CN202700226U - Filtration system used in injection liquid medicine preparation process - Google Patents

Filtration system used in injection liquid medicine preparation process Download PDF

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Publication number
CN202700226U
CN202700226U CN201220158753.1U CN201220158753U CN202700226U CN 202700226 U CN202700226 U CN 202700226U CN 201220158753 U CN201220158753 U CN 201220158753U CN 202700226 U CN202700226 U CN 202700226U
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CN
China
Prior art keywords
valve
filter core
polyether sulfone
sulfone filter
group
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.)
Withdrawn - After Issue
Application number
CN201220158753.1U
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Chinese (zh)
Inventor
张从俊
张云
高华林
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Jiangxi Kelun Pharmaceutical Co Ltd
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Jiangxi Kelun Pharmaceutical Co Ltd
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Priority to CN201220158753.1U priority Critical patent/CN202700226U/en
Application granted granted Critical
Publication of CN202700226U publication Critical patent/CN202700226U/en
Anticipated expiration legal-status Critical
Withdrawn - After Issue legal-status Critical Current

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Abstract

The utility model discloses a filtration process and a filtration system used in an injection liquid medicine preparation process. After injection is prepared in a preparation container (1), a liquid medicine pump (2) is used for circulation, a group of polypropylene filter elements (3) are used for filtration firstly, filtered liquid flows back to the preparation container (1) through a small circulation pipeline (8), then the same group of polypropylene filter elements (3) and two groups of polyether-sulfone filter elements (4 and 7) are connected in series for filtration, a discharging opening is mounted on a large circulation pipeline (5) behind the two groups of polyether-sulfone filter elements, the discharging opening is connected with the preparation container (1), and the other large circulation pipeline is used for production of the injection and detection of the quality of the injection. According to the filtration system used in the injection liquid medicine preparation process, a large circulation process and a small circulation process are used, impurities, heat sources, pigments and the like in the liquid medicine can be effectively removed, and the purpose of refining the liquid medicine is achieved; the filtration load of the polyether-sulfone filter elements is reduced, and the differential pressure between former pressure and later pressure in the process of steam sterilization is reduced; and use of activated carbon in the traditional process is reduced, the requirement of environment protection is met, the possibility that the activated carbon absorbs essential components is completely eradicated, and the quality of the liquid medicine is guaranteed.

