CN105999337A - Biological indicator storage device for pipeline steam sterilization - Google Patents
Biological indicator storage device for pipeline steam sterilization Download PDFInfo
- Publication number
- CN105999337A CN105999337A CN201610564626.4A CN201610564626A CN105999337A CN 105999337 A CN105999337 A CN 105999337A CN 201610564626 A CN201610564626 A CN 201610564626A CN 105999337 A CN105999337 A CN 105999337A
- Authority
- CN
- China
- Prior art keywords
- pipeline
- biological indicator
- cartridge
- fixed disk
- steam sterilization
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000000090 biomarker Substances 0.000 title claims abstract description 47
- 230000001954 sterilising effect Effects 0.000 title claims abstract description 41
- 238000004659 sterilization and disinfection Methods 0.000 title claims abstract description 39
- 238000012360 testing method Methods 0.000 claims abstract description 18
- 238000007789 sealing Methods 0.000 claims abstract description 5
- 241000237509 Patinopecten sp. Species 0.000 claims description 12
- 235000020637 scallop Nutrition 0.000 claims description 12
- 229910000831 Steel Inorganic materials 0.000 claims description 3
- 239000010959 steel Substances 0.000 claims description 3
- 230000000694 effects Effects 0.000 description 5
- 238000004140 cleaning Methods 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 238000012423 maintenance Methods 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000002131 composite material Substances 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000003670 easy-to-clean Effects 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 239000007787 solid 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
- A61L2/26—Accessories or devices or components used for biocidal treatment
- A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
-
- 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
- A61L2/04—Heat
- A61L2/06—Hot gas
- A61L2/07—Steam
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
The invention discloses a biological indicator storage device for steam sterilization of pipelines, which comprises a fixed disc, a storage barrel and a locking nut, wherein the fixed disc is provided with a central hole and a fan-shaped hole, the inner diameter and the outer diameter of the fixed disc are respectively the same as the inner diameter and the outer diameter of a pipeline of a steam sterilization pipeline, and the aperture of the central hole is smaller than the outer diameter of a biological indicator test tube; the two ends of the storage cylinder are opened, one end of the storage cylinder is fixed on the fixed disc, the central hole is covered on the inner side of the storage cylinder, the fan-shaped holes are dispersed outside the storage cylinder, the other end of the storage cylinder is locked by the locking nut, the storage cylinder is provided with strip-shaped holes, and a biological indicator test tube can be just accommodated in the storage cylinder; the edge of the fixed disk is provided with an annular sealing ring, and the storage cylinder is fixed in a pipeline of the steam sterilization pipeline by clamping the storage cylinder at the sealing ring through a chuck of the steam sterilization pipeline. The device provided by the invention can stably store the biological indicator, and the product quality risk caused by the pipeline pollution due to the damage of the biological indicator is avoided.
Description
Technical field
Embodiments of the present invention relate to technology of pharmaceutical engineering field, more specifically, embodiments of the present invention
Relate to a kind of biological indicator's storing unit for pipeline steam sterilization.
Background technology
The cleaning of pharmaceutical equipment pipeline and sterilizing are to ensure that the key point of pharmaceutical production quality, especially " change
Batch " with " replacing kind " time seem even more important.The equipment on-line that GMP advocates cleans (CIP) and goes out online
Bacterium (SIP) function, will become the developing direction of cleaning technique and sterilization technology.
The design of GMP specified devices, type selecting, installation should meet production requirement, it is easy to clean, sterilize or go out
Bacterium, it is simple to production operation and maintenance, maintenance, and mistake can be prevented and reduce pollution.Visible, on-line cleaning
It is to ensure that drug safety produces, do not occurs an important step of mistake with online sterilizing.
Pipeline sterilization effect challenge is particularly important, and pipeline sterilization effect is chosen by checking engineer at present
In wartime, biological indicator is easy to damage, causes the pollution of pipeline, product quality causes tool Risks.
Summary of the invention
Biological indicator's dress is deposited when it is an object of the invention to provide a kind of steam pipework sterilization effect challenge
Put, it is to avoid biological indicator pollutes pipeline, ensure that our pharmacy pipeline sterilization effect reaches to use requirement.
