KR100781022B1 - Containers and Peelable Seal Containers of Non-PVC Material - Google Patents

Abstract

The present invention provides a fluid material container 30. The container 30 has a first side wall 32 and a second side wall 32 that are sealed together along the peripheral seam 43 to define the fluid chamber. At least one of the side walls 32 is (1) a copolymer of ethylene and α-olefin having a density of less than about 0.915 g / cc, (2) ethylene copolymerized with lower alkyl acrylate, (3) lower alkyl substituted alkyl A first component present in an amount from about 99% to about 55% by weight in the blend, selected from the group consisting of ethylene copolymerized with acrylate and (4) ionomers, and (1) propylene containing polymers, (2) polybutene From about 45% to about 1% by weight of the blend, consisting of one or more polymers comprising a polymer, (3) a polymethylpentene polymer, (4) a cyclic olefin containing polymer, and (5) a crosslinked polycyclic hydrocarbon containing polymer Film 10 having at least one layer of blend of second components present in an amount, wherein film 10 has an elastic modulus of less than about 60,000 psi as measured according to ASTM D882, about 25% as measured according to ASTM D1003 Under internal blur (haz e) a film of greater than about 2 internal adhesion grade, about 5 mils to about 15 mils thick, having no more than 150% sample creep under a load of 27 psi at 120 ° C., and the film 10 being 121 It may be heat sealed with a container 30 having a seal which remains intact when autoclaved for 1 hour at < RTI ID = 0.0 >

Fluid Material Containers, Steam Sterilization, Heat Sealing, Flexible, Polymer Blends

Description

Containers and Peelable Seal Containers of Non-PVC Material

The present invention generally relates to polymers, more particularly to polymer blends for producing warp-free, non-sticky, steam-sealed, heat-sealable, suitable films for the manufacture of flexible medical containers.

In the field of medicine, where a beneficial drug is collected, processed, stored in a container, transported and eventually injected and delivered to a patient via a tube to achieve a therapeutic effect, the material used to make the container must have a unique combination of properties. . For example, the container must be optically transparent to visually examine whether the solution contains particle contaminants. In order to inject a solution by clamping the vessel wall without injecting air into the vessel, the material forming the vessel wall must be sufficiently flexible. Such materials must maintain flexibility and robustness over a wide temperature range. Because some solutions, such as certain premixed drug solutions, are stored and transported in containers at temperatures such as -25 to -30 ° C. to minimize drug degradation, these materials must be flexible and robust at low temperatures. do. In addition, these materials must function at high temperatures so that most medical fluid containers and nutritional products are not warped to withstand the heat of steam sterilization, a process where they are processed prior to shipment. Sterilization generally involves exposing the vessel to steam at a temperature of 121 ° C. and elevated pressure.

In order to facilitate the manufacture of useful articles, these materials are preferably sealable using heat seal techniques. Therefore, these materials must maintain sufficient thermoplastic properties to melt upon heating.

An additional condition is to minimize the impact on the environment when the articles made from these materials are used and disposed of as desired. In the case of articles disposed of in landfills, it is desirable to minimize or avoid incorporation of low molecular weight leaching components in the manufacture of the articles. Another advantage can be realized by using materials that can reprocess the scrap material produced during manufacture with heat.

For containers that are disposed of through incineration to minimize biological hazards, it is desirable to use materials that minimize or eliminate the formation of environmentally undesirable and corrosive inorganic acids.

In addition, such materials preferably contain no or small amounts of low molecular weight additives such as plasticizers, stabilizers and the like that can be released into pharmaceuticals or biological fluids.

Flexible polyvinyl chloride (PVC) was often the material of choice for medical bag applications because it could meet a wide range of functional conditions. In addition, the obvious advantage is that PVC is one of the most cost-effective materials for producing devices that meet these conditions. However, PVC has many disadvantages in the market. These shortcomings include concerns related to the incompatibility of PVC compounds with certain drugs, chlorine content and their environmental impact, and the general negative market growth of PVC. Therefore, many materials have been devised to replace PVC. However, most alternatives are too expensive to implement and still do not meet all of the above requirements.

Polyolefins and polyolefin mixtures have been developed to meet many of the conditions of medical containers and tubes without the disadvantages associated with PVC. Polyolefins are typically available for medical use because of their relatively low extractability to fluids. Most polyolefins are environmentally preferable because they do not produce harmful decomposition products upon incineration and are suitable for thermoplastic reactivation. Many polyolefins are cost saving materials that can provide an economic alternative to PVC. However, there are many obstacles to overcome in order to replace all the desirable properties of PVC with polyolefins.

