Patent Description:
It is advantageous for some biological medicaments and other substances intended for injection to be in a freeze-dried powder form free from moisture (lyophilized powder) to improve their stability, which may include reducing or preventing chemical reactions, degradation, aggregation, biological growth, heat sensitivity, etc. As a result, lyophilization increases the shelf life for such substances.

Typically, during lyophilization processing of pharmaceutical medicaments, the medicament is introduced into a vial and a stopper is positioned on the vial in a partially closed orientation or in a position where it can be readily closed, i.e., in a non-airtight manner. The stopper may be initially supplied within a cap containing a button and a cylindrical shell for securing the stopper and button to the vial at a subsequent processing operation or the shell and button may be provided at a later stage in the processing. The vial and stopper are then placed in a vacuum chamber to freeze-dry the medicament. During-freeze drying, moisture is evacuated from the inside of the vial including from the medicament itself. As the moisture evacuates the vial, residue of the medicament may deposit onto the external surface of the vial and stopper, and any additional vial components such as the button and shell.

After the medicament has been lyophilized, the stopper is positioned to form a hermetic seal with the vial and in a subsequent step the shell secures the stopper to the vial, either by crimping if the shell is aluminum or by locking if the shell is plastic.

After the vial is hermetically sealed a washing operation is then performed on the sealed vial (fill container) to remove deposited residue.

Unintended exposure to the medicament is a concern, as it may pose health risks, such as cytotoxicity among others. Prior art techniques have attempted to address this concern by performing a washing operation on the fill container and requiring a clinician to handle the fill container with safety gloves. However, the shell must be secured beforehand to prevent moisture from entering the fill container. Even if the fill container is hermetically sealed and secured by a shell, it is desirable to prevent moisture from becoming trapped under the shell and button as it could facilitate the growth of bacteria, among other concerns. Since the aluminum shell and the button are not typically present during the freeze-drying process, the outer surfaces of these components are free from any drug residues and are not washed.

In case the shell and the button are present within the freeze-drying chamber, there is a need in the art for a container holding fixture that reduces or eliminates deposited medicament residue from a fill container including the shell and button.

<CIT> discloses a device for storing and handling Petri dishes. The device includes a storage device structured and arranged for storing the Petri dishes in an upside-down orientation so that respective lids are oriented below their respective bases, an inspection device structured and arranged for automatic inspection of the Petri dishes without their respective lids, and a transfer device structured and arranged for transferring the Petri dishes between the storage device and the inspection device. The transfer device includes a gripper, with which a respective Petri dish without the lid can be grasped laterally on the base wall.

<CIT> discloses yet another device for Petri dishes. A rotating holder is envisioned to invert Petri dishes by <NUM>° and to loosen the bottom from the cover, which has two positions to accommodate Petri dishes. By inverting the rotating holder around a rotation axis, the Petri dishes are reversed and inverted in the two positions. Thus the bottom of the upper Petri dish will be lowered and be engaged by a gripper.

<CIT> refers to an automated pharmacy admixture system. This system can be equipped with devices for retaining the fill ports of intravenous bags that are commercially available. The retaining devices are designed as retention clips which include substantially rigid holders. For these holders the compliance of the fill port allows the fill port to be slightly deformed while inserting it into the.

<CIT> discloses a mechanical finger apparatus for grasping items which comprises various articulated elements. Not only can the distance between the fingers be adjusted but also their inclination with respect to a central axis thereby enabling the apparatus e.g., to grasp around a bottle neck.

In embodiments of the present invention, a holding fixture for a fill container as per claim <NUM>-<NUM>, a vial washing system as per claim <NUM>-<NUM> and a method for washing a fill container as per claim <NUM>-<NUM> are disclosed.

The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, the drawings show embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.

Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

The following description is directed towards various embodiments of a vial washing device and method in accordance with the present invention.

Referring to the drawings in detail, where like numerals indicate like elements throughout, there is shown in <FIG> embodiments of a vial washing system.