Description

Filtration system in a kind of injection liquid preparation
Technical field
The utility model belongs to the pharmaceutical technology field, relates to filtering technique and filtration system in a kind of injection liquid preparation.
Technical background
In the traditional handicraft of injection, the filtration of liquid comprises two kinds: a kind of employing be with charcoal absorption liquid magazine and microorganism, produce with one group of polypropylene filter core and one group of polyether sulfone filter element filtering again after then taking off charcoal by the titanium rod; Another kind does not add active carbon and directly produces with one group of polypropylene filter core and one group of polyether sulfone filter element filtering.The shortcoming of traditional handicraft is: front a kind of because active carbon is dust-like, can the clean area of pharmaceutical production be polluted during use, and can to environment, not meet the requirement of environmental protection after the use.Moreover for main ingredient inventory or the less product of solubility, active carbon can adsorb the content of main ingredient.A kind of afterwards, if it is long to continue filtration time, can not effectively remove microorganism.
Adopt the polyether sulfone aseptic filtration also to have certain deficiency in the filtration of injection, because the polyether sulfone filter core has good trafficability characteristic to water and has the effect of aseptic filtration, but the trafficability characteristic for steam is relatively poor, so steam can not effectively pass through when sterilizing online, easily there is larger pressure reduction before and after the filter core, at high temperature can cause internal damage and the dimensional deformation of filter core, thereby affect the service life of filter core, and have serious quality risk.
The utility model content
Deficiency for above-mentioned prior art existence, the purpose of this utility model is to provide a kind of and can removes impurity in the liquid, microorganism etc. and reach the injection quality requirement, can produce for a long time in a large number again, and can carry out online pure steam and sterilize and do not damage filtering technique and filtration system in the injection liquid preparation of filter core.
One of the technical solution of the utility model: added two groups of polyether sulfone filter core cascade filtrations in traditional handicraft, and increased lesser circulation, the filter parallel system is protected filter core.
Filtering technique is: after injection is prepared in dispensing containers, with the spray pump circulation, carry out filtering by one group of polypropylene filter core first, filtering liquid flow in the dispensing containers by the partial circulating back of pipeline; By same group of polypropylene filter core and two groups of polyether sulfone filter core cascade filtrations, road systemic circulation pipeline behind two groups of polyether sulfone filter cores is installed floss hole and is connected with dispensing containers again, and production and the quality testing of injection are carried out for liquid in another road.
Preferably: by being the 10-20 inch by 1-5 root length, the aperture is that the polypropylene filter core that the polypropylene filter core bar of 0.2um forms filters liquid first, and filtering liquid flow in the dispensing containers 1 by the partial circulating back of pipeline; Be the 10-20 inch by 1-5 root length respectively by this group polypropylene filter core and two groups again, the aperture is that the polyether sulfone filter core series connection that the polyether sulfone filter core bar of 0.2um forms advances to filter to liquid.
Further preferred: its filtering technique is:
(1) open the first valve and sewage draining valve, other valves are in closed condition, close the first valve and sewage draining valve after dispensing containers is cleaned up;
(2) the qualified liquid of preparation in dispensing containers is opened the first, the 4th and the 5th valve, starts spray pump, and liquid flow in the dispensing containers by the partial circulating back of pipeline through the filtering of polypropylene filter core;
(3) close the 5th valve, open the 6th, the 9th, the 11 and the 14 valve, start spray pump, make liquid behind two groups of polyether sulfone filter element filterings, be back to dispensing containers, circulate;
(4) after liquid passes through second group of polyether sulfone filter core, carry out production and the quality testing of injection by packing check valve for liquid.
To system's steam sterilizing the time, with the 9th valve and the 11 valve closing, open the 8th, the tenth, the 15 and the 16 valve, steam passes through from bypass, has eliminated filter core front and back pressure reduction; When unlatching the 7th and 17 valve, be communicated with outlet conduit respectively.
Two of the technical solution of the utility model:
Filtration system comprises dispensing containers, spray pump, polypropylene filter core, polyether sulfone filter core, systemic circulation pipeline and valve, the systemic circulation of systemic circulation pipeline communication, described dispensing containers is connected another road by the first valve one route sewage draining valve and is connected with spray pump by the 4th valve with sewage draining exit; One route the 5th valve of spray pump is connected with the partial circulating pipeline, the outlet of partial circulating pipeline is connected with the vessel port of dispensing containers, another road of spray pump is connected by the polyether sulfone filter core of the 6th valve with two groups of series connection, the 14 valve of leading up to of second group of polyether sulfone filter core is connected with the outlet of systemic circulation pipeline, the outlet of systemic circulation pipeline is connected with the vessel port of dispensing containers, and another road of second group of polyether sulfone filter core is connected with the packing verifying attachment by packing check valve.
Preferably: described the 6th valve, the 9th valve, first group of polyether sulfone filter core, the 11 valve and second group of polyether sulfone filter core sequentially are connected in series, the 9th valve and first group of polyether sulfone filter core are in parallel with the series circuit of the 8th valve and the tenth valve, and the 8th valve is crossed the 7th valve with the device for cleaning pipeline between the tenth valve and is connected with outlet conduit; The 11 valve and second group of polyether sulfone filter core are in parallel with the series circuit of the 15 valve and the 16 valve, and the device for cleaning pipeline between the 15 valve and the 16 valve is crossed the 17 valve and is connected with outlet conduit.
Described sewage draining valve is the second valve or is two groups of series connected valves of the second valve and the 3rd valve that packing check valve is the 12 valve or is two groups of series connected valves of the 12 valve and the 13 valve.
Described polypropylene filter core is the 10-20 inch by 1-5 root length, and the aperture is that the polypropylene filter core bar of 0.2um forms, and two groups of polyether sulfone filter cores are the 10-20 inch by 1-5 root length respectively, and the aperture is that the polyether sulfone filter core bar of 0.2um forms.
