U.S. patent application number 13/813182 was filed with the patent office on 2013-11-14 for disposable packaging item.
This patent application is currently assigned to ATMI BVBA. The applicant listed for this patent is Daniel Masseau, Jean-Pascal Zambaux. Invention is credited to Daniel Masseau, Jean-Pascal Zambaux.
Application Number | 20130299380 13/813182 |
Document ID | / |
Family ID | 42806253 |
Filed Date | 2013-11-14 |
United States Patent
Application |
20130299380 |
Kind Code |
A1 |
Zambaux; Jean-Pascal ; et
al. |
November 14, 2013 |
DISPOSABLE PACKAGING ITEM
Abstract
The invention relates to a disposable packaging item capable of
being sterilised and/or depyrogenated. The invention in particular
relates to the packaging of products and/or devices in the fields
of medicine, pharmaceutics, chemistry, biology, food or
electronics. The invention in particular relates to a disposable
packaging item (1) at least partially produced with at least one
thermoplastic film (10) that can withstand sterilisation and/or
depyrogenation, said disposable packaging item (1) defining at
least one inner enclosure (5) for receiving one or more elements
(50) to be packaged, said inner enclosure (5) being under vacuum
(40) and preferably sterile and/or depyrogenated, said packaging
item (1) including one or more packaged elements (50).
Inventors: |
Zambaux; Jean-Pascal;
(Allonzier La Caille, FR) ; Masseau; Daniel;
(Bordeaux, FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Zambaux; Jean-Pascal
Masseau; Daniel |
Allonzier La Caille
Bordeaux |
|
FR
FR |
|
|
Assignee: |
ATMI BVBA
Hoegaarden
BE
|
Family ID: |
42806253 |
Appl. No.: |
13/813182 |
Filed: |
July 29, 2011 |
PCT Filed: |
July 29, 2011 |
PCT NO: |
PCT/FR2011/051841 |
371 Date: |
July 2, 2013 |
Current U.S.
Class: |
206/525 |
Current CPC
Class: |
B65D 77/003 20130101;
B65D 81/2023 20130101; B65D 81/24 20130101; A61B 50/30 20160201;
A61B 50/33 20160201; A61B 2050/314 20160201; A61L 2202/181
20130101; A61L 2/26 20130101 |
Class at
Publication: |
206/525 |
International
Class: |
B65D 81/24 20060101
B65D081/24 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 30, 2010 |
FR |
1056346 |
Claims
1. Article disposable package (1) made at least partially with at
least one resistance of a thermoplastic film (10) to a
sterilization and/or depyrogenation and resistant to a temperature
above 225.degree. C. to 10 5 Pa, said article A disposable package
(1) defining at least an inner chamber (5) for receiving one or
more items (50) to be packaged, said inner shell (5) is a vacuum
(40) and sterile and/or depyrogenated, said packaging article (1)
comprising one or more elements (50) packaged.
2-14. (canceled)
Description
[0001] The invention relates to a primary or secondary disposable
packaging product that can be sterilized and/or depyrogenized.
[0002] The invention relates in particular to a packaging for
products and/or devices of the medical, pharmaceutical, chemical,
biological, alimentary, or electronic domains.
STATE OF THE ART
[0003] In the domain of heat sterilization and/or depyrogenation of
packaged products or devices, the practice is to place these
products or devices in the chamber of an oven with positive
pressure gradient in order to keep the product and the packaging
sterile and/or depyrogenized during the cooling phases. The oven
must therefore be specialized for this type of operation, which in
general requires continuous sterilizing filtration of the air
inside the oven and a laminar flow at the exit of the oven chamber,
in particular to isolate the inside of the oven chamber from the
exterior atmosphere and to guarantee that the sterilization is
maintained at the exit.
[0004] Very recently, the company DISPOSABLE-LAB (France) has
invented a new valve applicable to packaging for such products.
This product is currently the subject of an international patent
application PCT/EP2010/053617. The presence of this valve
eliminates the need for laminar flow at the exit of the
sterilization and/or depyrogenation chamber. However, the oven must
be under sterile atmosphere and in over-pressure during the
sterilization and/or depyrogenation operation.
