# US 2014/0150924 A1 · Leaktight joining device for the aseptic transfer of a biopharmaceutical product between a chamber and a container

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- Number: US 2014/0150924 A1
- Document ID: US20140150924A1
- Status: Published application
- Kind: A1
- Application number: 14/234,788
- Filed: 2012-07-12
- Published: 2014-06-05
- Earliest claimed: 2011-07-29
- Assignees: Sartorius Stedim Fmt SAS
- Inventors: Gaelle Nodin; Jeremy Gibelin
- Web page: https://patentgrep.com/patent/US20140150924A1

## CPC

- B01L 1/02: Air-pressure chambers; Air-locks therefor
- C12M 37/04: {Seals}
- G21F 7/005: Shielded passages through walls; Locks; Transferring devices between rooms (between glove-boxes G21F7/047)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- 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 leaktight joining device for ensuring the aseptic transfer of a biopharmaceutical product between a chamber equipped with a removable door and a container equipped with a removable cover, includes: stationary temporary flanging elements, stationary unlocking elements capable of changing the container from an initial locking position to an intermediate unlocking position so as to ensure an aseptic communication between the container and the chamber, stationary locking element capable of changing the container from the intermediate locking position to a final locking position, an annular functional ring gear capable of actuating the stationary unlocking elements and the stationary locking elements of the container. The stationary temporary flanging elements, the stationary unlocking elements, and the stationary locking elements are mechanically linked to the annular functional ring gear and arranged so that the unidirectional rotation of the annular functional ring gear about the geometric axis of rotation successively drives the actuation thereof.

## Claims

### Claim 1

Leaktight joining device (40) intended for ensuring the aseptic transfer of a biopharmaceutical product between a chamber (10) equipped with a removable door (18) and a container (20) equipped a removable cover (28), comprising:
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 transition the container (20) 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 removable 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 transition the container (20) from the intermediate unlocking position to a final locking position where said removable cover (28) once again seals the container (20);
an 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);
characterized in that the stationary temporary clamping means (50), stationary unlocking means (60), and stationary locking means (70) are mechanically linked to the annular functional ring gear (42) and are arranged 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) which ensures that the container (20) is held in position against the chamber (10), then the actuation of the stationary unlocking means (60) which ensures the transition to the intermediate unlocking position of the container (20), then the actuation of the stationary locking means (70) of the container (20) which ensures the transition to the final locking position of the container (20), and the actuation of the stationary temporary clamping means (50) of the container (20) in order to release the container (20).

### Claim 2 (depends on 1)

Leaktight joining device (40) according to claim 1, further comprising stationary retention/release means (80) able to disable/enable the opening of the removable door (18) of the chamber (10) and mechanically linked to the annular functional ring gear (42) such that the one-way rotation of the annular functional ring gear (42) about the geometric axis of rotation (R) successively causes the actuation of the stationary temporary clamping means (50) which ensures that the container (20) is held in position against the chamber (10), then simultaneously or successively the actuation of the stationary unlocking means (60) which ensures the transition to the intermediate unlocking position of the container (20) and the actuation of the stationary retention/release means (80) which ensures the release of the removable door (18) of the chamber (10), then the actuation of the stationary locking means (70) of the container (20) which ensures the transition to the final locking position of the container (20), then simultaneously or successively the actuation of the stationary retention/release means (80) which ensures the retention of the removable door (18) of the chamber (10) and the actuation of the stationary locking means (70) which ensures the transition to the final locking position of the container (20), then the actuation of the stationary temporary clamping means (50) in order to release the container (20) relative to the chamber (10).

### Claim 3 (depends on 2)

Leaktight joining device (40) according to claim 2, wherein the stationary retention/release means (80) comprise at least one stationary functional arrangement for retention/release (82) formed by a functional ring portion forming gear teeth (84) and a retention member (88) able to engage with the functional ring portion forming gear teeth (84) such that, during the one-way rotation of the annular functional ring gear (42), the retention member moves from a retention position where a covering portion prevents the removable door (18) of the chamber (10) from opening, to a release position where the covering portion no longer prevents the removable door (18) of the chamber (10) from opening.

