By means of mutually
mating or mutually corresponding stacking structures, stacking of
trays may require a predefined orientation of trays to be stacked
on top of each other.
[0033] Another aspect relates to an arrangement of at least two
storage and transportation trays as described above. The
transportation trays may be arranged next to each other, e.g. on a
support surface to form the arrangement of trays. Alternatively, or
additionally, the at least two storage and transportation trays may
be stacked on top of each other to form the arrangement of storage
and transportation trays. With an arrangement of multiple storage
and transportation trays the at least one cooling member can be
arranged below, above and/or around the arrangement of storage and
transport trays. In this way, the cooling member may be adapted and
equipped not only to refrigerate and to cool a single but a
multiplicity of trays arranged in an arrangement and/or in a stack
of trays. In this way, dissipation of cooling energy could be
decreased. The overall handling of a large number of cartridges and
even of a comparatively large number of trays could be facilitated
without running into danger that the medicament is heated or warmed
up to a critical temperature during assembly into a drug delivery
device.
[0034] According to a further embodiment the at least one cooling
member or at least one of the cooling members is arranged between
adjacently-arranged storage and transportation trays. In general,
any one of the above described cooling members could be arranged
between adjacently-located storage and transportation trays. The
cooling member could be arranged vertically, between columns or
stacks of storage and transportation trays. Alternatively, or
additionally the cooling member could also be oriented
horizontally, hence between rows of trays so that the cooling
member is located between groups of horizontally and
adjacently-located trays of a stack of trays.
[0035] With this embodiment, a single storage and transportation
tray does not have to be particularly modified. Simply by arranging
one or several cooling members between adjacently-arranged storage
and transportation trays, the entire stack or the entire
arrangement of transportation trays can be effectively cooled and
refrigerated.
[0036] According to another embodiment, the cooling member is
connectable with a cooling supply. Depending on the specific
implementation of the cooling member, the cooling member may either
be provided with electrical energy or with a coolant in order to
provide an effective cooling of adjacently-located storage and
transportation trays.
[0037] Another aspect also relates to a cooling system to
refrigerate an arrangement of at least two storage and
transportation trays. The cooling system is particularly configured
to refrigerate an arrangement of at least two storage and
transportation trays as described above. Typically, the
transportation trays comprise a planar bottom and at least one
sidewall at an outer edge of the bottom to form a storage volume
with the bottom, wherein said storage volume is adapted to
accommodate the manifold of cartridges. The storage volume is
accessible through an access opening formed by an upper edge of the
at least one sidewall.
[0038] The cooling system further comprises at least one cooling
member to thermally couple with at least one of the support and the
arrangement of trays. The cooling system is in particular adapted
to provide cooling of an entire stack or of an entire arrangement
of a multiplicity of storage and transportation trays. The cooling
system is particularly designed to provide cooling and
refrigerating of a whole batch of storage and transportation trays,
each of which being equipped with a manifold of cartridges filled
with a liquid medicament.
[0039] The carriage is a mobile carrier by way of which the
arrangement of trays located thereon can be transported in the
production environment. The carriage typically comprises a carrier
structure in order to carry the support on which the arrangement of
trays is stacked or located. The support may comprise a transport
pallet and is typically releasably attached and supported by the
carriage. The carriage itself comprises wheels or the like in order
to provide a smooth transportation of the arrangement of trays,
e.g. from a refrigerated environment to the production and assembly
line.
[0040] Since the cooling member of the cooling system is adapted to
thermally couple with the support and/or with the entire
arrangement of trays it provides a very efficient tool for
simultaneous cooling and refrigerating of a large number of trays
and cartridges located therein. By means of such a particularly
large scaled cooling member, individual trays do not have to be
separately equipped with a cooling member.
[0041] In this context, the cooling member of the cooling system
may be regarded as a global cooling member while cooling members
that are individually thermally coupled with at least one of
bottom, sidewall and access opening of the storage and
transportation tray may be regarded as local cooling members.
[0042] According to a further embodiment the cooling member forms
an enclosure to receive the carriage together with an arrangement
of trays located thereon. In particular, the cooling member may
comprise a kind of a cooling port, hence a surrounding structure
comprising sidewalls and a roof portion in between and under which
the carriage together with the arrangement of trays is arrangeable.
The cooling system could be implemented as an immobile cooling
device positioned near the assembly line. It may provide a
compartment into which the carriage together with the arrangement
of trays could be positioned so that the trays and the cartridges
located therein are kept refrigerated as long as possible prior to
their final assembly with or in the drug delivery device.
[0043] The cooling member may be further accommodated to receive
even more than only one carriage with trays stacked thereon. The
cooling member, hence the cooling device typically comprises an
access port and/or an exit port through which the carriage with an
arrangement of trays thereon can enter a cooling zone provided by
the cooling member. Typically, the access and/or exit ports are
equipped with at least one or several insulating curtains in order
to prevent and to limit dissipation of cooling energy into the
environment.
