CN102826260B - Production process of dual-layer sterile soft package infusion solution - Google Patents
Production process of dual-layer sterile soft package infusion solution Download PDFInfo
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- 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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- 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
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Abstract
The invention relates to a production process of a dual-layer sterile soft package infusion solution. The production process comprises the following steps of: 1, bagging an infusion solution membrane, sealing after filling an infusion solution; 2, placing a filled internal package bag into a sterilizing device to be subjected to water bath sterilization; 3, drying the sterilized internal package bag with clean air; 4, carrying out light inspection on the dried internal package bag; 5, sending the internal package bag into a packaging machine, packing an outer package bag, and boxing; and 6, carrying out gamma ray radiation on the boxed package bag for sterilization to obtain the dual-layer sterile soft package infusion solution. According to the production process, the production cost of an infusion solution bag can be reduced, the production efficiency is increased, and the sterilization effect is ensured.
Description
Technical field
The present invention relates to a kind of transfusion production technology, be specifically related to a kind of double-layer sterile soft-packing transfusion production technology.
Background technology
The production technology of current double-layer sterile soft-packing transfusion is to pack outer bag after inner bag embedding again, vacuumizes simultaneously, then carries out successively sterilizing, dry, vanning, can put in storage.Utilize this technique, when transfusion enters the clean environment uses such as operating room, can sterilize and directly use, avoided pollution risk, convenient operation uses.
But, double-layer sterile soft-packing transfusion production technology also has following shortcoming at present: (1) requires the high temperature of resistance to sterilizing to peplos, therefore select requirement harsher at the raw material of peplos, the peplos that common raw material is produced cannot reach sterilizing requirement, and productive costs is higher; (2) while packing, need to vacuumize, cause investment of production equipment higher, and production efficiency be lower; (3) due to the water-bath sterilization method adopting, when sterilizing, cannot guarantee that the sterilising temp between product penetrates evenly, thereby affect sterilization effect.
Summary of the invention
The object of this invention is to provide a kind of double-layer sterile soft-packing transfusion production technology, this technique can reduce the productive costs of transfusion, enhances productivity, and guarantees sterilization effect.
In order to reach above object, a kind of double-layer sterile soft-packing transfusion production technology that the present invention mentions, comprises the following steps:
(1) will after infusion film bag, liquid drug, seal;
(2) packing inside bag after embedding is good is inserted bactericidal unit and is carried out water-bath sterilization;
(3) dry with pure air to the packing inside bag after sterilizing;
(4) dried packing inside bag is carried out to lamp inspection;
(5) packing inside bag is sent into wrapping machine, pack outer bag, then case;
(6) product of casing is carried out to radiated by gamma-ray sterilizing, obtain double-layer sterile soft-packing transfusion product.
Wherein, the water-bath sterilization in described step (2), adopting sterilising temp is 115～121 ℃, sterilization time 12～40 minutes.
In described step (5), the material of outer packaging bag is that BOPP film and PE film are composited.
Radiated by gamma-ray sterilizing in described step (6), its radiation dose is 3.5 Kgy～25Kgy.
Double-layer sterile soft-packing transfusion production technology of the present invention, improve and traditional first carried out inner bag and outer bag packing, then the production technology of carrying out sterilizing, adopted the sterilization method of two-step method, first carry out inner bag water-bath sterilization, then carry out irradiation sterilization after outer bag packing.
Work out aseptic package bag microbial limit examination criteria according to " hospital disinfection hygienic standard " GB15982-1995 infusion bag is checked, as shown in the table:
| Test item | Limitation standard in microbe |
| Bacterial population | ≤5 cfu/cm 2 |
| Mould and saccharomycete | Must not detect |
| EHEC | Must not detect |
| Detection of Salmonella | Must not detect |
Testing crew has further done aseptic quality test experience, gets aseptic package bag and opens in clean room, uses aseptic cotton carrier wipe surfaces, then is worth test liquid by soaking cotton swab.Test liquid is by membrane filtration and carry out bacterium colony cultivation, counting.The content that has detected respectively bacterium, mould and saccharomycete, EHEC, detection of Salmonella, result shows, the double-layer sterile flexible-package transfusion bag of this explained hereafter meets " hospital disinfection hygienic standard " desired microbial limit completely.