### Claim 4 (depends on 1)

Leaktight joining device (40) according to claim 1, wherein the stationary unlocking means (60) comprise at least one stationary functional unlocking arrangement (62) formed by a functional ring portion forming an inward- and/or outward-facing radial cam (64) and a radially movable pushing element (68) cooperating with the functional ring portion forming a radial cam (64) so that, during the one-way rotation of the annular functional ring gear (42) to an intermediate unlocking position, the pushing element (68) is moved and causes the container (20) to transition from the initial locking position to the intermediate unlocking position.

### Claim 5 (depends on 1)

Leaktight joining device (40) according to claim 1, wherein the stationary locking means (70) comprise at least one stationary functional locking arrangement (72) formed by a functional ring portion forming an inward- and/or outward-facing radial cam (74), and a radially movable pushing element (78) cooperating with the functional ring portion forming a radial cam (74) such that, during the one-way rotation of the annular functional ring gear (42) to a final locking position, the pushing element (78) is moved and causes the removable cover (28) of the container (20) to transition from the intermediate unlocking position to the final locking position.

### Claim 6 (depends on 4)

Leaktight joining device (40) according to claim 4, wherein the functional ring portion forming a radial cam (64, 74) of the stationary locking means (70) and/or unlocking means (60) is formed by a guideway (66, 76) arranged in the annular functional ring gear (42), and the radially movable pushing element (68, 78) of said stationary locking means (70) and/or unlocking means (60) comprises a roller (68a) arranged in the guideway (66, 76) so that rotation of the annular functional ring gear (42) generates a radial movement of the roller (68a) which causes the corresponding movement of an activation pin (68b).

### Claim 7 (depends on 5)

Leaktight joining device (40) according to claim 5, wherein the stationary functional unlocking arrangement (62) and the stationary functional locking arrangement (72) are composed of the same radially movable pushing element (68, 78).

### Claim 8 (depends on 7)

Leaktight joining device (40) according to claim 7, wherein the functional ring portion forming a radial cam (74) of the stationary functional locking arrangement (72) is arranged in the extension of the functional ring portion forming a radial cam (64) of the stationary functional unlocking arrangement (62), considering the one-way direction of rotation of the annular functional ring gear (42).

### Claim 9 (depends on 8)

Leaktight joining device (40) according to claim 8, wherein the ring portions forming a radial cam (64, 74) of the stationary functional locking arrangement (72) and of the stationary functional unlocking arrangement (64) are formed by a continuous guideway (66, 76) arranged in the annular functional ring gear (42), and the radially movable pushing element (68, 78) comprises a roller (68a) arranged in the continuous guideway (66, 76) such that the rotation of the annular functional ring gear (42) generates radial movement of the roller which results in the corresponding displacement of an activation pin (68b).

### Claim 10 (depends on 5)

Leaktight joining device (40) according to claim 5, wherein the stationary unlocking means (60) and the stationary locking means (70) are structurally and functionally separate and independent of each other.

### Claim 11 (depends on 1)

Joining device (40) according to claim 1, wherein the stationary temporary clamping means (50) comprise at least one stationary functional arrangement for temporary clamping (52) implemented based on a functional clamping ring portion (54) having, on the one hand, a functional surface for axial clamping (56) and, on the other hand, an insertion opening (58) for built-in complementary clamping means arranged on a portion of the outer periphery of the container (20).

### Claim 12 (depends on 11)

Joining device (40) according to claim 11, wherein the functional clamping ring portion is implemented on an inner peripheral edge of the annular functional ring gear (42).

### Claim 13 (depends on 1)

Joining device (40) according to claim 1, comprising stationary operating means for the removable door (18) of the chamber (10), able to open and seal closed the removable door (18) the chamber (10).

