Package making – Methods – Sterilizing complete package
Reexamination Certificate
2002-03-19
2004-04-13
Gerrity, Stephen F. (Department: 3721)
Package making
Methods
Sterilizing complete package
C053S434000, C053S440000, C053S451000, C053S469000
Reexamination Certificate
active
06718735
ABSTRACT:
DESCRIPTION
1. Technical Field
The present invention relates generally to the packaging of a protein in a flexible polymeric container, and more specifically to the mass-packaging of albumin in flexible polymeric containers in an aseptic environment of a form-fill-seal packaging machine.
2. Background of the Invention
Many peptides and proteins for pharmaceutical or other use are known, including glycoproteins, lipoproteins, imunoglobulins, monoclonal antibodies, enzymes, blood proteins, receptor proteins, and hormones.
One type of such compound is albumin. Albumin is a sulfur-containing, water-soluble protein that congeals when heated, and occurs in blood. Albumin is often utilized as a blood expander to assist in maintaining a patient's blood pressure, or sometimes to assist with increasing a patient's blood pressure during blood loss.
Proteins, such as albumin, are adsorbed by most man-made materials, including liquid containers made of various polymers. Adsorption of the protein onto the artificial polymeric surface results in a lowering of the protein content of that solution. Some protein solutions can be adversely affected by protein adsorption onto artificial surfaces through a process called denaturing. Denaturing is a process whereby the protein is not permanently adsorbed onto the polymeric container, but rather the protein molecules are adsorbed onto the container and then released. The adsorption and release can change the shape of the molecule (i.e., denature it). Often, when protein molecules in drug solutions have undergone denaturing, they may lose their efficacy and utility. Accordingly, to date proteins such as albumin have been stored for individual use in glass vials in order to avoid the risk of denaturing. Because of the cost encountered in producing, packaging, boxing, shipping and storing glass vials, as well as the cost and weight of the glass vial, and the ease with which the glass vial may break, a more efficient, inexpensive and user friendly means of packaging proteins such as albumin to possibly eliminate the above drawbacks is desirable.
One type of packaging utilized for packaging non-protein pharmaceuticals is polymeric bags formed with a form-fill-seal packaging machine. Form-fill-seal packaging machines are typically utilized to package a product in a flexible container. The form-fill-seal packaging machine provides an apparatus for packaging certain pharmaceuticals and many other products in an inexpensive and efficient manner.
Pursuant to FDA requirements, certain pharmaceuticals packaged in form-fill-seal packages are traditionally sterilized in a post-packaging autoclaving step. The post-packaging step includes placing the sealed package containing the pharmaceutical in an autoclave and steam sterilizing or heating the package and its contents to a required temperature, which is often approximately 250° F., for a prescribed period of time. This sterilization step operates to kill bacteria and other contaminants found inside the package, whether on the inner layer of film or within the pharmaceutical itself.
Certain packaged pharmaceuticals, including certain proteins such as albumin, however, generally cannot be sterilized in such a manner. This is because the heat required to kill the bacteria in the autoclaving process destroys or renders useless certain pharmaceuticals. Further, in the case of albumin protein, the heat may operate to congeal the protein.
Form-fill-seal packaging may also present other problems beyond sterilization concerns when packaging certain proteins such as albumin. Specifically, conventional form-fill-seal packaging machinery introduces heat to certain areas of the polymeric material of the package to create seals. If the heat contacts the protein during the sealing process, the protein may congeal or otherwise denature such as during high-temperature sterilization. Further, since certain proteins such as albumin, as well as other pharmaceuticals, operate as insulators, all seal areas must be free of the substance in order for the polymeric materials to be heat sealed together. If any substance, such as albumin is present in the seal area prior to sealing, the integrity of the seal may be jeopardized.
Thus, a convenient and cost-effective means for packaging certain proteins, including proteins such as albumin is desirable.
SUMMARY OF THE INVENTION
The present invention provides a flexible polymeric container for holding a concentration of a solution, including peptides and/or proteins. Such peptides and proteins include: glycoproteins, lipoproteins, imunoglobulins, monoclonal antibodies, enzymes, blood proteins, receptor proteins, and hormones. Additionally, the present invention provides a method of packaging such a solution in a flexible polymeric container. Generally, the flexible polymeric container comprises a sheet of flexible polymeric film formed into a bag. The bag has a cavity enclosed by a first wall and an opposing second wall. The bag further has seals about a periphery of the first and second walls that join an interior portion of the opposing first and second walls to create a fluid-tight chamber within the cavity of the container. A concentration of the solution is stored within the fluid-tight chamber. In one embodiment, the solution is albumin.
According to one aspect of the present invention, the flexible polymeric container for holding a concentrate of water-soluble albumin comprises a sheet of flexible polymeric material that is initially converted into a tube with a former, and is subsequently converted into a series of adjacent bags. The bags have a first side member, a second side member peripherally sealed to the first side member, and a cavity between an interior of the first and second side members. A quantity of a concentration of water-soluble albumin is located within the cavity of the bag. The openings of the bags are subsequently sealed to create a fluid-tight chamber.
According to another aspect of the present invention, the container has a plurality of peripheral edges. Three of the peripheral edges are sealed with heat, and one of the peripheral edges contains a fold that separates the first wall or first side member from the opposing second wall or second side member.
According to another aspect of the present invention, a fitment is connected to the container adjacent the fold. The fitment extends from the outer shell of the container at the fold and has a sealed passageway that cooperates with the fluid-tight chamber of the container. The sealed passageway extends into the cavity of the container to allow the albumin to be released from the fluid-tight chamber. A chevron may be located a distance from the opposing sides of the fitment, and along the fold, to assist drainage of the albumin from the container.
According to another aspect of the present invention, a heat seal block is provided to insulate the fitment heater from the filler assembly.
According to another aspect of the present invention, the peripheral edge of the container opposing the fold contains a first seal and a second seal. The first and second seals join the first and second opposing walls. An aperture is located between the first seal and the second seal, and extends through the first and second opposing walls.
According to another aspect of the present invention, the flexible polymeric sheet material comprises a laminate film having an outside layer of linear low density polyethylene, a gas barrier layer, a core layer of polyamide, and an inside layer of linear low density polyethylene. The layers are bonded together by a polyurethane adhesive.
According to another aspect of the present invention, albumin in concentrations of 20% and 25% is packaged in the flexible polymeric container. Additionally, the flexible polymeric containers may have a volume of 50 ml. or 100 ml.
According to another aspect of the present invention, a method of packaging albumin protein, as well as other solutions, comprises providing a flexible polymeric container having an opening extending from a cavity of the po
Baccia William
Card John Carl
Eder Helmut
Habison Georg
Langer Theodor
Baxter International Inc.
Gerrity Stephen F.
Wallenstein Wagner & Rockey Ltd.
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