For solving above-mentioned technical problem, one embodiment of the present invention by the following technical solutions:
A kind of biological indicator's storing unit for pipeline steam sterilization, including fixed disk, cartridge and lock
Jack panel, the central authorities of described fixed disk arrange centre bore, in the dispersed scallop hole in the periphery of this centre bore,
The air line distance passed through in the outside cambered surface of two scallop holes of opposition between two points at fixed disk center is solid
The internal diameter of price fixing, fixed disk edge is fixed disk by the air line distance between two points at fixed disk center
External diameter, the internal diameter of described fixed disk is identical with the internal diameter of the pipeline of steam sterilization pipeline, the external diameter of fixed disk with
The outer diameter tube of steam sterilization pipeline is identical, the external diameter of aperture ＜ biological indicator's test tube of described centre bore；
Described cartridge both ends open, one end is fixed on described fixed disk, is covered on by centre bore inside cartridge,
Making scallop hole be dispersed in outside cartridge, the other end passes through locking nut locking, and cartridge is uniformly distributed bar shaped
Hole, the external diameter of internal diameter ＞ biological indicator's test tube of cartridge, the effective length of cartridge and biological indicator
Test tube length is equal, and described effective length refers to that cartridge is for accommodating the length of the part of biological indicator's test tube
Degree；Described fixed disk edge arranges O-ring seal, and is stuck in sealing ring by the chuck of steam sterilization pipeline
Place makes cartridge be fixed in the pipeline of steam sterilization pipeline.
Above-mentioned in biological indicator's storing unit of pipeline steam sterilization, described fixed disk, cartridge and
Locking nut all uses 316L rustless steel to be processed into.
Above-mentioned in biological indicator's storing unit of pipeline steam sterilization, the thickness of described fixed disk is
2mm, the wall thickness of described cartridge is 2mm.
Above-mentioned in biological indicator's storing unit of pipeline steam sterilization, the periphery of described centre bore is uniformly
4 scallop holes of scattering device.
Above-mentioned in biological indicator's storing unit of pipeline steam sterilization, described cartridge is uniformly distributed 4
Individual bar hole.
Compared with prior art, the method have the advantages that
1, the invention provides a kind of movable type and deposit the device of biological indicator, can be used for different pipeline, no
Install at the chuck of co-located.
2, the device utilizing the present invention to provide can firmly deposit biological indicator, will not be because of biological indicator
Damage and pollute pipeline and cause product quality risk.
Accompanying drawing explanation
The knot that Fig. 1 is the present invention to be arranged on pipeline for biological indicator's storing unit of pipeline steam sterilization
Structure schematic diagram.
Fig. 2 is present invention biological indicator's storing unit structural representation for pipeline steam sterilization.
Fig. 3 is the locking nut structure schematic diagram of the biological indicator's storing unit for pipeline steam sterilization.
Fig. 4 is the present invention fixed disk schematic diagram for biological indicator's storing unit of pipeline steam sterilization.
Detailed description of the invention
In order to make the purpose of the present invention, technical scheme and advantage clearer, below in conjunction with accompanying drawing and reality
Execute example, the present invention is further elaborated.Only should be appreciated that specific embodiment described herein
Only in order to explain the present invention, it is not intended to limit the present invention.