A fill container <NUM> may include a vial <NUM> comprised of a glass, ceramic, or polymeric material. The vial <NUM> may have a cylindrical lower part having a general longitudinal axis Xi and may have a neck at the upper part terminating into a lip defining an opening therein. During a pharmaceutical processing operation, the inside of the vial <NUM> may be filled with a medicament (not shown). The vial <NUM> with the medicament contained therein may undergo a lyophilization process, in which the medicament is subjected to a vacuum to remove moisture. During lyophilization, the stopper may be partially positioned within the opening of the vial <NUM> or it may be placed such that it may be readily inserted into the opening of the vial <NUM> to form an air-tight seal. After the medicament has been lyophilized and while under vacuum, the opening of the vial <NUM> is sealed with the stopper. Additionally, either before or after lyophilization, a cylindrical shell <NUM> having a button <NUM> may be placed in a position aligned colinearly with the longitudinal axis of the vial and circumscribing the lip and the stopper.

After the lyophilization, the fill container <NUM> may be transported to a wash <NUM> with one or more sprayers <NUM> where it can be washed to remove any residue that may have formed during lyophilization. The fill container <NUM> may be transported with one or more transport mechanisms, such as a horizontally oriented conveyer belt <NUM>. The transport mechanisms may also or alternatively include a helical screw (not shown), robotic arm (not shown) or other mechanisms known to those skilled in the art. The fill container <NUM> may also be transported by a pair of rigid support structures <NUM> (collectively referred to as a holding fixture). The rigid support structures <NUM> may be comprised of any rigid material, such as a rigid plastic or a metal, for example.

As shown in <FIG>, the rigid support structure <NUM> may include a first inner support <NUM> having a curved first inner surface <NUM> which faces radially inward. In a preferred embodiment, the first inner support <NUM> is semi-circular shaped and the first inner surface <NUM> is a cylindrical wall spanning a <NUM>-degree arc having a radius of curvature about a second longitudinal axis X<NUM>. The rigid support structure <NUM> may also include a second inner support <NUM> spaced axially apart from the first inner support <NUM>. The second inner support <NUM> may have a curved second inner surface <NUM> which faces radially inward. In a preferred embodiment, the second inner support <NUM> is semi-circular shaped and the second inner surface <NUM> is a cylindrical wall spanning a <NUM>-degree arc having a radius of curvature about a second longitudinal axis X<NUM>. The first and second inner surfaces <NUM>, <NUM> have different radii of curvature, however, in other embodiments the radius of curvature is the same for both.

The rigid support structure <NUM> may have at least one first support arm <NUM> connected to the first inner support <NUM> and extending in an outward direction away from the first inner surface <NUM>. In a preferred embodiment, the rigid structure <NUM> includes two first support arms <NUM> connected to the first inner support <NUM> at opposite ends and being parallel to one another. The rigid support structure <NUM> may also have at least one second support arm <NUM> connected to the second inner support <NUM> and extending in an outward direction away from the second inner surface <NUM>. In a preferred embodiment, the rigid structure <NUM> includes two second support arms <NUM> connected to the second inner support <NUM> at opposite ends and being parallel to one another. The at least one first support arm <NUM> and the at least one second support arm <NUM> may have a different geometry from one another or they may be the same.

In another embodiment shown in <FIG>, a rigid support structure 20a includes only one first support arm 22a connected to the median of the first inner support <NUM>. It may also include only one second support arm (not shown) connected to the median of the second inner support <NUM> (not shown). In another embodiment shown in <FIG>, a rigid support structure 20b includes two first support arms <NUM> connected to the first inner support and two axially oriented support arms <NUM> connecting the first inner support <NUM> to the second inner support <NUM>. Moreover, the support arms <NUM> are positioned radially outward from the first and second inner supports to permit washing along an uncovered annular surface of the shell <NUM>.

