Fluent material handling – with receiver or receiver coacting mea – Plural filling means – For plural receivers simultaneously filled
Patent
1995-09-19
1997-12-30
Jacyna, J. Casimer
Fluent material handling, with receiver or receiver coacting mea
Plural filling means
For plural receivers simultaneously filled
41 9, 41 10, 41 18, 41100, 41313, 41324, 41325, A61J 105
Patent
active
057019371
DESCRIPTION:
BRIEF SUMMARY
FIELD OF INVENTION
The present invention is directed to aseptically distributing sensitive fluids in conduits from a controlled atmosphere zone for their production by the means of manifold devices to containers for storing the said fluids, located outside the said zone,
DESCRIPTION OF THE INVENTION
Technically, a difficult problem is a encountered when aseptically distributing fluids from a dosed or sterile production zone to sterile sealable containers for storing the fluids. To maintain the highest possible grade of protection of the fluids is especially critical when handling sterile parenterally administerable fluids of nutrients and/or medicaments. In such cases the containers are preferably either filled immediately after preparation of the fluids or filled at the place at which they are used, i.e. hospitals and special centers. The preparation of the fluids and the filling of the storage containers must be performed under the highest possible sterile conditions. The content of the containers must otherwise be consumed within a very short time.
In many previous process the containers have been filled one at the time inside a sterile isolator zone, which is time consuming, inconvenient and expensive.
The object of the present invention is to provide a dosed aseptic fluid distribution system for delivering fluids from a controlled atmosphere zone, in which the fluids are prepared with a high grade of sterility, to containers for storage of the fluids, while maintaining the same protection in a lower grade sterility environment.
The invention is directed to a dosed aseptic system for aseptically distributing at least one sensitive fluid through conduits from a controlled atmosphere zone adapted to sterile production to single- or multi-compartment containers for storage of the fluid or fluids outside the said zone by one or several of the said manifold device. Especially preferred fluids to be handled by the system are parenterally administerable medical and/or nutritional fluids to be stored in collapsible or flexible containers.
The invention also relates to manifold devices which connects the conduits leading from a controlled atmosphere zone to containers for storage of the fluids. The manifold devices can distribute the fluids for simultaneous filling of several compartments of each container or in a special embodiment simultaneously fill all the containers. The manifold devices also provide convenient means of switching between different types of containers in a simple and efficient manner. Each manifold device has a singular inlet sealingly connected to a conduit for the distribution of one determined fluid from the sterile controlled atmosphere zone and it is provided with a plurality of fluid outlet orifices, each connected to a designated chamber of the container by a sealed tubing.
Another aspect of the invention is to provide methods for aseptically filling containers with fluids distributed from a controlled atmosphere zone for their production, to designated compartments in containers outside said zone, by means of the said manifold devices.
Each manifold device can be constructed so that the fluid flow is substantially the same in each of the tubings connecting the fluid outlet orifices of the manifold device to the compartments of the containers, during the filling.
The manifold devices can be provided with attachment means for the connection of several manifold devices, especially when the fluids are distributed to multi-compartment containers. Alternatively, they can be constructed as series of parallel, identical manifold devices in a pre-formed assembly. The manifold devices can also be assembled in a housing with arrangements to sealingly connect the outlet orifices of the manifold device to the tubings leading to the compartment or the compartments of the containers.
According to a special embodiment of the invention the manifold device can be adapted to simultaneous filling of all the containers connected thereto, by being constructed so that the pressure drop is substantiall
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Boucheteil Micheline
Bourboulou Yves
Philippon Celine
Tronchet Jean
Jacyna J. Casimer
Pharmacia & Upjohn Aktiebolag
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