CN102946909A - A package comprising a sterilized content - Google Patents

A package comprising a sterilized content Download PDF

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Publication number
CN102946909A
CN102946909A CN2011800299412A CN201180029941A CN102946909A CN 102946909 A CN102946909 A CN 102946909A CN 2011800299412 A CN2011800299412 A CN 2011800299412A CN 201180029941 A CN201180029941 A CN 201180029941A CN 102946909 A CN102946909 A CN 102946909A
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China
Prior art keywords
package body
mvtr
package
bag
god
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CN2011800299412A
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Inventor
帕斯卡·玛丽亚·休伯特·皮埃尔·泰杰森
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DSM IP Assets BV
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DSM IP Assets BV
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Publication of CN102946909A publication Critical patent/CN102946909A/en
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06114—Packages or dispensers for needles or sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B2050/314—Flexible bags or pouches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Food Science & Technology (AREA)
  • Packages (AREA)
  • Laminated Bodies (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

A package comprising a sterilized content, characterized in that at least a part of the package wall has a moisture vapor transmission rate (MVTR) of between 100 and 1500 g/m<2>.day measured according to ASTM E96/E96M-05 procedure B, at 38 DEG C and 50% Relative Humidity.

Description

The package body that contains the content of sterilizing
The present invention relates to comprise the package body of content of having sterilized, described package body has at least one polymer composition layer.
Described package body has wherein been described the package body that is used for storing the medical container that holds medical fluid from EP-398316 as can be known.The example of described container comprises blood bag or the transfusion bag (containing transfusion) that contains anticoagulant solution, and described solution for example comprises nutrition composition or medicine.Described package body also can comprise combination or even one or more medical apparatus and instruments of stitching thread, stitching thread and pin.
Advantageously, with the content that will the sterilize package body of packing into, then the sealed package body sterilizes to the package body with content first.Sterilization is often carried out in autoclave, and described autoclave is filled water and/or steam under the pressure that raises and temperature.
A problem of the described package body of EP-398316 is that water sees through the packing body wall and enters package body when sterilization.After the cooling, water exists with the water droplet form.Yet, when from package body, taking out, do not expect that very content (for example blood bag or instrument) wets.Because this stays this bag for the personnel that process this bag and content and is not properly sealed and the not sterile impression of this content.
Proposed package body and be comprised of the multi-layer polymer film structure in US 4537305, one deck wherein has water resistance.Because multiple structure, this package body is very complicated.In addition, water still can be present in the package body, for example sees through the water that blood bag wall is stored in the anticoagulant solution in the package body.
In JP-5084281, proposed to be formed by two compartments for the package body of blood bag sterilization, between two compartments, had barrier film.The blood bag is placed in one in the compartment and seals this compartment.Blood bag and package body are sterilized under vapor atmosphere, and steam permeates in the open compartment of package body and penetrates barrier film and enters into the enclosed compartment that contains the blood bag.After the sterilization, package body keeps several hours time at elevated temperatures, again removes from package body with the opening by barrier film and the second compartment and anhydrates.Finally also seal the second compartment.
This package body is very complicated, and exists antibacterial to enter open compartment and the danger of infiltration by barrier film in dry run, exists in barrier film in the situation of little defective especially.In addition, because allow first many water infiltrations by compartment, but have to again afterwards be removed, so sterilization steps is complicated.
Under some occasion, use to have nonwoven porous Pilus Caprae seu Ovis as the package body of packing body wall.These walls have high seepage of water, so that the content of dry packing body easily after the sterilization.Yet, can not guarantee fully that package body provides the complete barrier of little antibacterial and virus.
Target of the present invention provides a kind of for sterilization and the package body of stored contents thing, this package body simplification and allow direct sterilization process.
Surprisingly, if the packing body wall of at least a portion has 100 and 1500g/m 2During moisture vapor transmission rate between it (MVTR) (it is according to ASTM E96/E96M-05 process B, measures), can realize this target under 38 ℃ and 50% relative temperature.
Package body can only comprise a compartment now, and does not need extra barrier layer in package body.In addition, described sterilization process is very simple and direct.It is what seal that content (for example blood bag) places package body and package body.Package body can place the autoclaving still and use steam sterilization.Because the time that the permeability finite sum is sterilized is relatively short, so only have very limited amount water to penetrate into package body.After the sterilization, because the permeability of steam, so the drying steps under temperate condition has just satisfied the requirement of releasing water from package body.If when in the space of relatively dry, storing, water even can from package body, discharge, and do not need special processing.
Preferably, MVTR is 125g/m at least 2My god, more preferably 150g/m at least 2My god in addition more preferably 175g/m at least 2My god.
Preferably, MVTR is 1250g/m at the most 2My god, more preferably 1000g/m at the most 2My god in addition more preferably 750g/m at the most 2My god, 500g/m at the most most preferably 2My god.