The rigid support structure <NUM> may also include a first compression member <NUM> attached to the first inner surface <NUM> and a second compression member <NUM> attached to the second inner surface <NUM>. The first and second compression members <NUM>, <NUM> may be comprised of any compressible material such as an elastomer or soft plastic. Moreover, the first and second compression members <NUM>, <NUM> may be cylindrically-, toroidally-, half-toroidally-, or irregularly-shaped. In a preferred embodiment, the first and second compression members are half-toroidally-shaped, i.e. a toroid split along its equatorial plane. The first and second compression members may be sized appropriately to conform to one or more surfaces or edges on the vial <NUM>, the shell <NUM>, or the button <NUM>. In a preferred embodiment, the first compression member <NUM> is sized to conform with an edge or surface of the shell <NUM> and an edge or surface of the button <NUM>, such that any gap therebetween is shielded from a washing operation. The second compression member <NUM> is sized to conform with an edge or surface of the shell <NUM> and an edge or surface of the vial <NUM>. For similar purposes, any gap therebetween is shielded from a washing operation. The first and second compression members <NUM>, <NUM> may have an arc-length longer than the arc-length of the respective first and second inner surfaces <NUM>, <NUM> to allow them to compress against respective mating first and second compression members <NUM>, <NUM> in a closed orientation forming combined first and second annular compression members <NUM>, <NUM>. Each of the first and second inner supports <NUM>, <NUM> may have two free ends which terminate at abutment surfaces to abut against respective abutment surfaces from a mating rigid support member <NUM>. Thus, the first and second compression members <NUM>, <NUM> are compressed against respective first and second compression members <NUM>, <NUM> when the abutment surfaces from a pair of rigid support structures <NUM> abut their corresponding abutment surfaces.

The at least one first support arm <NUM> and the at least one second support arm <NUM> may terminate at a base surface. In a preferred embodiment, each of the pairs of support arms <NUM>, <NUM> terminate at base surfaces connected by a bar, but one having skill in the art would appreciate that the support arms may also terminate at a single base surface (such as a base plate, not shown) or at individual base surface, i.e., a base surface for each support arm (not shown). The base surfaces of the rigid support structures <NUM> may be attached to a right-hand side vertically oriented conveying belt <NUM> and to a left-hand side vertically oriented conveying belt (not shown) oppositely aligned from right-hand side vertically oriented conveying belt <NUM>. The bases may be attached by fasteners, adhesives, weave, or any other attachment mechanism known to those skilled in the art.

Both of the vertically-oriented conveying belts may rotate at the same speed and in the opposite angular direction such that they define an inner pathway <NUM> in which they move in the same linear direction at the same linear speed. The rigid support structures <NUM> may be spaced apart on each of the vertically oriented conveying belts such that a pair of rigid support structures <NUM> abut one another as they travel along the inner pathway <NUM>.

Claim 1:
A holding fixture for a fill container comprising a vial,
which vial is comprising a medicament contained therein, the vial having a first longitudinal axis and a neck at a proximal end of the thereof, the neck proximally terminating at a circumferential lip, the lip defining an opening, the final fill container further comprising a stopper positioned at least partially within the vial opening and forming an air-tight seal with the vial, and a cylindrical shell including a button aligned with the first longitudinal axis and circumscribing the lip and the stopper,
the holding fixture comprising:
a pair of rigid support structures (<NUM>, 20a, 20b), each rigid support structure (<NUM>, 20a, 20b) comprising:
a first inner support (<NUM>) having a first inner surface (<NUM>) with a first radius of curvature about a first inner support longitudinal axis, the first inner surface (<NUM>) facing radially inward; and
a first support arm (<NUM>, 22a) connected to the first inner support (<NUM>) and extending in an outward direction away from the first inner surface (<NUM>), the first support arm (<NUM>, 22a) having a base surface at a terminal end opposite from the first inner support (<NUM>), the holding fixture further comprising:
a first compression member (<NUM>) attached to the first inner surface (<NUM>), the first compression member (<NUM>) being configured to contact a shell (<NUM>) of a vial (<NUM>) when the first inner support longitudinal axis is colinear with a longitudinal axis of the vial (<NUM>),
characterized in that the pair of rigid support structures (<NUM>, 20a, 20b) has a closed orientation when the first compression member (<NUM>) from one of the pair of rigid support structures (<NUM>, 20a, 20b) contacts the first compression member (<NUM>) from the other one of the pair of rigid support structures (<NUM>, 20a, 20b) forming a first annular compression member.