For example, problems have arisen when certain polyolefins are used to make medical tubes. These tubes have been found to have inferior surface properties that are susceptible to being cut, torn or cracked when clamping the tubes using slide clamps. In addition, certain polyolefins with desirable modulus properties, such as ultra low density polyethylene, have melting points below the temperature reached during the autoclave treatment process.

It is well known that crosslinking by chemical or high energy ionizing radiation increases the heat resistance of the polymer matrix. Chemical crosslinks are covalent bonds between individual polymer chains, which significantly inhibit deformation and flow tendencies even at high temperatures above the melting point of the polymer. For example, U.S. Patent No. 4,465,487, assigned to Terumo, was used to irradiate ethylene vinyl acetate copolymer with a high energy (2 Mev) electron beam of 50 kGy to 100 kGy to achieve a gel content of 50% to 85%. This discloses the manufacture of a vapor autoclave treated medical container. US Pat. No. 4,465,487 discloses that the EVA sidewalls of a container are irradiated before being sealed together to achieve a gel content of at least about 50% and easily peel off (Col. 4, lines 20-30). Accordingly, US Pat. No. 4,465,487 discloses examining a sidewall of a container after sealing the container in the form of a pouch without sealing only the entrance area.

Similarly, US Pat. No. 4,453,940 discloses the manufacture of medical containers from EVA and other materials. U. S. Patent 4,453, 940 also discloses a step of crosslinking the material with a high energy electron beam to increase the autoclave treatment resistance of the EVA. U.S. Patent No. 4,453,940 warns that if the crosslink exceeds 50%, heat sealing becomes impossible (Col. 4, lines 27-35).

U. S. Patent No. 4,401, 536 discloses crosslinking a semi-rigid container made of a blend of polypropylene and EVA or EEA. This patent does not disclose the use of ethylene alpha olefins with polypropylene. It also discloses that pre-molding irradiation results in products with poor heat sealability (Col. 4, lines 25-28).

US Pat. Nos. 4,892,604 and 5,066,290, both assigned to the assignee of the present invention, provide a medical container comprising a coextruded high density polyethylene outer shell layer and a core layer of ethylene vinyl acetate copolymer having a vinyl acetate content of about 18%. It is starting. After the container is prepared by conventional high frequency heat sealing, the assembly is exposed to about 100 kGy of ionizing radiation from about 5 Mev of high energy electron beam accelerator. The high density polyethylene layer acts as a vapor and gas permeation barrier to maintain sterile fluid content at a relatively constant concentration as required by various pharmacopeias worldwide. However, in such material structures, 1) the crosslinked EVA layer is not impossible, but difficult to seal, so to manufacture a container from such a material structure, the container must be manufactured prior to the crosslinking process (which makes the manufacturing process very inefficient). ), 2) A number of serious drawbacks are evident that the dosage required for sufficient crosslinking also releases a significant amount of acetic acid, a byproduct of irradiation exposure. Since HDPE provides a barrier to gas permeation, confined acetic acid can make the fluid content quite acidic, which is a very undesirable result.

U. S. Patent No. 4,643, 926, assigned to W. R. Grace, discloses in certain embodiments the manufacture of a medical solution container from a multi-layered material in which the layer to be heat sealed is composed primarily of polypropylene. It is well known that polypropylene is chain cut when exposed to irradiation, so that the heat seal layer remains thermoplastic and can be heat sealed to similar surfaces. Thus, the entire multilayer film can be heat sealed and withstand autoclave processing. However, the complexity of the multilayer structure and the possibility of cleaning and the incorporation of acid scavenger compounds in the film to remove the acid byproducts of the EVA irradiation (US Pat. No. 5,445,893) make the process considerably complex and costly. do. Also, because the film is composed of many very different materials, reuse of edge trims and other film scraps is very difficult and impractical unless it significantly reduces optical and mechanical properties.

U.S. Patent 5,055,328 discloses a multi-layered, differentially crosslinked film in which the heat sealed layer contains additional antioxidants to prevent crosslinking and promote heat seal after crosslinking. Likewise, Canadian Patent 1,125,229 discloses another distinct crosslinked multilayer film in which the outer layer contains a crosslinking promoter. However, these structures are all multilayer structures and do not solve the problem of self-adhesion during autoclave treatment.

US Pat. No. 4,724,176, to Sun, discloses a multilayered, oriented heat shrinkable container that includes a radiation crosslinked outer layer, a noncrosslinked inner seal layer by adjusting the irradiation process. The inner and outer layers can be EVA copolymers. Such a container is designed to shrink upon heating and would be unsuitable for a container that must maintain substantially its full volume after the autoclave treatment process.

