CN101927047B - Method for removing the in-vitro cytotoxicity for disposable sterilized syringe - Google Patents
Method for removing the in-vitro cytotoxicity for disposable sterilized syringe Download PDFInfo
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- CN101927047B CN101927047B CN2010102329000A CN201010232900A CN101927047B CN 101927047 B CN101927047 B CN 101927047B CN 2010102329000 A CN2010102329000 A CN 2010102329000A CN 201010232900 A CN201010232900 A CN 201010232900A CN 101927047 B CN101927047 B CN 101927047B
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- disposable sterilized
- jar
- sterilized syringe
- vitro cytotoxicity
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- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
The invention relates to a method for removing the in-vitro cytotoxicity for disposable sterilized syringe, and is characterized in that the method comprises the following steps: 1) pressurizing and steaming at high temperature; 2) washing with acid; 3) rinsing and drying. In the invention, steaming is carried out under the condition of increasing pressure and temperature, thereby improving the solubility and dissolving speed rate of harmful chemical substance in cleaning solution; in acid soaking process, the harmful substance on the surface of the product is further removed, thereby greatly reducing or removing the damage of the harmful chemical substance to the cell, enabling the in-vitro cytotoxicity test to reach 0-1 grade and meeting GB/T16885.5 standard.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments, specifically, is the method for removing disposable sterilized syringe with in-vitro cytotoxicity about a kind of.
Background technology
The biology safety evaluation of medical apparatus and instruments is introduced from international standard ISO10993 series standard, after the domestic adopting by equation, is converted into the GB/T16886 series standard.Because it is slower that national sector standard transforms, " the YY/T0243-2003 disposable sterilized syringe is used piston " standard of carrying out is not now implemented requirement to the GB/T16886 standard code as yet.But have the foreign trader to propose, from 2010, this product also must provide the vitro cytotoxicity test report by the GB/T16886.5 standard.Disposable sterilized syringe is a druggist rubber sundrier with piston; Belong to three types of medical apparatus and instruments, the traditional mode of production flow process of this product is: raw material be equipped with, dry, plasticate mixing, check is parked, steaming and decocting under the refine slice, sulfidization molding, check, stamping-out deburring, normal pressure, dry, the packing warehouse-in of washing.Its cell toxicity test (in vitro method) can not satisfy the requirement of GB/T16886.5 standard techniques all below three grades.Evidence, cytotoxicity are the cell injury that is caused by chemical substance, remove the vitro cytotoxicity of product, and key is effectively to remove the harmful chemical in the product.
Summary of the invention
To above deficiency; The object of the present invention is to provide a kind of method of removing disposable sterilized syringe with in-vitro cytotoxicity: adopt intensified pressure, improve the temperature steaming and decocting; Carrying out acid solution again embathes; Remove disposable sterilized syringe with the harmful chemical in the piston, make product not only meet the YY/T0243 standard, can satisfy the requirement of GB/T16886.5 standard techniques simultaneously.
Technical scheme of the present invention realizes in the following manner: remove the method for disposable sterilized syringe with in-vitro cytotoxicity, it is characterized in that:
1), pressurized high-temperature steaming and decocting: disposable sterilized syringe mixes and inserts in the cooker with piston goods and the pure water part by weight with 1: 2;
Jar internal pressure: 0.20～0.25 MPa;
Temperature in jar: 120～125 ℃;
Digestion time: 3.0～4.0 hours
2), pickling processes: after the cooker release, inject food grade hydrochloric acid, making a jar interior concentration of hydrochloric acid is 0.5 ‰, seals cover, braises after 0.5 hour to go out jar.
3), rinsing is dry: the goods that will go out jar carry out rinsing with water for injection in 100,000 grades of dust proof workshops, dry back packing.
Described disposable sterilized syringe is a druggist rubber sundrier with piston.
The present invention, steaming and decocting under the condition of increase pressure and temperature has improved dissolubility and the rate of dissolution of solubility harmful chemical in cooking liquor in the goods; Braise in the process adding acid, further removed the harmful substance of product surface, reduce or eliminated the injury of harmful chemical pair cell greatly, can make the vitro cytotoxicity test of product reach 0～1 grade, satisfy the GB/T16886.5 standard-required.Production whole process of the present invention is: raw material be equipped with, dry, plasticate mixing, check is parked, refine slice, sulfidization molding, check, stamping-out deburring, check, pressurized high-temperature steaming and decocting, pickling, rinsing are dry, the packing warehouse-in.
