NZ763002A - Improved device for sterilising flexible bags by electron-beam irradiation and method for sterilising them - Google Patents
Improved device for sterilising flexible bags by electron-beam irradiation and method for sterilising them Download PDFInfo
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- NZ763002A NZ763002A NZ763002A NZ76300220A NZ763002A NZ 763002 A NZ763002 A NZ 763002A NZ 763002 A NZ763002 A NZ 763002A NZ 76300220 A NZ76300220 A NZ 76300220A NZ 763002 A NZ763002 A NZ 763002A
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- sterilisation
- electron beam
- flexible bags
- electron
- bags
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- 238000010894 electron beam technology Methods 0.000 title claims abstract description 51
- 230000001954 sterilising Effects 0.000 title claims description 10
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 37
- 210000002381 Plasma Anatomy 0.000 claims abstract description 13
- 238000000034 method Methods 0.000 claims abstract description 7
- 239000012460 protein solution Substances 0.000 claims abstract description 7
- 230000001225 therapeutic Effects 0.000 claims abstract description 3
- 239000000203 mixture Substances 0.000 claims description 5
- NKCXQMYPWXSLIZ-PSRDDEIFSA-N (2S)-2-[[(2S)-1-[(2S)-5-amino-2-[[2-[[(2S)-6-amino-2-[[2-[[(2S)-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-amino-3-hydroxybutanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-3-hydroxybutanoyl]amino]propanoyl]amino]-4-oxobutanoyl]amino]-3-m Chemical compound O=C([C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCCCN)NC(=O)CNC(=O)[C@@H](NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](C)NC(=O)[C@@H](NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@@H](N)[C@@H](C)O)[C@@H](C)O)C(C)C)N1CCC[C@H]1C(=O)N[C@@H](CO)C(O)=O NKCXQMYPWXSLIZ-PSRDDEIFSA-N 0.000 claims description 3
- 101710027066 ALB Proteins 0.000 claims description 3
- 102100001249 ALB Human genes 0.000 claims description 3
- 229960005348 Antithrombin III Drugs 0.000 claims description 3
- 108090000935 Antithrombin-III Proteins 0.000 claims description 3
- 102000004411 Antithrombin-III Human genes 0.000 claims description 3
- 210000004369 Blood Anatomy 0.000 claims description 3
- 108010039209 Blood Coagulation Factors Proteins 0.000 claims description 3
- 102000015081 Blood Coagulation Factors Human genes 0.000 claims description 3
- 210000003743 Erythrocytes Anatomy 0.000 claims description 3
- 102100009906 F7 Human genes 0.000 claims description 3
- 102100006624 F9 Human genes 0.000 claims description 3
- 229950003499 FIBRIN Drugs 0.000 claims description 3
- 108010076282 Factor IX Proteins 0.000 claims description 3
- 108010023321 Factor VII Proteins 0.000 claims description 3
- 108010054218 Factor VIII Proteins 0.000 claims description 3
- 229960000301 Factor VIII Drugs 0.000 claims description 3
- 102000001690 Factor VIII Human genes 0.000 claims description 3
- 102000009123 Fibrin Human genes 0.000 claims description 3
- 108010073385 Fibrin Proteins 0.000 claims description 3
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 claims description 3
- 108010049003 Fibrinogen Proteins 0.000 claims description 3
- 102000008946 Fibrinogen Human genes 0.000 claims description 3
- 229940012952 Fibrinogen Drugs 0.000 claims description 3
- 229940019698 Fibrinogen containing hemostatics Drugs 0.000 claims description 3
- 108010088842 Fibrinolysin Proteins 0.000 claims description 3
- 229940072221 IMMUNOGLOBULINS Drugs 0.000 claims description 3
- 108060003951 Immunoglobulins Proteins 0.000 claims description 3
- 102000018358 Immunoglobulins Human genes 0.000 claims description 3
- 229940012957 Plasmin Drugs 0.000 claims description 3
- 102000013566 Plasminogen Human genes 0.000 claims description 3
- 108010051456 Plasminogen Proteins 0.000 claims description 3
- 210000003324 RBC Anatomy 0.000 claims description 3
- 210000002966 Serum Anatomy 0.000 claims description 3
- 108090000190 Thrombin Proteins 0.000 claims description 3
- 102100019017 VWF Human genes 0.000 claims description 3
- 229940050528 albumin Drugs 0.000 claims description 3
- 230000015572 biosynthetic process Effects 0.000 claims description 3
