Intravenous solution producing systems and methods

• US 20050171501A1
• Filed: 12/28/2004
• Published: 08/04/2005
• Est. Priority Date: 02/03/2004
• Status: Abandoned Application

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Kelly, Thomas
• Application Number:
  US11/025,008
• Publication Number:
  US 20050171501A1
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61M 1/3462 Circuits for the preparation thereof
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: B01D 2311/04 Specific process operations in the feed stream; Feed pretreatment
• CPC Class Codes: B01D 2311/12 Addition of chemical agents
• CPC Class Codes: B01D 61/025 Reverse osmosis; Hyperfiltration
• CPC Class Codes: B01D 61/04 Feed pretreatment
• CPC Class Codes: B01D 61/08 Apparatus therefor
• CPC Class Codes: B01D 61/12 Controlling or regulating
• CPC Class Codes: B01D 61/145 Ultrafiltration
• CPC Class Codes: B01D 61/18 Apparatus therefor
• CPC Class Codes: B01D 61/22 Controlling or regulating
• CPC Class Codes: B01D 61/58 Multistep processes
• CPC Class Codes: C02F 1/283 using coal, charred products, or inorganic mixtures containing them
• CPC Class Codes: C02F 1/42 by ion-exchange ion-exchange in general B01J
• CPC Class Codes: C02F 1/441 by reverse osmosis
• CPC Class Codes: C02F 1/444 by ultrafiltration or microfiltration
• CPC Class Codes: C02F 1/68 by addition of specified substances, e.g. trace elements, for ameliorating potable water medicinal water A61K
• CPC Class Codes: C02F 2103/026 Treating water for medical or cosmetic purposes
• CPC Class Codes: C02F 2209/40 Liquid flow rate
• CPC Class Codes: C02F 9/20 : Portable or detachable small-scale multistage treatment devices, e.g. point of use or laboratory water purification systems

Abstract

A portable system is provided in one embodiment that combines stages of water purification to produce sterile pyrogen free water for injection. It also adds NaCl to the purified water to produce sterile and pyrogen free saline for injection in a relatively compact and mobile delivery package. The solution produced is then bagged via suitable bagging equipment. Various methods are also provided to deareate the solution, ensure its stability and to disinfect the solution between uses and prior to use. The systems and methods in one embodiment produce on-line saline of less than 0 cfu and less than 0.03 EU/ml, while meeting acceptable levels of other chemical contaminants, heavy metals and organics.

Claims

1. An injectable fluid preparation system comprising:

an inlet configured to be coupled to a source of water;

a filtering device operable to at least partially purify water flowing from the source;

an additive supply in fluid communication with the filtering device, the supply supplying at least one additive to the at least partially purified water to form an additive solution;

at least one sensor having an output indicative of a proportion of the additive in water;

a housing supporting at least the filtering device and the sensor, the housing including a connector in fluid communication with the additive solution; and

a container connected fluidly to the connector, the container receiving an amount of the additive solution and configured to store the additive solution for later use.

2. The injectable fluid preparation system of claim 1, which is operable to accept water from a source selected from the group consisting of:

a water tap, a container of water and a natural water source.

3. The injectable fluid preparation system of claim 1, wherein the filtering device is selected from the group consisting of:

a particulate filter, a carbon filter, a deionization unit, a reverse osmosis unit and an ultrafilter.

4. The injectable fluid preparation system of claim 1, wherein the filtering device is a first filtering device and is located upstream from the additive supply, and which includes a second filtering device, the second filtering device having at least one characteristic selected from the group consisting of:

(i) being located downstream from the additive supply;

(ii) being located between the connector and the container;

(iii) being coupled operably to a pressure testing apparatus;

(iv) being coupled operably to a control unit that monitors a rate of decay of pressure in the second filtering device;

(v) being an ultrafilter; and

(vi) including a membrane that has a pore size from about 10 to about 1000 Angstroms.