[0044] According to another embodiment the cooling member comprises
a cooling layer which is arranged between the support and the
carriage or which is arranged between the support and a lowermost
tray of the arrangement of trays. The cooling layer is connectable
with a cooling supply. The cooling supply may be provided immobile
at the manufacturing line and may provide a coolant to flow through
the cooling layer. By arranging the cooling layer across the entire
support surface of the support and/or of the carriage a cooling and
refrigerating of the support and/or of the lowermost tray can be
provided. It is of particular benefit, when the arrangement of
trays is covered by an insulating sheet providing a cooling
atmosphere or cooling environment inside the insulating sheet. In
this way also the other storage and transportation trays of the
arrangement of trays can be effectively cooled and refrigerated.
The cooling supply may be embodied as a cool water supply or as a
supply of a coolant featuring a comparatively high thermal heat or
cooling capacity. The cooling supply may be installed on the floor
of the production environment or assembly line.
[0045] According to another embodiment the cooling member comprises
a liftable and lowerable cooling bell to accommodate the
arrangement of trays. The cooling bell may either be supplied with
a coolant medium or may actively generate a cooling effect. The
cooling bell may for instance thermally coupled to an air
conditioning system of a building. The cooling bell serves to
enclose the entirety of the arrangement of trays. Hence, the
cooling bell either comprises a dome-shape structure or a kind of a
cubic or rectangular structure to enclose the arrangement of trays.
On demand, the cooling bell is liftable into a raised or lifted
position so as to provide access to the arrangement of trays. Then,
a single or multiple trays can be removed from the arrangement of
trays and can be provided and supplied to the manufacturing or
assembly line. Thereafter, the cooling bell may be lowered again in
order to keep the residual trays in a refrigerated environment.
[0046] The term "drug" or "medicament", as used herein, means a
pharmaceutical formulation containing at least one pharmaceutically
active compound,
wherein in one embodiment the pharmaceutically active compound has
a molecular weight up to 1500 Da and/or is a peptide, a protein, a
polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or
a fragment thereof, a hormone or an oligonucleotide, or a mixture
of the above-mentioned pharmaceutically active compound, wherein in
a further embodiment the pharmaceutically active compound is useful
for the treatment and/or prophylaxis of diabetes mellitus or
complications associated with diabetes mellitus such as diabetic
retinopathy, thromboembolism disorders such as deep vein or
pulmonary thromboembolism, acute coronary syndrome (ACS), angina,
myocardial infarction, cancer, macular degeneration, inflammation,
hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in
a further embodiment the pharmaceutically active compound comprises
at least one peptide for the treatment and/or prophylaxis of
diabetes mellitus or complications associated with diabetes
mellitus such as diabetic retinopathy, wherein in a further
embodiment the pharmaceutically active compound comprises at least
one human insulin or a human insulin analogue or derivative,
glucagon-like peptide (GLP-1) or an analogue or derivative thereof,
or exendin-3 or exendin-4 or an analogue or derivative of exendin-3
or exendin-4.
[0047] Insulin analogues are for example Gly(A21), Arg(B31),
Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28),
Pro(B29) human insulin; Asp(B28) human insulin; human insulin,
wherein proline in position B28 is replaced by Asp, Lys, Leu, Val
or Ala and wherein in position B29 Lys may be replaced by Pro;
Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human
insulin and Des(B30) human insulin.
[0048] Insulin derivates are for example B29-N-myristoyl-des(B30)
human insulin; B29-N-palmitoyl-des(B30) human insulin;
B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin;
B28-N-myristoyl LysB28ProB29 human insulin;
B28-N-palmitoyl-LysB28ProB29 human insulin;
B30-N-myristoyl-ThrB29LysB30 human insulin;
B30-N-palmitoyl-ThrB29LysB30 human insulin;
B29-N--(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;
B29-N--(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;
B29-N-(.omega.-carboxyheptadecanoyl)-des(B30) human insulin and
B29-N-(.omega.-carboxyheptadecanoyl) human insulin.
[0049] Exendin-4 for example means Exendin-4(1-39), a peptide of
the sequence
H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Gl-
u-Glu-Ala-Val-Arg-Leu-Phe-11e-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly--
Ala-Pro-Pro-Pro-Ser-NH2.