- 239000008280 blood Substances 0.000 claims description 3
- 239000010836 blood and blood product Substances 0.000 claims description 3
- 239000003114 blood coagulation factor Substances 0.000 claims description 3
- 229960004222 factor IX Drugs 0.000 claims description 3
- 229940012413 factor VII Drugs 0.000 claims description 3
- 238000005755 formation reaction Methods 0.000 claims description 3
- 239000003186 pharmaceutical solution Substances 0.000 claims description 3
- 230000000896 plasminic Effects 0.000 claims description 3
- 239000000243 solution Substances 0.000 claims description 3
- 229960004072 thrombin Drugs 0.000 claims description 3
- 108010047303 von Willebrand Factor Proteins 0.000 claims description 3
- 229960001134 von Willebrand factor Drugs 0.000 claims description 3
- 108010050122 alpha 1-Antitrypsin Proteins 0.000 claims description 2
- 229940024142 alpha 1-Antitrypsin Drugs 0.000 claims description 2
- 102000015395 alpha 1-Antitrypsin Human genes 0.000 claims description 2
- 238000007789 sealing Methods 0.000 claims description 2
- 239000000463 material Substances 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 4
- 239000000825 pharmaceutical preparation Substances 0.000 description 4
- 230000035515 penetration Effects 0.000 description 3
- 102000004169 proteins and genes Human genes 0.000 description 3
- 108090000623 proteins and genes Proteins 0.000 description 3
- 230000001070 adhesive Effects 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 230000001681 protective Effects 0.000 description 2
- LIVNPJMFVYWSIS-UHFFFAOYSA-N silicon monoxide Inorganic materials [Si-]#[O+] LIVNPJMFVYWSIS-UHFFFAOYSA-N 0.000 description 2
- 238000003786 synthesis reaction Methods 0.000 description 2
- 241000282412 Homo Species 0.000 description 1
- 231100000987 absorbed dose Toxicity 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 229920003013 deoxyribonucleic acid Polymers 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000009114 investigational therapy Methods 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 230000000149 penetrating Effects 0.000 description 1
- 238000005020 pharmaceutical industry Methods 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 239000002753 trypsin inhibitor Substances 0.000 description 1
Abstract
This invention relates to the pharmaceutical sector, specifically to an improved device for electron-beam irradiation sterilisation of flexible bags, in particular the type of flexible bags that may contain human plasma protein solutions for therapeutic use. This device comprises two electron accelerators: a first accelerator emitting an electron beam with energies between 400 and 500 keV and a second accelerator emitting an electron beam with an energy of at least 4 MeV. In addition, the present invention relates to a sterilisation method by electron-beam irradiation of such flexible bags and to an in-line filling process for flexible bags using the sterilisation device and method of this invention. rators: a first accelerator emitting an electron beam with energies between 400 and 500 keV and a second accelerator emitting an electron beam with an energy of at least 4 MeV. In addition, the present invention relates to a sterilisation method by electron-beam irradiation of such flexible bags and to an in-line filling process for flexible bags using the sterilisation device and method of this invention.
Description
Improved device for sterilising flexible bags by electron-beam irradiation
and method for sterilising them
This application claims priority from European patent application 19382282.2 filed 12 April 2019, the
entire content of which is incorporated by reference.
DESCRIPTION
This invention relates to the pharmaceutical sector, specifically to an improved device for sterilising
flexible bags, in particular the type of flexible bags that may contain human plasma protein solutions for
therapeutic use. In addition, the present invention relates to a sterilisation method for such flexible bags
by electron-beam irradiation and to an in-line filling method for flexible bags using the sterilisation device
and method of the present invention.