5. The injectable fluid preparation system of claim 1, wherein the filtering device includes a reverse osmosis unit and which includes at least one of:

(i) a water pretreatment unit located upstream of the reverse osmosis unit;

(ii) at least one reject fluid line in communication with the reverse osmosis unit; and

(iii) a fluid line enabling a portion of the additive solution to be recirculated back to the reverse osmosis unit.

6. The injectable fluid preparation system of claim 5, wherein the pretreatment unit includes at least one filter of a type selected from the group consisting of:

a particulate filter, a carbon filter and a deionization unit.

7. The injectable fluid preparation system of claim 5, which includes at least one additional filter located downstream from the reverse osmosis unit.

8. The injectable fluid preparation system of claim 5, wherein the reject fluid is at least one of:

(i) purified with respect to water from the source; and

(ii) rejected if an output of filtered water from the reverse osmosis unit exceeds a downstream demand for the filtered water.

9. The injectable fluid preparation system of claim 5, wherein a conductivity measurement of the recirculated portion is measured against a conductivity measurement of the RO unit'"'"'s output to determine a level of performance of the RO unit.

10. The injectable fluid preparation system of claim 5, wherein a percent rejection method is employed to determine a level of performance of the RO unit, and wherein an at least one of an alarm and a system shut down is triggered if the percent rejection is outside of an acceptable level.

11. The injectable fluid preparation system of claim 1, wherein the additive supply is of a type selected from the group consisting of:

an additive cartridge, a liquid concentrate container and an in-line additive delivery pack.

12. The injectable fluid preparation system of claim 1, wherein the additive is selected from the group consisting of:

NaCl, dextrose, sodium, potassium, calcium, chlorine, lactate, a non-sterile additive and any combination thereof.

13. The injectable fluid preparation system of claim 1, wherein the additive supply includes at least one of:

(i) an air separation device that removes air trapped in the at least partially purified water;

(ii) a pump requiring a priming fluid, wherein the at least partially purified water is used as the priming fluid; and

(iii) a recirculation loop that enables the at least partially purified water to be recirculated until being proportioned with the additive properly according to the sensor.

14. The injectable fluid preparation system of claim 1, wherein the sensor includes a conductivity sensing device.

15. The injectable fluid preparation system of claim 1, wherein the sensor is a first sensor and which includes a pressure sensor that is operable to provide a pressure decay signal used to evaluate the integrity of the filtering device.

16. The injectable fluid preparation system of claim 1, wherein the amount of the additive solution is a predefined amount, and which includes a flow metering device that meters the predefined amount of additive solution to the container.

17. The injectable fluid preparation system of claim 1, which includes multiple containers manifolded in fluid communication with the additive solution and a valve arrangement operable to selectively allow at least one of the containers at a given time to be filled with additive solution.

18. The injectable fluid preparation system of claim 17, wherein one of the containers is discarded after initial filling and which includes a filter between the discarded container and the remaining containers.

19. The injectable fluid preparation system of claim 1, which includes a disinfectant injector operable to disinfect at least the additive supply of the system, the disinfectant including a substance selected from the group consisting of:

high temperature water, diluted acid, citric acid, hydrogen peroxide, peracetic acid and any combination thereof.

20. The injectable fluid preparation system of claim 19, which includes a controller operable to perform at least one of the tasks selected from the group consisting of:

(i) automatically add the disinfectant in a desired proportion; and

(ii) rinse the disinfectant from the additive supply automatically.

21. The injectable fluid preparation system of claim 1, wherein the container has at least one property selected from the group consisting of:

(i) being at least substantially sterile;

(ii) being made of a biocompatible thermoplastic;

(iii) being made of a flexible material;

(iv) having a code to identify the additive solution; and

(iv) being operable with a labeling device that labels the container.

