JPS59115349A - Thermally sterilizable polyolefin composition and product - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION Parenteral 5oLrbt, 1
ons) is a fluid replacement (ft1bicl repla
cement), electrolyte replacement
It contains a wide range of drugs (te replacement) and is a valuable vehicle for medicine (drlLg medication). Solutions include plasma, platelets, blush bulbs, kidney dialysis solutions, saline solutions and nutritional products. These solutions were initially packaged in glass bottles, however, several years ago, collapsiple
ble) With the introduction of parenteral solution bags, airborne contamination has been considerably reduced as the flexible bags are emptied without outside air entering the system.

General requirements for resins used in the manufacture of parenteral solution bags include flexibility, transparency, toughness at low temperatures, heat sealability, good processability, resistance to moisture vapor permeation, and ability to be sterilized. include. The industry currently uses highly plasticized pVC films for this purpose. Although the resin satisfies most of the above requirements, materials containing little or no plasticizer are preferred. pVC
Films are also not very resistant to water vapor permeability, and as a result, continuous loss of water in a parenteral bath solution considerably reduces its shelf life. Therefore, the bag is an over' pouch manufactured from a film resin designed to have a low water vapor transmission rate (WVTR).
It is essential that it can be sealed within the vofu', /near+,'+. Recently, overpouch films have been manufactured from blends of high density polyethylene and butyl rubber and extruded into films approximately 4-5 mils thick to provide the required iP'VTR. This thickness is usually more required for physical properties and adds to the cost of the assembly. Another drawback of overpouch resin is that it lacks the desired transparency, an important property needed for easy and correct identification of the contents of the inner bag.

It is therefore an object of the present invention to provide a resin solution suitable for the production of sterilizable overpouch films of improved transparency and water vapor permeation resistance.

The object of the present invention is to provide a sterilizable (550ml) container for direct and indirect containment of parenteral solutions.
It is also an object of the present invention to provide a film useful in the production of collazable hugs.

Another object of the present invention is to provide an improved collapsible intravenous bag assembly.

Other objectives will be readily apparent from reading the specification and claims.

In accordance with the present invention, (a) about 10% to 60% by weight of a random copolymer of about 1% to about 6% by weight of ethylene and about 94% to about 99% by weight of propylene; prepared by copolymerization with at least one C4-Cl1lα-olefin comonomer and about 0.91511 m/
A sterilizable film resin composition is provided comprising a blend of about 40% to about 90% by weight linear side-density polyethylene having a density of cc to about 0.940 rm/cc.

The random copolymer component preferably has a melt flow in the range of about 710 minutes at 2oC to about 710 minutes at 5.0oC. Such polymers are readily available commercially, so their manufacture is unnecessary.

The linear low-density polyethylene component, expressed as L L i) PE, is ethylene and less,!
:41m C4-Cl3α-olefin comonomer interpolymer. Preferably the alpha-olefin comonomer contains 94-8 carbon atoms per molecule. Examples of particularly suitable comonomers are butene-1, pentene-1, hexene-1,4-methyl-pentene-1, heptene-1
, octene-1 and mixtures thereof such as butene-1/hexene-1 and butene-1/octene-1. These LLDPE resins can be produced using the recently introduced catalytic method (ca.
talytic processes). The resin is preferably heated to 190°C.
About 0.5'? /10 minutes to about 51/10 minutes. A variety of suitable resins are commercially available within the required density and melt flow ranges.

One optional component of the resin blend is an agent added in an effective amount to produce a film of improved transparency. Examples of suitable agents are sodium benzoate, sopensolidensorpitol, sorbitan monooleate, and others. Typically, the nucleating agent is added in an amount of about 0.1% to about 2% by weight, based on the weight of the total polymer. from about 2% to about 15% by weight high density polyethylene, i.e. at least 0%
, 945 fm/cc can also be included as another optional component in the resin for the purpose of increasing heat seal range. This characteristic is defined as the time between the minimum time for a good seal and the maximum time before the film burns through using standard heat sealing equipment.

In addition to high transparency, the blend compositions of the present invention can be readily processed into blown or cast film products that exhibit other desirable properties, such as flexibility, toughness at low temperatures, and heat sealability. be. The film also has good water vapor permeation resistance and can be steam sterilized at 1210 G without significantly affecting its physical properties.

Finally, the film does not contain additives that, in direct or indirect contact, would interfere with its use in food or pharmaceutical applications.

When used in inner parenteral solution containers, the film should have a thickness in the range of about 3 mils to about 10 mils, whereas overpouches should have a thickness of about 1 mil to more than about 6 mils. do not have to. If desired, coextruded films for the inner bag or outer bag can be used to reduce moisture or gas loss through the film walls. Materials such as fluorocarbon polymers, ethylene-vinyl alcohol copolymers, and polyvinylidene chloride materials are examples of suitable coextrudates.