Electron-beam irradiation, also known as “E-beam”, is a form of ionising radiation which is generally
characterised by low penetration and high doses of applied energy. Said beam is a stream of
concentrated and highly charged electrons. These electrons are generated by an accelerator capable of
producing beams which may be continuous or pulsed. The material to be sterilized absorbs the energy of
the electrons and said energy absorption, also known as absorbed dose, eliminates microorganisms by
destroying their DNA strands.
Commercial electron-beam accelerator equipment typically operates with a single energy, and in the
case of pharmaceutical product sterilisation, a high energy electron-beam is typically required to achieve
product and packaging penetration. A higher energy of the electron beam will cause a higher penetration
of the electron beam into the product.
When the electron beam is assessed in order to carry out a sterilisation method, different parameters
such as product density, size, orientation and packaging must be considered. Generally, E-beam
irradiation works better when used on low-density and uniformly packaged products.
In the specific case of flexible bags suitable for containing a solution of human plasma proteins, these are
made up of various materials and thicknesses. For example, the bag walls can be as thick as
approximately 130 µm, the tube of the outlet port of the bag, which is sealed to it, can be 1.24-mm thick,
while the twist-off cap is the thickest area, which can be approximately 3 mm. All these parts must be
decontaminated and sterilised before filling in the bags with these human plasma protein solutions. Bags
suitable for sterilising with the device of the present invention are those disclosed in the Spanish Patent
application No. ES201431561.
The patent application No. ES201730338 discloses a device for flexible bag sterilisation which comprises
40 an accelerator emitting an electron beam with energies between 450 and 500 keV and an accelerator
emitting another electron beam with energies between 700 and 750 keV. The bags are vertically placed
and both electron guns are facing each other, and the beam is shot parallel to the ground.
The inventors of this invention have discovered that using energies between 700 and 750 keV, and even
up to 2 MeV, in the higher energy electron beam, is not enough to sterilise the caps of such flexible bags,
due to the fact that some internal parts of them remain unsterilised, and they can later be in contact with
the pharmaceutical product that will contain the bag. This is due to the fact that since the accelerators are
on one side of the bag, radiation needs to cross a distance not only from the cap thickness in the area
closest to the electron accelerators, but also from the cap thickness in the furthest part of such
accelerators.
After an extensive investigation it has been determined that, in order to overcome the above-mentioned
drawbacks, it is necessary for this electron beam to have an energy equal to or greater than 4 MeV, that
is to say, at least 5 times higher than the energy known in the current state of the art.
Surprisingly, the inventors were able to use a combination of novel features that make the device of this
invention both very effective and safe. The inventors have determined that in the device of this invention,
accelerators should not be opposed to each other, because such radiation would cause damage to the
accelerators themselves, and should emit the electron beam perpendicularly and in the direction to the
ground, since the possibility of radiation escaping into the surrounding environment is very high when the
emissions are parallel to the ground, with consequences both for humans and the surrounding
environment. The position of the bag to be sterilised, which will be parallel to the ground, has also been
modified. In addition, containment measures have been taken to prevent the escape of radiation.
Therefore, the inventors of the present invention have developed an electron beam sterilisation device
that overcomes the disadvantages of the prior art, in which both accelerators are arranged at the top of
the device thus allowing the emission of the electron beam downwards, in a direction perpendicular to the
ground, with the bag parallel to the ground and with additional containment measures so that radiation
will not escape.
The invention will be explained below in connection to the figures, where:
Figure 1 is a front view of one embodiment of the electron-beam sterilisation device according to the
present invention.
Figure 2 is a front view of one embodiment of the electron-beam sterilisation device according to the
present invention with protective measures against the escape of radiation.
Figure 3 is a view in perspective of one embodiment of a twist-off stopper-port structure of a flexible bag
to be sterilised with the device of the present invention.
Figure 4 shows a view in perspective of the port-twist-off stopper structure of Figure 3.
40 Figure 5 shows a view in perspective of the port of Figure 4 both transverse and longitudinally sectioned.
Figure 6 shows a graph depicting the dose uniformity ratio (DUR), which indicates the ratio between the
maximum dose and the minimum dose applied to a material, of different electron beams as a function of
the distance run through the smaller diameter of the oval shape which makes up the flange of the port in
Figure 5.
