Fluent material handling – with receiver or receiver coacting mea – With soil removing – coating – lubricating – sterilizing and/or... – With cleaning – coating or drying means
Reexamination Certificate
1999-12-13
2001-10-30
Douglas, Steven O. (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
With soil removing, coating, lubricating, sterilizing and/or...
With cleaning, coating or drying means
C141S098000, C141S383000, C422S294000
Reexamination Certificate
active
06308749
ABSTRACT:
DESCRIPTION
1. Technical Domain
The invention relates to a process and a device for transferring previously sterilized products contained in a transport container, into a sterile isolator.
The invention may be used in all industrial fields involving handling of sterile products, and particularly in the pharmaceutical, medical, chemical, food processing industries, etc.
Throughout the rest of this text, the term “products” should be understood in its broadest sense, in other words in particular it covers powders, pellets, components of various shapes and natures, liquids, etc.
2. State of Prior Art
One known manner of transporting previously sterilized products (for example sterilized by gamma irradiation) to an isolator in which any other operations (for example packaging) are to be carried out is to place these products in containers in the form of flexible bags.
One frequently used manner of connecting a container to the isolator and for transferring products inside this isolator is to use connection means with a double door to obtain a sealed transfer. This type of known device comprises a flange normally closed by a door on the container and a flange normally closed by a door on the isolator. When the container is docked onto the isolator, the two flanges are fixed to each other in a sealed manner and the two doors are fixed to each other in a sealed manner. After opening the double door thus formed from the inside of the isolator, the products may be transferred without the need to carry out any prior sterilization operation.
This known technique is safe and is generally satisfactory. However, it has the disadvantage that it is expensive when the transfer frequency is high. Furthermore, the containers have to be either thrown away or recycled after each transfer.
Considering the price of the flange/door assembly fitted on each container, scrapping these containers after use introduces an operating cost that increases as the number of containers used increases.
Furthermore, container recycling operations are also expensive and penalizing when the number of containers used increases. They make it necessary to package flange/door assemblies after use, and then to unpackage them, to make a visual inspection and to clean them before reassembly and to make a new inspection and repackaging.
Another known technique, described particularly in document WO 96 21615, consists of equipping each container with a flange closed by a plug. This can significantly reduce the price of a container so that it can be thrown away after each use. The operating cost of the system thus remains reasonable when the number of transfers increases.
However since it does not use the double door transfer device, this technique has the disadvantage that a non-sterile volume is created after the container is connected onto the isolator, between the plug closing the container and the door closing the isolator.
Document WO 96 21615 proposes to overcome this disadvantage by fitting sterilization means consisting of ultraviolet lamps on the outside of the isolator door. More precisely, the isolator door comes into contact with the inside of the isolator flange in a sealed manner, and after docking the container plug is positioned practically in the same plane as the inside of the isolator flange. The small enclosed volume thus formed between the plug and the door is then sterilized. The isolator door is then opened and the plug is cut out so that products can be transferred.
However, this slystem has some disadvantages.
Thus, since sterilization means are placed in the isolator door, maintenance work (replacing a lamp, electrical repairs, etc.) can only be done after the isolator door is opened and from the inside of the isolator. This creates a major break in the seal and therefore the sterility of the isolator, and the only way to avoid this break is if the work is done in the presence of a container or a special plug designed for this purpose. Moreover, the need to work from inside the isolator is inconvenient.
Furthermore, the sterilization technique using ultraviolet lamps is not very efficient, so that use of the system is limited to relatively small transfer openings.
DESCRIPTION OF THE INVENTION
More precisely, the purpose of the invention is a process for the transfer of sterile products between a container and an isolator in order to overcome the disadvantages of existing processes, by enabling the use of inexpensive throwaway containers while enabling easy maintenance of sterilization means.
The invention achieves this result by means of a process for transferring sterile products between a transport container and a sterile isolator, in which:
the container is docked onto the isolator;
an enclosed volume between the container closer and the isolator closer is sterilized; and
the said closers are opened before starting to transfer the products;
characterized in that the container is docked onto a lock connected on the outside to the isolator and normally separated from it by its closer, the said lock including means of sterilization and delimiting the enclosed volume.
This layout makes it possible to use an inexpensive throwaway container equipped with a simple closer. Furthermore, it enables fast and easy maintenance work on the sterilization means.
In one preferred embodiment of the invention, the lock is fitted to the isolator by means of a sealed double door transfer device, in which the double door forms the isolator closer, before the container is docked onto the lock. This layout means that all sterilization means can be replaced very quickly.
In order to achieve fast and efficient sterilization without limiting the dimensions of the transfer opening, the enclosed volume is preferably sterilized using pulsed light sterilization means placed around a transparent tube delimiting the enclosed volume.
Advantageously, products are transferred after folding a protective sleeve internal to the container over inside the lock.
Preferably, the container closer is opened by cutting out from inside the isolator after opening the isolator closer.
In order to further improve the sterilization efficiency, a container may be used equipped with a closer on which the outside face (which can be turned towards the enclosed volume) is reflecting.
Depending on the case, the container may be connected to the lock either by using a flexible container and docking the container onto the lock using an elastic sleeve, or by using a container with a semirigid flange onto which the container closer is fitted and docking this closer on the lock by fitting the flange into a complementary flange on the lock.
Another purpose of the invention is a device for transferring sterile products between a transport container and a sterile isolator, comprising:
a container closer;
an isolator closer;
means of docking the container onto an isolator, in order to delimit an enclosed volume between the container closer and the isolator closer when docking is complete;
means of sterilizing the said enclosed volume;
the device being characterized in that it also includes a lock connected on the outside to the isolator and normally separated from the isolator by the isolator closer, the said lock including sterilization means and delimiting the enclosed volume.
REFERENCES:
patent: 5425400 (1995-06-01), Szatmary
patent: 5447699 (1995-09-01), Papciak et al.
patent: 5490546 (1996-02-01), Lhoest
patent: 6030578 (2000-02-01), McDonald
patent: 2 658 489 (1991-08-01), None
patent: WO 96/21615 (1996-07-01), None
Brossard Jean-Pierre
Fontcuberta Philippe
Riviere Jean-Michel
Douglas Steven O.
La Calhene
Pearne & Gordon LLP
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