A still further improvement comprises an inner sealed film bag containing the parenteral solution, an outer sealed film bag containing a small amount of water and surrounding the inner bag, the outer bag being larger than the inner bag. The outer film resin has a width and length of about 0.25 inches to about 1.5 inches greater than the corresponding dimensions of ((Z) about 1% to about 6% by weight ethylene and about 94% by weight propylene). (b) a random copolymer of from about 99 M weight percent to about 60 weight percent of a random copolymer, prepared by the copolymerization of ethylene and at least one C4-Cl3α-olefin comonomer and about 0.9159 M
A total parenteral solution bag assembly comprising a blend of about 40% to about 90% by weight linear low density polyethylene having a density of from about 0.940 S'm/cc to about 0.940 S'm/cc.

In one embodiment, a small amount of water is added directly to the outer pouch before the sealing operation of the reservoir enclosing the inner bag is performed. In other embodiments, the small amount of water is 2
Enclosed in separate smaller/four-walls made from two film layers.

For economic reasons, one of the films is preferably made of the same resin as that of the outer bag, while the other layers are
It should be manufactured from a porous material that allows vapor to escape but is resistant to liquid permeation. Materials suitable for this purpose are commercially available, such as Tyvek™ available from E.I., DuPont Donemore.
It is spwn-bonded polyethylene. Moisture vapor is thereby allowed to escape from the small container more quickly than from the outer bag, thus creating a saturated atmosphere between the inner and outer bags (
5 atmosphere), effectively removing the driving force for water to escape from the inner bag and reducing the rate at which water evaporates and leaves the inner bag. The area of one side of the smaller pouch should not exceed about 50% of the corresponding inner bag area.

The actual amount of water that should be used to inhibit water vapor removal from the inner bag depends on the parenteral solution's expiration date (ex
piration date). This amount will obviously vary and will depend on the maximum allowable shelf life of the parenteral solution, the dimensions of the outer bag and the rate of water vapor transmission through the bag.

A further feature of the invention is the ability to displace substances other than water in small pouches. For example, a carbon dioxide absorbent can be sealed within a small pouch and help remove carbon dioxide from the inner bag, or an oxygen generator can be added to help add oxygen to the inner bag. It is possible to increase the shelf life of the small plate.

Other substances and gases can also be manipulated and controlled in this manner to improve the storage performance of the system.

The use of a small pouch inserted into the space between the inner and outer bags greatly simplifies all packer song operations. Only one film and thickness would be needed to manufacture and inventory the inner bag for all types of solutions. Additionally, all outer bags can be of the same resin composition and one film thickness. It is necessary to include only different small pouches that can be distinguished, for example by color coding.

If the material packaged in the inner bag is sensitive to UV light, a small amount of UV screening agent can be introduced into the outer bag to prevent UV light from reaching the packaged product.

The film composition can also be sterilized with commercial energy radiation.

Either one or both of the bags of the parenteral solution bag assembly can be made from other polymeric film compositions. However, they must be sterilizable by heat or irradiation and satisfy the general requirements such as flexibility, toughness, heat sealability, etc. as described above.

The invention is further illustrated by the following examples.

Example 1 84, 75 parts L L J) PE (copolymer of ethylene and butene-1, density 0.918 f/cc, melt index 1.Or/10 min), 97.5% propylene and 2. Random copolymer of 5% ethylene (density 0.900r/Ce, melt 70-2.05'/10
A resin blend containing 0.25 parts of sobenzulidene norbitol was used to make blown films of 2.5 mil and 4.5 mil thickness.

The resulting film had good transparency, toughness, was easily heat-sealable, and was flexible.

Pouches are made from these films, filled with water, heat sealed, and thrown up into the air (t
oss, ed) and 1° foot drudge (foot
drop). All pouches survive at least 6 drops at ambient temperature (6s'F"). The water vapor transmission rate of the film is approximately 0.7S'/
mils/100 square inches/24 hours.

The other test specimen consisting of a 5" x 11" inner bag was 4.5
Prepared from Milfilm. These are filled with 100 Qcc of water and 6 // x 1 of 2-5 mil film
2 // Enclosed in the outer bag.

A portion of the sample was separated by 70cc between the inner bag and the outer bag.
It was equipped with water. All of the samples passed one steam sterilization test performed in an autoclave at 1210C for 60 minutes.

LLDPI/copolymer ratio from about 85:15 to about 60
Equivalently good results were obtained in experiments with films made from resin blends similar in all respects to the previous resin blends except that:

Example 2 5 from a resin containing varying amounts of high density polyethylene (0,952 fm/cc) in addition to the LLDPE and propylene-ethylene random copolymer used in Example 1.
Milfilm was manufactured. The two layered strips of cholera film were placed in open air at 250°F for one hour. The strips were then removed and examined for their tendency to stick to themselves. These same Fundindustries Inc. (5entinel In.
An Innolus type sealer manufactured by S.A. Industries, Ltd. was used for these tests. The heating cycle was varied (in seconds) and the cooling time (4 seconds) and air pressure (21 psic) were kept constant. The minimum time to form a good seal and the maximum time before the film burned from end to end were determined and the time difference was the sealing range. Table 1 summarizes the data from these experiments.