As shown in Figure 1 to 4, the present invention is for biological indicator's storing unit main of pipeline steam sterilization
Structure is fixed disk 201, cartridge 102 and locking nut 101.The global shape of fixed disk 201 is a circle
Dish, the central authorities at fixed disk 201 are provided with centre bore 401, and the shape of centre bore does not has strict requirements, but
Under normal circumstances, the centre bore of setting is circular hole.Dispersed in the periphery of this centre bore 401 multiple fan is set
Shape hole 203, a kind of practical embodiment is dispersed in the periphery of centre bore 401 to arrange 4 sectors
Hole 203.As shown in Figure 4, by two points at fixed disk center in the outside cambered surface of two scallop holes of opposition
Between the internal diameter that air line distance d is fixed disk, by between two points at fixed disk center on fixed disk edge
The external diameter that air line distance D is fixed disk, the pipeline 104 internal diameter phase of the internal diameter of fixed disk and steam sterilization pipeline
With, the external diameter of fixed disk is identical with the outer diameter tube of steam sterilization pipeline, is so fixed on pipe when fixed disk
Time in road, the ring on fixed disk only limit and tube contacts, pipeline will not block scallop hole.The aperture of centre bore
It is slightly less than the external diameter of biological indicator's test tube 103, its objective is to ensure that biological indicator's test tube 103 is fixed on
In cartridge；Cartridge 102 both ends open, one end is fixed on fixed disk 201, is covered on by centre bore 401 and deposits
Putting inside cylinder 102, make scallop hole dispersion 203 outside cartridge 102, the other end passes through locking nut 101 locking,
Being uniformly distributed bar hole 202 in cartridge 102, a kind of practical embodiment is equal in cartridge 102
4 bar holes of even distribution.The internal diameter of cartridge, slightly larger than the external diameter of biological indicator's test tube, its objective is conveniently
Picking and placeing of biological indicator's test tube, the effective length of cartridge is equal, effectively with biological indicator's test tube length
Length refers to that cartridge, for accommodating the length of the part of biological indicator's test tube, so can play preferably
Fixed effect；Fixed disk 201 edge arranges O-ring seal 107, and by the chuck 106 of steam sterilization pipeline
It is stuck at sealing ring and makes cartridge 102 be fixed in the pipeline 104 of steam sterilization pipeline.Meanwhile, can adopt
With clip 105, chuck 106 is fixed.
The preferred embodiment of the present invention uses 316L rustless steel to be processed into fixed disk, cartridge and locking screw
Female.The thickness of fixed disk is 2mm, with O-ring seal with the use of, it is ensured that at pipeline chuck seal intact,
No leakage, 4 scallop holes are for ensureing the smooth and easy circulation of steam, and centre bore is slightly less than the external diameter of biological indicator's test tube,
Except ensureing that biological indicator is fixed on inside and outside cartridge, steam to be ensured directly contacts biological indicator,
The external diameter of fixed disk is outer diameter tube, and fixed disk internal diameter is internal diameter of the pipeline, its objective is to be fixed on pipe interior,
The smooth and easy circulation of steam to be ensured, the wall thickness of cartridge is 2mm.Uniform 4 bar holes of cartridge, its purpose
Being to allow steam the most directly contact biological indicator, locking nut is for the fixing biology putting into cartridge
Indicator test tube.
Although reference be made herein to invention has been described for the explanatory embodiment of the present invention, however, it should reason
Solving, those skilled in the art can be designed that a lot of other amendments and embodiment, these amendments and enforcement
Mode will fall within spirit disclosed in the present application and spirit.More specifically, disclosed in the present application
In the range of, the building block of theme composite configuration and/or layout can be carried out multiple modification and improvement.Except
The modification that building block and/or layout are carried out and improve outside, to those skilled in the art, other
Purposes also will be apparent from.
Claims (5)
1. the biological indicator's storing unit for pipeline steam sterilization, it is characterised in that include fixed disk
(201), cartridge (102) and locking nut (101), the central authorities of described fixed disk arrange centre bore
(401), in the dispersed scallop hole in the periphery of this centre bore (203), two scallop holes of opposition
By the internal diameter that air line distance is fixed disk between two points at fixed disk center in the cambered surface of outside, Gu
By the external diameter that air line distance is fixed disk between two points at fixed disk center, institute on price fixing edge
The internal diameter stating fixed disk is identical with the pipeline of steam sterilization pipeline (104) internal diameter, the external diameter of fixed disk with
The outer diameter tube of steam sterilization pipeline is identical, aperture ＜ biological indicator's test tube (103) of described centre bore
External diameter；Described cartridge (102) both ends open, one end is fixed on described fixed disk (201), in inciting somebody to action
Central hole (401) covers on cartridge (102) inner side, makes scallop hole (203) be dispersed in cartridge (102) outward, another
End, by locking nut (101) locking, cartridge (102) is uniformly distributed bar hole (202), cartridge
The external diameter of internal diameter ＞ biological indicator's test tube, the effective length of cartridge and biological indicator's test tube length
Equal, described effective length refers to that cartridge is for accommodating the length of the part of biological indicator's test tube；
Described fixed disk (201) edge arranges O-ring seal (107), and by the chuck of steam sterilization pipeline
(106) it is stuck at sealing ring and makes cartridge (102) be fixed in the pipeline (104) of steam sterilization pipeline.