22. An injectable fluid sterilization system comprising:

a pretreatment unit that filters water from a source;

a filtering device that further filters the water from the pretreatment unit;

an additive supply in fluid communication with the filtering device, the supply supplying at least one additive to water exiting the filtering device; and

a delivery portion operable to meter additive solution exiting the additive portion to a container, the container configured to store the additive solution for later use.

23. The injectable fluid sterilization system of claim 22, which is operable to accept water from a source selected from the group consisting of:

a water tap, a container of water and a natural water source.

24. The injectable fluid sterilization system of claim 22, wherein the pretreatment unit includes at least one filter of a type selected from the group consisting of:

a particulate filter, a carbon filter and a deionization unit.

25. The injectable fluid sterilization system of claim 22, wherein the filtering device is selected from the group consisting of:

a particulate filter, a carbon filter, a deionization unit, a reverse osmosis unit and an ultrafilter.

26. The injectable fluid sterilization system of claim 22, wherein the filtering device is a reverse osmosis (“

RO”

) unit, and which at least one reject fluid line in communication with an inlet of the RO unit, the reject fluid line having at least one characteristic selected from the group consisting of;

(i) feeding the RO unit with a supply that has already passed through the RO unit to thereby lessen an overall load placed on the RO unit;

(ii) being configured to extend from the RO unit; and

(iii) being configured to extend from a location positioned downstream from the additive flow portion.

27. The injectable fluid sterilization system of claim 22, wherein the additive supply includes at least one of:

(i) an additive cartridge, (ii) a liquid concentrate container, (iii) an in-line additive supply pack, (iv) a recirculation loop operable to enable the at least partially purified water to be recirculated until being proportioned properly with the additive, and (v) a volumetric metering device.

28. The injectable fluid sterilization system of claim 22, wherein the additive is selected from the group consisting of:

NaCl, dextrose, sodium, potassium, calcium, chlorine, lactate and a combination thereof.

29. The injectable fluid sterilization system of claim 22, wherein a proportion of additive to water is controlled via conductivity measuring of the additive solution.

30. The injectable fluid sterilization system of claim 22, which includes multiple containers manfolded in fluid communication with the additive solution and a valve arrangement operable to selectively allow at least one of the containers at a given time to be filled with additive solution.

31. The injectable fluid sterilization system of claim 22, wherein the container has a property selected from the group consisting of:

(i) being at least substantially sterile;

(ii) being made of a biocompatible thermoplastic;

(iii) being made of a flexible material;

(iv) having a code to identify the additive solution; and

(iv) being labeled with at least one of a lot code, a date of filling and an expiration date.

32. The injectable fluid sterilization system of claim 22, further comprising a pump, in fluid communication with the filtering device, to pump the additive solution into the filtering device to aid in cleansing the filtering device.

33. An injectable fluid preparation system comprising:

an inlet configured to be coupled to a source of water;

a filtering device operable to at least partially purify water flowing from the source;

a metering device operable to meter an amount of injectable quality water to a container; and

an additive provided downstream of the metering device, the additive mixing with the injectable quality water to produce an injectable quality solution that is stored in the container, the container configured to store the additive solution for later use.

34. The injectable fluid preparation system of claim 33, wherein the additive has at least one characteristic selected from the group consisting of:

(i) being supplied inside the container;

(ii) being supplied outside the container;

(iii) including NaCl;

(iv) including dextrose;

(v) including sodium;

(vi) including potassium;

(vii) including calcium;

(viii) including chlorine; and

(ix) including lactate.

35. The injectable fluid preparation system of claim 33, which is operable to accept water from a source selected from the group consisting of:

a water tap, a container of water and a natural water source.

36. The injectable fluid preparation system of claim 33, wherein the filtering device is selected from the group consisting of:

a particulate filter, a carbon filter, a deionization unit, a reverse osmosis unit and an ultrafilter.

