IES991057A2 - A Water Purification Device - Google Patents
A Water Purification DeviceInfo
- Publication number
- IES991057A2 IES991057A2 IES991057A IES991057A2 IE S991057 A2 IES991057 A2 IE S991057A2 IE S991057 A IES991057 A IE S991057A IE S991057 A2 IES991057 A2 IE S991057A2
- Authority
- IE
- Ireland
- Prior art keywords
- supply
- filters
- water
- inlet
- outlet
- Prior art date
Links
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 title claims abstract description 32
- 238000000746 purification Methods 0.000 title 1
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims abstract description 20
- 239000002510 pyrogen Substances 0.000 claims abstract description 20
- 238000005070 sampling Methods 0.000 claims abstract description 14
- 229910052757 nitrogen Inorganic materials 0.000 claims abstract description 10
- 238000011144 upstream manufacturing Methods 0.000 claims abstract description 7
- 239000008367 deionised water Substances 0.000 claims abstract description 6
- 238000000108 ultra-filtration Methods 0.000 claims abstract description 4
- 238000012544 monitoring process Methods 0.000 claims description 6
- 238000010926 purge Methods 0.000 claims description 4
- 238000001914 filtration Methods 0.000 abstract description 2
- 229910021641 deionized water Inorganic materials 0.000 abstract 1
- 239000002158 endotoxin Substances 0.000 description 9
- 241000894006 Bacteria Species 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 239000012498 ultrapure water Substances 0.000 description 3
- 238000011065 in-situ storage Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 1
- 102000007474 Multiprotein Complexes Human genes 0.000 description 1
- 108010085220 Multiprotein Complexes Proteins 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 239000005708 Sodium hypochlorite Substances 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000036760 body temperature Effects 0.000 description 1
- 210000001185 bone marrow Anatomy 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000030833 cell death Effects 0.000 description 1
- 230000032823 cell division Effects 0.000 description 1
- 230000010261 cell growth Effects 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 238000004821 distillation Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000003532 endogenous pyrogen Substances 0.000 description 1
- 238000011013 endotoxin removal Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 239000007972 injectable composition Substances 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
- 229920006008 lipopolysaccharide Polymers 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000000242 pagocytic effect Effects 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 239000008238 pharmaceutical water Substances 0.000 description 1
- 238000005191 phase separation Methods 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 230000001698 pyrogenic effect Effects 0.000 description 1
- 238000001223 reverse osmosis Methods 0.000 description 1
- SUKJFIGYRHOWBL-UHFFFAOYSA-N sodium hypochlorite Chemical compound [Na+].Cl[O-] SUKJFIGYRHOWBL-UHFFFAOYSA-N 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
Landscapes
- Separation Using Semi-Permeable Membranes (AREA)
Abstract
A device 1 for producing pyrogen controlled water on a small to medium factory scale comprises a number of charged ultrafiltration units 10 arranged in parallel. The filter units 10 are mounted on a frame 2 with a wheeled chassis 3 which may be pushed or moved by a forklift truck to a site where pyrogen controlled water is required. The device 1 has an inlet line 4 for connection to a supply of deionized water and an outlet line 6 for connection to a user of pyrogen controlled water. The device 1 may be purged with nitrogen from a supply 18. Sampling ports 17 in a common supply inlet 4 and outlet 6 ensure that the filtration efficiency can be closely monitored. The flow of water is monitored by a flowmeter 19 and pressure sensors 16 upstream of each filter facilitate a high level of control. <Figure 1>
Description
The invention relates to a device for the generation of pyrogen controlled water used especially for the preparation of active pharmaceuticals for injectable formulations.
Pyrogen contamination of water used in the production of pharmaceutical products is a major concern of pharmaceutical manufacturers and regulatory authorities. Both chemical and biological pyrogenicity are well documented and by far the most significant pyrogen within the pharmaceutical industry is bacterial endotoxins.
Bacterial cell associated endotoxins are high molecular weight lipopolysaccharide - protein complexes within an outer membrane of Gram negative bacteria. Endotoxins are ubiquitous, and are found in any liquid where Gram negative bacteria are present. They are continually shed into the surrounding environment by the bacteria during cell growth, division and on cell death, when the bacteria fragment.
