CN109276732A - A kind of desinfection chamber sterilization method in medicine production process - Google Patents
A kind of desinfection chamber sterilization method in medicine production process Download PDFInfo
- Publication number
- CN109276732A CN109276732A CN201811251560.9A CN201811251560A CN109276732A CN 109276732 A CN109276732 A CN 109276732A CN 201811251560 A CN201811251560 A CN 201811251560A CN 109276732 A CN109276732 A CN 109276732A
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- production process
- desinfection chamber
- sterilization method
- medicine production
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- 238000000034 method Methods 0.000 title claims abstract description 48
- 238000004659 sterilization and disinfection Methods 0.000 title claims abstract description 31
- 239000003814 drug Substances 0.000 title claims abstract description 29
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 27
- 230000001954 sterilising effect Effects 0.000 title claims abstract description 23
- 238000009423 ventilation Methods 0.000 claims abstract description 14
- 239000000645 desinfectant Substances 0.000 claims abstract description 9
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 6
- 239000007921 spray Substances 0.000 claims abstract description 6
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 claims description 8
- 230000005855 radiation Effects 0.000 claims description 4
- 239000012153 distilled water Substances 0.000 claims description 3
- 239000010648 geranium oil Substances 0.000 claims description 3
- 235000019717 geranium oil Nutrition 0.000 claims description 3
- 239000003921 oil Substances 0.000 claims description 3
- 235000019198 oils Nutrition 0.000 claims description 3
- 238000000746 purification Methods 0.000 claims description 3
- 239000000341 volatile oil Substances 0.000 claims description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- OSDLLIBGSJNGJE-UHFFFAOYSA-N 4-chloro-3,5-dimethylphenol Chemical compound CC1=CC(O)=CC(C)=C1Cl OSDLLIBGSJNGJE-UHFFFAOYSA-N 0.000 claims 1
- 231100000167 toxic agent Toxicity 0.000 claims 1
- 239000003440 toxic substance Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 abstract description 5
- 238000012865 aseptic processing Methods 0.000 abstract description 3
- 244000005700 microbiome Species 0.000 description 6
- 241000894006 Bacteria Species 0.000 description 3
- IVSZLXZYQVIEFR-UHFFFAOYSA-N 1,3-Dimethylbenzene Natural products CC1=CC=CC(C)=C1 IVSZLXZYQVIEFR-UHFFFAOYSA-N 0.000 description 2
- 241000205585 Aquilegia canadensis Species 0.000 description 2
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 2
- -1 Meta-xylene phenol Chemical compound 0.000 description 2
- 241000209094 Oryza Species 0.000 description 2
- 235000007164 Oryza sativa Nutrition 0.000 description 2
- 239000000460 chlorine Substances 0.000 description 2
- 229910052801 chlorine Inorganic materials 0.000 description 2
- 235000009566 rice Nutrition 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- CBENFWSGALASAD-UHFFFAOYSA-N Ozone Chemical compound [O-][O+]=O CBENFWSGALASAD-UHFFFAOYSA-N 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 238000009395 breeding Methods 0.000 description 1
- 230000001488 breeding effect Effects 0.000 description 1
- 230000003559 chemosterilizing effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 238000002309 gasification Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000000053 physical method Methods 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 239000003206 sterilizing agent Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N31/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic oxygen or sulfur compounds
- A01N31/08—Oxygen or sulfur directly attached to an aromatic ring system
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N65/00—Biocides, pest repellants or attractants, or plant growth regulators containing material from algae, lichens, bryophyta, multi-cellular fungi or plants, or extracts thereof
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N65/00—Biocides, pest repellants or attractants, or plant growth regulators containing material from algae, lichens, bryophyta, multi-cellular fungi or plants, or extracts thereof
- A01N65/08—Magnoliopsida [dicotyledons]
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N65/00—Biocides, pest repellants or attractants, or plant growth regulators containing material from algae, lichens, bryophyta, multi-cellular fungi or plants, or extracts thereof
- A01N65/08—Magnoliopsida [dicotyledons]
- A01N65/12—Asteraceae or Compositae [Aster or Sunflower family], e.g. daisy, pyrethrum, artichoke, lettuce, sunflower, wormwood or tarragon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
- A61L2/10—Ultraviolet radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L9/00—Disinfection, sterilisation or deodorisation of air
- A61L9/16—Disinfection, sterilisation or deodorisation of air using physical phenomena
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/25—Rooms in buildings, passenger compartments
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Environmental Sciences (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Dentistry (AREA)
- Plant Pathology (AREA)
- Agronomy & Crop Science (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Biotechnology (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Microbiology (AREA)
- Pest Control & Pesticides (AREA)
- Chemical & Material Sciences (AREA)
- Botany (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
The present invention provides the desinfection chamber sterilization method in a kind of medicine production process.Desinfection chamber sterilization method in medicine production process of the invention, it is characterized in that: this method comprises: (1) carries out ventilation ventilation process 1-2 hours to process(ing) cell daily;(2) at interval of progress spray disinfectant agent disinfection in 3-4 hours;(3) progress in every 12 hours ultraviolet lamp disinfection 15-30 minutes.The present invention is combined by the method for physics and chemistry, reaches more thorough aseptic processing environment, provides more structurally sound safety guarantee to drug production.
