CN102793933A - Online sterilization super-high purity medium conveying equipment - Google Patents
Online sterilization super-high purity medium conveying equipment Download PDFInfo
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- CN102793933A CN102793933A CN2012102579819A CN201210257981A CN102793933A CN 102793933 A CN102793933 A CN 102793933A CN 2012102579819 A CN2012102579819 A CN 2012102579819A CN 201210257981 A CN201210257981 A CN 201210257981A CN 102793933 A CN102793933 A CN 102793933A
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- high purity
- outlet pipe
- injection water
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Abstract
The invention discloses online sterilization super-high purity medium conveying equipment. The equipment consists of a water tank, an injection water circulation device and a pure steam introduction pipe, wherein the injection water circulation device comprises an injection water inlet pipe and an injection water outlet pipe; the injection water inlet pipe is connected to the inlet of the water tank, and the pure steam introduction pipe is connected to the inlet of the water tank; the injection water outlet pipe is arranged under the water tank; the injection water outlet pipe is provided with a steam trap bypass pipeline; and the bypass pipeline is provided with a temperature sensor. According to the online sterilization super-high purity medium conveying equipment, the sterilization temperature and effective temperature time of the equipment can be recorded, and the verifiability of an SIP (sterilization in place) process can be guaranteed.
Description
Technical field:
The present invention relates to the FLUID TRANSPORTATION field, be specially a kind of online sterilization formula ultra-high purity medium conveying equipment.
Background technology:
1998, along with the domestic economy technical development, living standards of the people progressively improved; The requirement of health care also improves thereupon; In order to improve national medical level, change the backward situation of Chinese pharmacy industry, producing and selling, the medicine of standard China pharmacy industry recalled etc. and to be carried out in order; Make domestic pharmacy industry standard in line with international standards, state food and drug administration is in beginning that domestic pharmaceutical factory is implemented GMP (good pharmaceutical manufacturing standard) approval procedure this year.After the GMP authentication is implemented; Pharmacy industry has also risen to a new height for the requirement of pharmaceutical equipment and technology; And progressively near or reach world's level of synchronization; As being directly connected to ultra-high purity medium (purified water, water for injection, pure steam, proportioning process) system crucial in drug quality, the pharmaceutical technology, be the emphasis of GMP inspection, its correlation theory and apparatus and process design and manufacturing, engineering construction level are also in continual development and improve.Recent years, the design of ultra-high purity medium induction system and the more detailsization of constructing, more and more to the concern of cleanliness factor, whether qualified automatic controlling level verifiability increasingly high and system become an one of system crucial reference standard especially.In order to open the international market, the high-end producer of domestic few part requires to build the system of oneself with than the domestic stricter U.S., the European perhaps GMP standard of World Health Organization (WHO), so that can realize products export through international GMP authentication, generates profit.
Be accompanied by implementing in full of GMP, occurred a collection ofly at home, comprised also that wherein the ultra-high purity medium that specialty is provided carries the company of integrated design, installation and the service for checking credentials for pharmacy producer provides the company of specialized engineering service.At present most of this type of company can provide the ultra-high purity medium that meets Chinese GMP standard system; But because domestic GMP and American-European GMP standard and emphasis are not quite similar; Seldom there is domestic corporation to have the ability to provide the ultra-high purity medium that meets external GMP standard integrated service, satisfies the requirement of this part high-end customer.
Summary of the invention
For overcoming the defective of prior art, the invention discloses a kind of online sterilization formula ultra-high purity medium conveying equipment.
The present invention reaches goal of the invention through following technical scheme:
A kind of online sterilization formula ultra-high purity medium conveying equipment; Form by water pot, water for injection EGR, pure steam access tube; Said water for injection EGR comprises water for injection water inlet pipe and water for injection outlet pipe; Said water for injection water inlet pipe is connected in the import of said water pot, and said pure steam access tube is connected in the import of said water pot, and said water pot below is provided with the water for injection outlet pipe; On said water for injection outlet pipe, the steam trap by-pass line is installed, a temperature sensor is set on said by-pass line.
It is necessary in the ultra-high purity medium induction system that main feature of the present invention has provided ultra-high purity medium induction system SIP (online sterilization) solution: SIP; Both at home and abroad the ultra-pure system of pharmacy industry particularly the SIP of water for injection and material system physics and chemical two kinds of operational approach are generally arranged, wherein use at most, be exactly pure steam sterilization; This method belongs to the physical method sterilization; Sterilization effect is good, and noresidue is easy to verify.In pure steam SIP operation, require temperature must be higher than 121 ℃, just can reach sterilization effect, and require usually to keep more than 30 minutes.Usually the way that is adopted is, inserts the ultra-high purity medium induction system to pure steam, opens the valve of system's end outlet simultaneously, discharges condensed water, keeps steam mobile simultaneously.This scheme can run into site inspection official's query in through external GMP authentication, because have no temperature and the effect of digital proof SIP.To this, the present invention proposes the new SIP scheme of a cover, on the water for injection outlet pipe of water pot, install the steam trap by-pass line of one section one end sealing additional; Open this by-pass line during SIP; Avoid the pure steam of high temperature to flow out and cause corrosion on Equipment, save the consumption of pure steam simultaneously, the steam trap by-pass line belongs to the cold spot in the entire equipment in addition; At reload temperature pick off on this by-pass line (when the temperature of cold spot reaches 121 ℃; Other local temperature also meet or exceed 121 ℃ in the system), recording equipment sterilising temp and effective temperature time, guaranteed the verifiability of SIP process.