It is a primary object of the present invention to provide a polymerizable material which is generally superior to the materials as we know it so far known in the art or used commercially or commercially. The properties of these materials include flexibility, optical transparency for visual inspection and sufficient heat resistance to withstand steam sterilization processes at temperatures up to 121 ° C. without significant distortion or self-adhesion. The material must also be non-oriented, non-adhesive and able to be sealed using heat seal techniques. The material should also be substantially free of low molecular weight leach additives and be able to be disposed of safely by incineration without producing significant amounts of corrosive inorganic acids. Finally, the material should serve as a cost-effective alternative to the various PVC formulations currently used in medical devices.

U.S. Patent 5,879,768 discloses (A) (1) 5 to 95% of at least one uniformly branched substantially linear ethylene / α-olefin interpolymer, and (2) a high pressure low density polyethylene having a density of 0.916 to 0.930 g / cc. 5 to 95% of the mixture 10 to 100%, and (B) one polymer selected from the group consisting of ultra low density polyethylene, linear low density polyethylene, high pressure low density polyethylene, ethylene vinyl acetate copolymer and uniformly branched linear ethylene polymer A fluid material packaging pouch made from a material having a sealing layer of a polymerizable composition comprising 90% is disclosed. U. S. Patent No. 5,879, 768 does not disclose exposing this blend to irradiation, or blending a homogeneously valuable substantially linear ethylene / a-olefin interpolymer with polypropylene.

When blending one or more polymers to form a mixed composition, it is difficult to achieve all of the above objectives simultaneously. For example, many mixtures cause significant light scattering so that they fail to meet the purpose of optical transparency. Light scattering intensity (measured by the blur) is dependent on the domain size in the micrometer (μ) range of the components and the proximity of the refractive indices of the components. In general, the selection of components that can be satisfactorily processed with very small domain sizes while minimizing refractive index shifts is a difficult task. The present invention is provided to solve these and other problems.

Summary of the Invention

The present invention provides a flowable material container in which the first sidewall and the second sidewall are sealed together along a peripheral seam to define a fluid chamber. At least one of the first sidewall and the second sidewall is a film having one or more layers of a blend of the first component and the second component. The first component is copolymerized with (1) a copolymer of ethylene and α-olefin having a density of less than about 0.915 g / cc, (2) ethylene copolymerized with lower alkyl acrylate, (3) lower alkyl substituted alkyl acrylate Ethylene and (4) ionomers. The first component is present in an amount of about 99% to about 55% based on the blend weight. The second component is present in an amount from about 45% to about 1% based on the blend weight and includes (1) propylene containing polymer, (2) polybutene polymer, (3) polymethylpentene polymer, (4) cyclic olefin At least one polymer from the group consisting of a containing polymer and (5) a crosslinked polycyclic hydrocarbon containing polymer. The film has an elastic modulus of less than about 60,000 psi as measured in accordance with ASTM D882, an internal haze of less than about 25% as measured in accordance with ASTM D1003, an internal adhesion rating of greater than about 2 (as defined below), about 5 mil to about 15 mil thick film having a sample creep of less than 150% at a load of 27 psi at 120 ° C., the film having a seal that remains intact when the container is autoclaved at 121 ° C. for 1 hour. The container may be heat sealed.

1 is a cross-sectional view of a monolayer film of the present invention,

2 is a cross-sectional view of a multilayer film of the present invention,

3 is a material container made from the film of the present invention,

4 is a set for intravenous fluid administration,

5 is a peritoneal dialysis vessel and tube set,

6 is a double chamber bag with a peelable seal separating the chambers.

<Detailed Description of the Invention>

The invention is applicable to many different forms of embodiments. While preferred embodiments of the invention are disclosed, it is to be understood that such disclosure is considered as an illustration of the principles of the invention and is not intended to limit aspects of the broad meaning of the invention to the illustrated embodiments.

I. Polymer Blends and Monolayer Films Therefrom

1 shows a monolayer film 10 of the present invention. The monolayer film 10 is made from a polymer blend comprising a first component and a second component. The first component comprises (1) an interpolymer of ethylene and an α-olefin having a density of less than about 0.915 g / cc, (2) an interpolymer of ethylene and lower alkyl acrylate, (3) an ethylene and lower alkyl substituted alkyl acrylate Interpolymers and (4) ionic polymers generally referred to as ionomers. The first component is present in an amount from about 99% to about 55%, more preferably from about 60% to about 85%, most preferably from about 65% to about 80% by weight in the blend. The second component is selected from the group consisting of (1) propylene containing polymers, (2) butene containing polymers, (3) polymethyl pentene containing polymers, (4) cyclic olefin containing polymers, and (5) crosslinked polycyclic hydrocarbon containing polymers. Is selected. The second component is present in an amount from about 45% to about 1% by weight, more preferably from about 15% to about 40%, most preferably from about 20% to about 35% by weight of the blend.