GOALS OF THE INVENTION
[0005] The main goal of the invention is to resolve the new
technical problem of providing a packaging that can be used in all
types of ovens or sterilization and/or depyrogenation chambers. The
goal of the invention is therefore to introduce the use of a
sterilization and/or depyrogenation chamber not requiring a laminar
flux at the exit, or a sterile over-pressure atmosphere, which are
not advantageous operational conditions.
[0006] The goal of the invention is also to resolve the technical
problem of providing a packaging which keeps the product sterile
and/or depyrogenized during its storage and up to its use.
[0007] The goal of the invention is also to resolve the technical
problem of providing a sterilization and/or depyrogenation method
for a disposable packaging, which is easier to produce and/or less
costly.
[0008] The goal of the invention is also to resolve the technical
problem of providing a sterilization and/or depyrogenation method
for a disposable packaging that can be used in all types of
sterilization or depyrogenation devices, in particular by heating
and holding at a certain sterilization and/or depyrogenation
temperature.
[0009] The goal of the invention is to provide a solution to all of
the aforementioned technical problems in a simple, industrial
manner, and at low cost. In particular, the invention aims at
providing an easy to use disposable sterile packaging.
DESCRIPTION OF THE INVENTION
[0010] The invention relates to a packaging that can be sterilized
and/or depyrogenized, in other words freed of pyrogenic agents. A
pyrogenic agent is an agent that can provoke fever in humans or
animals. The expression "freed of pyrogenic agents" means that
pyrogenic agents are not present or that their quantity is smaller
than the acceptable standards for the use of the subject product or
device. The term "depyrogenation" refers in particular to the
removal of pyrogenic agents from the devices or products, and more
particularly from injectable pharmaceutical products, sterile
creams, or pharmaceutical, medical or surgical devices.
[0011] The present invention covers in particular a disposable
packaging (1) made at least partially from at least one
thermoplastic film (10) resistant to sterilization and/or
depyrogenation, and resistant to a temperature greater than
225.degree. C. at 10.sup.5 Pa, said item of disposable packaging
(1) defines at least one interior space (5) intended to receive one
or more elements (50) to be packaged, whereby said space (5) is
under vacuum (40) and sterile and/or depyrogenized, and said
packaging (1) is containing one or more packaged elements (50).
[0012] The term "thermoplastic" refers to a polymeric material
obtained by polymerization of monomers comprising at least one atom
of carbon, and susceptible of being softened by heating and
hardened by cooling, in repeatable manner.
[0013] By vacuum is understood a pressure in the interior space
that is lower than the exterior pressure on the packaging in
storage conditions. By preference, the vacuum is a pressure between
1 and 500 hPa, by preference between 1 and 400 hPa, and for
instance approximately 300 to 350 hPa.
[0014] According to a variant, the item of the invention comprises
at least one entry and/or exit opening for one or more elements to
be packaged in the interior space of the item, said at least one
entry and/or exit opening is closed by at least one closing means
after introduction of the elements to be packaged in the interior
space of the item, such as for instance by means of welding and/or
mechanical pinching of the film of a thermoplastic resistant to
sterilization and/or depyrogenation, and resistant to a temperature
greater than 225.degree. C. at 10.sup.5 Pa.
[0015] By preference, the entry and/or exit opening is formed by
the thermoplastic film.
[0016] By polymeric material resistant to sterilization and/or
depyrogenation is understood a material that is not degrading, or
not in appreciable manner, during sterilization and/or
depyrogenation. In particular, this material should not partially
assume a liquid or gaseous state, or be the subject of degradation
caused by the form of the item and/or products or devices to be
conditioned. Typically the melting temperature of this material is
higher than 225.degree. C. at 10.sup.5 Pa.
[0017] Advantageously, a vacuum is drawn in the interior packaging
space, by preference before or simultaneously to the closing, by at
least one closing means, of the entry and/or exit openings, such as
for instance closing by at least one weld or a mechanical
action.
[0018] According to one implementation mode, the disposable
packaging is a disposable bag, for instance a single or multiple
bag made from one or several films of at least one thermoplastic.
Advantageously, the external edges of the thermoplastic film(s)
forming the periphery of the introduction opening are welded.
[0019] According to one implementation mode, the disposable
packaging has walls formed from at least one thermoplastic film
resistant to sterilization and/or depyrogenation, and resistant to
a temperature higher than 225.degree. C. at 10.sup.5 Pa.
