Fluent material handling – with receiver or receiver coacting mea – Filling means with receiver or receiver coacting means – With receiver and supply securing means
Reexamination Certificate
2000-04-27
2001-11-13
Douglas, Steven O. (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Filling means with receiver or receiver coacting means
With receiver and supply securing means
C141S301000, C141S098000, C141SDIG001
Reexamination Certificate
active
06315013
ABSTRACT:
FIELD OF THE INVENTION
The invention is a system for ensuring the sterility of a container with a device for distributing or mixing pharmaceutical, food or similar products into another container that is also sterile whilst maintaining conditions of sterility during the operations of connecting the two containers with a cylindrical section, as the distribution device comprises a disk with an external diameter that is the same as the container's internal diameter, which disk can be rotated through 90° and which enables a change to be made from a horizontal closed position to a vertical open position by adjusting from the exterior a shaft that is connected to the disk. The invention also prevents toxic products from being expelled after the discharge process is terminated. The invention therefore addresses two very important aspects of the treatment of such products, namely:
a) maintenance of the sterility of the distributor container during the movements of the product distribution device;
b) elimination of any contact with the outside environment during connection of the two containers for product transfer.
BACKGROUND OF THE INVENTION
With regard to the first point, devices are currently made that have addressed the problem of sealing off the distribution disk during closing from the internal wall of the container by means of plastic material or by inserting a rubber gasket in the area in which the container wall comes into contact with the distribution disk. In both cases there are nevertheless seal problems in the area where the shaft joins the disk because it is controlled by an organ outside the container. In addition, if the seal is provided by a disk made of plastic material, clear wear problems arise, which are less marked in the case of seals provided by rubber gaskets, but the latter have to be frequently dismantled for cleaning, which is anyway necessary when the product being treated is changed, because of the fixing system of the gasket, which comprises fittings consisting of mechanical connecting organs on which dust often collects.
With regard to the second aspect, we have attempted to transfer material from one container to another without its coming into contact with the external atmosphere, by giving each of the two containers its own independent distribution organ. This ensures that the insides of the containers that are to be connected to one another are opened only after they have been connected. To protect the internal space between the connection sleeves and their valves from dust, dust caps are fitted to the sleeves, these caps, obviously, must be removed before connecting and this has the grave disadvantage of bringing the front spaces of the two containers into contact, albeit for a short time, with the external atmosphere and therefore making it possible for dust to settle.
In order to avoid this disadvantage a double-disk check device has been fitted: the check organ of the receiving container, by means of external control, is arranged with the bottom surface on the same level as the flange's connecting surface; the same thing happens with the top surface of the check organ of the transfer container in relation to the surface of its own connection flange, except that the latter does not have any control organ but carries out the rotary opening movement only if it is impelled by the other organ after the two containers have been connected. In this way the surfaces that have been contaminated by contact with the external atmosphere should not cause any disadvantages because they come into contact with one another and not with the internal atmosphere that thus remains sterile. This method of procedure nevertheless does not guarantee freedom from contamination, because contamination may arise, for example, from imperfect adherence of the two surfaces, which could cause, although to a minimal degree, dust to enter the inside of the containers.
SUMMARY OF THE INVENTION
The purpose of this invention is to introduce new devices in order to prevent the disadvantages that the two aspects of the problem that have been described.
The first aspect, as we have mentioned, is the imperfect seal of the valve body with the drive shaft and the complexity of the devices for dismantling the gasket for cleaning. For the first case the invention installs a diaphragm inside the gasket in order to completely shut off the shaft's through hole: the shaft consists of two sections, one outside the container and one inside, which are kept together by the force of magnets embedded in the surfaces of the semi-shafts facing one another.
For the second case a top fixing flange is provided for the gasket fixed to the body of the container by means of the attraction exercised by the magnets.
The second aspect is, as we have mentioned, the elimination of any contact with the outside environment whilst the two containers are connected together for the product transfer and is overcome by closing the bottom of the distributor container and the top part of the transfer container, by means of plates, appropriately fashioned, of magnetic ferrous material, fixed to the parts by magnetic fittings arranged on the surfaces of the aforementioned containers. During connection the surfaces of the two plates that have been contaminated by the outside environment come into contact. The connection between the two containers is established by removing the two plates with the help of an extractor. This enables the two containers to be connected without contaminating the internal environment with the external atmosphere. Finally, in order to prevent any contact between the internal parts of the containers and the internal part of the extractor, a cylindrical screen is fitted between the two parts that intervenes before the valve opens to transfer the material from one container to another.
REFERENCES:
patent: 5988951 (1999-11-01), DiFrank et al.
patent: 6003734 (1999-10-01), Oh
patent: 6056027 (2000-05-01), Patterson
Douglas Steven O.
Young & Thompson
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