Radiant energy – Supported for nonsignalling objects of irradiation
Reexamination Certificate
1999-04-15
2001-10-23
Anderson, Bruce C. (Department: 2878)
Radiant energy
Supported for nonsignalling objects of irradiation
C250S50400H
Reexamination Certificate
active
06307206
ABSTRACT:
TECHNICAL FIELD
The invention relates to a tight transfer device of the double door or port type for the provisional or permanent linking of two sterile volumes, without any risk of contaminating the latter.
A device designed in this way is used in all fields requiring the presence of a sterile atmosphere. In non-limitative manner, reference is made to the pharmaceutical and chemical industries, the medical sector, etc.
PRIOR ART
In all cases where it is wished to maintain a sterile atmosphere, it is standard practice to use a tight confinement insulator internally defining a sterile volume. A sterilizer associated with the insulator makes it possible to establish and, if appropriate, renew the sterile character of the atmosphere which it contains.
To permit the performance of a certain number of tasks within such an insulator and also for introducing into it and extracting from it products and equipments, use is conventionally made of double door or port, tight connection or transfer devices, commonly known as resin transfer ports (RTP).
A RTP device conventionally comprises two flanges connectable to one another, as well as two ports normally sealing the openings defined by the flanges. The flanges are installed on the walls of the two assemblies which it is wished to connect (insulator and rigid container insulator and flexible container, insulator and insulator, insulator and glove, etc.).
In order to ensure the connection of the two assemblies, the flanges are connected to one another and then the ports are connected to one another, whilst disconnecting them from the corresponding flanges. The removal of the thus formed double port ensures the linking of the volumes within the two assemblies.
If one of the volumes which it is wished to link is not initially sterile, it is sterilized by means of a sterilizer provided for this purpose prior to the opening of the double port.
Existing RTP devices are designed so as to ensure that none of the surfaces in contact with the non-sterile, external atmosphere, prior to the connection of the two assemblies, is in contact with the sterile, internal volume common to the two assemblies, following the opening of the double port. In practice, this result is obtained by means of two annular gaskets, which are respectively fitted to one of the flanges and to the port sealing the other flange. Each of these gaskets has, in cross-section, a V-shaped portion and the points of these two portions approximately face one another when their connection has taken place and the ports are still in place.
This conventional arrangement satisfies in general terms the sought objective. However, it has been found that bacteria can sometimes be deposited on the points of the V-shaped portions of the two gaskets and in the immediate vicinity thereof prior to the connection of the two assemblies. These points and immediately adjacent portions of the gaskets are contacted with the sterile volume common to the two assemblies following the connection and opening of the double port.
One solution to this problem has been proposed in EP-A-662 373. According to the latter document, a heating resistor is integrated into the gasket-free flange, so as to be in contact with the gaskets, in the vicinity of their points, when connection has taken place and prior to the opening of the double port. At this stage, the use of the heating element makes it possible to sterilize the possibly contaminated regions of the gaskets.
However, this known solution is not completely satisfactory. Thus, the efficiency of the decontamination obtained with the aid of such a heating element is of an arbitrary nature. Moreover, the possible obtaining of a satisfactory decontamination assumes a relatively long heating time, which is highly prejudicial to the use of the device.
DESCRIPTION OF THE INVENTION
The invention specifically relates to a tight transfer device of the RTP or some other type, whose original design makes it possible to reliably and rapidly decontaminate the facing points of gaskets and the immediately adjacent portions, following the connection of the two assemblies and prior to the opening of the double port.
According to the invention, this result is obtained by means of a tight transfer device between two sterile volumes, including two flanges connectable to one another, two ports connectable to one another and to said flanges, and two annular gaskets respectively fitted to a first of the flanges and to the port connectable to the second flange, said gaskets having in cross-section V-shaped portions, whose points face one another when the ports and flanges are connected to one another, characterized in that into the second flange are intergrated means for the decontamination, by ultraviolet, pulsed ultraviolet or pulsed light radiation, of the points of the V-shaped portions of the gaskets and immediately adjacent regions.
In a preferred embodiment of the invention, the decontamination means comprise a collar made from a material able to diffuse radiation, said collar having, in cross-section, a V-shaped portion contactable with the V-shaped portions of the gaskets, and optical fibres, whose first ends are regularly distributed around said collar and turned towards the point of the V-shaped portion thereof.
The two ends of the optical fibres are then connected to a radiation source.
Preferably, outside the collar, the optical fibres are grouped into at least one cable. Thus, according to a preferred, but in no way limitative arrangement, the optical fibres are grouped into two cables penetrating the second flange at diametrically opposite locations.
In order to facilitate installation, the second flange advantageously comprises two parts connected to one another by assembly means and between which is installed the aforementioned collar. The cable then travels in a passage formed in a first of the two parts, which is turned towards the outside of the corresponding sterile volume, sealing means being provided between the two parts, opposite to the collar with respect to said passage.
In the preferred embodiment of the invention, the first ends of the optical fibres are housed in blind holes formed in the collar, said holes being located in regularly spaced planes passing through the axis of the collar and on a truncated cone-shaped surface, bisecting the V-shaped portion of the collar.
The first ends of the optical fibres are separated from one another by a distance such that the point of the V-shaped portion of the collar is swept over its entire circumference by the radiation.
REFERENCES:
patent: 6198106 (2001-03-01), Barney et al.
patent: 0 662 373 A1 (1995-12-01), None
patent: 2 700 882 (1994-07-01), None
patent: 2 165 155 A (1996-09-01), None
Riviere Jean-Michel
Senges Patrick
Anderson Bruce C.
La Calhene
Pearne & Gordon LLP
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