# US 2014/0150926 A1 · Container for the aseptic transfer of a biopharmaceutical product

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- Number: US 2014/0150926 A1
- Document ID: US20140150926A1
- Status: Published application
- Kind: A1
- Application number: 14/234,815
- Filed: 2012-07-12
- Published: 2014-06-05
- Earliest claimed: 2011-07-29
- Assignees: Sartorius Stedim Fmt SAS
- Inventors: Gaelle Nodin
- Web page: https://patentgrep.com/patent/US20140150926A1

## CPC

- B01L 1/02: Air-pressure chambers; Air-locks therefor
- B65B 7/16: Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
- C12M 23/34: {Internal compartments or partitions}
- C12M 37/04: {Seals}
- G21F 7/005: Shielded passages through walls; Locks; Transferring devices between rooms (between glove-boxes G21F7/047)
- B01L 2200/141: Preventing contamination, tampering
- B01L 2300/0832: cylindrical, tube shaped
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)
- C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS}
- G21F: PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR (radiation protection by pharmaceutical means A61K8/00, A61Q17/04; in cosmonautic vehicles B64G1/54; combined with a reactor G21C11/00; combined with X-ray tubes H01J35/16; combined with X-ray apparatus H05G1/02)

## Abstract

A container for ensuring the transport and the aseptic transfer of a biopharmaceutical product from or to a closed chamber provided with a leaktight joining device, includes: an annular flange delimiting an opening, a removable cover, built-in elements for locking/unlocking the removable cover and a peripheral envelope. The built-in locking/unlocking elements include a built-in functional locking/unlocking arrangement formed by a through-housing formed in the annular flange and a blind housing formed in the removable cover, and by a pin at an inner radial position and a pin at an outer radial position. The container is capable of being in an initial locking position, in an intermediate unlocking position and in a final locking position owing to the displacements of the pin at an inner radial position and the pin at an outer radial position in the blind hole of the removable cover and in the through-housing of the annular flange.

## Claims

### Claim 1

A container (20) specially intended for the transport and the aseptic transfer of a biopharmaceutical product to or from a closed chamber (10) equipped with a leaktight joining device (40), comprising:
an annular flange (30) delimiting an opening (26);
a removable cover (28) adapted for sealing the opening (26) of the annular flange (30);
built-in means for locking/unlocking (110) the removable cover (28) on the annular flange (30); and
a peripheral envelope (22) integral with the annular flange (30) and delimiting an enclosed inside space (24) adapted for receiving products belonging to the biopharmaceutical field;
wherein the built-in locking/unlocking means (110) comprise at least one built-in functional locking/unlocking arrangement (112) formed, on the one hand, by a through-housing (114) formed in the annular flange (30) and a blind housing (116) formed in the removable cover (28) and in the extension of the through-housing (114) when the removable cover (28) seals the opening of the annular flange (30), and, on the other hand, by a pin at an inner radial position (118) and a pin at an outer radial position (120) which can be introduced and moved within the blind housing (116) of the removable cover (28) and the through-housing (114) of the annular flange (30);
the container (20) being able to be in an initial locking position where, on the one hand, the pin at an inner radial position (118) has an internal functional portion for initial locking (118INT) arranged in the blind housing (116) of the removable cover (28) and an external functional portion for initial locking (118EXT) arranged in the through-housing (114) of the annular flange (30) so as to prevent the relative movement of the removable cover (28) with respect to the annular flange (30), and, on the other hand, the pin at an outer radial position (120) is at least partially arranged in the through-housing (114) of the annular flange (30);
the container (20) being able to be in an intermediate unlocking position in which, on the one hand, the pin at an inner radial position (118) is at least partially arranged in the blind housing (116) of the removable cover (28) and is completely outside the through-housing (114) of the annular flange (30) and, on the other hand, the pin at an outer radial position (120) is at least partially arranged in the through-housing (114) of the annular flange (30) and is completely outside the blind housing (116) of the removable cover (28) so as to allow the relative movement of the removable cover (28) with respect to the annular flange (30);
characterized in that the container (20) is able to be in a final locking position where, on the one hand, the pin at an inner radial position (118) is arranged in the blind housing (116) of the removable cover (28), and, on the other hand, the pin at an outer radial position (120) has an internal functional portion for final locking (120INT) arranged in the blind housing (116) of the removable cover (28) and an external functional portion for final locking (120EXT) arranged in the through-housing (114) of the annular flange (30) so as to prevent the relative movement of the removable cover (28) with respect to the annular flange (30).

