CN1663775A - Multilayer co-extrusion transfusion film and manufacturing method thereof - Google Patents
Multilayer co-extrusion transfusion film and manufacturing method thereof Download PDFInfo
- Publication number
- CN1663775A CN1663775A CN 200510049011 CN200510049011A CN1663775A CN 1663775 A CN1663775 A CN 1663775A CN 200510049011 CN200510049011 CN 200510049011 CN 200510049011 A CN200510049011 A CN 200510049011A CN 1663775 A CN1663775 A CN 1663775A
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- Prior art keywords
- layer
- extrusion
- infusion film
- extrusion infusion
- ethylene
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Images
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- Laminated Bodies (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Description
Cleanliness class | Dust maximum allowable number/cubic meter | The microorganism maximum allowable number | Rate of ventilation | ||
????≥0.5um | ????≥5um | Bacterium/cubic meter swims | Sedimentation bacterium/ware | ||
??100 | ??3500 | ??0 | ????5 | ????1 | Vertical laminar flow 〉=0.3 meter per second horizontal laminar flow 〉=0.4 meter per second |
??10000 | ??350000 | ??2000 | ????100 | ????3 | 〉=20 times/time |
??100000 | ??3500000 | ??20000 | ????500 | ????10 | 〉=15 times/time |
??3000000 | ??10500000 | ??60000 | ????- | ????15 | 〉=12 times/time |
SEBS content in the ground floor | Ground floor thickness (μ m) | Second layer thickness (μ m) | Threeply degree (μ m) | The 4th layer thickness (μ m) | Layer 5 thickness (μ m) | Whether electron irradiation is handled | |
Embodiment 1 | ?40wt% | 30 | ?20 | ?65 | ?20 | ?25 | Not |
Embodiment 2 | ?50wt% | 30 | ?20 | ?65 | ?20 | ?25 | Not |
Embodiment 3 | ?60wt% | 30 | ?20 | ?65 | ?20 | ?25 | Not |
Embodiment 4 | ?50wt% | 30 | ?20 | ?65 | ?20 | ?25 | Be |
Embodiment 5 | ?50wt% | 20 | ?15 | ?80 | ?15 | ?36 | Not |
Embodiment 6 | ?50wt% | 45 | ?26 | ?50 | ?25 | ?36 | Not |
Embodiment 7 | ?50wt% | ?30 | ?26 | ?80 | ?25 | ?18 | Not |
Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????35.5 |
Laterally 〉= | ??GB/T13022-91 | ????24 | ????30.6 | |
Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????486 |
Laterally 〉= | ??GB/T13022-91 | ????400 | ????465 | |
Heat sealing strength | Must not be lower than 20N/15mm | ????34N/15mm | ||
Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????76 | |
Glossiness % | ??GB8807-88 | ????80 | ????81% | |
Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????3.8g | |
Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????951cm3 | |
Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????517cm3 | |
Residue on ignition | Must not surpass 0.05% | ????0.04% | ||
Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 1/ml of 17/ml of 69/ml | |
6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified |
Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified |
Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified |
Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified |
The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified |
Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified |
Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified |
Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????36.8 |
Laterally 〉= | ??GB/T13022-91 | ????24 | ????31.1 | |
Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????499 |
Laterally 〉= | ??GB/T13022-91 | ????400 | ????471 | |
Heat sealing strength | Must not be lower than 20N/15mm | ????35N/15mm | ||
Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????77 | |
Glossiness % | ??GB8807-88 | ????80 | ????82% | |
Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????3.9g | |
Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????891cm3 | |
Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????551cm3 | |
Residue on ignition | Must not surpass 0.05% | ????0.04% | ||
Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 1/ml of 12/ml of 53/ml | |
6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified |
Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified |
The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified |
Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified |
Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified |
Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????38.7 |
Laterally 〉= | ??GB/T13022-91 | ????24 | ????31.6 | |
Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????507 |
Laterally 〉= | ??GB/T13022-91 | ????400 | ????468 | |
Heat sealing strength | Must not be lower than 20N/15mm | ????37N/15mm | ||
Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????85 | |
Glossiness % | ??GB8807-88 | ????80 | ????81% | |
Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????3.9g | |
Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????881cm3 | |
Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????492cm3 | |
Residue on ignition | Must not surpass 0.05% | ????0.04% | ||
Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 0/ml of 6/ml of 27/ml | |
6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified | |
Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified | |
The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified |
Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified |
Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified |
Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????39.1 |
Laterally 〉= | ??GB/T13022-91 | ????24 | ????32.5 | |
Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????516 |
Laterally 〉= | ??GB/T13022-91 | ????400 | ????478 | |
