Detection of the integrity of a tight, closed, soft plastic pouch for receiving and protecting a product or a biopharmaceutical device
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
G01N-031/22
G01N-021/78
B65D-075/38
B65D-079/02
B65D-081/20
A61L-002/26
A61J-001/14
출원번호
US-0876612
(2011-08-22)
등록번호
US-9005978
(2015-04-14)
우선권정보
FR-10 57930 (2010-09-30)
국제출원번호
PCT/FR2011/051942
(2011-08-22)
§371/§102 date
20130328
(20130328)
국제공개번호
WO2012/042139
(2012-04-05)
발명자
/ 주소
Bottcher, Lars
Dahlberg, Martin
출원인 / 주소
Sartorius Stedim FMT SAS
대리인 / 주소
Young & Thompson
인용정보
피인용 횟수 :
1인용 특허 :
25
초록▼
A pouch (2) includes: a first, inner, envelope (1) which is closed, delimiting a first space (6) forming a pouch stricto sensu (1) intended for receiving a biopharmaceutical product or device; a second, outer, envelope (8) which is closed, delimiting a second space (9) in which is located the first
A pouch (2) includes: a first, inner, envelope (1) which is closed, delimiting a first space (6) forming a pouch stricto sensu (1) intended for receiving a biopharmaceutical product or device; a second, outer, envelope (8) which is closed, delimiting a second space (9) in which is located the first envelope/pouch stricto sensu (1); a spacer element (11); at least one tracer gas located in the first space (6) or in the intermediate space (14) at a partial pressure different from that of the intermediate space or of the first space; and at least one colorimetric detection layer (12), responding to the concentration of tracer gas which reaches it by changing from a first color to a second color, and being an integral part of a wall (3, 4) of the first envelope/defined pouch (1) and/or of a wall (13) of the second envelope and/or of the spacer element.
대표청구항▼
1. Integrity/non-integrity indicator pouch (2) intended for receiving and protecting a biopharmaceutical product or device, comprising: a first, inner, envelope (1) which is flexible, closed, fluid-tight, and of plastic material, comprising a wall (3, 4) delimiting a first space (6), forming a pouch
1. Integrity/non-integrity indicator pouch (2) intended for receiving and protecting a biopharmaceutical product or device, comprising: a first, inner, envelope (1) which is flexible, closed, fluid-tight, and of plastic material, comprising a wall (3, 4) delimiting a first space (6), forming a pouch stricto sensu (1) intended to receive the biopharmaceutical product or device, comprising first introduction means (7) and first extraction means for respectively introducing/extracting the product or device, said means being in the closed state,a second, outer, envelope (8) which is closed, fluid-tight, and of plastic material, comprising a wall (13) delimiting a second space (9) in which is located the first envelope/pouch stricto sensu (1), comprising second introduction means and second extraction means for respectively introducing/extracting the second envelope/pouch stricto sensu (1), said means being in the closed state, an intermediate space (14) thus being arranged in the second space (9) outside the first envelope/pouch stricto sensu (1),spacing means (11) placed between the wall (3, 4) and the wall (13) such that the inner face (8a) of the wall (13) does not occlude any integrity-impacting opening in the outer face (1a) of the wall (3, 4),at least one tracer gas, located either in the first space (6) or in the intermediate space (14), at a partial pressure that is different from that of the intermediate space (14) or of the first space (6), respectively, introduced into the first space (6) and/or the intermediate space (14) by tracer gas introduction means (15), now in the closed state,at least one continuous colorimetric detection layer (12) for detecting the tracer gas, responding to the concentration of tracer gas which reaches it by changing from a first color to a second and different color, being an integral part of a wall (3, 4) of the first envelope/pouch stricto sensu (1) and/or of a wall (13) of the second envelope (8) and/or of the spacer means (11),the arrangement of the walls (3, 4, 13) of the first envelope/pouch stricto sensu (1) and of the second envelope (8), the spacer means (11), the tracer gas, and the colorimetric detection layer (12), on the one hand, and the permeability or impermeability to the tracer gas of the colorimetric detection layer (12), and of the spacer means (11), on the other hand, being chosen so that the colorimetric detection layer (12) cannot be reached by tracer gas located in the intermediate space (14) or in the first space (6) at a concentration beyond the transition value, when the first envelope/pouch stricto sensu (1) is of satisfactory integrity, and so that the colorimetric detection layer (12) is an any case reached by tracer gas located in the intermediate space (14) or in the first space (6) at a concentration beyond the transition value, when the first envelope/pouch stricto sensu (1) is of unsatisfactory integrity,such that if the colorimetric detection layer (12) is identified as being of the first color, the first envelope/pouch stricto sensu (1) is considered to be of satisfactory integrity and suitable for receiving and protecting the biopharmaceutical product or device, whereas if it is identified as being of the second color, it is considered to be of unsatisfactory integrity and unsuitable for receiving and protecting the biopharmaceutical product or device. 2. Integrity/non-integrity indicator pouch (2) according to claim 1, wherein the spacer means (11) comprise at least one porous layer fully and functionally covering the outer face (1a) of the wall (3, 4) of the first envelope/pouch stricto sensu (1) and/or the inner face (8a) of the wall (13) of the second envelope (8) and/or the face of the colorimetric detection layer (12) facing the intermediate space (14). 