Stock material or miscellaneous articles – Structurally defined web or sheet – Including components having same physical characteristic in...
Reexamination Certificate
2002-04-05
2003-07-15
Zacharia, Ramsey (Department: 1773)
Stock material or miscellaneous articles
Structurally defined web or sheet
Including components having same physical characteristic in...
C428S332000, C428S337000, C428S422000, C428S423100, C428S480000, C428S500000, C428S522000, C428S523000, C428S220000, C206S531000, C206S532000
Reexamination Certificate
active
06592978
ABSTRACT:
TECHNICAL FIELD
The subject invention relates generally to a three component laminate barrier film used for packaging and a method for making such a film. The film is particularly useful where a high barrier material having a fluoro-polymer content is used in pharmaceutical packaging and must be bonded on both surfaces with other materials to produce a blister package.
BACKGROUND OF THE INVENTION
Blister packaging, has applications in a variety of industries including the food and medical markets. But it is in the pharmaceutical area where metered provision to patients of ampoules, tablets or capsules to patients provided in blister packs occurs that it has found its broadest application in the past. This type of packaging typically consists of a thermoformed blister to the top side of which an information bearing material is applied and to the bottom side of which a tear susceptible material such as aluminum foil is applied. Blister packages used in the pharmaceutical industry also have particularly demanding requisites which the packaging industry has found difficult to meet concurrently in a single product formulation.
One of these demands is for a package having high moisture vapor barrier characteristics. This type of barrier is called for to protect stored products from environmentally-based deterioration. Such a barrier can be achieved by including a layer comprised of a fluoro-polymer material such as ACLAR®-laminated vinyl. ACLAR® is a poly chloro-tri-fluoro ethylene film and is a registered trademark of Honeywell, Inc. However, due precisely to their high fluorine content, it is extremely difficult for other substrates to adhere to such films. As a result, it has been necessary to use separate adhesives and adhesive application and curing techniques to achieve a bond between other substrates, such as aluminum foil or PVC, and laminates having a high fluorine content. For example, a dry-bond laminating adhesive may be used to provide adequate adhesion between PVC and a high fluorine content laminate.
In some blister package designs, it is desirable to apply a printed PVC card displaying important product information to one side of a high fluorine content surface and an aluminum foil lidding to its other side. There do not appear to be any adequate aluminum foil or plastics heat seal coatings for sealing to a high fluorine content surface. Consequently, in the past it has been necessary in such cases to produce a basic PVC/Aclar® product using a dry bonding laminating adhesive and then to heat seal aluminum foil to the PVC surface while adhering the printed PVC card to the high fluorine content surface by means of ultrasonic welding. The PVC card is provided with a heat seal coating on the side opposite of the printing to allow for adhering the card to the high fluorine content surface by means of ultrasonic welding. The ultrasonic welding process increases the temperature of the high fluorine content surface and the PVC card, allowing the two materials to fuse together. The resultant product has several disadvantages. First, there is poor adhesion between the high fluorine content surface and the coated surface of the printed PVC card so that the printed PVC cards will occasionally detach from the blister package. The poor adhesion is due to the basic incompatibility between the high fluorine content surface and the adhesive-coated PVC card. Second, the ultrasonic welding increases the temperature of the blister package which can create holes in the package. These holes can compromise the package barrier thereby causing leaking. Finally, the ultrasonic welding of the package is performed manually at a significant cost in time and labor thereby reducing productivity and increasing costs.
There exists, therefore, a need for a material having the high moisture vapor barrier properties of a high fluorine content layer but without the adhesive difficulties inherent in layers comprised of fluoro-polymers alone or the disadvantages encountered when ultrasonic welding is used.
SUMMARY OF THE INVENTION
The present invention relates to blister packages. It has particular utility in the pharmaceutical industry for the packaging, storing and dispersal of medications although it may also be used in a variety of other fields such as the food industry and general retailing. A three part, unoriented laminate film having a crystallinity level of 35% or less for use in such packaging is disclosed which may be thermoformed and includes a high moisture barrier. The central core layer of the laminate is a fluoro-polymer-based sheet material. Separate polymer films are attached adhesively to each side of the central core layer. The polymer films may be the same or differ from each other chemically depending on the characteristics sought.
An alternative embodiment would provide a package structure in which the laminated film would not be thermoformed but would be used as a flat sheet to which a pouch containing a product could be attached.
It is a primary objective of this invention to provide a laminated material for use in blister packaging incorporating a fluoro-polymer which can be readily sealed on both surfaces while maintaining good inter-laminar strength within the laminated material itself.
An additional objective of this invention is to provide a laminated film for use in blister packaging having a high moisture barrier.
Another objective of this invention is to provide a laminated film incorporating a core fluoro-polymer layer to which both aluminum foil and plastic heat seal coatings can be applied.
It is a further objective of this invention to provide a laminated film which reduces the length of time needed for ultrasonic welding in the package forming process thereby virtually eliminating the likelihood that holes will be created in the resulting blister package due to prolonged exposure to increased temperatures associated with the welding process.
It is yet another objective of this invention to provide a laminated film which will increase the speed with which blister packages requiring high moisture barriers can be made by replacing manual ultrasonic welding with automated ultrasonic welding thereby increasing productivity and reducing costs.
It is still another objective of this invention to provide a laminated film with improved inter-laminar adhesion and decreased likelihood of inter-laminar detachment.
Yet an additional objective of this invention is to provide a laminated film for use in a blister packages which have a lower coefficient of friction and better “denest” properties than similar packages of the prior art.
Still another objective of this invention is to provide a three layer laminated structure to the outer surface of which a PVC printed card will adhere without the need for a heat seal coating, thereby reducing production costs and wherein the structure includes a core layer comprised of a fluoro-polymer product.
Yet a further object of this invention is to provide a three layer laminated structure in which the outer layers may be symmetrical or asymmetrical with respect to each other in that they may be of equal or differing thicknesses and/or of the same or differing materials.
Still another object of this invention is to reduce the possibility that a laminated film including a fluoro-polymer based product such as Aclar® will stick to machine heating plates and tooling when exposed to high temperatures during a manufacturing process.
Yet an additional object or this invention is to produce a symmetrical, three layer laminated film employing a fluoro-polymer based product such as Aclar® for use in manufacturing packaging in which package curl may be substantially reduced in comparison with two layer films known in the art.
Still another object of this invention is to provide a three layer laminated product employing a fluoro-polymer central layer for use in manufacturing blister packaging having improved moisture barrier characteristics when compared with known two layer products used for the same purpose.
Yet another object of this invention is to prov
Carter Kevin Junior
Miller Mark Ralph
Kloeckner Pentaplast of America, Inc.
Rosden Peter E.
Zacharia Ramsey
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