[0050] Exendin-4 derivatives are for example selected from the
following list of compounds:
H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,
H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,
des Pro36 Exendin-4(1-39),
des Pro36 [Asp28] Exendin-4(1-39),
des Pro36 [IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or
[0051] des Pro36 [Asp28] Exendin-4(1-39), [0052] des Pro36
[IsoAsp28] Exendin-4(1-39), [0053] des Pro36 [Met(O)14, Asp28]
Exendin-4(1-39), [0054] des Pro36 [Met(O)14, IsoAsp28]
Exendin-4(1-39), [0055] des Pro36 [Trp(O2)25, Asp28]
Exendin-4(1-39), [0056] des Pro36 [Trp(O2)25, IsoAsp28]
Exendin-4(1-39), [0057] des Pro36 [Met(O)14 Trp(O2)25, Asp28]
Exendin-4(1-39), [0058] des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28]
Exendin-4(1-39), [0059] wherein the group -Lys6-NH2 may be bound to
the C-terminus of the Exendin-4 derivative; [0060] or an Exendin-4
derivative of the sequence [0061] des Pro36
Exendin-4(1-39)-Lys6-NH2 (AVE0010), [0062] H-(Lys)6-des Pro36
[Asp28] Exendin-4(1-39)-Lys6-NH2, [0063] des Asp28 Pro36, Pro37,
Pro38Exendin-4(1-39)-NH2, [0064] H-(Lys)6-des Pro36, Pro38 [Asp28]
Exendin-4(1-39)-NH2, [0065] H-Asn-(Glu)5des Pro36, Pro37, Pro38
[Asp28] Exendin-4(1-39)-NH2, [0066] des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-(Lys)6-NH2, [0067] H-(Lys)6-des Pro36, Pro37, Pro38
[Asp28] Exendin-4(1-39)-(Lys)6-NH2, [0068] H-Asn-(Glu)5-des Pro36,
Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, [0069]
H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,
[0070] H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25]
Exendin-4(1-39)-NH2, [0071] H-(Lys)6-des Pro36, Pro37, Pro38
[Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, [0072] H-Asn-(Glu)5-des
Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, [0073]
des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2, [0074] H-(Lys)6-des Pro36, Pro37, Pro38
[Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, [0075]
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2, [0076] H-(Lys)6-des Pro36 [Met(O)14,
Asp28] Exendin-4(1-39)-Lys6-NH2, [0077] des Met(O)14 Asp28 Pro36,
Pro37, Pro38 Exendin-4(1-39)-NH2, [0078] H-(Lys)6-des Pro36, Pro37,
Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, [0079]
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2, [0080] des Pro36, Pro37, Pro38 [Met(O)14,
Asp28] Exendin-4(1-39)-(Lys)6-NH2, [0081] H-(Lys)6-des Pro36,
Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, [0082]
H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-(Lys)6-NH2, [0083] H-Lys6-des Pro36 [Met(O)14,
Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, [0084] H-des Asp28
Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] Exendin-4(1-39)-NH2,
[0085] H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2, [0086] H-Asn-(Glu)5-des Pro36, Pro37, Pro38
[Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, [0087] des Pro36,
Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2, [0088] H-(Lys)6-des Pro36, Pro37, Pro38
[Met(O)14, Trp(O2)25, Asp28] Exendin-4(S1-39)-(Lys)6-NH2, [0089]
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2; [0090] or a pharmaceutically acceptable
salt or solvate of any one of the afore-mentioned Exendin-4
derivative.
[0091] Hormones are for example hypophysis hormones or hypothalamus
hormones or regulatory active peptides and their antagonists as
listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine
(Follitropin, Lutropin, Choriongonadotropin, Menotropin),
Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin,
Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
[0092] A polysaccharide is for example a glucosaminoglycane, a
hyaluronic acid, a heparin, a low molecular weight heparin or an
ultra-low molecular weight heparin or a derivative thereof, or a
sulphated, e.g. a poly-sulphated form of the above-mentioned
polysaccharides, and/or a pharmaceutically acceptable salt thereof.
An example of a pharmaceutically acceptable salt of a
poly-sulphated low molecular weight heparin is enoxaparin
sodium.
[0093] Antibodies are globular plasma proteins (.about.150 kDa)
that are also known as immunoglobulins which share a basic
structure. As they have sugar chains added to amino acid residues,
they are glycoproteins. The basic functional unit of each antibody
is an immunoglobulin (Ig) monomer (containing only one Ig unit);
secreted antibodies can also be dimeric with two Ig units as with
IgA, tetrameric with four Ig units like teleost fish IgM, or
pentameric with five Ig units, like mammalian IgM.
[0094] The Ig monomer is a "Y"-shaped molecule that consists of
four polypeptide chains; two identical heavy chains and two
identical light chains connected by disulfide bonds between
cysteine residues. Each heavy chain is about 440 amino acids long;
each light chain is about 220 amino acids long. Heavy and light
chains each contain intrachain disulfide bonds which stabilize
their folding. Each chain is composed of structural domains called
Ig domains. These domains contain about 70-110 amino acids and are
classified into different categories (for example, variable or V,
and constant or C) according to their size and function. They have
a characteristic immunoglobulin fold in which two 1 sheets create a
"sandwich" shape, held together by interactions between conserved
cysteines and other charged amino acids.