The utility model is effectively removed impurity in the liquid, thermal source, pigment etc., and liquid is reached refining purpose; Reduce the use of active carbon in the traditional handicraft, more met the requirement of environmental protection, stopped simultaneously the possibility of charcoal absorption main component, guaranteed quality of liquid medicine; By partial circulating the impurity in the liquid is carried out filtering, the degree of purity of the liquid of raising behind the polypropylene filter core, front and back pressure reduction when reducing the filtration load of polyether sulfone filter core and steam sterilizing again by the circulation aseptic filtration, reaches the quality that microorganisms grow in effective control liquid guarantees liquid; Solve in the time of should not using the large production of product of active carbon simultaneously, microorganism is grown in the oversize meeting of system operation time, the problem that the shortening cycle of having to sterilizes repeatedly.
Description of drawings
Fig. 1 is the structural representation of the utility model embodiment 1 filtration system.
Fig. 2 is the structural representation of the existing filtration system of the utility model.
The specific embodiment
The utility model is by the following examples can the utility model will be further described, yet scope of the present utility model is not limited to following embodiment.
Embodiment 1:
Added two groups of polyether sulfone filter core cascade filtrations in traditional handicraft, and increased lesser circulation, the filter parallel system is protected filter core.
The described dispensing containers 1 of filtration system is connected with sewage draining exit by valve 11,12 by valve 10 1 routes, and another road is connected with spray pump 2 by valve 13; A route valve 14 was connected with partial circulating pipeline 8 after spray pump 2 was connected with polypropylene filter core 3, the outlet of partial circulating pipeline 8 is connected with the vessel port of dispensing containers 1, spray pump 2 is connected with two groups of polyether sulfone filter cores 4,7 of connecting by valve 15 with another road after polypropylene filter core 3 is connected, the valve 23 of leading up to of second group of polyether sulfone filter core 7 is connected with the outlet of systemic circulation pipeline 5, the outlet of systemic circulation pipeline 5 is connected with the vessel port of dispensing containers 1, and another road of second group of polyether sulfone filter core 7 is connected with packing verifying attachment 6 by valve 21,22.
Valve 15, valve 18, first group of polyether sulfone filter core 4, valve 20 and second group of polyether sulfone filter core 7 order are connected in series, valve 18 and first group of polyether sulfone filter core 4 are in parallel with the series circuit of valve 17 and valve 19, and valve 17 is crossed valve 16 with the device for cleaning pipeline between the valve 19 and is connected with outlet conduit; Valve 20 and second group of polyether sulfone filter core 7 are in parallel with the series circuit of valve 24 and valve 25, and the device for cleaning pipeline between valve 24 and the adjusting valve door 25 is crossed valve 26 and is connected with outlet conduit.
Described polypropylene filter core 3 is the 10-20 inch by 1-5 root length, and the aperture is that the polypropylene filter core bar of 0.2um forms, and polyether sulfone filter core 4,7 is the 10-20 inch by 1-5 root length respectively, and the aperture is that the polyether sulfone filter core bar of 0.2um forms.
Filtering technique is: after injection was prepared in dispensing containers 1, with spray pump 2 circulations, by carrying out filtering at one group of polypropylene filter core 3, filtering liquid was back in the dispensing containers 1 by partial circulating pipeline 8 first; By same group of polypropylene filter core 3 and two groups of polyether sulfone filter cores 4,7 cascade filtrations, road systemic circulation pipeline 5 behind two groups of polyether sulfone filter cores is installed floss holes and is connected with dispensing containers 1 again, and another road confession liquid carries out production and the quality testing of injection.
By being the 10-20 inch by 1-5 root length, the aperture is that 3 pairs of liquids of polypropylene filter core that the polypropylene filter core bar of 0.2um forms filter first, and filtering liquid is back in the dispensing containers 1 by partial circulating pipeline 8; Be the 10-20 inch by 1-5 root length respectively by this group polypropylene filter core 3 and two groups again, the aperture is that polyether sulfone filter core 4,7 series connection that the polyether sulfone filter core bar of 0.2um forms advance to filter to liquid.
Concrete filtering technique is as follows:
(1) open 10,11, No. 12 valves, other valves are in closed condition, close valve 10,11, No. 12 after dispensing containers 1 is cleaned up;
(2) the qualified liquid of preparation in dispensing containers 1 is opened 10,13, No. 14 valve, starts spray pump 2, and liquid is back in the dispensing containers 1 through polypropylene filter core 3, partial circulating pipeline 8; By partial circulating the impurity in the liquid is carried out filtering, improve the degree of purity of the liquid behind polypropylene filter core 3, reduce polyether sulfone filter core 4,7 filtration load;
(3) close valve No. 14, open 15,18,20, No. 23 valve, start spray pump 2, make liquid after two groups of polyether sulfone filter cores 4,7 filter, be back to dispensing containers, circulate.
When system is carried out pure steam sterilizing, because the polyether sulfone filter core is hydrophily, but the permeability to it is very poor, the washing and sterilizing of system must reach 121 ℃ requirement in the production of injection, so must guarantee the pressure of steam, but steam can not effectively pass through filter core, cause the filter core front and back to form pressure reduction, the polyether sulfone filter core at high temperature because thereby the inconsistent meeting of pressure reduction before and after the filter core causes the damage of filter core to affect the effect of filter core aseptic filtration, causes risk for the quality of product.
Implementing method: as shown in Figure 1, to system's steam sterilizing the time, valve 18 and valve 20 are closed, Open valve 17,19,24,25, steam passes through from bypass, has eliminated filter core front and back pressure reduction; In case of necessity, Open valve 16,26 is communicated with outlet conduit.
Do not add in the injection prescription of active carbon in part, adopt the utility model during the production of example hydrochloric acid bromhexine glucose injection, can effectively hold back impurity and microorganism in the liquid, system is increased to more than 24 hours by 12 hours at stream time, guarantee quality and the aseptic level of liquid, effective minimizing system number of processes, the disposal ability of raising system.
Under the prerequisite of identical quality guarantee level, cancelled the use of active carbon, effectively reduce the pollution of production environment, and produce the generation of discarded object.Can be become the existing injection prescription of active carbon that added in one of improved thinking direction aspect the environmental protection by the design of system.