37. The injectable fluid preparation system of claim 33, wherein the filtering device includes a reverse osmosis (“

RO”

), unit and which includes at least one of;

(i) a water pretreatment unit located upstream of the RO unit;

(ii) at least one additional filter located downstream from the RO unit; and

(iii) at least one reject fluid line in communication with the reverse osmosis unit.

38. The injectable fluid preparation system of claim 33, wherein the pretreatment unit includes at least one filter of a type selected from the group consisting of:

a particulate filter, a carbon filter and a deionization unit.

39. The injectable fluid preparation system of claim 38, wherein the reject fluid line includes at least one characteristic selected from the group consisting of:

(i) extending from the reverse osmosis unit and (ii) producing reject fluid that is purified with respect to water from the source.

40. The injectable fluid preparation system of claim 33, wherein the metering device is a balanced flow chamber that outputs the amount of fluid to the container by intaking the same amount of fluid.

41. The injectable fluid preparation system of claim 33, which includes multiple ones of the containers manifolded in fluid communication with the solution, and a valve arrangement operable to selectively allow at least one of the containers at a given time to be filled with the solution.

42. The injectable fluid preparation system of claim 33, which includes multiple containers manifolded in fluid communication with the injectable solution and at least one of:

(i) a feeder mechanism to fill each container and (ii) an apparatus operable to seal each container after it is filled.

43. The injectable fluid preparation system of claim 33, wherein the sealing apparatus includes a laser apparatus or a hot knife.

44. An injectable fluid preparation method performed by an apparatus, the method comprising:

accepting water from a source;

purifying the water to an injectable quality;

adding at least one additive to the injectable quality water to create an injectable quality solution; and

metering portions of the injectable quality solution to individual containers.

45. The injectable fluid preparation method of claim 44, wherein purifying the water to an injectable quality includes at least one of:

(i) flowing the water through at least one filter provided by the apparatus and (ii) recirculation fluid downstream of the filter back to an input of the filter.

46. The injectable fluid preparation method of claim 44, wherein adding at least one additive to the injectable quality water includes at least one of:

(i) flowing the water through an additive source used in connection with the apparatus;

(ii) flowing the water through an additive recirculation loop provided by the apparatus until a desired amount of the additive is added to the water; and

(iii) metering the portions though an additive source.

47. The injectable fluid preparation method of claim 44, wherein creating the injectable quality solution includes controlling the conductivity of the solution.

48. The injectable fluid preparation method of claim 44, which includes configuring the container to store the injectable quality solution for later use.

49. The injectable fluid preparation method of claim 44, which includes at least one additional step selected from the group consisting of:

(i) disinfecting at least a portion of the apparatus;

(ii) labeling at least one of the individual containers; and

activating a flow path to shunt to rinse residual powder from the apparatus.

50. An injectable fluid preparation method performed by an apparatus, the method comprising:

accepting water from a source;

purifying the water to an injectable quality;

metering portions of the injectable quality water to individual containers; and

supplying the containers with an additive that mixes with the injectable quality water to produce an injectable quality solution.

51. The injectable fluid preparation method of claim 50, wherein purifying the water to an injectable quality includes flowing the water through at least one filter provided by the apparatus.

52. The injectable fluid preparation method of claim 51, which includes at least one additional step selected from the group consisting of:

(i) recirculation fluid downstream of the filter back to an input of the filter;

(ii) configuring the container to store the injectable quality solution for later use;

(iii) disinfecting at least a portion of the apparatus; and

(iv) labeling at least one of the individual containers.

53. A filter performance level determination method for an injectable fluid preparation system, the method comprising:

measuring the conductivity of an output flow of a filter;

reticulating a portion of the output through the filter;

measuring the conductivity of the portion after being flowed through the filter; and

using a percent rejection method according to the equation, % rejection=1−

(output flow conductivity/recirculated output flow conductivity)×

100, to determine the performance level of the filter.

54. The method of claim 53, wherein the filter is a reverse osmosis unit.