[0095] There are five types of mammalian Ig heavy chain denoted by
.alpha., .delta., .epsilon., .gamma., and .mu.. The type of heavy
chain present defines the isotype of antibody; these chains are
found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
[0096] Distinct heavy chains differ in size and composition;
.alpha. and .gamma. contain approximately 450 amino acids and
.delta. approximately 500 amino acids, while .mu. and .epsilon.
have approximately 550 amino acids. Each heavy chain has two
regions, the constant region (CH) and the variable region (VH). In
one species, the constant region is essentially identical in all
antibodies of the same isotype, but differs in antibodies of
different isotypes. Heavy chains .gamma., .alpha. and .delta. have
a constant region composed of three tandem Ig domains, and a hinge
region for added flexibility; heavy chains .mu. and .epsilon. have
a constant region composed of four immunoglobulin domains. The
variable region of the heavy chain differs in antibodies produced
by different B cells, but is the same for all antibodies produced
by a single B cell or B cell clone. The variable region of each
heavy chain is approximately 110 amino acids long and is composed
of a single Ig domain.
[0097] In mammals, there are two types of immunoglobulin light
chain denoted by .lamda. and .kappa.. A light chain has two
successive domains: one constant domain (CL) and one variable
domain (VL). The approximate length of a light chain is 211 to 217
amino acids. Each antibody contains two light chains that are
always identical; only one type of light chain, .kappa. or .lamda.,
is present per antibody in mammals.
[0098] Although the general structure of all antibodies is very
similar, the unique property of a given antibody is determined by
the variable (V) regions, as detailed above. More specifically,
variable loops, three on the light (VL) and three on the heavy (VH)
chain, are responsible for binding to the antigen, i.e. for its
antigen specificity. These loops are referred to as the
Complementarity Determining Regions (CDRs). Because CDRs from both
VH and VL domains contribute to the antigen-binding site, it is the
combination of the heavy and the light chains, and not either
alone, that determines the final antigen specificity.
[0099] An "antibody fragment" contains at least one antigen binding
fragment as defined above, and exhibits essentially the same
function and specificity as the complete antibody of which the
fragment is derived from. Limited proteolytic digestion with papain
cleaves the Ig prototype into three fragments. Two identical amino
terminal fragments, each containing one entire L chain and about
half an H chain, are the antigen binding fragments (Fab). The third
fragment, similar in size but containing the carboxyl terminal half
of both heavy chains with their interchain disulfide bond, is the
crystalizable fragment (Fc). The Fc contains carbohydrates,
complement-binding, and FcR-binding sites. Limited pepsin digestion
yields a single F(ab').sub.2 fragment containing both Fab pieces
and the hinge region, including the H--H interchain disulfide bond.
F(ab').sub.2 is divalent for antigen binding. The disulfide bond of
F(ab').sub.2 may be cleaved in order to obtain Fab'. Moreover, the
variable regions of the heavy and light chains can be fused
together to form a single chain variable fragment (scFv).
[0100] Pharmaceutically acceptable salts are for example acid
addition salts and basic salts. Acid addition salts are e.g. HCl or
HBr salts. Basic salts are e.g. salts having a cation selected from
alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion
N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other
mean: hydrogen, an optionally substituted C1-C6-alkyl group, an
optionally substituted C2-C6-alkenyl group, an optionally
substituted C6-C10-aryl group, or an optionally substituted
C6-C10-heteroaryl group. Further examples of pharmaceutically
acceptable salts are described in "Remington's Pharmaceutical
Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing
Company, Easton, Pa., U.S.A., 1985 and in Encyclopaedia of
Pharmaceutical Technology.
[0101] Pharmaceutically acceptable solvates are for example
hydrates.
[0102] Some embodiments may provide an improved storage and
transportation tray for a manifold of cartridges filled with a
liquid medicament by way of which a risk of a critical exposure to
room temperature can be decreased. As a result of the improved
storage and transportation tray, the time interval during which the
tray may be exposed to room temperature should be extended compared
to conventional storage and transportation tray solutions.
Consequently, certain aspects may facilitate the handling of
cartridges in a mass manufacturing process and to simplify the
product flow in such processes while fulfilling the demands in
respect of cooling or refrigerating of the cartridges.
[0103] Further, it is to be noted, that any reference numerals used
in the appended claims are not to be construed as limiting the
scope of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0104] In the following, various embodiments will be described in
detail by making reference to the drawings, in which:
[0105] FIG. 1 schematically shows a storage and transportation tray
for a manifold of cartridges,
[0106] FIG. 2 schematically illustrates a cartridge assembled in a
drug delivery device, such like an injection-pen,
[0107] FIG. 3 shows an arrangement of trays equipped and thermally
coupled with a cooling member,
[0108] FIG. 4 schematically shows a cooling system with a cooling
member at least partially enclosing the arrangement of trays,
[0109] FIG. 5 shows a different embodiment of the cooling system
with a cooling layer arranged between a support and a carriage,
[0110] FIG. 6 shows a further embodiment of the cooling system,
wherein the cooling member comprises a liftable cooling bell,
[0111] FIG. 7 schematically shows a storage and transportation tray
with a cooling line extending along or inside the sidewalls of the
storage and transportation tray,
[0112] FIG. 8 is illustrative of a storage and transportation tray
comprising a refrigerating machine,
[0113] FIG. 9 schematically shows a planar cooling pad with several
cooling lamellas to cover the access opening of the storage and
transportation tray,
[0114] FIG. 10 shows a stack or an arrangement of storage and
transportation trays, each of which comprising a cooling
member,
[0115] FIG. 11 schematically illustrates a storage and
transportation tray with a fastening structure to releasably
connect with a cooling member filled with a coolant medium and
[0116] FIG. 12 schematically depicts the storage and transportation
tray according to FIG. 11 with the cooling member attached to an
outside-facing portion of its sidewall.