Biological indicator's storing unit for pipeline steam sterilization the most according to claim 1, its feature
It is that described fixed disk, cartridge and locking nut all use 316L rustless steel to be processed into.
Biological indicator's storing unit for pipeline steam sterilization the most according to claim 1, its feature
The thickness being described fixed disk is 2mm, and the wall thickness of described cartridge is 2mm.
Biological indicator's storing unit for pipeline steam sterilization the most according to claim 1, its feature
It is that the periphery of described centre bore is dispersed and 4 scallop holes are set.
Biological indicator's storing unit for pipeline steam sterilization the most according to claim 1, its feature
It is in described cartridge to be uniformly distributed 4 bar holes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610564626.4A CN105999337B (en) | 2016-07-18 | 2016-07-18 | Biological indicator storage device for pipeline steam sterilization |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610564626.4A CN105999337B (en) | 2016-07-18 | 2016-07-18 | Biological indicator storage device for pipeline steam sterilization |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN105999337A true CN105999337A (en) | 2016-10-12 |
| CN105999337B CN105999337B (en) | 2018-08-21 |
Family
ID=57119462
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610564626.4A Active CN105999337B (en) | 2016-07-18 | 2016-07-18 | Biological indicator storage device for pipeline steam sterilization |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105999337B (en) |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS60100052A (en) * | 1983-10-03 | 1985-06-03 | Technol Control:Kk | Method and apparatus for inspecting internal situation of pipe or the like |
| CN1780645A (en) * | 2003-03-28 | 2006-05-31 | 乌尔里希·凯泽 | Testing body, particularly for verifying the penetration properties of a sterilizing agent in sterilization processes |
| JP2006296850A (en) * | 2005-04-22 | 2006-11-02 | Olympus Medical Systems Corp | Sterilized state confirming tool |
| CN101444632A (en) * | 2009-01-15 | 2009-06-03 | 杭州三源医疗设备有限公司 | Peroxide plasma body sterilizing equipment effect verification device and method and indicator used |
| CN105087361A (en) * | 2015-09-08 | 2015-11-25 | 湖州一控医疗科技有限公司 | Suspension type biological indicator and preparation method thereof |
| CN204814967U (en) * | 2015-07-22 | 2015-12-02 | 青岛高科技工业园海博生物技术有限公司 | Biological indicator sub -assembly |
| CN206045039U (en) * | 2016-07-18 | 2017-03-29 | 四川科伦药业股份有限公司 | Biological indicator storage device for pipeline steam sterilization |
-
2016
- 2016-07-18 CN CN201610564626.4A patent/CN105999337B/en active Active
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS60100052A (en) * | 1983-10-03 | 1985-06-03 | Technol Control:Kk | Method and apparatus for inspecting internal situation of pipe or the like |
| CN1780645A (en) * | 2003-03-28 | 2006-05-31 | 乌尔里希·凯泽 | Testing body, particularly for verifying the penetration properties of a sterilizing agent in sterilization processes |
| JP2006296850A (en) * | 2005-04-22 | 2006-11-02 | Olympus Medical Systems Corp | Sterilized state confirming tool |
| CN101444632A (en) * | 2009-01-15 | 2009-06-03 | 杭州三源医疗设备有限公司 | Peroxide plasma body sterilizing equipment effect verification device and method and indicator used |
| CN204814967U (en) * | 2015-07-22 | 2015-12-02 | 青岛高科技工业园海博生物技术有限公司 | Biological indicator sub -assembly |
| CN105087361A (en) * | 2015-09-08 | 2015-11-25 | 湖州一控医疗科技有限公司 | Suspension type biological indicator and preparation method thereof |
| CN206045039U (en) * | 2016-07-18 | 2017-03-29 | 四川科伦药业股份有限公司 | Biological indicator storage device for pipeline steam sterilization |
Also Published As
| Publication number | Publication date |
|---|---|
| CN105999337B (en) | 2018-08-21 |
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