[0020] Advantageously, said item comprises at least one
introduction opening for one or more elements to be packaged in the
interior space of the item, the entry and/or exit openings are
closed by welding or by a mechanical pinching mechanism of the
thermoplastic film.
[0021] By preference, only one thermoplastic is used, but the
invention covers also the use of several polymeric materials in
order to associate their properties and to improve the properties
of the packaging. Among the preferred polymers, one or more
polymers are used selected among: PE (Polyethylene), PP
(Polypropylene), PFA (Perfluoroalkoxy), Polyaryletherketone, FEP
(fluoro ethylene propylene), PEEK (Poly(ether ether ketone)) (PEEK
MT or ST), PAI (polyamide imide), PI (Polyimide), PPSU
(Polyphenylene sulfon), PES (Polyether sulfon), PPP
(Polyparaphenylene), POM (Polyoxymethylene), and the analog
polymers. PEEK is a preferred polymer.
[0022] The item of the invention is made, at least partially, and
by preference completely, by preference, from PEEK or PFA.
[0023] According to an advantageous implementation mode, the
pressure of the interior space is between 1 and 500 hPa, by
preference between 1 and 400 hPa, and for instance approximately
300 to 350 hPa. The vacuum is created in such manner as to limit to
the maximum the expansion of the interior space of the packaging.
According to a particular implementation mode, enough gas is left
behind (air, oxygen, nitrogen or other inert gas, or gas necessary
for the packaged product or device) to expand the interior space so
that the products or devices are in the presence of the same gas,
and in order to validate the sterilization and/or depyrogenation,
at least from the point of view of quality.
[0024] Advantageously, the item of the invention comprises, by
preference close to an introduction opening, means of easy opening
by ripping of the thermoplastic film. Typically, a V shaped notch
is provided.
[0025] According to a variant, the easy opening means consist of a
notch, for instance "V" shaped, made in the thermoplastic film. By
preference the notch is made in directional manner for easy ripping
of the plastic film if the thermoplastic opposes a resistance which
is mainly directional.
[0026] Advantageously, the item of the invention comprises as
vacuum packaged element, one or more recipients for one or more
products, and in particular chemical, pharmaceutical, biological,
or alimentary products, or one or more medical, surgical or
electronic devices.
[0027] According to one implementation mode, the interior space is
sterile and/or depyrogenized with one or more products and/or
devices packaged in the interior space.
[0028] According to a variant, the packaging is made of at least
one thermoplastic film resistant to sterilization and/or
depyrogenation, and resistant to a temperature greater than
225.degree. C. at 10.sup.5 Pa, and by preference is made of PEEK or
PFA, said thermoplastic film has a tubular form closed in its
extremities to define said interior space.
[0029] Advantageously, the item comprises one or more flasks or
vials containing chemical, pharmaceutical or biological products to
be sterilized and/or depyrogenized.
[0030] According to an implementation mode of the invention, the
flasks or vials are placed on a tray or support with separators for
the flasks or vials. The tray including flasks or vials is placed
in the interior space for sterilization and/or depyrogenation.
[0031] According to a preferred implementation mode of the
invention, the flasks and vials are positioned by means of one or
more flask or vial separating elements. The assembly of
flasks/vials and separating elements is placed in the interior
space for sterilization and depyrogenation. In this implementation
mode, the packaging has no support or tray and only one or more
separating elements of flasks and vials.
[0032] Advantageously, the separating element is an element
comprising partitions defining contiguous pockets for receiving, by
preference at regular intervals, the flasks, vials or other product
to be packaged.
[0033] By preference, in packaged form, the separating element is
held in place solely by the reduced pressure applied in the
interior space acting through progressive compression of the
thermoplastic film. In other terms, when, for instance, flasks or
vials are used, the separating element can be held at a height
between the lower part and the upper part of the flasks,
essentially thanks to the reduced pressure (the vacuum) existing in
the interior space. In practice, the creation of the vacuum causes
progressive displacement of the separating element from a position
"at rest" corresponding, by preference, with the lower part of the
flasks to a "vacuum" position corresponding, by preference, with a
median position located between the lower part and the upper part
of the flasks.