DETAILED DESCRIPTION
[0117] FIG. 2 shows a rather schematic representation of a drug
delivery device 2 equipped with a cartridge 1 that is filled with a
medicament. The cartridge 1 typically comprises a vitreous barrel
3, which in proximal direction, hence to the right in FIG. 2, is
sealed by a plunger or piston 4 of elastomeric material. Its
opposite distal end is sealed by a pierceable septum 5 which is
kept in position at a socket or neck portion 6 if the barrel 3 by
means of a crimp cap 7. The drug delivery device 2 typically
comprises a housing 2 to accommodate the cartridge 1 and to
accommodate a drive mechanism 8 by way of which the piston 4 is
displaceable in distal direction, hence towards the distal septum 5
for expelling of a dose of the medicament from the interior of the
barrel 3. The septum 5 is typically pierced by a double-tipped
injection needle which is releasably attachable to the drug
delivery device 2.
[0118] The drug delivery device 2 is typically of disposable type.
After consumption of the medicament and/or after emptying of the
cartridge 1 the entire device 2 is intended to be discarded. With
disposable drug delivery devices 2, the cartridge 1 has to be
assembled inside the drug delivery device 2 during the process of
assembly of the drug delivery device 2. Since assembly and
manufacturing of such drug delivery devices 2 is automated to a
large degree in a mass manufacturing process a rather large amount
of cartridges 1 has to be provided to a respective assembly line.
In order to supply the production line with a batch of cartridges 1
storage and transportation trays 10, as illustrated in FIG. 1 are
used.
[0119] The tray 10 comprises a planar bottom 11 and four sidewalls
12 or respective sidewall sections. The sidewalls 12 are attached
or integrally formed with the planar bottom 10 at the outer edge
11a of the bottom 11. Typically, a lower edge 12b of the sidewall
12 is located adjacent or is connected with the outer edge 11a of
the planar bottom 11. Hence, with a rectangular or quadratic-shaped
planar bottom 11 and with four sidewalls 12 of equal height, a
box-shaped storage and transportation tray 10 is provided. The
storage and transportation tray 10 is typically lidless and
comprises an access opening 16 that is confined by the upper edges
12a of the sidewalls 12. The sidewalls 12 and the planar bottom 11
form a storage volume 14 in which a manifold of identical
cartridges 1 can be accommodated and arranged in a densely-packed
configuration. Typically, the cylindrically-shaped cartridges are
arranged upright on the bottom 11. They might be arranged to form a
densely packed hexagonal structure so as to maximize the transport
capacity of the storage and transportation trays 10.
[0120] As it is further illustrated in FIG. 1, the storage tray 10
comprises a first stacking structure 18 on top or at the upper edge
12a of the sidewalls 12 and further has a second stacking structure
19 at a lower edge 12b of the sidewall 12 or at the outer edge 11a
of the bottom 11. First and second stacking structures 18, 19
mutually correspond and cooperate to form a stack of storage trays
10 arranged on top of each other. For instance, one of the stacking
structures 18, 19 may comprise male stacking elements, such like
pins while the other of the stacking structures 18, 19 comprises
female stacking elements, such like depressions or recesses to
accommodate and to engage with the male stacking elements.
[0121] As it is further indicated in FIG. 1, the tray 10 comprises
at least one cooling member 110, which is integrated into at least
one of the sidewalls 12. Here, at least one of the sidewall 12
comprises a hollow shell 112 filled with a coolant medium. In other
embodiments as shown in FIGS. 3 to 9 and in FIGS. 11 to 12 the
cooling members 40, 42, 50, 60, 70, 80, 90, 100 are implemented in
a different way but the trays 10 comprise the general structure of
sidewalls 12 and bottom 11 as it is described in detail with
respect to FIG. 1.
[0122] In the various embodiments according to FIGS. 3-12 the
storage and transportation tray 10 as shown in FIG. 1 is equipped
with at least one cooling member 40, 42, 50, 60, 70, 80, 90, 100,
110, 120 in order to refrigerate and/or to keep the cartridges 1
located inside the storage volume 14 below a predefined temperature
level when located near or at the assembly line at room
temperature.