The invention has the advantages that:
(1) packing after adopt irradiation sterilization, guarantee sterilization effect in advance under, reduced the requirement to peplos material, greatly reduce the productive costs of product.
(2) adopt the sterilization method of two-step method, liquid sterilizing is common process, and packaging bag sterilizing is irradiation sterilization in enormous quantities, has avoided the method that vacuumizes, has simplified technique, has reduced investment of production equipment, has improved production efficiency.
(3) adopt radiation mode to carry out packaging bag sterilizing, avoided water-bath sterilization cannot guarantee that the sterilising temp between product penetrates uniform shortcoming, has guaranteed sterilization effect and product design.
Accompanying drawing explanation
Fig. 1 is production technological process of the present invention.
In figure, digitized representation operational sequence, its 1. inner bag processed; 2. filling; 3. sealing; 4. water-bath sterilization; 5. dry; 6. lamp inspection; 7. packing outer bag; 8. vanning; 9. irradiation sterilization.
The specific embodiment
Below in conjunction with embodiment, the present invention will be further described.
By infusion film bag, after liquid drug, seal, then carry out water-bath sterilization 40 minutes at 115 ℃.Then carry out pure air dry, dry laggard portable lighter inspection, and then inner packing is sent into wrapping machine, pack outer bag, then case.Finally the product of casing is carried out to radiated by gamma-ray sterilizing, dosage is 3.5 Kgy.
Product outer bag is carried out to aseptic detection, and its assay is:
| Test item | Content of microorganisms |
| Bacterial population | ≤3 cfu/cm 2 |
| Mould and saccharomycete | Do not detect |
| EHEC | Do not detect |
| Detection of Salmonella | Do not detect |
As can be seen here, the product that this production technology makes, meets aseptic package bag microbial limit examination criteria.
By infusion film bag, after liquid drug, seal, then carry out water-bath sterilization 12 minutes at 121 ℃.Then carry out pure air dry, dry laggard portable lighter inspection, and then inner packing is sent into wrapping machine, pack outer bag, then case.Finally the product of casing is carried out to radiated by gamma-ray sterilizing, dosage is 25 Kgy.
Product outer bag is carried out to aseptic detection, and its assay is:
| Test item | Content of microorganisms |
| Bacterial population | ≤1 cfu/cm 2 |
| Mould and saccharomycete | Do not detect |
| EHEC | Do not detect |
| Detection of Salmonella | Do not detect |
As can be seen here, the product that this production technology makes, meets aseptic package bag microbial limit examination criteria.