The film has an elastic modulus of less than about 60,000 psi as measured according to ASTM D882, an internal haze of less than about 25% as measured according to ASTM D1003, an internal adhesion rating of greater than about 2 (as defined below), 27 psi at 120 ° C. It can be heat-sealed with a container having a sample creep up to 150% under a load of and the liquid filled container remains sealed when autoclaved at 121 ° C. for 1 hour.

The term "interpolymer" as used herein includes random or block copolymers, terpolymers.

Suitable interpolymers of ethylene and α-olefins preferably have a density of less than about 0.915 g / cc, as measured according to ASTM D-792, and are generally referred to as very low density polyethylene (VLDPE), ultra low density ethylene (ULDPE), and the like. It is called. The α-olefins should have 3 to 17, more preferably 4 to 12 and most preferably 4 to 8 carbons. In one preferred form of the invention, copolymers of ethylene and α-olefins are obtained using a single site catalyst. Suitable single site catalyst systems among others are those disclosed in US Pat. Nos. 5,783,638 and 5,272,236. Suitable copolymers of ethylene and α-olefins are copolymers sold under the trade name AFFINITY by Dow Chemical Company, under the trade name Engon by Dupont-Dow. Copolymers sold under the trade names EXACT and PLASTOMER by Exxon.

The term "lower alkyl acrylate" means a comonomer of formula

Wherein R group means alkanes having from 1 to 17 carbons. Thus, the term "lower alkyl acrylate" includes but is not limited to methyl acrylate, ethyl acrylate, butyl acrylate and the like.

The term "alkyl substituted alkyl acrylate" means a comonomer of formula (2)

Wherein R ₁ and R ₂ are alkanes having 1 to 17 carbons and may have the same or different carbon numbers. Thus, the term "alkyl substituted alkyl acrylates" includes, but is not limited to, methyl methacrylate, ethyl methacrylate, methyl methacrylate, ethyl acrylate, butyl methacrylate, butyl acrylate, and the like. Do not.

Suitable propylene containing polymers include those selected from homopolymers of polypropylene, copolymers of propylene with at least one comonomer selected from α-olefins having from 2 to 17 carbons, and terpolymers. Suitable polypropylene copolymers and terpolymers include random or block copolymers of propylene and ethylene or random or block terpolymers of propylene / ethylene / butene. Suitable copolymers of polypropylene and α-olefins are commercially available from Montel under the trade names PRO FAX, PRO FAX ULTRA and CATALLOY.

The present invention also contemplates using a blend of propylene containing polymers as the second component of the blend. In a preferred form of the invention, the blend comprises at least a first propylene containing polymer and a second propylene containing polymer. The first propylene containing polymer and the second propylene containing polymer may be selected from the propylene homopolymers, copolymers and terpolymers described above. In a preferred form of the invention, the first propylene containing polymer differs from the second propylene containing polymer in at least two respects. The first difference is that the melt flow rate of the first propylene containing polymer should preferably be about three times, more preferably about five times greater than the melt flow rate of the second propylene containing polymer. The second difference is that the melting point of the first propylene containing polymer is preferably at least about 5 ° C., more preferably at least about 10 ° C. above the melting point of the second propylene containing polymer. Melting points are measured according to ASTM D3417 (Fusion and Crystallization Enthalpy of Polymers Measured by Differential Scanning Calorimetry). The first propylene containing polymer may be different from the second propylene containing polymer in terms of first difference, second difference, or both.

Suitable homopolymers and copolymers of cyclic olefins and crosslinked polycyclic hydrocarbons and their blends are incorporated by reference in their entirety and form part of the present invention, which is incorporated herein by reference in U.S. Pat. Nos. 5,795,945, 5,792,824, and EP 0 291,208, EP 0 283,164, EP 0 497,567.

In a preferred form of the invention, suitable cyclic olefin monomers are monocyclic compounds having from 5 to about 10 carbons in the ring. Cyclic olefins may be selected from the group consisting of substituted and unsubstituted cyclopentene, cyclopentadiene, cyclohexene, cyclohexadiene, cycloheptene, cyclohepdiene, cyclooctene, cyclooctadiene. Suitable substituents include lower alkyl, acrylate derivatives and the like.

In a preferred form of the invention, suitable crosslinked polycyclic hydrocarbon monomers have at least two rings, more preferably contain at least 7 carbons. The ring may be substituted or unsubstituted. Suitable substituents include lower alkyl, aryl, aralkyl, vinyl, allyloxy, (meth) acryloxy and the like. The crosslinked polycyclic hydrocarbons are selected from the group consisting of those disclosed in the patents and patent applications described above. Suitable crosslinked polycyclic hydrocarbon containing polymers are available from Ticona under the tradename TOPAS, from Nippon Zeon under the tradenames ZEONEX and ZEONOR, and under the tradename CZ resin. Commercially available from Daikyo Gomu Seiko and from Mitsui Petrochemical Company under the trade name Apel.