### Claim 2 (depends on 1)

Container (20) according to claim 1, wherein the through-housing (114) and the pin at an outer radial position (120) have lengths such that, when the built-in locking/unlocking means (110) are in the initial locking position, said pin at an outer radial position (120) has a functional end portion at the outer radial position (122) which is either completely outside the through-housing (114), or is housed inside the through-housing (114), or is flush with the outer end opening of the through-housing (114).

### Claim 3 (depends on 1)

Container (20) according to claim 1, wherein the through-housing (114) and the pin at an outer radial position (120) have lengths such that, when the built-in locking/unlocking means (110) are in the intermediate unlocking position, said pin at an outer radial position (120) has a functional end portion at the outer radial position (122) which is either completely outside the through-housing (114), or is housed inside the through-housing (114), or is flush with the outer end opening of the through-housing (114).

### Claim 4 (depends on 1)

Container (20) according to claim 1, wherein the through-housing (114) and the pin at an outer radial position (120) have lengths such that, when the built-in locking/unlocking means (110) are in the final locking position, said pin at an outer radial position (120) has a functional end portion at the outer radial position (122) which is either completely outside the through-housing (114), or is housed inside the through-housing (114), or is flush with the outer end opening of the through-housing (114).

### Claim 5 (depends on 1)

Container (20) according to claim 1, wherein the pin at an inner radial position (118) and pin at an outer radial position (120) have substantially identical lengths.

### Claim 6 (depends on 1)

Container (20) according to claim 1, wherein the through-housing (114), the blind housing (116), the pin at an inner radial position (118), and the pin at an outer radial position (120) are coaxial and oriented in a radial direction relative to the annular flange (30).

### Claim 7 (depends on 1)

Container (20) according to claim 1, wherein the through-housing (114), the blind housing (116), the pin at an inner radial position, and the pin at an outer radial position (120) are coaxial and oriented in a direction forming an angle α with respect to a radial direction relative to the annular flange (30).

### Claim 8 (depends on 1)

Container (20) according to claim 1, comprising built-in isolation and protection means (124) arranged on an outer peripheral edge of the annular flange (30) so as to obstruct an inadvertent manipulation of the built-in locking/unlocking means (110).

### Claim 9 (depends on 8)

Container (20) according to claim 8, wherein the built-in isolation and protection means (124) comprise at least one built-in functional arrangement for isolation and protection (126), provided around the through-housing (114) so as to obstruct an advertent manipulation of the pin at an outer radial position (120).

### Claim 10 (depends on 9)

Container (20) according to claim 9, wherein the built-in functional arrangement for isolation and protection (126) has radial dimensions such that, in a temporary locking position, the pin at an outer radial position (120) does not extend beyond said isolation and protection means (124).

### Claim 11 (depends on 9)

Container (20) according to claim 9, wherein the built-in arrangement for functional isolation and protection (126) comprises at least one lug (128), preferably two lugs (128), arranged around the through-housing (114) of the annular flange (30).

### Claim 12 (depends on 9)

Container (20) according to claim 9, wherein the isolation and protection arrangement (126) comprises a bore formed in the annular flange (30) and having a diameter greater than the diameter of the through-housing (114).

### Claim 13 (depends on 1)

Container (20) according to claim 1, comprising built-in temporary clamping means (100) arranged on an outer peripheral edge of the annular flange (30) so as to allow temporarily clamping the container (20) by preventing axial movement on the closed chamber (10) via actuation of the leaktight joining device (40).

### Claim 14 (depends on 13)

Container (20) according to claim 13, wherein the built-in temporary clamping means (100) comprise at least one built-in functional arrangement for temporary clamping (102) formed by at least one lug (104), preferably two lugs (104) having a built-in functional surface for axial clamping (106) adapted to abut against a stationary functional surface for axial clamping (56), of the leaktight joining device (40), so as to prevent axial movement of the container (20) relative to the chamber (10).

### Claim 15 (depends on 14)

Container (20) according to claim 14 comprising built-in isolation and protection means (124) arranged on an outer peripheral edge of the annular flange (30) so as to obstruct an inadvertent manipulation of the built-in locking/unlocking means (110), wherein the built-in temporary clamping means (100) are at least partly formed by the isolation and protection means (124).

### Claim 16 (depends on 15)

Container (20) according to claim 15, wherein the built-in functional arrangement for temporary clamping (102) and the built-in functional arrangement for isolation and protection (126) are formed by at least one common lug (104, 128), and preferably two common lugs (104, 128).

### Claim 17 (depends on 1)

Container (20) according to claim 1, wherein the built-in locking/unlocking means (110) comprise n built-in functional arrangements for locking/unlocking (112), regularly distributed around the annular flange (30) and the removable cover (28), with n greater than or equal to 1.