In a first aspect, this invention relates to a device for the sterilisation of flexible bags characterised in that
it comprises a sterilisation zone comprising two electron accelerators: a first electron accelerator, which
emits an electron beam with energies between 400 and 500 keV and a second electron accelerator,
which emits an electron beam with an energy of at least 4 MeV, preferably between 4 and 5 MeV, most
preferably of 4 MeV.
In one embodiment, the device of the present invention is arranged in a radiation-proof area, in which
measures have been taken to contain the radiation emitted by the accelerators. Said containment
measures can be both walls and floor, the walls must be at least 65-cm thick, preferably between 65 and
80 cm, and preferably made of lead. The floor can be made of the same thickness and material as the
walls.
Figure 1 shows a front view of the sterilisation zone of one embodiment of the sterilisation device
according to the present invention. Said sterilisation zone is formed by one accelerator or emitter of
electron beams of lower energy (400-500 keV), one accelerator or emitter of electron beams of higher
energy than the previous one (4-5 MeV) and a flexible bag to be sterilised that includes two areas:
the port-twist-off stopper structure and the body of the bag. In this embodiment, both accelerators
are arranged at the top of the device and shoot their electron beams downwards, in a direction
perpendicular to the ground. The lower energy accelerator shoots electron beams towards the body
zone of the bag, while the higher energy accelerator shoots electron beams towards the
port-twist-off stopper of the bag.
Figure 2 shows a front view of the sterilisation zone of one embodiment of the sterilisation device
according to the present invention. Said sterilisation zone consists of one accelerator or emitter of
electron beams with lower energy (400-500 keV), one accelerator or emitter of electron beams with
higher energy than the previous one (4-5 MeV) and a flexible bag to be sterilised which comprises
two areas: the port-twist-off stopper structure and the body of the bag. In this embodiment, both
accelerators are arranged at the top of the device and shoot their electron beams downwards, in a
direction perpendicular to the ground. In addition, protective measures can be observed on both walls
and the floor that surround the device of this invention. In one embodiment, the walls of the device
of this invention are at least 65-cm thick, preferably between 65 and 80 cm. Preferably, the weight of the
containment measures of the device of this invention must be of at least 40 tons, and the material is
preferably lead.
Figure 3 shows a view in perspective of a port-twist-off stopper structure of a flexible bag to be
sterilised. This port-twist-off stopper structure normally consists of a twist-off stopper and a port
40 .The twist-off stopper has an activation key in its upper part, which normally has a weakened
zone in its contact with the rest of the twist-off stopper structure, which therefore, can be removed and
activated by the user by means of a mechanical action, for example, by rotation, at the moment the bag
is intended to be used.
Figure 4 shows a view in perspective of the port of the port-twist-off stopper structure of Figure 3.
This port has an oval-shaped flange , which has an upper surface with a continuous protrusion
that runs the periphery of its upper surface describing the same oval shape as the flange . In the
centre of the flange, there is a channel through which the product to be contained by the flexible bag
will pass.
In another aspect, the present invention discloses a method for sterilising flexible bags containing a
solution of human plasma proteins that uses the electron beam accelerator device mentioned above.
Such method is characterized in that it comprises the following steps:
a) at least one emission of an electron beam with energies of 400-500 keV made by a first electron
accelerator;
b) after approximately 10 nsec to 1.5 sec, emission of a second electron beam by a second
electron accelerator with an energy of at least 4 MeV.
Preferably, the energy of this second electron accelerator is between 4 and 5 MeV, most preferably being
4 MeV.
In one embodiment of the electron beam accelerator device of the present invention, the distance from
the flexible bag to be sterilised to the irradiation source is between 1.5 cm and 7 cm. Preferably, such
distance is 4 cm.
The sterilisation method of the present invention may be carried out before or after the filling of the bag
and it is preferably made in a sterile room.
The flexible bag to be sterilised by the method of the present invention may be made from any of the
materials appropriate for the pharmaceutical industry known in the state of the art. Flexible bags that can
be sterilised with the method of this invention can have a volume of 50 mL to 500 mL.