The specific embodiment:
Embodiment one:
1, pressurized high-temperature steaming and decocting: 500 kilograms in goods, 1000 kilograms of pure water, pressure 0.25 MPa, 125 ℃ of temperature, 4.0 hours time.
2, pickling processes: after the pressurized high-temperature steaming and decocting finishes, release, implantation concentration is 2.0 kilograms of 25% food grade hydrochloric acids in jar, closes cover, braises after 0.5 hour to go out jar.
3, rinsing is dry: the goods that will go out jar carry out rinsing with water for injection in 100,000 grades of dust proof workshops, dry back packing.
Embodiment two:
1, pressurized high-temperature steaming and decocting: 300 kilograms in goods, 600 kilograms of pure water, pressure 0.20 MPa, 120 ℃ of temperature, 3.0 hours time.
2, pickling processes: after the pressurized high-temperature steaming and decocting finishes, release, implantation concentration is 1.2 kilograms of 25% food grade hydrochloric acids in jar, closes cover, braises after 0.5 hour to go out jar.
3, rinsing is dry: the goods that will go out jar carry out rinsing with water for injection in 100,000 grades of dust proof workshops, dry back packing.
Claims (2)
1. remove the method for disposable sterilized syringe, it is characterized in that: may further comprise the steps with in-vitro cytotoxicity:
1), pressurized high-temperature steaming and decocting: disposable sterilized syringe mixes and inserts in the cooker with piston goods and the pure water part by weight with 1: 2;
Jar internal pressure: 0.20～0.25 MPa;
Temperature in jar: 120～125 ℃;
Digestion time: 3.0～4.0 hours;
2), pickling processes: after the cooker release, inject food grade hydrochloric acid, making a jar interior concentration of hydrochloric acid is 0.5%, seals cover, braises after 0.5 hour to go out jar.
3), rinsing is dry: the goods that will go out jar carry out rinsing with water for injection in 100,000 grades of dust proof workshops, dry back packing.
2. removal disposable sterilized syringe according to claim 1 is characterized in that with the method for in-vitro cytotoxicity: described disposable sterilized syringe is druggist rubber sundriers with the piston goods.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010102329000A CN101927047B (en) | 2010-07-21 | 2010-07-21 | Method for removing the in-vitro cytotoxicity for disposable sterilized syringe |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010102329000A CN101927047B (en) | 2010-07-21 | 2010-07-21 | Method for removing the in-vitro cytotoxicity for disposable sterilized syringe |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101927047A CN101927047A (en) | 2010-12-29 |
| CN101927047B true CN101927047B (en) | 2012-11-21 |
Family
ID=43366643
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2010102329000A Active CN101927047B (en) | 2010-07-21 | 2010-07-21 | Method for removing the in-vitro cytotoxicity for disposable sterilized syringe |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101927047B (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3139323A (en) * | 1962-01-25 | 1964-06-30 | Foremost Dairies Inc | Sterilizing process |
| US3853622A (en) * | 1971-05-19 | 1974-12-10 | Huber Gmbh & Co Kg A | Sterilizer for rubber parts |
| CN85201778U (en) * | 1985-04-30 | 1986-04-16 | 欧阳士波 | Fully automatic cleaning device for syringes |
| CN101247838A (en) * | 2005-08-26 | 2008-08-20 | 贝克顿迪肯森公司 | Methods of sterilizing elastomeric sealing articles |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101724180B (en) * | 2009-11-04 | 2011-06-22 | 淄博东大橡塑有限公司 | Potential cytotoxicity-free rubber piston for disposable sterile syringe and manufacturing method thereof |
-
2010
- 2010-07-21 CN CN2010102329000A patent/CN101927047B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3139323A (en) * | 1962-01-25 | 1964-06-30 | Foremost Dairies Inc | Sterilizing process |
| US3853622A (en) * | 1971-05-19 | 1974-12-10 | Huber Gmbh & Co Kg A | Sterilizer for rubber parts |
| CN85201778U (en) * | 1985-04-30 | 1986-04-16 | 欧阳士波 | Fully automatic cleaning device for syringes |
| CN101247838A (en) * | 2005-08-26 | 2008-08-20 | 贝克顿迪肯森公司 | Methods of sterilizing elastomeric sealing articles |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101927047A (en) | 2010-12-29 |
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