Package making – Methods – Sterilizing complete package
Patent
1997-11-10
2000-06-20
Moon, Daniel B.
Package making
Methods
Sterilizing complete package
53445, 53449, 53474, B65B 5502
Patent
active
060763337
DESCRIPTION:
BRIEF SUMMARY
THIS INVENTION relates to the manufacture and distribution of intravenous solutions. It relates more specifically to a method of manufacturing intravenous solutions, to a method of distributing intravenous solutions, to a manufacturing plant for use in the manufacture of intravenous solutions, and to a shipping container suitable for use in the manufacture and distribution of intravenous solutions.
Conventionally, in one version, intravenous solutions are provided to an end user such as a hospital, clinic or the like as an intravenous solution container in the form of a hermetically sealed container such as a flexible bag of synthetic plastics material containing the solution. The synthetic plastics bag is wrapped or contained in an overwrapper or overpouch. Such bags are filled with intravenous solution via a port under clean, preferably sterile, conditions, hermetically sealed, wrapped in an overpouch which is hermetically sealed and evacuated and sterilised in the hermetically sealed condition in an autoclave. They are thereafter shipped to intermediate or end destinations.
In another version, the intravenous solutions are charged into containers, such as semi-rigid pouches or sachets of polypropylene material, hermetically sealed, sterilized and then distributed.
In accordance with a first aspect of this invention, there is provided a method of manufacturing a batch of intravenous solution, the method including
in a central manufacturing plant, obtaining premanufactured components and materials including active ingredient, containing means for intravenous solution and a shipping container and excluding solvent, performing manufacturing steps on the containing means in the manufacture of individual ported containers for intravenous solution, dispensing the active ingredient in predetermined dosages into holders, and packing the containing means and the holders in the shipping container;
shipping the shipping container to a decentralised manufacturing plant;
in the decentralised manufacturing plant, unpacking the shipping container, obtaining solvent, preparing a predetermined solution from the solvent and the pre-dispensed active ingredient, completing manufacture of the containing means into individual ported containers, filling the respective individual ported containers with the prepared solution, sealing the filled containers and sterilising the sealed containers in an autoclave.
The method may include, in the central manufacturing plant, verifying the quality of the components and materials obtained in the central manufacturing plant. The method may further include, in the decentralised manufacturing plant, performing quality assurance steps as required or as appropriate for the product being manufactured.
When the individual ported containers are in the form of flexible bags of synthetic plastics material, the method may include overwrapping the flexible bags in overpouches, and hermetically sealing and evacuating the overpouches prior to sterilizing.
Manufacturing steps performed on the containing means in the central manufacturing plant may include processing of premanufactured sheet material into lay flats, laminates, bags or the like. The method may include mounting ports in the bags. Generally, in a preferred method, the bags are manufactured and printed in the central manufacturing plant ready to be filled. The manufacturing steps in manufacture of overpouches may merely include providing a double layered web in roll form (also known as "lay flat") which has to be sealed bottom and top to contain the bag after it has been filled with the intravenous solution. Thus, the method may further include marking at least one of the bags and the overpouch material with identification markings. The method may further advantageously include preparing documentation including records and certification documents in association with manufacturing in the central manufacturing plant and associating such documentation with the respective batch of intravenous solution. Such documentation may, in some instances,
REFERENCES:
patent: 2659187 (1953-11-01), Barnes
patent: 3893280 (1975-07-01), King
patent: 4467588 (1984-08-01), Carveth
patent: 5014494 (1991-05-01), George
patent: 5157900 (1992-10-01), Kupersmit
patent: 5373684 (1994-12-01), Vacca
patent: 5406770 (1995-04-01), Fikacek
patent: 5511594 (1996-04-01), Brennan et al.
patent: 5682728 (1997-11-01), DeBusk et al.
patent: 5715646 (1998-02-01), Smekens
Inmed Investment Holding Company (Proprietary) Limited
Moon Daniel B.
LandOfFree
Manufacture and distribution of intravenous solutions does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Manufacture and distribution of intravenous solutions, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Manufacture and distribution of intravenous solutions will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-1841883