In a preferred form of the invention, the film has (1) an elastic modulus of less than about 60,000 psi as measured in accordance with ASTM D882, (2) an internal haze of less than about 25% as measured in accordance with ASTM D1003, and (3) as defined below. Self-adhesion grade greater than about 2, (4) non-adherence to over pouch material, (5) no more than 150% sample creep under a load of about 27 psi at 120 ° C., and (6) liquid filled containers 121 It will have physical properties that can be heat sealed to a container with a seal that remains intact when autoclaved for 1 hour at &lt; RTI ID = 0.0 &gt;

The film is also flexible enough to construct a flowable material container. The film has an elastic modulus of less than about 60,000 psi, more preferably less than about 40,000 psi, even more preferably less than about 30,000 psi, most preferably less than about 20,000 psi as measured according to ASTM D-882. If the flexible material container is an intravenous administration container, it is desirable that the container be crushed or nearly crushed upon discharge, and therefore less than about 40,000 psi, more preferably less than about 30,000 psi, even more as measured according to ASTM D-882. It should preferably have an elastic modulus of less than about 20,000 psi.

For the purposes of the present invention, self adhesion is defined as the tendency for the film to adhere to itself during the autoclave treatment. This property can be measured by the following test. The film strip is cut 8 "x 2" so that the long dimension is in the machine direction. These strips are wound in a 2 "long tube about 0.5" in diameter. The wound film is held in place by compressing the film layer with paper tongs at one end. The tube is then placed in a steam autoclave at 121 ° C. for 30 minutes. The sample is cooled for at least 1 hour. Next, unpack the film. The resistance to annealing and the relative damage of the film are graded as shown in Table 1 below.

Rating Observation One The film could not be unwound without breaking the film. 2 It is difficult to peel off the film and there was significant surface damage. 3 There was some resistance to delamination, with some surface damage. 4 There is little resistance to delamination and little or no surface damage. 5 There is no resistance to delamination and no surface damage. Grades were measured for at least three and reported as average values.

Adhesion to the overpouch material is measured by the following qualitative test. A 1 "wide strip of film is sealed in a typical over pouch bag (medium or high density polypropylene). The over pouch bag is then placed in a laboratory autoclave at 252 ° F. and 24.5 psig gauge pressure for 1 hour. The bag is then cut open, the strip is removed, and if the film is detached from the overpouch without causing damage on the film surface, it is graded non-stick (N). , Grade (Y) to indicate the presence of residue in the overpouch, and grade (S) for even slightly sticky ones.

Creep properties were measured at 120 ° C. by clamping a film strip having a thickness of about 5 mils to about 15 mils in a temperature controlled oven and loading the weight to provide a stress of about 27 psi. After loading for 40 minutes, the film strip was removed and the dimensional change in the previously marked 1 "gap was recorded.

The film can be sealed using standard heat sealing techniques. Suitable heat seals are formed when sealing the peripheral edges from the film to define a centrally located fluid chamber to produce a fluid container such as that shown in FIG. 3. Fill the vessel with water and perform a standard autoclave sterilization process. Appropriate heat seals remain in place upon completion of the autoclave cycle.

The film of the present invention has a haze of less than about 25%, most preferably less than about 15% as measured according to ASTM D1003. For the purposes of the present invention, the internal haze is defined as the haze measured when both surfaces of the film are wetted with isopropyl alcohol.

II. Polymer and Film Processing

To produce the film of the present invention, the raw material is fed to the extrusion hopper at a desired mixing ratio using a weight feeder. The material is extruded using an extrusion die to produce a single layer film. The film is irradiated with a suitable energy source and then sealed to form a fluid container. It is also contemplated to expose the blend to radiation before extrusion. The raw material may be premixed before extrusion by using a single screw method, a twin screw method or other compounding methods known to those skilled in the art.

A preferred method of film irradiation is to apply the film to an electron beam having a beam energy of about 150 Kev to 10 Mev, more preferably 200 to 300 Kev and an irradiation amount of about 20 kGy to about 200 kGy, more preferably about 60 to 150 kGy. To expose it. Alternatively, the film can be crosslinked using methods known to those skilled in the art. Industrially used crosslinking methods include exposure to ionizing radiation (gamma, beta, ultraviolet, etc.) and chemicals (peroxide and condensation reactions).