Additionally, such flexible bag may contain pharmaceutical solutions of biological origin, such as blood or
blood products, such as plasma, serum, red blood cells, albumin, αantitrypsin, von Willebrand factor,
coagulation factors including factor VII, factor VIII and factor IX, immunoglobulins, plasminogen, plasmin,
antithrombin III, fibrinogen, fibrin, thrombin or combinations thereof. It is also considered that the
pharmaceutical product or liquid may not be of biological origin but obtained by any other procedure or
method known in the state of the art, e.g. chemical synthesis, recombinant production or transgenic
production.
In a last aspect, the present invention relates to an in-line filling method for flexible bags of human
40 plasma proteins, comprising a step of sterilisation by means of electron beams with a device as
mentioned above.
Such in-line filling process for flexible bags comprises the following steps:
a) bag formation and thermo-printing;
b) sterilisation of the bags by electron beam, in accordance with the method described above;
c) filling of the bags with the human plasma protein solution in a sterile setting; and
d) sealing of bags.
In the said in-line process, the formation of the bags is carried out from coils where the film that will form
the wall of the bags is rolled into tube shapes and to which the port-twist-off stopper structure is attached
and welded. Subsequently, the bags are identified by means of thermo printing on the surface thereof.
The flexible bags that can be sterilised with the method of this invention may have a volume of 50 mL to
500 mL.
Additionally, said flexible bags may contain pharmaceutical solutions of biological origin, such as blood or
blood products, such as plasma, serum, red blood cells, albumin, α 1 antitrypsin, von Willebrand factor,
coagulation factors including factor VII, factor VIII and factor IX, immunoglobulins, plasminogen, plasmin,
antithrombin III, fibrinogen, fibrin, thrombin or combinations thereof. It is also considered that the
pharmaceutical product or liquid may not be of biological origin but obtained by any other procedure or
method known in the state of the art, e.g. chemical synthesis, recombinant production or transgenic
production.
For a better understanding, this invention is described below in reference to the following example, which
in no case is intended to limit the present invention.
EXAMPLE. Determination of the highest electron beam energy needed to sterilise the twist-off stopper of
the flexible bag.
Bags produced by Laboratorios Grifols S.A. with four different volumes (50, 100, 250 and 500 mL) were
tested. However, the thicknesses of all the bags are the same in all four formats, the characteristics of
which are summarised in Table 1 below. The walls of the bags consist of a multi-layer film in which the
different layers are joined together by a layer of adhesive.
Table 1. Characteristics of the flexible bag walls.
Bag Layer 1 Layer 2 Layer 3 Layer 4
(PET-SiO) (OPA) (PP-SiO) (PP)
Formulation C10H8O4SiO C8H6O2 C3H6SiO C3H6
Density (g/cm ) 1.42 1.13 0.889 0.894
Thickness (µm) 12 15 18 85
The total wall thickness of the bag is 130 µm, not taking into consideration the intermediate layers of
adhesive which can be as thick as ± 12 µm. On the other hand, the thickness of the twist-off stopper was
measured, and a total thickness of 2.85 mm was obtained. The smaller diameter of the oval shape
forming the flange of the port of the port-twist-off stopper structure is approximately 16 mm, as
shown in Figure 5.
Five energies from the highest energy electron beam were chosen for this study: 1.8 MeV (curve A in
Figure 6), 2.2 MeV (curve B), 3 MeV (curve C), 4 MeV (curve D) and 5 MeV (curve E), represented in
Figure 6. The last two were also fitted with a collector, which is a stainless-steel plate represented in
curves D' and E' in Figure 6.
As shown in Figure 6, the electron beams of 1.8 MeV (curve A), 2.2 MeV (curve B) and 3 MeV (curve C)
were not penetrating enough to cross the entire smaller diameter of the flange (16 mm). The graph in
Figure 6 shows how from 11 mm onwards (x-axis), the energy of the electrons begins to fall sharply. This
causes them to lose their sterilising power and, therefore, there will be a zone , as shown in Figure 5,
which will not be correctly sterilised, and which may come into contact with the product contained in the
bag. On the other hand, from 4 MeV onwards (curve D), this zone is sterilised because the energy of the
electrons is kept up to 16 mm.