The part of chamber wall can have the MVTR different from top definition value.In this case, preferably this part of wall has the MVTR lower than MVTR defined above.Preferably, the whole wall of package body has identical structure and composition, so that the MVTR value of whole container is identical or approximately identical.
Package body can be container, and is for example disclosed in EP-398316.Preferably, package body is bag.This be because, bag usually satisfy in sterilization, transportation and in storing to the requirement of package body, and be easy to from various polymer compositions, produce bag.
The polymer that is suitable for packing body wall of the present invention comprises polyamide, for example PA-6, PA-66, PA-666.
Preferably, polymer is polar thermoplastic elastomer.
Thermoplastic elastomer (TPE) is elastomeric material, and it has the processing characteristics of conventional thermoplastic and at its fusing point or have the performance of traditional thermoset rubber below the softening temperature.Thermoplastic elastomer (TPE) is described in Handbook of Thermoplastic Elastomers, second edition, and Van Nostrand Reinhold is in New York (ISBN 0-442-29184-1).
Polar thermoplastic elastomer preferably includes oxygen (O) atom and/or nitrogen (N) atom.Preferably per 8 the C atoms of polar thermoplastic elastomer, preferred per 6 C atoms, more preferably per 4 C atoms comprise at least one N or an O atom.The good example that is contained in the polar group in the polar thermoplastic elastomer has-NH-,-O-,-COO-and-the CO-NH-group.
The good example of polar thermoplastic elastomer has polyester-based thermoplastic elastomer (TPE), polyamide based thermoplastic elastomer and polyurethane.The example of polyester-based thermoplastic elastomer (TPE) comprises polyester elastomer, polyurethane ester elastomer, Merlon ester elastomer.
Preferably, use thermoplastic copolyether ester elastomer.
This is because can obtain pliable and tough and solid package body all under the generable low temperature when the high-temperature of sterilization process and transportation and storage.In addition, obtain the package body of zero defect or few defects, and in the package body of present this area, can have the pin hole that allows antibacterial pass and infect content in the package body.Also can access the package body with high grade of transparency.This needs, and can identify easily content because process the staff of package body.In addition, the antistatic property of this package body is very favorable.This is very important, because the discharge of static can otherwise damage package body, for example forms pin hole at the packing body wall, so that antibacterial can penetrate in the package body again.
Thermoplastic copolyether ester elastomer suitably comprises the hard fragment of setting up by derived from the repetitive of at least one aklylene glycol and at least one aromatic dicarboxylate or its ester.As the alternative of " fragment ", also can use term " block ".Aklylene glycol can be linear or alicyclic aklylene glycol.Linear or alicyclic aklylene glycol generally comprises 2 ~ 6 C atoms, preferred 2 ~ 4 C atoms.The example comprises ethylene glycol, propylene glycol and butanediol.Preferred propylene glycol or butanediol, the more preferably BDO of using.Suitable aromatic dicarboxylate's example comprises p-phthalic acid, 2,6-naphthalene dicarboxylic acids, 4,4 '-diphenyl dicarboxylic acid or its combination.Its advantage is that resulting polyester is generally fusing point and is higher than 150 ℃, preferably is higher than 175 ℃ and the hypocrystalline that more preferably is higher than 190 ℃.Hard fragment also can comprise on a small quantity alternatively derived from the unit of other dicarboxylic acids (for example M-phthalic acid), the general like this melting point depression that makes polyester.The amount that limits other dicarboxylic acids preferably is not higher than 10mol%, more preferably no more than 5mol%, do not affect adversely with the crystallization behavior of guaranteeing copolyether ester.Hard fragment is preferably set up as repetitive by ethylene glycol terephthalate, propylene glycol ester terephthalate, and is particularly set up as repetitive by the mutual-phenenyl two acid bromide two alcohol ester.These advantages of holding facile unit comprise favourable crystallization behavior and high-melting-point, thereby acquisition has the thermostability of excellent machinability, excellence and the copolyether ester of chemical resistance and good puncture resistance.
In thermoplastic copolyether ester elastomer, suitable aliphatic polyether soft segment is essentially amorphous and has the pliable and tough polyethers of the glass transformation temperature (Tg) that is lower than 0 ℃.Preferably, Tg is lower than-20 ℃, more preferably is lower than-40 ℃ and most preferably be lower than-50 ℃.The molal weight of this fragment can change in wide region, but preferably select molal weight between 400 and 6000, more preferably between 500 and 4000 and most preferably 750 and 3000g/mol between.Suitable aliphatic polyether comprises poly-(alkylidene oxygen) glycol, it is derived from the epoxyalkane (alkylene oxide) with 2 ~ 6 C atoms, preferred 2-4 C atom or its combination.The example comprises poly-(ethylidene oxygen) glycol, poly-(tetramethylene oxygen) glycol or poly-(oxolane) glycol, poly-(inferior neopentyl-altogether-tetramethylene oxygen) two pure and mild poly-(propylidene oxygen) glycol.One preferred embodiment in, thermoplastic polyether ester elastomer comprises ethylene oxide-capped poly-(propylidene oxygen) the glycol fragment as polyether segment.
If thermoplastic copolyether ester elastomer comprises chain branching agent, can obtain good result so.Suitable chain branching agent comprises for example trimellitic acid, trimellitic anhydride and trimethylolpropane.Select amount and the type of chain extender or chain branching agent, to obtain having the blocked copolyester of required melt viscosity.In general, the amount of chain branching agent is not higher than 6.0 equivalents with respect to the per 100 moles dicarboxylic acids that are present in copolyether ester.Copolyether ester can also comprise common catalyst and stabilizing agent.
The example of copolyether ester and preparation example be as at Handbook of Thermoplastics, ed.O.Olabishi, the 17th chapter, Marcel Dekker Inc., New York 1997, ISBN 0-8247-9797-3; At Thermoplastic Elastomers, the 2nd edition, the 8th chapter, Carl Hanser Verlag (1996), ISBN 1-56990-205-4; At Encyclopedia of Polymer Science and Engineering, the 12nd volume, Wiley﹠amp; Sons, New York (1988), ISBN 0-471-80944, the 75-117 page or leaf reaches in the list of references of wherein quoting and describes to some extent.
