Fluent material handling – with receiver or receiver coacting mea – Processes
Reexamination Certificate
1998-12-24
2001-05-08
Douglas, Steven O. (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Processes
C141S094000, C141S083000, C141S284000
Reexamination Certificate
active
06227261
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to the preparation of emulsions, solutions, and other liquid compounds, and more particularly to a method and an apparatus for the addition of a sterile liquid to an aseptic processing system.
BACKGROUND OF THE INVENTION AND TECHNICAL PROBLEMS POSED BY THE PRIOR ART
The preparation of sterile liquid compounds, including emulsions and solutions, is well known. In certain cases it is necessary to sterilize the resulting liquid compound prior to using it for its intended purpose. Sterile filtration and heat-processing are well-known techniques for the terminal sterilization of such liquid compounds.
In certain situations it is preferable to provide a system that aseptically produces the liquid compound, thereby obviating the need for terminal sterilization of the compound. For example, it is possible that terminal sterilization will damage certain characteristics of the liquid compound. In the course of aseptic processing of a liquid compound it is usually necessary to add components of the compound into the aseptic processing system, thus requiring that each added component be sterile when it is introduced into the system. However, in many cases one or more of these components is provided in a non-sterile form. In order to ensure that each component is sterile when it enters the processing system, a sterilizing-grade filter or other known sterilization process can be used to sterilize the ingredient immediately prior to its introduction into the system.
It is difficult to ensure the accurate delivery of a pre-measured amount of a component when a sterilizing-grade filter is used due to the fact that the filter tends to retain a quantity of the component during filtration. In order to overcome this shortcoming of sterile filtration techniques, some prior art systems have employed a pre-sterilized hypodermic syringe to introduce sterile ingredients into a septum or injection site associated with the processing system. However, this technique can be cumbersome and is prone to failure due to the need to maintain the sterility of both the syringe and the septum or injection site, as well as the need to sterilize the component prior to its introduction into the hypodermic syringe.
The present invention contemplates an arrangement whereby a sterile ingredient that has been sterilized through the use of a sterile-grade filter can be efficiently and accurately added to a processing system, such as that used in the production of a sterile emulsion.
SUMMARY OF THE INVENTION
The present invention is directed to an apparatus, and a method, for adding a selected quantity of a sterilized liquid to an aseptic processing system. The apparatus of the present invention employs an additive reservoir which is fluidly connected to a liquid container. The additive reservoir is constructed to retain a sterile liquid therein prior to addition of the sterile liquid into a processing system. A filter is provided to sterilize liquid as it flows from the liquid container into the additive reservoir. A fill valve is provided between the liquid container and the additive reservoir in order to control flow therebetween. The additive reservoir is constructed to be fluidly connected to an aseptic processing system.
In one embodiment of the present invention, an addition valve is interposed between the additive reservoir and the processing system to which a measured quantity of sterile liquid is to be added, the addition valve being constructed to control flow between the additive reservoir and the system.
In another embodiment of the apparatus of the present invention, the additive reservoir includes a vent for venting the additive reservoir when liquid flows to or from the reservoir. In this embodiment, a sterile gas filter preferably is provided in order to filter the gas before it enters the additive reservoir, thereby maintaining sterility within the reservoir.
Other features and advantages of the present invention will become readily apparent from the following detailed description, the accompanying drawings, and the appended claims.
REFERENCES:
patent: 4563170 (1986-01-01), Aigner et al.
patent: 4203905 (1993-08-01), None
patent: 0722744 (1996-07-01), None
patent: 9636370 (1996-11-01), None
Database WPI Section Ch, Week 199533—Derwent Publications Ltd., London, GB; Class B04, AN 1995-253233, XP002137116 & RU 2 026 723 C (Appl Microbiology Res Inst), Jan. 20, 1995 abstract.
Patent Abstracts of Japan vol. 1998, No. 14, Dec. 31, 1998 & JP 10 230260 A Sep. 2, 1998 abstract—Patent Abstracts of Japan JP 10 230260 A Sep. 22, 1998, figure 1.
Patent Abstracts of Japan vol. 1995, No. 01 Feb. 28, 1995 & JP 06 292546 A, Oct. 21, 1994, abstract.
Das Wilfred
McDonald John
Abbott Laboratories
Douglas Steven O.
Woodworth Brian R.
LandOfFree
Method and apparatus for the addition of sterile liquid to... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method and apparatus for the addition of sterile liquid to..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method and apparatus for the addition of sterile liquid to... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2570909