As can be seen from the results, a small amount of high density polyethylene greatly increased the heat seal range.

Peel tests also showed that the seal was significantly stronger in films made from resins containing high density polyethylene as the third resin component. Other film properties were not adversely affected by this inclusion.

(1) DNS did not stick □ Slight stickiness It is understood that many changes and modifications may be made to the present invention without departing from the scope of the invention as defined by the specification and claims. It should be.

Patent applicant El Paso Polyolefins ■46
9882 @ August 18, 1983 @ United States (US) ■ 524114 0 Inventor John H. Myers Pennsylvania, United States of America Formerly 9081 Swarthmore Strath Haven Avenue 440

Claims (1)

[Claims] 1. (a) About 1% to about 6% by weight of ethylene
and about 10% to 60% by weight of a random copolymer of about 94% to about 99% propylene, (b) prepared by copolymerization of ethylene and at least one C4-CIII α-olefin comonomer and about O1915
1m/cc to approx. 0.940・tm/cc
A sterilizable film resin composition comprising a blend of from about 40% to about 90% by weight of linear low density polyethylene having a density of . 2 Random ethylene propylene copolymer at 230°C
The composition of claim 1 having a melt flow ranging from about 1.0 f/10 min to about 5.0 i710 min. 3. The composition according to claim 1, wherein the comonomer of the linear low density polyethylene component is at least one C4-C,α-olefin. 4. The composition according to claim 1, wherein the linear low density polyethylene is a copolymer of ethylene and butene-1. 5. Linear low density polyethylene has a temperature of about o at 190°C,
The composition of claim 1 having a melt index in the range of 5r/lo minutes to about sr/lo minutes. 6. The composition according to claim 1, which also contains an agent for imparting improved transparency. 7. Claim 6, wherein the agent for imparting improved transparency is sobensolidensorpitol in an amount of about 0.1% to about 2% by weight based on total polymer weight. Compositions as described in Section. 8. A sterilizable film produced from the resin according to any one of claims 1 to 7. 9. The film of claim 8 produced by coextrusion of said resin with a coextrudate resin selected from fluorocarne mf polymer, ethylene-vinyl alcohol copolymer, and polyvinylidene chloride resin. io, comprising an inner sealed plastic film bag containing a parenteral solution and an outer sealed bag for surrounding the inner bag, the outer bag being approximately smaller than the corresponding dimension of the inner bag; The outer film bag has a width and length of 0.25 inches to about 1.5 inches and contains (α) about 1% to about 6% by weight ethylene and about 94% to about 99% by weight propylene. (b) from about 10% to 60% by weight of a random copolymer prepared by copolymerization of ethylene and at least one 64-Clα-olefin comonomer and about 0.9151 m/cc;
the inner bag film wall in the space between the outer bag and the inner bag; 1b1 to control the removal of ingredients from the parenteral bath solution through or the addition of ingredients to the parenteral solution through the inner bag film wall.
] A sterilizable parenteral solution bag assembly containing a quantity of substance sufficient to control the parenteral solution. 11. Random ethylene-propylene copolymer is 2
Approximately 1.0 f/10 minutes to approximately 5.09/ at 30°G
11. An assembly according to claim 10 having a melt flow in the range of 10 minutes. 17. The assembly of claim 10, wherein the comonomer of the linear low density polyethylene component is at least one C,-C,α-olefin. 13 Linear low density polyethylene contains ethylene and butene-1
11. The assembly of claim 10, which is a copolymer of z, H-shaped low density polyethylene has a temperature of about 0.
5? / 10 minutes to about 5. 11. The assembly of claim 10 having a melt index in the range of /10 minutes. 15 outside 41111 film bag resin blend ha Elj
11. An assembly according to claim 10, which also contains a protective agent that imparts the desired transparency. 16. Claim 1, wherein the agent for imparting improved clarity is dipene soliden sorbitol in an amount of about 0.1% to about 2% by weight based on total polymer weight.
Assembly according to item 5. 17. Claim 1, wherein the substance is water in an amount sufficient to inhibit the removal of water in vapor form from the parenteral solution.
The assembly described in item 0. 18. The assembly of claim 10, wherein the parenteral solution is platelets and the substance is an oxygen-generating compound in an amount sufficient to oxygenate the platelets through the inner bag film wall. 19. The assembly of claim 10, wherein the parenteral solution is platelets and the substance is a carbon dioxide absorbent in an amount sufficient to remove carbon dioxide from the platelets through the inner bag film wall. . 20, the substance is enclosed within a sealed pouch located in a space between an inner bag and an outer bag, and at least one wall of the pouch is permeable to vapors and gases; 11. The assembly of claim 10, wherein the assembly is resistant to liquid permeability. 21. from about 2% to about 1% by weight of a high density polyethylene homopolymer having a density of at least 0.9459 m/cc
A composition according to claim 1 containing also 5% by weight. 22, the outer film bag resin has at least 0, (
11. The assembly of claim 10, also comprising from about 2% to about 15% by weight high density polyethylene homopolymer having a density of 1451 m/cc.