In order to reduce or minimize oxidative degradation of the film during and after electron beam exposure, it is desirable to reduce the oxygen partial pressure in the peripheral region of the film to be exposed to radiation. The oxygen partial pressure can be reduced by applying a vacuum or by adding another gas, such as nitrogen, under pressure, or by using other known techniques to achieve this object. In a preferred form of the invention, the oxygen concentration during nitrogen flushing is less than about 100 ppm, more preferably less than about 40 ppm.

III. Multilayer film

2 shows an example of a multilayer film 20 comprising the single layer 12 described above. In a preferred form of the invention, the monolayer is a sealing layer. Multilayer film 20 includes any additional layer 14, or a combination of additional layers selected from, for example, outer layers, high frequency sensitive layers, water vapor barrier layers, gas barrier layers, scrap layers, sealing layers, core layers, and the like. can do.

The outer layer can be added to increase the scratch resistance of the film. The outer layer can be an olefinic material such as homopolymers and copolymers of propylene and ethylene. The outer layer can also be polyester, copolyester, polyamide or copolyamide. The term “copolyester” and the like refers to polyesters synthesized from one or more diols and dibasic acids. Copolyesters as used herein can also be characterized as copolymers of polyethers and polyethylene terephthalates. More preferably, the copolyesters used herein are polymers derived from 1,4 cyclohexane dimethanol, 1,4 cyclohexane dicarboxylic acid, and polytetramethylene glycol ether, or the equivalents of any of these as reactants. Can be characterized as a substance.

Suitable water vapor barriers include, but are not limited to, HDPE, MDPE, and polyesters (PET, PBT, PEN, etc.).

Suitable gas barriers are to inhibit the passage of oxygen, carbon dioxide or other gases. Suitable gas barriers include, but are not limited to, polyesters and polyamides.

The resulting scrap material may be introduced in one or more layers prior to irradiation.

IV. Fluid material container

3 shows a flowable substance container, in particular an intravenous administration container 30. 4 shows an intravenous set of administrations 40, and FIG. 5 shows a peritoneal dialysis set 50. The present invention also contemplates the manufacture of medical tubes from the blends of the present invention. Radiation treatment for the tube is performed differently from the film due to the increased thickness and the circular shape of the tube, but can effectively treat the tube within the radiation energy range set above for the film. "Fluid material" means a material that flows by gravity. Thus, flowable materials include both liquid products and powdered or granular products and the like. The vessel 30 has a sidewall 32 that is mated and defines a chamber 34 that is sealed along the peripheral edge to contain a flowable material, such as a liquid or granular material. For containers made by blow molding alone or through blow extrusion, the longitudinal edges will be sealed. An entry tube 36 or a plurality of entry tubes is provided for filling and discharging the contents of the vessel 30. The side wall and the entry tube can be made of one of the single or multilayer films described above. Surprisingly, medical products made from the films and blends described above can be heat sealed even if the film is electron beam irradiated.

Heat sealing can be accomplished using standard heat sealing techniques known to those skilled in the art.

V. Double chamber peelable sealed container

FIG. 6 shows a dual chamber container 70 having a first chamber 72 and a second chamber 74 separated by a peelable seal 76. The container sidewall 75 is made from one of the polymer blends, monolayer films or multilayer films described above. Dual chamber vessels can be used for a number of uses, such as two components packaged separately for subsequent mixing. The components can be liquid or powdery. The peelable seal can be formed by modifying the sealing conditions such that a force can be applied to the side wall 75 of the container to rupture the peelable seal 76. Typically, one of the chambers will contain a liquid. Pressurizing the container sidewall 75 onto the liquid containing chamber causes the liquid contents to flow towards the peelable seal 76 and, by applying sufficient pressure, the seal 76 is ruptured and the components stored in a separate chamber are mixed. will be.

6 shows only one peelable seal 76, it is contemplated to provide numerous peelable seals to form numerous chambers. 6 also shows a peelable seal extending between the transverse edges. It is also contemplated that the peelable seal extends between the longitudinal edges, or simply around the region defining the chamber, without crossing the permanent peripheral seam 79.

The peelable seal 76 may be formed at the same time as sealing the peripheral sidewall or before or after forming the permanent peripheral seal. The peelable seal 76 can be formed by adjusting the sealing conditions. The peelable seal may be formed by applying a temperature and pressure lower than that used to provide a permanent peripheral seal, or by reducing the number of seals than that used to provide a permanent seal. To further improve the peeling properties, the film surface properties can be locally modified (corona or other suitable treatment).

It is conceivable to seal the vessel using ultrasonic welding techniques, conductive heat sealing techniques and other sealing techniques well known in the art.