Claims (1)
1. a kind of double-layer sterile soft-packing transfusion production technology that the present invention mentions, comprises the following steps:
(1) will after infusion film bag, liquid drug, seal;
(2) packing inside bag after embedding is good is inserted bactericidal unit and is carried out water-bath sterilization;
(3) dry with pure air to the packing inside bag after sterilizing;
(4) dried packing inside bag is carried out to lamp inspection;
(5) packing inside bag is sent into wrapping machine, pack outer bag, then case;
(6) oneself vanning product is carried out to radiated by gamma-ray sterilizing, obtain double-layer sterile soft-packing transfusion product;
Water-bath sterilization in step (2), adopting sterilising temp is 115～121 ℃, sterilization time 12～40 minutes;
In step (5), the material of outer packaging bag is that BOPP film and PE film are composited;
Radiated by gamma-ray sterilizing in step (6), its radiation dose is 3.5 Kgy～25Kgy.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210363236.2A CN102826260B (en) | 2012-09-26 | 2012-09-26 | Production process of dual-layer sterile soft package infusion solution |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210363236.2A CN102826260B (en) | 2012-09-26 | 2012-09-26 | Production process of dual-layer sterile soft package infusion solution |
Publications (2)
| Publication Number | Publication Date |
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| CN102826260A CN102826260A (en) | 2012-12-19 |
| CN102826260B true CN102826260B (en) | 2014-06-25 |
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| CN201210363236.2A Active CN102826260B (en) | 2012-09-26 | 2012-09-26 | Production process of dual-layer sterile soft package infusion solution |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103919679A (en) * | 2014-05-06 | 2014-07-16 | 四川太平洋药业有限责任公司 | Negative pressure type soft infusion bag |
| CN103919677A (en) * | 2014-05-06 | 2014-07-16 | 四川太平洋药业有限责任公司 | Negative pressure type double-valve soft infusion bag |
| CN103961260A (en) * | 2014-05-25 | 2014-08-06 | 四川太平洋药业有限责任公司 | Vacuum leak-detection sterile dual-valve soft bag transfusion combined bag |
| CN105125402B (en) * | 2015-08-14 | 2018-03-16 | 石家庄四药有限公司 | A kind of butt-ended bag transfusion double-layer sterile packaging system and preparation method thereof |
| CN105460306B (en) * | 2015-12-30 | 2017-12-29 | 山东新华医疗器械股份有限公司 | Lamp inspection dry integrated machine |
Citations (8)
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|---|---|---|---|---|
| EP0083448A2 (en) * | 1981-12-31 | 1983-07-13 | International Paper Company | Sterilization of packaging materials |
| JP2000281023A (en) * | 1999-03-30 | 2000-10-10 | House Foods Corp | Method and device for sterilizing container |
| CN101123998A (en) * | 2003-12-15 | 2008-02-13 | 贝克顿·迪金森公司 | Terminal sterilization of prefilled containers |
| CN101224799A (en) * | 2007-01-19 | 2008-07-23 | F.S.韩国工业公司 | Sterilization packing case and method for packing thereof |
| CN101428698A (en) * | 2008-12-10 | 2009-05-13 | 江西3L医用制品集团有限公司 | Combined packaging bag and sterilizing-drying method |
| CN101618770A (en) * | 2009-08-17 | 2010-01-06 | 湖南千山制药机械股份有限公司 | Packaging method of sodium bicarbonate injection |
| CN101678939A (en) * | 2008-06-09 | 2010-03-24 | 贝克顿迪金森法国两合公司 | Sterile packing and sterilization method using this packing |
| CN102488617A (en) * | 2011-11-22 | 2012-06-13 | 四川科伦药物研究有限公司 | Sodium bicarbonate injection plastic soft bag package and preparation method thereof |
-
2012
- 2012-09-26 CN CN201210363236.2A patent/CN102826260B/en active Active
Patent Citations (8)
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|---|---|---|---|---|
| EP0083448A2 (en) * | 1981-12-31 | 1983-07-13 | International Paper Company | Sterilization of packaging materials |
| JP2000281023A (en) * | 1999-03-30 | 2000-10-10 | House Foods Corp | Method and device for sterilizing container |
| CN101123998A (en) * | 2003-12-15 | 2008-02-13 | 贝克顿·迪金森公司 | Terminal sterilization of prefilled containers |
| CN101224799A (en) * | 2007-01-19 | 2008-07-23 | F.S.韩国工业公司 | Sterilization packing case and method for packing thereof |
| CN101678939A (en) * | 2008-06-09 | 2010-03-24 | 贝克顿迪金森法国两合公司 | Sterile packing and sterilization method using this packing |
| CN101428698A (en) * | 2008-12-10 | 2009-05-13 | 江西3L医用制品集团有限公司 | Combined packaging bag and sterilizing-drying method |
| CN101618770A (en) * | 2009-08-17 | 2010-01-06 | 湖南千山制药机械股份有限公司 | Packaging method of sodium bicarbonate injection |
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| CN102826260A (en) | 2012-12-19 |
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Inventor after: An Yonghua Inventor after: Li Huayu Inventor before: An Yonghua |
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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 |