Claims (17)
1. Device for sterilisation of flexible bags, characterised in that it comprises a sterilisation zone comprising a first accelerator that emits an electron beam with energies between 400-500 keV and a 5 second accelerator that emits an electron beam with an energy of at least 4 MeV.
2. Device for sterilisation of flexible bags, according to claim 1, characterised in that said second accelerator emits an electron beam with energies between 4 and 5 MeV. 10
3. Device for sterilisation of flexible bags, according to claim 2, characterised in that said second accelerator emits an electron beam with an energy of 4 MeV.
4. Device for sterilisation of flexible bags, according to any one of claims 1 or 3, characterised in that the accelerators are arranged in parallel at the top of the device and in such a way that they emit the 15 electron beam downwards, in a direction perpendicular to the ground.
5. Device for sterilisation of flexible bags, according to any one of claims 1 to 4, characterised in that said device is arranged in a radiation-proof area where measures have been taken to contain the radiation emitted by the electron accelerators.
6. Device for sterilisation of flexible bags, according to claim 5, characterised in that said containment measures are the walls and/or the floor which are at least 65-cm thick.
7. Device for sterilisation of flexible bags, according to claim 6, characterised in that said walls and/or 25 floors are made of lead.
8. Method for sterilisation of flexible bags containing human plasma protein solution with electron beam using the device according to claims 1 to 7, characterised in that it comprises the following steps: a) emission of at least one electron beam with energy between 400 and 500 keV; 30 b) after approximately 10 nsec to 1.5 sec, emission of at least a second electron beam pulse with an energy of at least 4 MeV.
9. Method, according to claim 8, characterised in that said second accelerator emits an electron beam with energies between 4 and 5 MeV.
10. Method, according to claim 9, characterised in that said second accelerator emits an electron beam with an energy of 4 MeV.
11. Method, according to any of the claims 8 to 10, characterised in that the distance from the flexible 40 bag to be sterilised to the irradiation source is between 1.5 cm and 7 cm.
12. Method, according to claim 11, characterised in that said distance from the flexible bag to be sterilised to the irradiation source is 4 cm.
13. Method, according to any of the claims 8 to 12, characterised in that the bags to be sterilised may contain a volume of 50 mL to 500 mL.
14. Method, according to any of the claims 8 to 13, characterised in that said method may be performed 5 before or after bag filling.
15. Method, according to any of the claims 8 to 14, characterised in that the accelerators are arranged in parallel at the top of the device and in such a way that they emit the electron beam downwards, in a direction perpendicular to the ground.
16. Method, according to any of the claims 8 to 15, characterised in that the solutions contained in said flexible bags are pharmaceutical solutions of biological origin, such as blood or blood products, such as plasma, serum, red blood cells, albumin, α-1 antitrypsin, von Willebrand factor, coagulation factors including factor VII, factor VIII and factor IX, immunoglobulins, plasminogen, plasmin, antithrombin III, 15 fibrinogen, fibrin, thrombin or combinations thereof.
17. An in-line filling method for flexible bags, characterised in that it comprises the following steps: a) bag formation and thermo-printing; b) sterilisation of the bags by electron beam, with the method according to claims 8 to 14; 20 c) filling of the bags with the human plasma protein solution in a sterile setting; and d) sealing of bags. SUMMARY Improved device for sterilising flexible bags by electron-beam irradiation and method for sterilising them 5 This invention relates to the pharmaceutical sector, specifically to an improved device for electron-beam irradiation sterilisation of flexible bags, in particular the type of flexible bags that may contain human plasma protein solutions for therapeutic use. This device comprises two electron accelerators: a first accelerator emitting an electron beam with energies between 400 and 500 keV and a second accelerator emitting an electron beam with an energy of at least 4 MeV. In addition, the present invention relates to a 10 sterilisation method by electron-beam irradiation of such flexible bags and to an in-line filling process for flexible bags using the sterilisation device and method of this invention.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP19382282.2 | 2019-04-12 |
Publications (1)
Publication Number | Publication Date |
---|---|
NZ763002A true NZ763002A (en) | 2020-03-27 |
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