Particularly preferably be such copolyether ester, this copolyether ester has from the hard fragment of mutual-phenenyl two acid bromide two alcohol ester unit foundation with derived from the ethylene oxide-capped soft segment of gathering (propylidene oxygen) glycol.
Most preferably, conjugated polyether ester elastomer has carried out after-condensation technique.Elastomeric after-condensation is the suitable and economic method that obtains high molecular, and elastomer is had for obtaining the good necessary desired viscosity of compositions processability, to obtain according to tubular film of the present invention.Only is the solid phase after-condensation.In this technique, heating solid phase conjugated polyether ester elastomer is to being lower than the about 10-20 of its fusing point ℃ temperature in cylinder drying machine.Apply vacuum from elastomer, to remove condensation product.
The packing body wall can have multiple structure.Preferred packing body wall has double-decker, ground floor be comprise one or multiple above the basic unit of described polymer, and second layer polymer composition can sealing bag.The example of polymer that can sealing bag comprises PA-6,6,6, copolymer or the vinyl alcohol of polyvinyl acetate (PVAc), ethylene and (methyl) acrylate.These polymer also provide suitable MVTR for this layer, so that the MVTR of whole packing body wall within the required range.The second layer preferably the fusing point of the compositions of and the second layer thinner than ground floor preferably than low 20 ℃ of the fusing point of the compositions of basic unit, more preferably low 30 ℃.Usually by being implemented to heat and pressurize, package body seals.
Yet the packing body wall can also be single layer structure, so that the packing body wall is made of basic unit.In this case, the packing body wall is had to by for example welding or is used sealant and seal.
The packing body wall except basic unit can also have can be as the tissue adhesion layer to stop the skin of package body coherent polymer composition in the storage of package body.The good example of tissue adhesion layer is one deck PBT or PA-6.Preferably use PA-6 in the tissue adhesion layer.
The MVTR of packing body wall reduces along with each layer thickness and increases.Yet when selecting, layer thickness is also very important to other functions of considering this layer.If basic unit's attenuation, the packing body wall can be lost its intensity.Therefore, suitable groundwork thickness is between 20 and 80 microns, between preferred 30 and 60 microns.The thickness of the layer of energy sealed packaging can be between 10 and 30 microns, and the tissue adhesion layer can be between 5 and 15 microns.
Basic unit according to package body of the present invention preferably is comprised of the blend of PA-6 and thermoplasticity copolyether ester, preferably with the PA-6 between 90:10 and 50:50: the ratio of thermoplasticity copolyether ester.Certainly, except PA-6 and thermoplasticity copolyether ester, blend can comprise non-polymeric additive.The basic unit of this blend is very solid, have required MVTR and have good tissue adhesion performance, thereby no longer needs special tissue adhesion layer.
For the production of package body, can use the technique of the known manufacturing polymer composition of those skilled in the art package body.
If package body is bag, can for example produce by the following bag so: blown film, the film that then will blow over cuts and is fused into bag.Other method is to produce the film with slit die, and this mould is fused into tubular mold, then produces in an identical manner bag by cutting and welding.
Sterilization process can may further comprise the steps: the content that will sterilize places package body, and sterilization packaging body and content thereof in steam autoclave are by heat treatment dry packing body and content thereof.
Be less than and be considered to drying time of 5 hours acceptable drying time.Show follow-up and drawback economy long drying time.
Also can sterilize by using gas (for example ethylene oxide gas).
The present invention will further set forth by reference the following examples and Comparative Examples, but be not limited to this.
Embodiment
For experiment, use 60 microns the thick film that is consisted of by following polymer composition:
Embodiment 1:
Figure BDA00002603030800061
Embodiment 2:
Figure BDA00002603030800062
Embodiment 3:
Figure BDA00002603030800063
Figure BDA00002603030800064
Embodiment 4:
Figure BDA00002603030800065
Figure BDA00002603030800066
Embodiment 5:
The comparative example A:
Figure BDA00002603030800068
Comparative Examples B: compositions B=BOPP(Biaxially oriented polypropylene)
Polymer composition 1-6 can buy from DSM Engineering Plastics, and compositions 7 is standard BOPP thin film.
Use CTS type C+10/350 weather controlling chamber to test the moisture vapor transmission rate of these films, and according to ASTM E96/E96M-95 process B, specimen under 38 ℃ and 50% relative temperature.
The moisture vapor transmission rate of table 1. film 1 to 7
? Thickness MVTR MVTR
? Micron Gram/M 2My god Gram .mm/M 2My god
Embodiment 1 57 578 33.0
Embodiment 2 61 977 59.6
Embodiment 3 58 121 7.0
Embodiment 4 60 173 10.4
Embodiment 5 52 102 6.3
The comparative example A 59 66 3.9
Comparative Examples B 60 2 0.1
Mode by heated sealant is made sack by these films.The size of sack is based on the A4 paper, and whole bag area is 21cm*29.5cm*2=1239CM 2(0.1239M namely 2).
In order to simulate the infiltration of the water in high-pressure sterilizing course, we place pre-sealed bag with 2 ml waters, and by the last sealing member of heated sealant method sealing.The bag of sealing is placed circulatory stove under 38 ℃
Figure BDA00002603030800071
Type NTU 60/60) in.In order to check the rate of drying of bag, from stove, takes out per half an hour bag, and be placed in the refrigerator 30 seconds.Subsequently, bag is estimated to check that the inboard water of bag condenses.The anhydrous hourage that condenses of bag can be thought the measuring of effectiveness of expelling water (drive of water).The results are shown in Table 2.
Time before the table 2. bag drying
? Hour
? ?
Embodiment 1 1.0
Embodiment 2 0.5
Embodiment 3 3.5
Embodiment 4 2.5
Embodiment 5 4.0
The comparative example A 7.0
Comparative Examples B >24