3. Integrity/non-integrity indicator pouch (2) according to claim 2, wherein the spacer means (11) comprise at least one porous layer which either structurally covers the outer face (1a) of the wall (3, 4) of the first envelope/pouch stricto sensu (1) and/or the inner face (8a) of the wall (13) of the second envelope (8) and/or the face of the colorimetric detection layer (12) facing the intermediate space (14), or is placed within the intermediate space (14). 4. Integrity/non-integrity indicator pouch (2) according to claim 2, wherein either the tracer gas is in the first space (6) at a higher partial pressure than in the intermediate space (14), the colorimetric detection layer (12) changing from the first color to the second color in response to the concentration of tracer gas which reaches it rising above a transition value, or the tracer gas is in the first space (6) at a lower partial pressure than in the intermediate space (14), the colorimetric detection layer (12) changing from the first color to the second color in response to the concentration of tracer gas which reaches it falling below a transition value. 5. Integrity/non-integrity indicator pouch (2) according to claim 2, comprising one of the following characteristics: a colorimetric detection layer (12) is permeable to the tracer gas and is an integral part of the wall (3, 4) of the first envelope/pouch stricto sensu (1), being located on the outer face (1a) and in the intermediate space (14), or located on the inner face (1b) and in the first space (6), or inserted within the wall (3, 4), between its outer face (1a) and its inner face (1b) and between the first space (6) and the intermediate space (14);a colorimetric detection layer (12) is an integral part of the wall (13) of the second envelope (8), being either located on the inner face (8a) and in the intermediate space (14), or inserted within the wall (13), between the inner face (8a) and its outer face (8b), the layer (16) of the wall (13) of the second envelope (13) adjacent on one side to the colorimetric detection layer (12) and on the other side to the inner face (8a) then being permeable to the tracer gas;a colorimetric detection layer (12) is an integral part of a porous layer of the spacer means (11) which is either located near the outer face (1a) of the wall (3, 4) of the first envelope/pouch stricto sensu (1), or is located near the inner face (8a) of the second envelope (8);a colorimetric detection layer (12) and a porous layer of the spacer means (11) are structurally combined to form a single layer. 6. Integrity/non-integrity indicator pouch (2) according to claim 1, wherein either the tracer gas is in the first space (6) at a higher partial pressure than in the intermediate space (14), the colorimetric detection layer (12) changing from the first color to the second color in response to the concentration of tracer gas which reaches it rising above a transition value, or the tracer gas is in the first space (6) at a lower partial pressure than in the intermediate space (14), the colorimetric detection layer (12) changing from the first color to the second color in response to the concentration of tracer gas which reaches it falling below a transition value. 7. Integrity/non-integrity indicator pouch (2) according to claim 1, comprising one of the following characteristics: a colorimetric detection layer (12) is permeable to the tracer gas and is an integral part of the wall (3, 4) of the first envelope/pouch stricto sensu (1), being located on the outer face (1a) and in the intermediate space (14), or located on the inner face (1b) and in the first space (6), or inserted within the wall (3, 4), between its outer face (1a) and its inner face (1b) and between the first space (6) and the intermediate space (14);a colorimetric detection layer (12) is an integral part of the wall (13) of the second envelope (8), being either located on the inner face (8a) and in the intermediate space (14), or inserted within the wall (13), between the inner face (8a) and its outer face (8b), the layer (16) of the wall (13) of the second envelope (13) adjacent on one side to the colorimetric detection layer (12) and on the other side to the inner face (8a) then being permeable to the tracer gas;a colorimetric detection layer (12) is an integral part of a porous layer of the spacer means (11) which is either located near the outer face (1a) of the wall (3, 4) of the first envelope/pouch stricto sensu (1), or is located near the inner face (8a) of the second envelope (8);a colorimetric detection layer (12) and a porous layer of the spacer means (11) are structurally combined to form a single layer. 8. Integrity/non-integrity indicator pouch (2) according to claim 1, wherein the first envelope/pouch stricto sensu (1) is a 2D pouch. 9. Integrity/non-integrity indicator pouch (2) according to claim 1, wherein the first envelope/pouch stricto sensu (1) is a 3D pouch comprising two gussets (4). 10. Integrity/non-integrity indicator pouch (2) according to claim 9, wherein the spacer means (11) comprise at least one porous layer completely and functionally, and where necessary structurally, covering the outer face of the inside of the gussets (4). 11. Integrity/non-integrity indicator pouch (2) according to claim 1, comprising one or more of the following characteristics: the spacer means (11) comprise at least one porous layer which fully and functionally, and where necessary structurally, covers the first introduction means and the first extraction means for respectively introducing/extracting the biopharmaceutical product or device and the tracer gas introduction means of the first envelope/pouch stricto sensu (1);the spacer means (11) comprise at least one porous layer of fabric, nonwoven fabric, PE, PP, PTFE;a tracer gas is chosen from among the group comprising oxygen, carbon dioxide, and helium;one among the first space (6) or the intermediate space (14) contains tracer gas and the other among the intermediate space (14) or the first space (6) does not contain or substantially does not contain tracer gas;the second envelope (8) is such that it allows identifying from outside of itself whether the colorimetric detection layer (12) is of the first color or the second color;the second envelope (8) is flexible;it additionally comprises an outer protective packaging (17) which houses the second envelope (8) within which the first envelope/pouch stricto sensu (1) is located. 