### Claim 18 (depends on 17)

Container (20) according to claim 17, wherein the built-in isolation and protection means (124) comprise n built-in functional arrangements for isolation and protection (126), regularly distributed around the annular flange (30) and indexed relative to the n built-in functional arrangements for locking/unlocking (112).

### Claim 19 (depends on 14)

Container (20) according to claim 14, wherein the built-in temporary clamping means (100) comprise m built-in functional arrangements for temporary clamping (102), regularly distributed around the annular flange (30), with m greater than or equal to 1.

### Claim 20 (depends on 19)

Container (20) according to claim 19, wherein the built-in functional arrangement for temporary clamping (102) and the built-in functional arrangement for isolation and protection (126) are formed by at least one common lug (104, 128), and n is equal to m and the built-in functional arrangements for temporary clamping (102) are indexed relative to the built-in functional arrangements for locking/unlocking (112).

### Claim 21 (depends on 1)

Container (20) according to claim 1, wherein the container (20) is disposable.

### Claim 22 (depends on 1)

Assembly comprising a chamber (10), a leaktight joining device (40), and a container (20) according to claim 1, for performing the aseptic transfer of a biopharmaceutical product between the chamber (10) and the container (20).

### Claim 23 (depends on 22)

Assembly according to claim 22, wherein the chamber (10) comprises a peripheral wall in which is arranged an opening sealed by a removable door, and wherein the leaktight joining device (40) comprises:
stationary temporary clamping means (50) able to keep the container (20) clamped against the chamber (10) so that the removable cover (28) of said container (20) is sealingly held against the removable door (18) of said chamber (10);
stationary unlocking means (60) able to cause the container (20) to transition from an initial locking position where the removable cover (28) seals the container (20) to an intermediate unlocking position where the removable cover (28) is disengaged from the container (20) and is sealingly held against the door of the chamber (10) so as to ensure an aseptic communication between said container (20) and said chamber (10);
stationary locking means (70) able to cause the container (20) to transition from the intermediate unlocking position to a final locking position where said removable cover (28) once again seals the container (20);
a annular functional ring gear (42) able to rotate about a geometric axis of rotation (R) so as to actuate the stationary unlocking means (60) and the stationary locking means (70) of the container (20);
the stationary temporary clamping means (50), the stationary unlocking means (60), and the stationary locking means (70) being mechanically linked to the annular functional ring gear (42) so that the one-way rotation of said annular functional ring gear (42) about the geometric axis of rotation (R) successively causes the actuation of the stationary temporary clamping means (50) to hold the container (20) in position against the chamber (10), then the actuation of the stationary unlocking means (60) which causes the container (20) to transition to the intermediate unlocking position, then the actuation of the stationary locking means (70) of the container (20) which causes the container (20) to transition to the final locking position, and the actuation of the stationary temporary clamping means (50) of the container (20) which results in the release of the container (20).

### Claim 24 (depends on 22)

Method for aseptic transfer, intended for the aseptic transfer of a biopharmaceutical product between a container (20) and a chamber (10) which are part of an assembly according to claim 22, characterized in that it comprises successive steps consisting of:
having available the chamber (10), the leaktight joining device (40), and the container (20);
positioning the container (20) against the peripheral wall (12) of the chamber (10);
generating an axial clamping of the annular flange (30) of the container (20) against the peripheral wall (12) of the chamber (10) by one-way rotation of the annular functional ring gear (42);
generating the transition of the container (20) from the initial locking position to the intermediate unlocking position by one-way rotation of the annular functional ring gear (42), causing the displacement of the pins at the inner (118) and outer (120) radial positions within the through-housing (114) and blind housing (116);
simultaneously opening the removable door (18) of the chamber (10) and the removable cover (28) of the container (20), the removable cover (28) being sealingly attached against the removable door (18);
aseptically transferring one or more biopharmaceutical product(s) between the container (20) and the chamber (10);
simultaneously closing the removable door (18) of the chamber (10) and the removable cover (28) of the container (20), the removable cover (28) being sealingly attached against the removable door (18);
generating the transition of the container (20) from the intermediate unlocking position to the final locking position by one-way rotation of the annular functional ring gear (42) which causes movement of the pins at the inner (118) and outer (120) radial positions within the through-housing (114) and blind housing (116);
generating the axial unclamping of the annular flange (30) of the container (20) relative to the peripheral wall (12) of the chamber (10) by one-way rotation of the annular functional ring gear (42).