A Purified Water Testing Process in Pharmaceutical Engineering

Abstract

The invention discloses a purified water detection process in pharmaceutical engineering, relates to the pharmaceutical field, comprises a liquid taking device and a water bath device, and the following steps: step one: preparing a test solution, using the liquid taking device to measure three portions of 5 ml of the test solution and placing them in three different test tubes, and cooling them respectively after sealing treatment; step two: adding 0.4 ml of a 10% potassium chloride solution and 0.1 ml of a 0.1% diphenylamine sulfuric acid solution to the test tubes cooled in the step one respectively, shaking and standing; the invention performs sampling and detection on purified water through the liquid taking device, and utilizes vacuum technology to absorb purified water, thereby greatly reducing the contact between the purified water to be detected and the air, and effectively improving the detection accuracy; at the same time, during the detection process, the water bath device can conveniently and quickly observe the color change in the water bath process, and at the same time, according to the display comparison situation, the storage environment of the purified water storage system can be effectively adjusted to avoid the waste of purified water.

Description

Technical Field

[0001] The invention relates to the pharmaceutical field, in particular to a purified water detection process in pharmaceutical engineering. Background Art

[0002] With the continuous development of our science and technology, the water used in biopharmaceutical engineering is a kind of water without any additives. It is purified water produced by distillation, ion exchange, reverse osmosis or other methods. It is widely used in drug production and scientific experiments. The requirements for purified water used in the field of biomedicine are relatively high, because the quality of purified water has a great influence on the quality of drugs. Therefore, the purified water used in pharmaceutical engineering must undergo strict sampling inspection to ensure the quality of purified water;

[0003] However, in the current traditional testing process for purified water, it is very easy for the purified water sampled for testing to be contaminated by impurities in the air, resulting in inaccurate test data. At the same time, it is difficult to make appropriate adjustments to the purified water storage system after the test to improve the qualification of the purified water, which can easily cause a large amount of purified water to be wasted and increase production costs. Summary of the invention

[0004] The purpose of the present invention is to provide a purified water detection process in pharmaceutical engineering to solve the problems raised in the above background technology.

[0005] To achieve the above object, the present invention provides the following technical solution: a purified water detection process in pharmaceutical engineering, comprising a liquid taking device and a water bath device, and the following steps:

[0006] Step 1: Preparation of the test solution: use the liquid taking device to measure three 5 ml portions of the test solution and place them in three different test tubes, and seal them and cool them separately;

[0007] Step 2: Add 0.4 ml of 10% potassium chloride solution and 0.1 ml of 0.1% diphenylamine sulfuric acid solution to the test tube cooled in step 1, shake well and let stand;

[0008] Step 3: placing the test tube after standing in step 2 in the water bath device for 15 minutes and observing the color change;

[0009] Step 4: Preparation of control solution: use the liquid taking device to measure three portions of 0.3 ml of standard nitrate solution and place them in three different test tubes, and add 4.7 ml of nitrate-free water to each of them, and seal them and cool them down respectively;

[0010] Step 5: Add 0.4 ml of 10% potassium chloride solution and 0.1 ml of 0.1% diphenylamine sulfuric acid solution to the three test tubes cooled in step 4 respectively, and slowly add 5 ml of sulfuric acid while shaking;

[0011] Step 6: Place the three test tubes shaken in step 5 in the water bath for 15 minutes and observe the color change;

[0012] Step 7: Place the test solution and control solution in step 3 and step 6 respectively under fluorescent light for observation.

[0013] Preferably, the liquid taking device comprises a liquid taking tube, a liquid taking tube inner cavity is arranged in the liquid taking tube, a liquid suction cavity is arranged in communication with the lower side wall of the liquid taking tube inner cavity, a switch valve is arranged in the liquid suction cavity, a metering scale plate is fixedly arranged on the right end face of the liquid taking tube, a fixed sleeve block is fixedly arranged on the outer end face of the liquid taking tube, a vacuum generator is fixedly arranged in the fixed sleeve block, an energy module is arranged on the right side of the vacuum generator, an air suction hood is arranged on the upper side of the inner cavity of the liquid taking tube, a sterile air pipe is connected between the air suction hood and the vacuum generator, an arc-shaped electric heating plate is fixedly arranged on the outer end face of the lower side of the liquid taking tube, and the arc-shaped electric heating plate It is electrically connected to the energy module, and a control switch is provided on the fixed sleeve block at the left side of the liquid collection tube. The control switch is electrically connected to the vacuum generator. When the liquid collection device is used to measure the solution, the control switch is pressed to control the suction hood to suck air so that a vacuum is formed in the inner cavity of the liquid collection tube, so that the liquid suction cavity absorbs the solution. The control switch is released by observing the scale on the measuring scale plate. At the same time, after use, the arc-shaped electric heating plate can be started to perform high-temperature heating and sterilization on the position of the liquid collection device suction head to avoid cross infection during the next use.