### Claim 14 (depends on 13)

Joining device (40) according to claim 13, wherein the stationary operating means (90) for the removable door (18) of the chamber (10) are mechanically driven by the annular functional ring gear (42).

### Claim 15 (depends on 13)

Joining device (40) according to claim 13, wherein the stationary operating means (90) for the removable door (18) of the chamber (10) are driven by a motor (92) controlled by the movements of the annular functional ring gear (42).

### Claim 16 (depends on 13)

Joining device (40) according to claim 13, wherein the stationary operating means (90) for the removable door (18) of the chamber (10) are adapted to move the removable door of the chamber first in an axial direction, then in a direction substantially perpendicular to the axial direction so that the door does not obstruct the passage of the biopharmaceutical product.

### Claim 17 (depends on 1)

Joining device (40) according to claim 1, wherein the annular functional ring gear (42), the stationary temporary clamping means (50) of the container (20), the stationary unlocking means (60) of the container (20), and the stationary locking means (70) of the container (20) are positioned outside the chamber (10).

### Claim 18 (depends on 3)

Joining device (40) according to claim 3, wherein, firstly, the annular functional ring gear (42), the stationary temporary clamping means (50) of the container (20), the stationary unlocking means (60) of the container (20), the stationary locking means (70) of the container (20), and the functional ring portion forming gear teeth (84) of the stationary functional arrangement for retention/release (82) are positioned outside the chamber (10), secondly, the retention member (88) of said stationary functional arrangement for retention/release (82) is positioned inside the chamber (10), and thirdly, said retention member (88) is driven by a drive shaft (86) which passes through the peripheral wall (12) of the chamber (10).

### Claim 19 (depends on 1)

Joining device (40) according to claim 1, wherein the stationary temporary clamping means (50) of the container (20), the stationary unlocking means (60) of the container (20), and the stationary locking means (70) of the container (20) respectively comprise n stationary functional arrangement(s) for temporary clamping (52), n stationary functional unlocking arrangement(s) (62), n stationary functional locking arrangement(s) (72), with n greater than or equal to 1, so that with each rotational movement of the annular functional ring gear (42) in the one-way direction corresponding to 1/n complete revolutions there is the corresponding successive actuation of the stationary temporary clamping means (50) of the container (20) to hold the container (20) in position against the chamber (10), of the stationary unlocking means (60) of the container (20) to ensure the transition to the intermediate unlocking position of the container (20), of the stationary locking means (70) of the container (20) to ensure the transition to the final locking position of the container (20), and of the stationary temporary clamping means (50) of the container (20) to ensure the release of said container (20).

### Claim 20 (depends on 19)

Joining device (40) according to claim 19, wherein n is equal to 3 or 4.

### Claim 21 (depends on 1)

Assembly comprising a chamber (10) and a leaktight joining device (40) specially intended for association with a single-use container (20) equipped with a removable cover (28) in order to perform the aseptic transfer of a biopharmaceutical product between the chamber (10) and the container (20), wherein the chamber (10) comprises an enclosed peripheral wall (12) having an annular opening (16) that is sealed by a removable door (18), and wherein the leaktight joining device (40) is implemented according to claim 1.

### Claim 22 (depends on 21)

Assembly according to claim 21, further comprising a single-use container (20) equipped with a removable cover (28).

### Claim 23 (depends on 22)

Assembly according to claim 22, wherein the single-use container (20) is specially intended for the transport and the aseptic transfer of a product belonging to the biopharmaceutical field and comprises:
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 (110) for locking/unlocking 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 bulit-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 (26) 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) both capable of being 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 locking portion (118INT) arranged in the blind housing (116) of the removable cover (28) and an external functional locking portion (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 where, 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);
the container (20) being 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 24 (depends on 21)

Aseptic transfer method, 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 21, 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 a 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);
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 gate (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);
generating the axial unclamping of the annular flange (30) of the container (20) with respect to the peripheral wall (12) of the chamber (10) by one-way rotation of the annular functional ring gear (42).