[0123] As it is indicated in FIG. 10 a stack and an arrangement of
storage and transportation trays 10, each of which accommodating a
manifold of cartridges 1, each and every storage and transportation
tray 10 is provided with a separate and individual cooling member
110. As indicated in FIG. 10 at least a sidewall 12 of the storage
and transportation trays 10 comprises a hollow shell 112 filled
with a coolant medium. In this way, the sidewall 12 of each tray 10
comprises and provides a cooling reservoir that helps to keep the
storage volume 14 and the cartridges 1 located therein below a
predefined critical temperature in regard to the medicament. The
coolant medium contained in the hollow shell 112 of the at least
one of sidewall 12 and bottom 11 may be kept together with the
cartridges 1 in a cooling or refrigerated environment. When taken
out of the refrigerator the cooling capacity of the coolant medium
allows to extend a critical time interval until the critical
temperature has been reached when the storage and transportation
tray is kept at room temperature and/or in a non-refrigerated
environment.
[0124] In FIGS. 11 and 12 another embodiment is shown, wherein the
cooling member 120 comprises a fastening structure 116 to mate with
a corresponding fastening structure 118 of the sidewall 12 of the
storage and transportation tray. The cooling member 120 may
comprise a kind of a cool pack 121 that is e.g. filled with a
coolant medium, that may even be cooled below the refrigerated
temperature of the cartridges. By means of the mutually
corresponding fastening structures 116, 118, the cooling member 120
can be separately cooled to a different and lower temperature level
compared to the cartridges 1. When the storage and transportation
tray is removed from a refrigerator, the cooling members 120 can be
manually or automatically attached to the sidewall 12 in order to
provide a cooling effect to the cartridges 1 located therein. The
mutually corresponding fastening structures 116, 118 may provide
mutual clamping and/or a positive and releasable engagement between
the cooling member 120 and a sidewall 12 or a bottom 11 of the
storage and transportation tray 10. Typically, the sidewall's 12
and/or the bottom's 11 fastening structure 118 is located at an
outside-facing portion thereof in order to maximize the storage
capacity of the storage and transportation tray 10.
[0125] In FIG. 12, an assembly configuration is illustrated,
wherein the cooling member 120 is actually attached to the
outside-facing portion of a sidewall 12 of the storage and
transportation tray 10.
[0126] The fastening structures 116 of the storage and
transportation tray 10 may also be arranged at an inside facing
portion of the at least one side wall 12 or of the planar bottom
11. Then, the cooling member 120 or several cooling members 120 may
be arranged inside the storage volume 14 of the storage and
transportation tray 10, thereby improving a rather direct thermal
coupling between the cartridges 1 located therein and the at least
one cooling member 120. For increasing the total cooling capacity
of the storage and transportation tray 10 it is even conceivable
that cooling members 120 are attached to an outside facing side and
to an inside facing side of at least one of the side wall 12 or
planar bottom 11.
[0127] The mutually fastening structures 116, 118 of the storage
and transportation tray and the at least one cooling member 120 may
comprise mutually corresponding or mutually engaging protrusions
and recesses to enable an intuitive and detachable fastening of the
at least one cooling member 120 to the storage and transportation
tray 10.
[0128] Even though not explicitly shown in FIGS. 1, 7 and 8 the
storage and transportation trays 10 according to FIGS. 1, 7 and 8
may be all equipped with fastening structures 116 for a detachable
fastening with at least one cooling member 120.
[0129] In FIG. 7 another embodiment of the storage and
transportation tray 10 is illustrated. There, the cooling member 80
comprises a cooling line 81 extending in a coil or meander-like
fashion through or across the planar sidewalls 12. The cooling line
81, which may comprise a cooling tube is in flow communication with
a feed line 82 as well as with a discharge line 84 extending into
and out of the sidewalls 12. By way of the feed line 82, a
refrigerated coolant may enter the cooling line 81 thereby
effectively cooling or refrigerating the sidewalls 12 of the
storage tray 10. By means of the discharge line 84, the coolant
medium may leave the cooling line 81 in a controlled way so as to
establish a closed circulation of a coolant flowing through the
sidewalls 12 of the storage tray 10.
[0130] The feed line 82 is connectable to a cooling supply, e.g. by
standardized connectors while the discharge line 84 is connectable
to a drain. Depending on the type of coolant medium flowing through
the cooling line 81 the discharge line 84 and the feed line 82 may
be connected or in flow communication outside the storage and
transportation tray 10 in order to form a closed circulation,
wherein further coolant flower through the discharge line 84 is
cooled by some kind of heat exchanger before the respective coolant
re-enters the feed line 82 and hence the cooling line 81 extending
through and/or across the sidewalls 12. For instance, the feed line
82 can be connected and coupled with a cool water supply.
[0131] In a further embodiment as shown in FIG. 8, the storage and
transportation tray 10 comprises a cooling member 90 featuring a
refrigerating machine 91. The refrigerating machine 91 may comprise
a Joule-Thomson machine or may be based on the Joule-Thomson
effect, like conventional fridges or air conditioning devices. In
addition, the cooling member 90 comprises a temperature sensor 92
as well as a controller 94, connected with both, the temperature
sensor 92 and the refrigerating machine 91. By means of the
controller 94, a closed loop can be established by way of which a
rather constant temperature level can be realized inside the
storage and transportation tray 10. In this embodiment and in order
to reduce dissipation of cooling energy the access opening 16 can
be covered by a removable lid 22. The removable lid 22 as well as
the sidewalls 12 and the bottom 11 comprise or consist of an
insulating material 26 in order to keep the degree of dissipation
of cooling energy at a rather moderate and low level.