Heat sealing strength | Must not be lower than 20N/15mm | ????38N/15mm | ||
Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????89.5 | |
Glossiness % | ??GB8807-88 | ????80 | ????86% | |
Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????3.6g | |
Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????758cm3 | |
Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????418cm3 | |
Residue on ignition | Must not surpass 0.05% | ????0.04% | ||
Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 0/ml of 5/ml of 28/ml | |
6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified | |
Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified | |
The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified | |
Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified | |
Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified |
Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????31.2 |
Laterally 〉= | ??GB/T13022-91 | ????24 | ????34.2 | |
Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????527 |
Laterally 〉= | ??GB/T13022-91 | ????400 | ????465 | |
Heat sealing strength | Must not be lower than 20N/15mm | ????19N/15mm | ||
Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????77 | |
Glossiness % | ??GB8807-88 | ????80 | ????80% | |
Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????4.7g | |
Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????789cm3 | |
Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????491cm3 | |
Residue on ignition | Must not surpass 0.05% | ????0.05% | ||
Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 2/ml of 23/ml of 96/ml | |
6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified | |
Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified | |
The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified | |
Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified | |
Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified |
Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????37.7 |
Laterally 〉= | ??GB/T13022-91 | ????24 | ????31.6 | |
Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????511 |
Laterally 〉= | ??GB/T13022-91 | ????400 | ????470 | |
Heat sealing strength | Must not be lower than 20N/15mm | ????39N/15mm | ||
Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????81.2 | |
Glossiness % | ??GB8807-88 | ????80 | ????80.7% | |
Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????3.5g | |
Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????756cm3 | |
Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????423cm3 | |
Residue on ignition | Must not surpass 0.05% | ????0.06% | ||
Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 0/ml of 4/ml of 27/ml | |
6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified | |
Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified | |
The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified | |
Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified | |
Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified |
Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????36.2 |
Laterally 〉= | ??GB/T13022-91 | ????24 | ????30.8 | |
Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????461 |
Laterally 〉= | ??GB/T13022-91 | ????400 | ????423 | |
Heat sealing strength | Must not be lower than 20N/15mm | ????36N/15mm | ||
Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????79.3 | |
Glossiness % | ??GB8807-88 | ????80 | ????79% | |
Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????5.1g | |
Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????1246cm3 | |
Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????631cm3 | |
Residue on ignition | Must not surpass 0.05% | ????0.04% | ||
Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 1/ml of 8/ml of 40/ml | |
6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified | |
Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified | |
The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified | |
Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified | |
Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified |
Inspection product title | Glucose sugar sodium chloride injection | Experimental condition | 40 ℃ ± 2 ℃ humidity 20% ± 5% of accelerated test temperature |
Lot number | 040,705 1 | Specification | 250ml: glucose 12.5g and sodium chloride 2.25g |
Packing | A multi-layer co-extrusion infusion bag film lot number 040604 | The check purpose | Accelerated test 6 months |
Inspection product quantity | 28 bags | ||
For sample unit | High-capacity injection G workshop | Receive the inspection date | On July 6th, 2004 |
Test basis | " two ones of Chinese pharmacopoeia versions in 2000 | Reporting date | On January 13rd, 2005 |
Interventions Requested standard code assay [proterties] should be colourless colourless clear liquid [inspection] the pH value of clear liquid and should be 3.5~5.5 3.9 5-hydroxymethylfurfurals at the wavelength place of 284nm, and trap must not must not cross 5/1000000ths greater than 0.25 0.06 heavy metal should clarity up to specification (disqualification rate) must not cross less than 5/1000000ths particulate matters that 5% bacterial endotoxin up to specification is should be up to specification aseptic should [assay] up to specification to contain glucose (C6H 12O 6H 2O) should be 95.0% of labelled amount~105.0% 98.0% sodium chloride-containing (NaCl) and should be 95.0% of labelled amount~105.0% 98.3% | |||
Conclusion: this product is by " two checks of Chinese pharmacopoeia version in 2000, the result is up to specification. |
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