IV. Example

The blends shown in the table below were made into a monolayer film using an extrusion process. The film was exposed to electron beam radiation with an acceleration pressure of 200 Kev to 300 Kev for the dose sets described in the table below.

Formulation One 2 3 4 5 6 7 8 9 10 DuPont / Dow Engage 8003 100 95 90 90 70 Dow Affinity PL-1880 100 95 90 80 70 Exxon PP3505GE1 5 10 20 Montel SA-861 5 10 20 30 20 Montel SG-982 10 Self-Adhesive Rating-100 kGy One 2 3.7 4 One NA One 2 4 NA 150 kGy One 2 4.5 5 One NA 1.3 2.3 3.3 NA 200 kGy One 3.3 4.7 5 One 1.7 2 2 4 NA Residue on Over Pouch-100 kGy Y S N N Y NA Y S N NA 150 kGy Y S N N Y NA Y N N NA 200 kGy Y S N N Y NA Y N N NA 120 ° C. Creep (%)-0 kGy NA NA NA NA NA NA Melting NA 550 NA 100 kGy 200 138 88 41 263 NA 216 98 28 NA 150 kGy 63 38 31 18 43 NA 31 25 13 NA 200 kGy 25 13 16 16 21 22 16 9 22 NA Autoclave ability 100 kGy NA NA Y Y NA NA NA Y Y Y 150 kGy NA NA Y Y NA NA NA Y Y Y NAV Blur (ASTM D1003) One 1.2 1.6 2.8 2.7 2.7 3.5 4.3 4.8 2.2 Tensile Modulus (psi) (ASTM D882) 2860 3800 6650 16260 6110 NA 12830 19810 28820 21060 Dow Affinity PL 1880 is a ULDPE with a density of 0.902 g / cc. DuPont Dow Engage 8003 is a ULDPE with a density of 0.885 g / cc. Exon PP305GE1 is a propylene homopolymer (MFR 440). Montel SA-861 is a propylene and ethylene copolymer (MFR 6.5). Montel SA 982 is a propylene and ethylene copolymer (MFR 100). "NA" means not valid.

Claims (41)