Claims (4)

1. the filtration system during an injection liquid prepares, it comprises dispensing containers (1), spray pump (2), polypropylene filter core (3), polyether sulfone filter core (4,7), systemic circulation pipeline (5) and valve, systemic circulation pipeline (5) is communicated with systemic circulation, it is characterized in that described dispensing containers (1) is connected another road by the first valve (10) one route sewage draining valves and is connected with spray pump (2) by the 4th valve (13) with sewage draining exit; One route the 5th valve (14) of spray pump (2) is connected with partial circulating pipeline (8), the outlet of partial circulating pipeline (8) is connected with the vessel port of dispensing containers (1), the polyether sulfone filter core (4 of connecting with two groups by the 6th valve (15) in another road of spray pump (2), 7) connect, the 14 valve (23) of leading up to of second group of polyether sulfone filter core (7) is connected with the outlet of systemic circulation pipeline (5), the outlet of systemic circulation pipeline (5) is connected with the vessel port of dispensing containers (1), and another road of second group of polyether sulfone filter core (7) is connected with packing verifying attachment (6) by packing check valve.
2. the filtration system during a kind of injection liquid according to claim 1 prepares, it is characterized in that: described the 6th valve (15), the 9th valve (18), first group of polyether sulfone filter core (4), the 11 valve (20) and second group of polyether sulfone filter core (7) order are connected in series, the 9th valve (18) and first group of polyether sulfone filter core (4) are in parallel with the series circuit of the 8th valve (17) and the tenth valve (19), and the 8th valve (17) is crossed the 7th valve (16) with the device for cleaning pipeline between the tenth valve (19) and is connected with outlet conduit; The 11 valve (20) and second group of polyether sulfone filter core (7) are in parallel with the series circuit of the 15 valve (24) and the 16 valve (25), and the device for cleaning pipeline between the 15 valve (24) and the 16 valve (25) is crossed the 17 valve (26) and is connected with outlet conduit.
3. the filtration system during a kind of injection liquid according to claim 1 and 2 prepares, it is characterized in that: described sewage draining valve is the second valve (11) or is two groups of series connected valves of the second valve (11) and the 3rd valve (12) that packing check valve is the 12 valve (21) or is two groups of series connected valves of the 12 valve (21) and the 13 valve (22).
4. the filtration system during a kind of injection liquid according to claim 1 and 2 prepares, it is characterized in that: described polypropylene filter core (3) is the 10-20 inch by 1-5 root length, the aperture is that the polypropylene filter core bar of 0.2um forms, two groups of polyether sulfone filter cores (4,7) are the 10-20 inch by 1-5 root length respectively, and the aperture is that the polyether sulfone filter core bar of 0.2um forms.
CN201220158753.1U 2012-04-16 2012-04-16 Filtration system used in injection liquid medicine preparation process Withdrawn - After Issue CN202700226U (en)

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CN201220158753.1U CN202700226U (en) 2012-04-16 2012-04-16 Filtration system used in injection liquid medicine preparation process

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Application Number Priority Date Filing Date Title
CN201220158753.1U CN202700226U (en) 2012-04-16 2012-04-16 Filtration system used in injection liquid medicine preparation process

Publications (1)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102626569A (en) * 2012-04-16 2012-08-08 江西科伦药业有限公司 Filtering process and filtering system for use in preparation of injection liquid medicament

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102626569A (en) * 2012-04-16 2012-08-08 江西科伦药业有限公司 Filtering process and filtering system for use in preparation of injection liquid medicament
CN102626569B (en) * 2012-04-16 2014-03-19 江西科伦药业有限公司 Filtering process and filtering system for use in preparation of injection liquid medicament

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Granted publication date: 20130130

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Effective date of abandoning: 20140319

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