[0034] According to another implementation mode, the invention does
not comprise a tray or support, or separating elements. In other
words, the interior space of the packaging according to the
invention contains only, for instance, the products, the
recipients, the flasks or vials to be packaged.
[0035] According to a particular implementation mode, the item of
the invention encloses in the interior space of the packaging one
or more disposable packagings as defined previously, for instance
to constitute at least a double pocket. This double pocket, triple
pocket, or multiple pocket, allows for the sterilization and/or
depyrogenation of the exterior of the first pocket.
[0036] According to a preferred implementation mode, different
thermoplastics are used to make the different films of a double
pocket, triple pocket or multiple pocket. According to one variant,
a different thermoplastic is used for each layer. Advantageously,
the double pocket, triple pocket or multiple pocket comprises a
PEEK film forming the layer closest to the elements to be packaged,
and a PFA film for the layer farthest away forming the exterior
layer of the packaging. In this way, different properties of
thermoplastics are combined, avoiding in particular the phenomenon
of adhesion of one film against the other films of the same
thermoplastic during a temperature rise, such as during a
sterilization and/or depyrogenation phase.
[0037] In general, the thickness of the thermoplastic film of the
invention is between 25 and 500 microns, by preference between 300
and 50 microns and often approximately 200 microns.
[0038] According to an implementation mode, the packaging is a
partially or totally flexible bag. The flexibility can be conferred
in particular by varying the nature of the thermoplastic and/or the
film thickness. It is also possible to make one part of the
packaging with lateral walls and a bottom in order to receive
products, devices, flasks or vials, and to close the entry or exit
opening (the surface above the bottom) by means of a thermoplastic
film welded to the periphery of the edges of the lateral walls. The
lateral walls and bottom can be made of rigid material. The film
can be withdrawn. The bottom of the item can constitute a support
surface for the products, devices, flasks and vials. Each of the
products, devices, flasks or vials can be placed in an individual
compartment.
[0039] The invention relates also to an under partial vacuum
sterilized and depyrogenized product and/or device, ready to use,
contained in a packaging as defined above and here after. The
packaged product and/or device of the invention can be removed from
its packaging by a simple motion of ripping the thermoplastic film,
in particular at the location of the easy opening means.
[0040] The invention relates also to a method for sterilizing
and/or depyrogenating a disposable packaging, by preference such as
previously defined, characterized in that it comprises: [0041] the
introduction of one or more products and/or devices inside the
interior space of a disposable packaging made at least partially
from a thermoplastic film resistant to sterilization and/or
depyrogenation, and resistant to a temperature greater than
225.degree. at 10.sup.5 Pa, and by preference with walls made of a
thermoplastic film resistant to sterilization and/or
depyrogenation, and resistant to a temperature greater than
225.degree. C. at 10.sup.5 Pa, said introduction takes place by
means of at least one introduction opening defined in said item;
[0042] applying a vacuum to the disposable packaging; and [0043]
the closing, by preference by welding or mechanical pinching of the
thermoplastic film, and of the introduction opening(s); and [0044]
the sterilization and/or depyrogenation of the disposable packaging
enclosing in its interior space, under vacuum, one or more products
and/or devices.
[0045] The packaging contains in this way one or more sterilized
and/or depyrogenized products and/or devices.
[0046] The European Pharmacopoeia, 5.1.1 "methods for preparing
sterile products" defines sterilization methods among which
sterilization by dry heat. The vacuum in the interior space can be
drawn through the intermediary of a system for aspirating the gas
in the interior space. The aspiration system can be connected to a
tube ending in the interior space. Once the vacuum is drawn, the
tube is retracted operculating the space left by the retracted
tube, then before the total retraction of the tube, the opening is
closed rendering the interior space impermeable.
[0047] According to a variant, the closing phase includes welding
of the thermoplastic film. A typical weld consists of a continuous
double linear weld rendering impermeable the interior space from
the atmosphere outside the packaging.
[0048] Advantageously, the method comprises the introduction in a
closed space, such as for instance an oven, of the disposable
packaging under vacuum, then the sterilization and/or
depyrogenation of the disposable packaging, then the removal of the
disposable packaging from the closed space.