A first sidewall and a second sidewall sealed together along the peripheral seam to define a fluid chamber, wherein at least one of the first and second sidewalls is (1) ethylene and α- having a density of less than 0.915 g / cc; 99% to 55% by weight in the blend, selected from the group consisting of copolymers of olefins, (2) ethylene copolymerized with lower alkyl acrylates, (3) ethylene copolymerized with lower alkyl substituted alkyl acrylates, and (4) ionomers A first component present in an amount of% and containing (1) a propylene containing polymer, (2) a polybutene polymer, (3) a polymethylpentene polymer, (4) a cyclic olefin containing polymer and (5) a crosslinked polycyclic hydrocarbon A film having at least one layer of blend of second components present in an amount of 45% to 1% by weight in the blend, selected from the group consisting of polymers, The film has an elastic modulus of less than 60,000 psi as measured in accordance with ASTM D882, an internal haze of less than 25% as measured in accordance with ASTM D1003, an internal adhesion grade of greater than 2, and a film of 5 mil to 15 mil thick at 120 ° C. A flowable material container having a sample creep of 150% or less under a load of 27 psi and the film can be heat sealed with a container having a seal that remains intact when the container is autoclaved at 121 ° C. for 1 hour. . The method of claim 1, wherein the second component is a propylene containing polymer, which is a random and block copolymer and a random of homopolymers of polypropylene and at least one comonomer selected from propylene and an α-olefin having from 2 to 17 carbons. And a block terpolymer. The container of claim 2 wherein the second component is a propylene and ethylene copolymer having an ethylene content of 1 to 6 weight percent of the copolymer. The container of claim 1 wherein the second component is a blend of the first propylene containing polymer and the second propylene containing polymer. The container of claim 4, wherein the first propylene containing polymer has a first melt flow rate, the second propylene containing polymer has a second melt flow rate, and the first melt flow rate is three times greater than the second melt flow rate. The container of claim 4, wherein the first propylene containing polymer has a first melt flow rate, the second propylene containing polymer has a second melt flow rate, and the first melt flow rate is five times greater than the second melt flow rate. The container of claim 4, wherein the first propylene containing polymer has a first melting point, the second propylene containing polymer has a second melting point, and the first melting point is at least 5 ° C. higher than the second melting point. The container of claim 4, wherein the first propylene containing polymer has a first melting point, the second propylene containing polymer has a second melting point, and the first melting point is at least 10 ° C. higher than the second melting point. The container of claim 1 wherein the second component is a cyclic olefin having 5 to 10 carbons in the ring. The container of claim 9, wherein the cyclic olefin is selected from the group consisting of substituted and unsubstituted cyclopentene, cyclopentadiene, cyclohexene, cyclohexadiene, cycloheptene, cycloheptadiene, cyclooctene and cyclooctadiene. delete delete The container of claim 1 wherein the first component is a copolymer of ethylene and an α-olefin having 3 to 17 carbons. The container of claim 1 wherein the first component is a copolymer of ethylene and an α-olefin having 4 to 8 carbons. 15. The vessel of claim 14 wherein a copolymer of ethylene and an -olefin is obtained using a single site catalyst. The container of claim 1, wherein the blend is exposed to electron beam radiation at a dosage of 20 kGy to 200 kGy. The container of claim 1 comprising a peelable seal that separates the container into a first chamber and a second chamber. 18. The container of claim 17, wherein the peelable seal extends between the transverse edges of the container. 18. The container of claim 17, wherein the peelable seal extends between the terminal edges of the container. 18. The container of claim 17, wherein the peelable seal does not cross the perimeter seal of the container. (1) a copolymer of ethylene and α-olefin having a density of less than 0.915 g / cc, the sidewall including a first sidewall and a second sidewall sealed together along a peripheral seam to define a fluid chamber, (2) lower A first component present in an amount of 99% to 55% by weight in the blend selected from the group consisting of ethylene copolymerized with alkyl acrylate, (3) ethylene copolymerized with lower alkyl substituted alkyl acrylate and (4) ionomer And (1) a propylene containing polymer, (2) polybutene polymer, (3) polymethylpentene polymer, (4) cyclic olefin containing polymer and (5) crosslinked polycyclic hydrocarbon containing polymer. A film having at least one layer of blend of second components present in an amount of 45% to 1% by weight, A film of fluid mass exposed to electron beam radiation having an energy of 150 Kev to 10 Kev to provide a dosage of 20 kGy to 200 kGy. The film of claim 21, wherein the film has an elastic modulus of less than 60,000 psi as measured in accordance with ASTM D882, less than 25% internal haze as measured in accordance with ASTM D1003, a film of greater than 2 internal adhesion rating, 5 mil to 15 mil thick. Wherein the film has a sample creep of 150% or less under a load of 27 psi at 120 ° C. and the film can be heat sealed with a container having a seal that remains intact when the container is autoclaved at 121 ° C. for 1 hour. The container of claim 21 wherein the blend is exposed to an oxygen partial pressure lower than an oxygen partial pressure at ambient conditions when the blend is exposed to electron beam radiation. The random and block copolymers of claim 21 wherein the second component is a homopolymer of polypropylene and at least one comonomer selected from propylene with an α-olefin having from 2 to 17 carbons. A container which is a propylene containing polymer selected from the group consisting of: The container of claim 21, wherein the second component is a copolymer of propylene and ethylene having an ethylene content of 1 to 6 weight percent of the copolymer. The container of claim 21, wherein the second component is a blend of the first propylene containing polymer and the second propylene containing polymer. 27. The container of claim 26, wherein the first propylene containing polymer has a first melt flow rate, the second propylene containing polymer has a second melt flow rate, and the first melt flow rate is three times greater than the second melt flow rate. 27. The container of claim 26, wherein the first propylene containing polymer has a first melt flow rate, the second propylene containing polymer has a second melt flow rate, and the first melt flow rate is five times greater than the second melt flow rate. 27. The container of claim 26, wherein the first propylene containing polymer has a first melting point, the second propylene containing polymer has a second melting point, and the first melting point is at least 5 ° C higher than the second melting point. The container of claim 26, wherein the first propylene containing polymer has a first melting point, the second propylene containing polymer has a second melting point, and the first melting point is at least 10 ° C. higher than the second melting point. The vessel of claim 21 wherein the second component is a cyclic olefin having 5 to 10 carbons in the ring. 32. The container of claim 31, wherein the cyclic olefin is selected from the group consisting of substituted and unsubstituted cyclopentene, cyclopentadiene, cyclohexene, cyclohexadiene, cycloheptene, cycloheptadiene, cyclooctene and cyclooctadiene. delete delete The container of claim 21, wherein the first component is an α-olefin having 3 to 17 carbons. The container of claim 21, wherein the first component is a copolymer of ethylene and an α-olefin having 4 to 8 carbons. 36. The vessel of claim 35 wherein a copolymer of ethylene and an -olefin is obtained using a single site catalyst. 22. The container of claim 21, further comprising a peelable seal that separates the container into a first chamber and a second chamber. The container of claim 38, wherein the peelable seal extends between the transverse edges of the container. The container of claim 38, wherein the peelable seal extends between the terminal edges of the container. The container of claim 38, wherein the peelable seal does not cross the perimeter seal of the container.

Images