CN102826260B - 一种双层无菌软包装输液生产工艺 - Google Patents
一种双层无菌软包装输液生产工艺 Download PDFInfo
- Publication number
- CN102826260B CN102826260B CN201210363236.2A CN201210363236A CN102826260B CN 102826260 B CN102826260 B CN 102826260B CN 201210363236 A CN201210363236 A CN 201210363236A CN 102826260 B CN102826260 B CN 102826260B
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- Prior art keywords
- bag
- packing
- infusion solution
- sterilization
- layer sterile
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 23
- 239000003978 infusion fluid Substances 0.000 title abstract 6
- 239000002355 dual-layer Substances 0.000 title abstract 3
- 230000001954 sterilising effect Effects 0.000 claims abstract description 46
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 27
- 238000012856 packing Methods 0.000 claims abstract description 26
- 230000005251 gamma ray Effects 0.000 claims abstract description 7
- 238000007689 inspection Methods 0.000 claims abstract description 6
- 238000004806 packaging method and process Methods 0.000 claims abstract description 5
- 230000005855 radiation Effects 0.000 claims abstract description 4
- 238000005516 engineering process Methods 0.000 claims description 13
- 239000007788 liquid Substances 0.000 claims description 7
- 238000001802 infusion Methods 0.000 claims description 5
- 239000003814 drug Substances 0.000 claims description 4
- 229940079593 drug Drugs 0.000 claims description 4
- 239000000463 material Substances 0.000 claims description 3
- 230000000844 anti-bacterial effect Effects 0.000 claims description 2
- 239000011127 biaxially oriented polypropylene Substances 0.000 claims description 2
- 229920006378 biaxially oriented polypropylene Polymers 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 5
- 238000007789 sealing Methods 0.000 abstract description 2
- 238000001035 drying Methods 0.000 abstract 1
- 239000012528 membrane Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
- 238000000034 method Methods 0.000 description 11
- 238000012360 testing method Methods 0.000 description 7
- 238000001514 detection method Methods 0.000 description 6
- 241000235342 Saccharomycetes Species 0.000 description 4
- 241000607142 Salmonella Species 0.000 description 4
- 230000000813 microbial effect Effects 0.000 description 4
- 230000001580 bacterial effect Effects 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 229920000742 Cotton Polymers 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 244000005700 microbiome Species 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 238000013461 design Methods 0.000 description 1
- 238000005374 membrane filtration Methods 0.000 description 1
- 238000002791 soaking Methods 0.000 description 1
Images
Landscapes
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
Description
检测项目 | 微生物限度标准 |
细菌数 | ≤5 cfu/cm2 |
霉菌及酵母菌 | 不得检出 |
大肠埃希菌 | 不得检出 |
沙门菌 | 不得检出 |
检测项目 | 微生物含量 |
细菌数 | ≤3 cfu/cm2 |
霉菌及酵母菌 | 未检出 |
大肠埃希菌 | 未检出 |
沙门菌 | 未检出 |
检测项目 | 微生物含量 |
细菌数 | ≤1 cfu/cm2 |
霉菌及酵母菌 | 未检出 |
大肠埃希菌 | 未检出 |
沙门菌 | 未检出 |
Claims (1)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201210363236.2A CN102826260B (zh) | 2012-09-26 | 2012-09-26 | 一种双层无菌软包装输液生产工艺 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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CN201210363236.2A CN102826260B (zh) | 2012-09-26 | 2012-09-26 | 一种双层无菌软包装输液生产工艺 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN102826260A CN102826260A (zh) | 2012-12-19 |