Pyrogenic substances produce an increase in body temperature after intravenous injection into man and most animals. Bacterial endotoxins intravenously injected result in the development of fever by inducement of synthesis and release of endogenous pyrogens from host bone marrow derived phagocytic leukocytes. These in tum induce a wide range of chemically harmful events which are. manifested in the febrile response.
Methods currently applied in the preparation of high purity water, primarily involve distillation or reverse osmosis. These effectively remove endotoxins by
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WARNll/C/IES liquid/vapour phase separation, and by solute rejection respectively. There are other methods for the removal of endotoxins in high purity pharmaceutical water systems such as ultrafiltration, however of all the methods currently used, positively charged filter media are unique in utilising low pore size for selective removal of pyrogen assisted by opposite charge attraction of the negatively charged pyrogen to the filter media. For maximum efficiency of endotoxin removal, the positively charged filter media requires closely controlled flow rates of the water for treatment. In addition there is a requirement for in-situ sanitisation of the media and pipes and sterile sampling of the high purity water produced.
The object of the present invention is to provide a portable high purity water unit that utilises positively charged filter media but incorporates all the controls essential for a validated water system on a small to medium scale that has low capital cost, high efficiency and is easy to use.
Statements of Invention
According to the invention there is provided a device for producing pyrogen controlled water on a small to medium factory scale comprising:a transportable frame;
a number of positively charged filters mounted to the frame and arranged in parallel, each filter having an inlet conduit from a common supply and an outlet conduit to a common outlet;
flow restricting means mounted in each individual inlet conduit to control the flow through the filter;
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WARNll/C/lES a flowmeter in the inlet supply for monitoring the flow of water to the filters;
the inlet supply having a nitrogen purge inlet port for purging the filters and the conduits; and an outlet port at the lowest point in the unit.
In one embodiment of the invention the flow restricting means is an orifice plate.
In another embodiment the device includes pressure sensors upstream of the filters for monitoring back pressure from the filters.
Preferably a pressure sensor is installed in each individual inlet conduit.
Most preferably the device includes at least one sampling port for water sampling. Ideally the device has a sampling port in the common supply inlet and a sampling port in the common supply outlet.
The device includes a fitting in the supply for connection to a supply of deionised water. Preferably the device also includes a fitting in the outlet for user connection to a pyrogen controlled water supply.
In one embodiment of the invention the filters are positively charged ultrafiltration devices.
Preferably the transportable frame has a wheeled chassis. Most preferably the transportable frame has a forklift mounting means.
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WARN11/C/IES
Brief Description of the Drawings
The invention will be more clearly understood from the following description given by way of example only with reference to the accompanying drawings in which:Fig.l is a schematic representation of a device for producing pyrogen controlled water according to the invention;
Fig. 2 is a front perspective view of the device according to the invention;
Fig. 3 is a side perspective view of the device ofFig. 2;
Fig. 4 is an exploded perspective view of an oudet/point complete with triclover fitting and sampling valve and sample point fitting;
Fig. 5 is an exploded perspective view of a filter of the device; and
Fig. 6 is an exploded perspective view of a nitrogen filter and regulation gauge of the device.
Detailed Description
Referring to Figs. 1 to 3 there is illustrated a device 1 for producing pyrogen controlled water on a small to medium factory scale. The device 1 comprises a frame 2 mounted on a wheeled chassis 3 which may be pushed on wheels or moved by a forklift truck to a site where pyrogen controlled water is required.
Referring to Fig. 1 in particular there is illustrated a schematic representation of a device 1 for producing pyrogen controlled water on a small to medium factory
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WARN11/C/IES scale. The device 1 has an inlet line 4 with a triclover fitting 5 for connection to a supply of deionised water and an outlet line 6 with a triclover fitting 7 for connection to a user of pyrogen controlled water.
A number of filters, in this case three filters 10, are arranged in parallel, each filter 10 having an inlet conduit 11 from the common supply inlet line 4 and an outlet conduit 12 to the common outlet 6. A flow restricting orifice plate 15 is installed in each of the inlet conduits 11 to limit the maximum flow of deionised water to the filters 10. A pressure sensor 16 is installed upstream of each filter 10 for monitoring back pressure from the filters 10. A sanitary flush valve/sampling port 17 is located both upstream and downstream of the filters 10 in the common supply inlet line 4 and common outlet line 6.