Description
Technical field:
The present invention relates to the desinfection chamber sterilization methods in a kind of medicine production process, belong to chemical technology field.
Background technique:
Aseptic medicine quality is concerning patient vitals' safety, because drug is directly administered by injection or wound, although curative effect is fast
Risk is larger.Therefore, the production of no aseptic medicine has to strictly design and carry out according to the method for verifying and regulation, it is sterile and
Quality control must start from design, through production overall process.
There is no living microorganism in product to reach, aseptic medicine needs that various methods is taken to make a return journey in the fabrication process
Except microorganism original in product and prevent pollution of the product by microorganism.It can be used to control microorganism there are many method
Microorganism is killed or removes in growth, these methods are usually divided into chemically and physically two major classes in drug process for making.
Wherein, chemical method has chemosterilant, gasification hydrogen peroxide, ozone and ethylene oxide etc.;Physical method has damp and hot or xeothermic goes out
Bacterium, radiation sterilization and filtration sterilization etc..The reliability of these methods requires to prove using the test of the growth and breeding of microorganism.
Existing sterile working is mainly realized by the methods of ventilation, sterile clothes, and bacterial content can be substantially reached
It is lower, it is unable to reach more thorough gnotobasis.
Summary of the invention:
The purpose of the present invention is providing the desinfection chamber sterilization method in a kind of medicine production process in view of the above problems, lead to
The method for crossing physics and chemistry combines, and reaches more thorough aseptic processing environment, provides more structurally sound peace to drug production
All risk insurance barrier.
Above-mentioned purpose is realized by following technical scheme:
Desinfection chamber sterilization method in medicine production process, this method comprises:
(1) ventilation ventilation process 1-2 hours is carried out to process(ing) cell daily;
(2) at interval of progress spray disinfectant agent disinfection in 3-4 hours;
(3) progress in every 12 hours ultraviolet lamp disinfection 15-30 minutes.
Desinfection chamber sterilization method in the medicine production process, the ventilation ventilation is carried out using purification air and nothing
The indoor air exchange of bacterium.
Desinfection chamber sterilization method in the medicine production process, the disinfectant include honeysuckle in parts by weight
3-9 parts of extract, 2-5 parts of geranium oil, 4-9 parts of volatile argyi leaf oil, 5-8 parts of Rhzoma Atractylodis Lanceae volatile oil, 10-14 parts of hydrogen peroxide, to chlorine
Meta-xylene phenol 5-12,50 parts of distilled water.
Desinfection chamber sterilization method in the medicine production process, the dosage of the spray disinfectant agent are 10-20ml/
Rice3Space.
Desinfection chamber sterilization method in the medicine production process, the dosage of the ultraviolet light irradiation are to ask radiation
The intensity of 253.7nrn ultraviolet light are as follows: > 180uW/CM2。
The utility model has the advantages that
1. the present invention is combined by the method for physics and chemistry, reach more thorough aseptic processing environment, is mentioned to drug production
For more structurally sound safety guarantee.
Specific embodiment:
Embodiment 1:
Desinfection chamber sterilization method in medicine production process, this method comprises:
(1) ventilation ventilation process 1-2 hours is carried out to process(ing) cell daily;
(2) at interval of progress spray disinfectant agent disinfection in 3-4 hours;
(3) progress in every 12 hours ultraviolet lamp disinfection 15-30 minutes.
Desinfection chamber sterilization method in the medicine production process, the ventilation ventilation is carried out using purification air and nothing
The indoor air exchange of bacterium.
Desinfection chamber sterilization method in the medicine production process, the disinfectant include honeysuckle in parts by weight
3-9 parts of extract, 2-5 parts of geranium oil, 4-9 parts of volatile argyi leaf oil, 5-8 parts of Rhzoma Atractylodis Lanceae volatile oil, 10-14 parts of hydrogen peroxide, to chlorine
Meta-xylene phenol 5-12,50 parts of distilled water.
Desinfection chamber sterilization method in the medicine production process, the dosage of the spray disinfectant agent are 10-20ml/
Rice3Space.
Desinfection chamber sterilization method in the medicine production process, the dosage of the ultraviolet light irradiation are to ask radiation
The intensity of 253.7nrn ultraviolet light are as follows: > 180uW/CM2。
The above is only highly preferred embodiment of the present invention, the method for the present invention includes but be not limited to the above embodiments, the present invention
Unaccomplished matter, belong to the common knowledge of those skilled in the art.
Claims (5)
1. the desinfection chamber sterilization method in a kind of medicine production process, it is characterized in that: this method comprises:
(1) ventilation ventilation process 1-2 hours is carried out to process(ing) cell daily;
(2) at interval of progress spray disinfectant agent disinfection in 3-4 hours;
(3) progress in every 12 hours ultraviolet lamp disinfection 15-30 minutes.
2. the desinfection chamber sterilization method in medicine production process according to claim 1, it is characterized in that: the ventilation is divulged information
It is carried out and sterile indoor air exchange using purification air.