[0049] The thermoplastic film is welded in particular by a
permanent assembly technique which ensures by fusion a continuity
of the same nature of the surfaces to be joined, by approaching,
making contact then holding until solidification of the mixture
formed in this manner. Welding can take place in particular by
means of hot air, friction, mirror, ultrasound, high frequency or
laser.
[0050] Other goals, characteristics and advantages of the invention
will become clear by reading the explanatory description with
reference to the implementation modes illustrated by the attached
drawings, in which:
[0051] FIG. 1 illustrates an implementation mode in which a
disposable packaging (1) is made at least partially, and here
completely, from a thermoplastic film (10) resistant to
sterilization and/or depyrogenation, and resistant to a temperature
greater than 225.degree. C. at 10.sup.5 Pa. This film is made of
PEEK. Said disposable packaging (1) defines at least one interior
space (5) intended to receive one or more elements (50) to be
packaged. The film (10) comprises a first weld (20) closing one end
of the packaging. This weld is also visible in the implementation
modes of FIGS. 2 and 3 (20, 320).
[0052] FIGS. 2 and 3 illustrate a disposable packaging (1, 301)
according to the implementation mode of FIG. 1 in which the
interior space (5, 305) of the item (1, 301) is under vacuum (40,
340) and sterile and/or depyrogenized, said packaging (1, 301)
comprises one or more packaged elements (50, 350). The packaged
elements (50, 350) are sterile and/or depyrogenized. This is
obtained by introducing the elements (50, 350) to be packaged, then
closing the thermoplastic film (10, 310), here by welding (30, 330)
edge to edge at the location of the introduction opening (15, 315).
The extraction of one or more packaged elements (50, 350) can take
place through the introduction opening (15, 315) which serves then
as exit opening, or by ripping the film (10, 310) in another place
or in a predefined place, typically by means of a notch
facilitating the ripping of the film (10).
[0053] FIG. 3 illustrates a disposable packaging (301) in which the
packaged elements (350) are under vacuum (340), sterile and/or
depyrogenized in the interior space (305) and placed on a tray
comprising separations (360). These elements (350) are here flasks
which can contain a product of interest in chemistry, pharmacy,
biology, biotechnology, or food industry;
[0054] FIG. 4 illustrates an implementation mode of the invention
in which a disposable packaging (401) is produced at least
partially by means of a thermoplastic film (410) resistant to
sterilization and/or depyrogenation, and resistant to a temperature
greater than 225.degree. C. at 10.sup.5 Pa. This film is made of
PEEK. Said disposable packaging (401) defines at least one interior
space (405) intended to receive one or more elements (450) to be
conditioned. The film (410) is welded by a weld (430) attaching the
film (410) to the periphery of the upper surface of the interior
space (405) of the packaging (401). The elements (450) are packaged
under vacuum (440).
[0055] In a preferred mode of the invention the interior space
comprises a buffer volume or "dead" volume which limits the forces
exercised on the closing means when the volume of the interior
space increases. Typically, during the sterilization and/or
depyrogenation procedure, the rise in temperature causes a volume
increase of the interior space. The buffer volume serves therefore
as expansion zone of the gas present in the interior space. A
typical buffer zone comprises an extension of several centimeters
of the thermoplastic film not facing the packaged elements,
typically 5 to 10 cm.
[0056] FIG. 5 shows a variant of the buffer volume (570). The other
references are deduced by adding 500 to the references of FIGS. 1
and 2.
[0057] FIG. 6 is a photo of an implementation mode of the
invention. In this interior space comprising flasks, the vacuum is
approximately 320 hPa.
[0058] FIG. 7 illustrates a packaging (1, 701) in which the
packaged elements (750) are under vacuum (740), sterile and/or
depyrogenized in the interior space (720) and separated by
separating elements (780). The other references are deduced by
adding 700 to the references of FIGS. 1 and 2.
[0059] FIG. 8 is a photo of an implementation mode of the
invention. In this interior space, a separating element comprising
partitions defining contiguous pockets is used to ensure the
separation of the flasks.
[0060] The examples which have been given are an integral part of
the present invention and any characteristic appearing novel
relative to the prior state of technology, starting from the
description as a whole, including the examples, is an integral part
of the invention in its function and generality.
[0061] Each example has a general reach.
* * * * *