A filtered nitrogen supply inlet 18 at a predetermined pressure is located on the common supply inlet 4 and allows the system to be purged with nitrogen to remove unused water from the system. As illustrated particularly in Figs. 2 and 3 nitrogen is filtered by passing through a nitrogen filter 30. Flow of nitrogen through the filter 30 is regulated by a pressure gauge/regulator 31. Upstream of the nitrogen supply inlet 18 is a flowmeter 19 for monitoring the flow of water to the filters 10. The flowmeter 19 is connected to a controller 32 which measures the flow of water through the system. Tri-clover connector fittings 20 upstream and downstream of each filter 10 allow the filters to be easily removed from the system and replaced.
Each of the filters 10 may be commercially available filters, for example Posidyne Pall Ntf™ filters. Such filters are capable of efficiently removing negatively charged contaminants such as endotoxins as well as removal of particles. The filters 10 have valves that may be used to drain superfluous water from the housing when not in use.
WARNll/C/IES 6
Referring in particular to Figs. 2 to 5 in use, deionised water enters the device 1 through the common supply inlet line 4 along the three inlet conduits 11 to the filters 10. After filtering, the water passes along the outlet conduits 12 to the common outlet 6 which may be connected to a user of pyrogen controlled water by means of a triclover fitting 7.
The unit is self-draining which allows complete displacement flow through the unit when in operation and full drainage when not in use. The unit can be fully sanitised with the positively charged filters 10 in situ by charging 200ppm sodium hypochlorite solution through the lowest point and filling until the solution exits through the high level sampling point 17.
Each filter is supplied with water at less then 3 litres per minute as controlled by the orifice plate 15. Back pressure values of greater than 4 bar indicate that the filter media is spent and should be changed.
At any point in the water generation process a sample can be collected from the sanitary flush valve/sampling port 17 and taken for analysis. When not in use the unit can be fully drained and sealed.
The filter unit of the present invention is capable of consistently producing bulk quantities, up to 540 litres/hour of pyrogen controlled water with endotoxins levels of not more than 5.0 EU/ml. The system can be fully validated and sanitised at a predetermined frequency.
The invention is not limited to the embodiments hereinbefore described which may be varied in detail.
Claims (5)
1. A device for producing pyrogen controlled water on a small to medium factory scale comprising:a transportable frame; a number of positively charged filters mounted to the frame and arranged in parallel, each filter having an inlet conduit from a common supply and an outlet conduit to a common outlet; flow restricting means mounted in each, individual inlet conduit to control the flow through a filter; and a flowmeter in the inlet supply for monitoring the flow of water to the filters; the inlet supply having a nitrogen purge inlet port for purging the filters and the conduits; an outlet port at the lowest point in the unit.
2. A device as claimed in claim 1 wherein the flow restricting means is an orifice plate.
3. A device as claimed in claim 1 or 2 including pressure sensors upstream of the filters for monitoring back pressure from the filters.
4. A device as claimed in claim 3 wherein a pressure sensor is installed in each individual inlet conduit. |E 9 9 1 0 5 7 WARNll/C/IES
5. A device as claimed in any preceding claim including at least one sampling port for water sampling, preferably the device has a sampling port in the common supply inlet and a sampling port in the common supply outlet, 5 preferably the device includes a fitting in the supply for connection to a supply of deionised water, preferably the device includes a fitting in the outlet for connection to a pyrogen controlled water supply, preferably the filters are positively charged ultrafiltration devices, preferably the transportable frame has a wheeled chassis, preferably the transportable frame has a forklift mounting means.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IES991057 IES991057A2 (en) | 1999-12-17 | 1999-12-17 | A Water Purification Device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IES991057 IES991057A2 (en) | 1999-12-17 | 1999-12-17 | A Water Purification Device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| IES991057A2 true IES991057A2 (en) | 2000-10-18 |
Family
ID=27620509
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IES991057 IES991057A2 (en) | 1999-12-17 | 1999-12-17 | A Water Purification Device |
Country Status (1)
| Country | Link |
|---|---|
| IE (1) | IES991057A2 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105819548A (en) * | 2016-04-27 | 2016-08-03 | 上海立泉环境科技有限公司 | Ultrafiltration system |
-
1999
- 1999-12-17 IE IES991057 patent/IES991057A2/en not_active IP Right Cessation
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105819548A (en) * | 2016-04-27 | 2016-08-03 | 上海立泉环境科技有限公司 | Ultrafiltration system |
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| FD4E | Short term patents deemed void under section 64 |