[0132] Furthermore, the lid 22 is supported by the upper edges 12a
of the sidewalls 12. In order to even improve cooling efficiency,
the interface between lid 22 and upper edges 12a of the sidewalls
12 may be provided with a seal 24. With such an active cooling or
refrigerating means the time interval during which the tray 10 can
be stored and kept at room temperature can be extended almost
infinitesimally.
[0133] Further, the local cooling members 80, 90 as shown in FIGS.
7 and 8 can be mutually coupled when several storage and
transportation trays 10 are arranged in a stack. For instance,
having several identical storage and transportation trays 10
according to FIG. 7 arranged on a stack, the feed line 82 of a
lowermost tray 10 may be connected with a discharge line 84 of a
tray located there above, and so on. By way of a mutual
interconnection of the various local cooling members 80 of a
multiplicity of storage and transportation trays 10 only a single
or a few feed lines 82 and discharge lines 84 will have to be
connected with an external supply of a coolant medium, when the
arrangement 20 of storage and transportation trays 10 is positioned
near the assembly line.
[0134] Moreover, also the cooling members 90, hence the
refrigerating machines 91 of multiple storage and transportation
trays 10 can be mutually coupled and connected in order to save
energy and in order to facilitate a supply of the multiplicity of
storage and transportation trays 10 with a coolant or with cooling
energy, e.g. by means of a central cooling supply, either providing
a coolant medium or providing electrical energy.
[0135] In FIG. 9 another embodiment of a cooling member 100 is
schematically shown. There, the cooling member 100 comprises a
planar-shaped cooling pad 102 that may be flexibly deformable. From
a bottom or from a lower side thereof extend various cooling
lamellas 104. The cooling member 100 is adapted and designed to
cover and to obstruct the access opening 16 of the storage and
transportation tray 10. The cooling pad 102 may be flexible and the
lamellas 104 are adapted to thermally couple with a series of
cartridges 1 located inside the storage and transportation tray 10.
Like the hollow shell 112 of the sidewall 12 the cooling pad 102
may be also filled with a coolant medium, such like cooling water
or other coolant media that exhibit a comparatively large heat
storage capacity. Like the cool packs 121 also the cooling pad 102
could be stored or pre-cooled at a much lower temperature compared
to the predefined cooling temperature of the medicament.
[0136] The shape and design of the cooling lamellas 104 is selected
and prepared such that they at least partially snuggle around
individual cartridges of a densely-packed configuration of
cartridges 1 of a storage and transportation tray 10.
[0137] While the embodiments of various cooling members 80, 90,
100, 110, 120 according to FIGS. 7-12 represent local cooling
members, that are individually attachable or implementable with a
single storage and transportation tray 10, the further embodiments
as shown in FIGS. 3-6 relate to global cooling members 40, 42, 50,
60, 70 by way of which a multiplicity, hence at least two storage
and transportation trays 10 can be cooled and refrigerated.
[0138] In FIGS. 3-6 various arrangements 20 of storage and
transportation trays 10 are illustrated. As shown in FIG. 3, the
arrangement 20 of a multiplicity of storage and transportation
trays 10 comprises three stacks, each of which comprising five
storage and transportation trays 10 stacked on one another, and
wherein the three stacks are arranged next to each other on a
common support 32, such like a pallet. The support 32 together with
the arrangement 20 of storage and transportation trays 10 thereon
is located on a carriage 30 having wheels 34 by way of which the
carriage 30 is mobile for transporting the arrangement 20 of trays
10 from a refrigerated environment to the assembly line, which is
typically located in a room temperature environment.
[0139] In the embodiment according to FIG. 3, there are provided
various cooling members 40 extending between the three stacks of
storage and transportation trays 10. The cooling members 40 extend
substantially vertical between a left stack and a middle stack as
well as between the middle stack and a right-handed stack. There is
provided a further cooling member 42 extending across the three
stacks of storage and transportation trays 10. This additional
cooling member 42 is located on top of the uppermost row of storage
and transportation trays 10. By way of the upper and horizontally
arranged cooling member 42, dissipation of cooling energy towards
the top can be reduced. The horizontally extending cooling member
42 and the various vertically oriented cooling members 40 might be
mutually attached and/or thermally coupled. It is even conceivable
that cooling members 40 and 42 are integrally formed.
[0140] As further indicated in FIG. 3, at least one of the cooling
members 40, 42 is connected with a cooling supply 44, which may
comprise a cooling tube or cooling line. The cooling supply 44 is
further connectable to a cooling port 48 located in or at a floor
46 of the production or assembly environment. The cooling supply 44
and the cooling port 48 comprise mutually corresponding connectors
so that the cooling members 40, 42 can be supplied with a coolant
medium from the cooling port 48 once the carriage 30 with the
storage trays 10 located thereon reached a predefined position at
the assembly line.