CN102826260B true CN102826260B (zh) | 2014-06-25 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN201210363236.2A Active CN102826260B (zh) | 2012-09-26 | 2012-09-26 | 一种双层无菌软包装输液生产工艺 |
Country Status (1)
Country | Link |
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CN (1) | CN102826260B (zh) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103919677A (zh) * | 2014-05-06 | 2014-07-16 | 四川太平洋药业有限责任公司 | 负压式双阀软袋输液 |
CN103919679A (zh) * | 2014-05-06 | 2014-07-16 | 四川太平洋药业有限责任公司 | 负压式软袋输液 |
CN103961260A (zh) * | 2014-05-25 | 2014-08-06 | 四川太平洋药业有限责任公司 | 真空检漏无菌双阀软袋输液组合袋 |
CN105125402B (zh) * | 2015-08-14 | 2018-03-16 | 石家庄四药有限公司 | 一种直立袋输液双层无菌包装***及其制备方法 |
CN105460306B (zh) * | 2015-12-30 | 2017-12-29 | 山东新华医疗器械股份有限公司 | 灯检干燥一体机 |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0083448A2 (en) * | 1981-12-31 | 1983-07-13 | International Paper Company | Sterilization of packaging materials |
JP2000281023A (ja) * | 1999-03-30 | 2000-10-10 | House Foods Corp | 容器の殺菌方法及び装置 |
CN101123998A (zh) * | 2003-12-15 | 2008-02-13 | 贝克顿·迪金森公司 | 预装填容器的最终灭菌 |
CN101224799A (zh) * | 2007-01-19 | 2008-07-23 | F.S.韩国工业公司 | 灭菌包装容器及利用该灭菌包装容器的包装方法 |
CN101428698A (zh) * | 2008-12-10 | 2009-05-13 | 江西3L医用制品集团有限公司 | 一种组合包装袋及其灭菌干燥的方法 |
CN101618770A (zh) * | 2009-08-17 | 2010-01-06 | 湖南千山制药机械股份有限公司 | 一种碳酸氢钠注射液的包装方法 |
CN101678939A (zh) * | 2008-06-09 | 2010-03-24 | 贝克顿迪金森法国两合公司 | 无菌包装和使用这种包装的灭菌方法 |
CN102488617A (zh) * | 2011-11-22 | 2012-06-13 | 四川科伦药物研究有限公司 | 一种碳酸氢钠注射液塑料软袋包装及其制备方法 |
-
2012
- 2012-09-26 CN CN201210363236.2A patent/CN102826260B/zh active Active
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0083448A2 (en) * | 1981-12-31 | 1983-07-13 | International Paper Company | Sterilization of packaging materials |
JP2000281023A (ja) * | 1999-03-30 | 2000-10-10 | House Foods Corp | 容器の殺菌方法及び装置 |
CN101123998A (zh) * | 2003-12-15 | 2008-02-13 | 贝克顿·迪金森公司 | 预装填容器的最终灭菌 |
CN101224799A (zh) * | 2007-01-19 | 2008-07-23 | F.S.韩国工业公司 | 灭菌包装容器及利用该灭菌包装容器的包装方法 |
CN101678939A (zh) * | 2008-06-09 | 2010-03-24 | 贝克顿迪金森法国两合公司 | 无菌包装和使用这种包装的灭菌方法 |
CN101428698A (zh) * | 2008-12-10 | 2009-05-13 | 江西3L医用制品集团有限公司 | 一种组合包装袋及其灭菌干燥的方法 |
CN101618770A (zh) * | 2009-08-17 | 2010-01-06 | 湖南千山制药机械股份有限公司 | 一种碳酸氢钠注射液的包装方法 |
CN102488617A (zh) * | 2011-11-22 | 2012-06-13 | 四川科伦药物研究有限公司 | 一种碳酸氢钠注射液塑料软袋包装及其制备方法 |
Non-Patent Citations (2)
Title |
---|
吴耀根等.国内外BOPP膜发展概述.《国外塑料》.2004,第22卷(第10期),第34-37页. |
国内外BOPP膜发展概述;吴耀根等;《国外塑料》;20041231;第22卷(第10期);第34-37页 * |
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CN102826260A (zh) | 2012-12-19 |
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Inventor after: An Yonghua Inventor after: Li Huayu Inventor before: An Yonghua |
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Free format text: CORRECT: INVENTOR; FROM: AN YONGHUA TO: AN YONGHUA LI HUAYU |
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GR01 | Patent grant | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
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Denomination of invention: A production process of double-layer sterile flexible packaging infusion Effective date of registration: 20211202 Granted publication date: 20140625 Pledgee: CITIC Bank Limited by Share Ltd. Zibo branch Pledgor: SHANDONG QIDU PHARMACEUTICAL Co.,Ltd. Registration number: Y2021980013861 |
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Date of cancellation: 20220719 Granted publication date: 20140625 Pledgee: CITIC Bank Limited by Share Ltd. Zibo branch Pledgor: SHANDONG QIDU PHARMACEUTICAL Co.,Ltd. Registration number: Y2021980013861 |