12. Integrity/non-integrity indicator pouch (2) of satisfactory integrity consisting of an integrity/non-integrity indicator pouch (2) according to claim 1 where the colorimetric detection layer (12) is of the first color. 13. Method for creating an integrity/non-integrity indicator pouch (2) according to claim 1, wherein: one provides a first envelope/pouch stricto sensu (1), a second envelope (8) in which the second introduction means for introducing the first envelope/pouch stricto sensu (1) are in the open state, spacer means (11), the tracer gas, the colorimetric detection layer (12) which is an integral part of a wall (3, 4) of the first envelope/pouch stricto sensu (1) and/or of a wall (13) of the second envelope (8) and/or of the spacer means (11),the first envelope/pouch stricto sensu (1) is introduced into the second space (9) of the second envelope (8) via the second introduction means in the open state, the spacer means (11) being placed between the wall (3, 4) and the wall (13) such that the inner face (8a) of the wall (13) does not occlude any integrity-impacting opening on the outer face (1a) of the wall (3, 4),the tracer gas is introduced into either the first space (6) or the intermediate space (14), at a partial pressure that is different from that of the intermediate space (14) or of the first space (6), respectively, via the tracer gas introduction means which are in the open state, then these introduction means are brought to the closed state,the arrangement is chosen so that the colorimetric detection layer (12) cannot be reached or conversely is necessarily reached by the tracer gas, as required, and the permeability or impermeability to the tracer gas of the colorimetric detection layer (12) and of the spacer means (11) is accordingly chosen so that the colorimetric detection layer (12) is in fact reached by the tracer gas when such is necessary,the first envelope/pouch stricto sensu (1) and the second envelope (8) being closed. 14. Process for making use of a pouch stricto sensu (1), which when of satisfactory integrity is intended for receiving and protecting a biopharmaceutical product or device, said process comprising: at a point of manufacture, initial operations consisting of manufacturing a pouch stricto sensu (1),at a point of use, final operations consisting of using the pouch stricto sensu (1) by placing the biopharmaceutical product or device within,intermediate storage, shipping, handling operations, at one or more locations, characterized by:the creation by the method according to claim 13, at the point of manufacture, of an integrity/non-integrity indicator pouch (2) comprising a first envelope/pouch stricto sensu (1),the shipping of the integrity/non-integrity indicator pouch (2) from the point of manufacture to the point of use, including storage and handling operations when there are such,and, at least at the point of use and before extracting the first envelope/pouch stricto sensu (1) from the second envelope (8) in order to place the biopharmaceutical product or device within, the identification of whether the colorimetric detection layer (12) is of the first color or the second color,if the colorimetric detection layer (12) is identified as being of the first color, the first envelope/pouch stricto sensu (1) is considered to be of satisfactory integrity and is used for placing the biopharmaceutical product or device within in order to receive and protect it,whereas if the colorimetric detection layer (12) is identified as being of the second color, the first envelope/pouch stricto sensu (1) is considered to be of unsatisfactory integrity and is not used for placing the biopharmaceutical product or device within. 15. Process according to claim 14, wherein the identification of whether the colorimetric detection layer (12) is of the first color or of the second color is done concurrently with intermediate storage, shipping, or handling operations. 16. Process according to claim 14, wherein the identification of whether the colorimetric detection layer (12) is of the first color or of the second color is done at the point of use immediately prior to extracting the first envelope/pouch stricto sensu (1) from the second envelope (8) in order to place the biopharmaceutical product or device within. 17. Method for obtaining a pouch stricto sensu (1) of satisfactory integrity and ready to receive and protect a biopharmaceutical product or device, wherein: one provides an integrity/non-integrity indicator pouch (2) according to claim 1,the colorimetric detection layer (12) is identified as being of the first color or the second color,if the colorimetric detection layer (12) is identified as being of the first color:the second extraction means, with which the second envelope (8) is equipped in order to extract the first envelope/pouch stricto sensu (1), are brought to the open state,the first envelope/pouch stricto sensu (1) is extracted from the second space (9) of the second envelope (8),and the first introduction means (7), with which the first envelope/pouch stricto sensu (1), considered to be of satisfactory integrity, is equipped in order to introduce the biopharmaceutical product or device, are brought to the open state in order to place the biopharmaceutical product or device within,whereas if the colorimetric detection layer (12) is identified as being of the second color, the first envelope/pouch stricto sensu (1) is considered to be of unsatisfactory integrity and is not used for placing a biopharmaceutical product or device within.
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