[0141] In the further embodiment according to FIG. 4, the cooling
member 50 at least partially encloses the arrangement 20 of storage
and transportation trays 10. The cooling member 50 comprises a roof
portion 51 and at least two sidewall portions 53 that are
connectable with a cooling port 48 in order to supply the cooling
member 50 with a coolant medium or with energy in order to generate
a cooling effect.
[0142] The cooling member 50 is shown from a front view. The front
and/or the back of the cooling member 50 may be covered with an
insulating sheet, typically by an insulating curtain 52 as
indicated in FIG. 4. In this way, dissipation of cooling energy
into the environment can be reduced. At the same time, the flexible
curtain 52 provides access to the interior or the enclosing formed
by the cooling member 50.
[0143] The cooling member 50 may either be implemented as an
immobile device or as a mobile device. Hence, the lowermost and
bottom portions of the sidewall portions 53 of the cooling member
50 may be equipped with wheels or the like transportation means in
order to enable a displacement of the cooling member 50 over the
arrangement 20 of storage trays 10. The lower ends of the sidewall
portions 53 may be also thermally coupled with a cooling port 48 by
way of which a coolant medium could circulate through the hollow
shaped cooling member 50.
[0144] In FIG. 5 a different embodiment of a cooling system is
shown, wherein the cooling member 60 comprises a cooling layer 61
that is arranged between the carriage 30 and the support 32. In
addition, an insulating sheet 66 is provided by way of which the
entire space above the carriage 30 can be encapsulated. In this
way, the cooling layer 61 and hence the cooling member 60 is
located in a common encapsulated atmosphere with all storage trays
10. A cooling effect provided by the cooling layer 61 may then
distribute across and through the arrangement 20 of storage and
transportation trays 10, e.g. via thermal convection. The
insulating sheet 66 is detachably attached to the carriage 30 in
order to provide access to the storage and transportation trays 10.
The cooling layer 61 is further connected and in flow communication
with a cooling supply 64, which can be embedded or provided in or
at the floor 46 of the assembly site.
[0145] In FIG. 6, another embodiment of a cooling system is shown,
wherein the cooling member 70 comprises a liftable and lowerable
cooling bell 71. The bell 70 is designed to accommodate the entire
arrangement 20 of trays 10 together with the carriage 30 and the
support 32. The cooling bell 71 is thermally coupled with a cooling
supply 74 so that a roof portion 73 and a sidewall portion 75
thereof are kept at a predefined refrigerating temperature. The
cooling supply 74 may either be implemented as a supply for a
coolant medium, it may comprise an air conditioning for a building
or it may be thermally coupled therewith. Alternatively, it may
comprise a refrigerating machine as described above, which is
either based on the Joule-Thomson effect or Peltier effect.
[0146] In addition, a lifting and lowering mechanism 77 is provided
by way of which the cooling member 70, hence the cooling bell 71
can be raised into a lifted position in which individual storage
and transportation trays 10 can be removed from the arrangement 20
or from the stacks of trays 10.
LIST OF REFERENCE NUMBERS
[0147] 1 cartridge [0148] 2 drug delivery device [0149] 3 barrel
[0150] 4 piston [0151] 5 septum [0152] 6 neck portion [0153] 7 cap
[0154] 8 drive mechanism [0155] 10 storage and transportation tray
[0156] 11 bottom [0157] 11a edge [0158] 12 sidewall [0159] 12a edge
[0160] 12b edge [0161] 14 storage volume [0162] 16 access opening
[0163] 18 stacking structure [0164] 19 stacking structure [0165] 20
arrangement of trays [0166] 22 lid [0167] 24 seal [0168] 26
insulating material [0169] 30 carriage [0170] 32 support [0171] 34
wheel [0172] 40 cooling member [0173] 42 cooling member [0174] 44
cooling supply [0175] 46 floor [0176] 48 cooling port [0177] 50
cooling member [0178] 51 roof portion [0179] 52 curtain [0180] 53
sidewall portion [0181] 60 cooling member [0182] 61 cooling layer
[0183] 64 cooling supply [0184] 66 insulating sheet [0185] 70
cooling member [0186] 71 cooling bell [0187] 73 roof portion [0188]
74 cooling supply [0189] 75 sidewall [0190] 77 lifting mechanism
[0191] 80 cooling member [0192] 81 cooling line [0193] 82 feed line
[0194] 84 discharge line [0195] 90 cooling member [0196] 91
refrigerating machine [0197] 92 temperature sensor [0198] 94
controller [0199] 100 cooling member [0200] 102 cooling pad [0201]
104 lamella [0202] 110 cooling member [0203] 112 hollow shell
[0204] 116 fastening structure [0205] 118 fastening structure
[0206] 120 cooling member [0207] 121 cool pack
* * * * *