3. the desinfection chamber sterilization method in medicine production process according to claim 1, it is characterized in that: the disinfectant
In parts by weight including Honegsukle flower P.E 3-9 parts, 2-5 parts of geranium oil, 4-9 parts of volatile argyi leaf oil, 5-8 parts of Rhzoma Atractylodis Lanceae volatile oil,
10-14 parts of hydrogen peroxide, parachlorometaxylenol 5-12,50 parts of distilled water.
4. the desinfection chamber sterilization method in medicine production process according to claim 1, it is characterized in that: the sprinkling disappears
The dosage of toxic agent is 10-20ml/ meters3Space.
5. the desinfection chamber sterilization method in medicine production process according to claim 1, it is characterized in that: the ultraviolet lamp
The dosage of irradiation is the intensity for seeking radiation 253.7nrn ultraviolet light are as follows: > 180uW/CM2。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN201811251560.9A CN109276732A (en) | 2018-10-25 | 2018-10-25 | A kind of desinfection chamber sterilization method in medicine production process |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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CN201811251560.9A CN109276732A (en) | 2018-10-25 | 2018-10-25 | A kind of desinfection chamber sterilization method in medicine production process |
Publications (1)
Publication Number | Publication Date |
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CN109276732A true CN109276732A (en) | 2019-01-29 |
Family
ID=65177967
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN201811251560.9A Pending CN109276732A (en) | 2018-10-25 | 2018-10-25 | A kind of desinfection chamber sterilization method in medicine production process |
Country Status (1)
Country | Link |
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CN (1) | CN109276732A (en) |
Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN2064873U (en) * | 1990-01-20 | 1990-10-31 | 王伟 | Indoor air cleaner |
WO2009046561A2 (en) * | 2007-10-10 | 2009-04-16 | Hanspeter Steffen | Method for the disinfection of poultry barns and livestock sheds using ozone, electrolytically oxidative radicals, uv-c radiation, electrostatic spray technology, excess pressure ventilation and air-humidification technology |
KR20110087516A (en) * | 2010-01-26 | 2011-08-03 | 이용화 | Hand sterilizer with self purifying function |
CN102845482A (en) * | 2012-08-14 | 2013-01-02 | 青岛叁鼎卫生制品有限公司 | Air disinfectant with natural fragrance |
CN106524384A (en) * | 2016-11-14 | 2017-03-22 | 安徽名杰净化科技有限公司 | Circular ventilation GMP sterile purification workshop |
CN206167435U (en) * | 2016-07-21 | 2017-05-17 | 四川康而好动物药业有限公司 | A degassing unit for production of pharmaceuticals in -process |
CN107198784A (en) * | 2017-05-03 | 2017-09-26 | 安徽省伟业净化设备有限公司 | A kind of I grades of clean operating room sterilization method |
CN108246027A (en) * | 2017-12-20 | 2018-07-06 | 佛山杰致信息科技有限公司 | A kind of medicine production sterilizing dust removing room |
CN108405018A (en) * | 2018-06-07 | 2018-08-17 | 苏州朝霞生物科技有限公司 | A kind of Bioexperiment aseptic operating platform |
-
2018
- 2018-10-25 CN CN201811251560.9A patent/CN109276732A/en active Pending
Patent Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN2064873U (en) * | 1990-01-20 | 1990-10-31 | 王伟 | Indoor air cleaner |
WO2009046561A2 (en) * | 2007-10-10 | 2009-04-16 | Hanspeter Steffen | Method for the disinfection of poultry barns and livestock sheds using ozone, electrolytically oxidative radicals, uv-c radiation, electrostatic spray technology, excess pressure ventilation and air-humidification technology |
KR20110087516A (en) * | 2010-01-26 | 2011-08-03 | 이용화 | Hand sterilizer with self purifying function |
CN102845482A (en) * | 2012-08-14 | 2013-01-02 | 青岛叁鼎卫生制品有限公司 | Air disinfectant with natural fragrance |
CN206167435U (en) * | 2016-07-21 | 2017-05-17 | 四川康而好动物药业有限公司 | A degassing unit for production of pharmaceuticals in -process |
CN106524384A (en) * | 2016-11-14 | 2017-03-22 | 安徽名杰净化科技有限公司 | Circular ventilation GMP sterile purification workshop |
CN107198784A (en) * | 2017-05-03 | 2017-09-26 | 安徽省伟业净化设备有限公司 | A kind of I grades of clean operating room sterilization method |
CN108246027A (en) * | 2017-12-20 | 2018-07-06 | 佛山杰致信息科技有限公司 | A kind of medicine production sterilizing dust removing room |
CN108405018A (en) * | 2018-06-07 | 2018-08-17 | 苏州朝霞生物科技有限公司 | A kind of Bioexperiment aseptic operating platform |
Non-Patent Citations (2)
Title |
---|
冯骏著: "《工业用水处理微生物分析》", 30 November 1989, 广东科技出版社 * |
安欣良主编: "《血站(库)实用管理手册》", 31 August 1993, 苏州大学出版社 * |
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