Claims (9)

1. the package body that comprises the content of having sterilized, the packing body wall that it is characterized in that at least a portion have 100 and 1500g/m 2Moisture vapor transmission rate between it (MVTR), described moisture vapor transmission rate be according to ASTM E96/E96M-05 process B, measures under 38 ℃ and 50% relative temperature.
2. package body as claimed in claim 1 is characterized in that described MVTR is 100g/m at least 2My god.
3. package body as claimed in claim 1 is characterized in that described MVTR is 150g/m at least 2My god.
4. such as the described package body of any one among the claim 1-3, it is characterized in that described MVTR is 1250g/m at the most 2My god.
5. such as the described package body of any one among the claim 1-3, it is characterized in that described MVTR is 1000g/m at the most 2My god.
6. such as the described package body of any one among the claim 1-5, it is characterized in that PA-6, PA-66, PA-666, thermoplastic elastomer (TPE) are used to described packing body wall.
7. package body as claimed in claim 6 is characterized in that as described thermoplastic elastomer (TPE), uses per 8 C atoms to have the thermoplastic elastomer (TPE) of at least one N and/or an O.
8. such as claim 6 or 7 described package bodies, it is characterized in that described thermoplastic elastomer (TPE) is copolyether ester.
9. such as the described package body of any one in the claim of front, it is characterized in that described packing body wall comprises basic unit or is comprised of basic unit, described basic unit is comprised of the blend of PA-6 and described copolyether ester.
CN2011800299412A 2010-06-16 2011-06-14 A package comprising a sterilized content Pending CN102946909A (en)

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EP10166109.8 2010-06-16
EP10166109 2010-06-16
PCT/EP2011/059836 WO2011157705A1 (en) 2010-06-16 2011-06-14 A package comprising a sterilized content

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WO (1) WO2011157705A1 (en)

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US20130206634A1 (en) 2013-08-15
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Application publication date: 20130227