Description of drawings
Fig. 1 is a kind of structural representation of online sterilization formula ultra-high purity medium conveying equipment
The specific embodiment:
Further specify the present invention through embodiment below:
As shown in Figure 1; A kind of online sterilization formula ultra-high purity medium conveying equipment; Be made up of water pot 41, water for injection EGR, pure steam access tube 42, the water for injection EGR comprises water for injection water inlet pipe 44 and water for injection outlet pipe 45, and water for injection water inlet pipe 44 is connected in the import of water pot 41; Pure steam access tube 42 is connected in the import of water pot 41; Water pot 41 belows are provided with water for injection outlet pipe 45, and steam trap by-pass line 43 is installed on water for injection outlet pipe 45, and a temperature sensor is set on by-pass line 43.As shown in the figure, steam trap by-pass line 43 1 ends are airtight, and pure like this steam can not revealed. and temperature sensor can be adopted the temperature sensor 46 of digital display.
The above only is a preferred implementation of the present invention; Should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention; Can also make some improvement and retouching, these improvement and retouching also should be regarded as protection scope of the present invention.
Claims (1)
1. online sterilization formula ultra-high purity medium conveying equipment; Form by water pot (41), water for injection EGR, pure steam access tube (42); Said water for injection EGR comprises water for injection water inlet pipe and water for injection outlet pipe; Said water for injection water inlet pipe is connected in the import of said water pot (41), and said pure steam access tube (42) is connected in the import of said water pot (41), and said water pot (41) below is provided with the water for injection outlet pipe; It is characterized in that: steam trap by-pass line (43) is installed on said water for injection outlet pipe, on said by-pass line (43), a temperature sensor is set.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210257981.9A CN102793933B (en) | 2008-01-07 | 2008-01-07 | Online sterilization super-high purity medium conveying equipment |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210257981.9A CN102793933B (en) | 2008-01-07 | 2008-01-07 | Online sterilization super-high purity medium conveying equipment |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200810032327 Division CN101482224B (en) | 2008-01-07 | 2008-01-07 | Ultra-high purity medium transporting integration process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102793933A true CN102793933A (en) | 2012-11-28 |
| CN102793933B CN102793933B (en) | 2014-01-22 |
Family
ID=47193398
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210257981.9A Expired - Fee Related CN102793933B (en) | 2008-01-07 | 2008-01-07 | Online sterilization super-high purity medium conveying equipment |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102793933B (en) |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4891188A (en) * | 1987-05-21 | 1990-01-02 | Mdt Corporation | Unplumbed sterilizer |
| US5512249A (en) * | 1994-11-10 | 1996-04-30 | Schering Corporation | Sterilizing apparatus |
| JPH0919488A (en) * | 1995-07-05 | 1997-01-21 | Yuyama Seisakusho:Kk | Method of controlling steam sterilizing device |
| CN2415765Y (en) * | 2000-04-11 | 2001-01-24 | 北京天利医药设备有限公司 | Steam sterilising structure for vacuum cooling drier |
| JP2004016035A (en) * | 2002-06-13 | 2004-01-22 | Tlv Co Ltd | Steam heating method |
| CN2676033Y (en) * | 2003-12-19 | 2005-02-02 | 上海九州医药成套设备厂 | Pure steam generator |
| CN1868860A (en) * | 2006-06-26 | 2006-11-29 | 山东新华医疗器械股份有限公司 | Constant pressure filling system |
-
2008
- 2008-01-07 CN CN201210257981.9A patent/CN102793933B/en not_active Expired - Fee Related
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4891188A (en) * | 1987-05-21 | 1990-01-02 | Mdt Corporation | Unplumbed sterilizer |
| US5512249A (en) * | 1994-11-10 | 1996-04-30 | Schering Corporation | Sterilizing apparatus |
| JPH0919488A (en) * | 1995-07-05 | 1997-01-21 | Yuyama Seisakusho:Kk | Method of controlling steam sterilizing device |
| CN2415765Y (en) * | 2000-04-11 | 2001-01-24 | 北京天利医药设备有限公司 | Steam sterilising structure for vacuum cooling drier |
| JP2004016035A (en) * | 2002-06-13 | 2004-01-22 | Tlv Co Ltd | Steam heating method |
| CN2676033Y (en) * | 2003-12-19 | 2005-02-02 | 上海九州医药成套设备厂 | Pure steam generator |
| CN1868860A (en) * | 2006-06-26 | 2006-11-29 | 山东新华医疗器械股份有限公司 | Constant pressure filling system |
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| Publication number | Publication date |
|---|---|
| CN102793933B (en) | 2014-01-22 |
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Granted publication date: 20140122 Termination date: 20150107 |
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