Abstract: A pouch includes: a first closed, inner casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a first space, forming a pouch stricto sensu for accommodating a biopharmaceutical product or device, a second closed, outer casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a second space in which the pouch stricto sensu is located, spacer elements, at least one selected tracer gas, located in the first or second space outside of the pouch stricto sensu, with a higher partial pressure than in the second space outside of the pouch stricto sensu or in the first space, at least one colorimetric detector located, respectively, in the second space outside of the pouch stricto sensu or in the first space responsive to the concentration of the tracer gas, by switching from a first color to a second different color.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A pouch includes: a first closed, inner casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a first space, forming a pouch stricto sensu for accommodating a biopharmaceutical product or device, a second closed, outer casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a second space in which the pouch stricto sensu is located, spacer elements, at least one selected tracer gas, located in the first or second space outside of the pouch stricto sensu, with a higher partial pressure than in the second space outside of the pouch stricto sensu or in the first space, at least one colorimetric detector located, respectively, in the second space outside of the pouch stricto sensu or in the first space responsive to the concentration of the tracer gas, by switching from a first color to a second different color.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A pouch includes: a first closed, inner casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a first space, forming a pouch stricto sensu for accommodating a biopharmaceutical product or device, a second closed, outer casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a second space in which the pouch stricto sensu is located, spacer elements, at least one selected tracer gas, located in the first or second space outside of the pouch stricto sensu, with a higher partial pressure than in the second space outside of the pouch stricto sensu or in the first space, at least one colorimetric detector located, respectively, in the second space outside of the pouch stricto sensu or in the first space responsive to the concentration of the tracer gas, by switching from a first color to a second different color.

Abstract: A system for use in freezing, storing and thawing biopharmaceutical materials includes a flexible sterile container means for holding biopharmaceutical material therein and a holder more rigid than said container means. The container means is received in a cavity of the holder and the holder extends along a perimeter of the container means. The holder is fixedly connected to the container means. The holder includes opposing sides defining an opening and the container means extends between the opposing sides of the holder defining the opening. The container means includes a substantially smooth exterior surface extending between the opposing sides.

Abstract: There is a bag (1) that has at least one lateral gusset (4) and at least one port (8), a source (10) of pressurized gas, elements (11) for measuring the pressure of the gas; —there are two restraining plates and spacer strips. The bag is placed flat between the two restraining plates (2a, 2b). At least one spacer strip (15a, 15b) is inserted between the two small walls of each gusset in order to prevent these walls from resting on one another. The port is connected to the gas source and the pressure measuring elements. The gas is sent under pressure into the bag, the expansion of the bag being limited by the restraining plates; then, the pressure drop in the bag is compared to a predefined threshold.

Abstract: A pouch includes: a first closed, inner casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a first space, forming a pouch stricto sensu for accommodating a biopharmaceutical product or device, a second closed, outer casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a second space in which the pouch stricto sensu is located, spacer elements, at least one selected tracer gas, located in the first or second space outside of the pouch stricto sensu, with a higher partial pressure than in the second space outside of the pouch stricto sensu or in the first space, at least one colorimetric detector located, respectively, in the second space outside of the pouch stricto sensu or in the first space responsive to the concentration of the tracer gas, by switching from a first color to a second different color.

Abstract: A system for use in storing biopharmaceutical materials includes a holder and a container for holding biopharmaceutical materials therein. The container includes a storage portion and a sampling portion connected to each other by a connecting portion. The holder has a storage cavity receiving the storage portion and a sampling cavity receiving the sampling portion. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior storage cradle bounding the storage cavity of the holder. The holder includes an interior sampling cradle bounding the sampling cavity. The sampling cradle is separated from the storage cradle and connected to the storage cradle by a passage receiving the connecting portion connecting the storage portion to the sampling portion. An outer rim of the holder is connected to the cradle and separated from the cavity.

Abstract: A system for use in freezing, storing and thawing biopharmaceutical materials includes a flexible sterile container means for holding biopharmaceutical material therein and a holder more rigid than said container means. The container means is received in a cavity of the holder and the holder extends along a perimeter of the container means. The holder is fixedly connected to the container means. The holder includes opposing sides defining an opening and the container means extends between the opposing sides of the holder defining the opening. The container means includes a substantially smooth exterior surface extending between the opposing sides.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A system for use in freezing, storing and thawing biopharmaceutical materials includes a flexible sterile container means for holding biopharmaceutical material therein and a holder more rigid than said container means. The container means is received in a cavity of the holder and the holder extends along a perimeter of the container means. The holder is fixedly connected to the container means. The holder includes opposing sides defining an opening and the container means extends between the opposing sides of the holder defining the opening. The container means includes a substantially smooth exterior surface extending between the opposing sides.

Abstract: There is a bag (1) that has at least one lateral gusset (4) and at least one port (8), a source (10) of pressurized gas, elements (11) for measuring the pressure of the gas; —there are two restraining plates and spacer strips. The bag is placed flat between the two restraining plates (2a, 2b). At least one spacer strip (15a, 15b) is inserted between the two small walls of each gusset in order to prevent these walls from resting on one another. The port is connected to the gas source and the pressure measuring elements. The gas is sent under pressure into the bag, the expansion of the bag being limited by the restraining plates; then, the pressure drop in the bag is compared to a predefined threshold.

Abstract: A system for use in storing biopharmaceutical materials includes a holder and a container for holding biopharmaceutical materials therein. The container includes a storage portion and a sampling portion connected to each other by a connecting portion. The holder has a storage cavity receiving the storage portion and a sampling cavity receiving the sampling portion. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior storage cradle bounding the storage cavity of the holder. The holder includes an interior sampling cradle bounding the sampling cavity. The sampling cradle is separated from the storage cradle and connected to the storage cradle by a passage receiving the connecting portion connecting the storage portion to the sampling portion. An outer rim of the holder is connected to the cradle and separated from the cavity.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A system for freezing, thawing, transporting, and storing a biopharmaceutical material, which includes a container, a supporting structure, a temperature control unit, and a transportation cart. The container is adapted to receive the biopharmaceutical material therein for freezing, thawing, storing, and transporting, with the container also being receivable in the supporting structure. The temperature control unit has a cavity for receiving the supporting structure, when the supporting structure supports the container, and the transportation cart has a channel for receiving the supporting structure, when the supporting structure supports the container.