[0014] Preferably, the water bath device comprises a bottom plate, an upper surface of the bottom plate is fixedly provided with a water bath shell, and a water bath cavity is arranged in the water bath shell. A heating plate is fixedly provided on the lower side wall of the water bath cavity, and open slide grooves are respectively provided on the left and right side walls of the water bath cavity, a first test tube placement plate is slidably connected between the two slide grooves, a fixing column is fixedly connected to the upper end surface of the first test tube placement plate, a second test tube placement plate is slidably connected on the fixing column, and the left and right sides of the second test tube placement plate are slidably connected to the corresponding slide grooves respectively, test tube placement holes are equidistantly provided on the second test tube placement plate, and four supporting slide columns are equidistantly fixed on the lower end surface of the second test tube placement plate, the lower end of each supporting slide column slides through the first test tube placement plate, and a card block is fixedly provided to abut against the lower end surface of the first test tube placement plate, the test tube is passed through the test tube placement hole and placed on the upper end surface of the first test tube placement plate, the first test tube placement plate is sunk into the water bath cavity for water bath heating.

[0015] Preferably, both left and right end surfaces of the first test tube placement tray and the second test tube placement tray are provided with protrusions which are embedded in the corresponding slide grooves for sliding. The outer end surface of the protrusion in the first test tube placement tray is smooth, and the outer end surface of the protrusion on the second test tube placement tray is rough, so that the test tube can be pulled out of the water for observation by pulling the fixing column.

[0016] Preferably, a sponge layer is provided in the side wall of each test tube placement hole, thereby effectively preventing the test tubes from colliding.

[0017] Preferably, in step 1 and step 4, sterile pads are used for sealing respectively, and the cooling environments are respectively -5°C, 0°C, and 5°C.

[0018] Preferably, in step seven, the color depth of the test solution and the control solution at the three groups of temperatures is observed, and the test solution is unqualified if the color is darker.

[0019] Preferably, in step seven, when the test solution is qualified and the colors in the three test tubes are the same, there is no need to adjust the storage temperature of the purified water. As the cooling environment temperature increases and the color becomes darker, the storage temperature of the purified water needs to be lowered, and vice versa.

[0020] Preferably, an arc-shaped handle is provided on the upper end surface of the fixing column and is covered with a heat-insulating rubber layer.

[0021] In summary, the beneficial effects of the present invention are:

[0022] The present invention samples purified water for testing through a liquid taking device and absorbs purified water using vacuum technology, thereby greatly reducing the contact between the purified water to be tested and the air, effectively improving the accuracy of the test, and at the same time, during the test, the color change in the water bath process can be conveniently and quickly observed through a water bath device, and at the same time, the storage system of purified water can effectively adjust the storage environment of purified water according to the display comparison situation, thereby avoiding the waste of purified water. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0024] Figure 1 It is a schematic diagram of the main cross-sectional structure of a liquid taking device 1 in a purified water detection process in a pharmaceutical engineering of the present invention;

[0025] Figure 2 It is a schematic diagram of the main cross-sectional structure of a water bath device 2 in a purified water detection process in a pharmaceutical engineering of the present invention;

[0026] Figure 3 For the present invention Figure 2 A schematic diagram of the structure of the second test tube placement tray 29 of the middle component viewed from above.

[0027] The markings in the accompanying drawings are described as follows: 1. liquid collection device; 2. water bath device; 10. liquid collection tube; 11. inner cavity of liquid collection tube; 12. arc-shaped electric heating plate; 13. liquid suction cavity; 14. control switch; 15. metering scale plate; 16. vacuum generator; 17. fixed sleeve block; 18. energy module; 19. suction hood; 21. bottom plate; 22. water bath shell; 23. heating plate; 24. water bath cavity; 25. slide; 26. first test tube placement plate; 27. fixed column; 28. supporting slide column; 29. ​​second test tube placement plate; 30. test tube placement hole. DETAILED DESCRIPTION

[0028] All features disclosed in this specification, or steps in all methods or processes disclosed, except mutually exclusive features and / or steps, can be combined in any manner.

[0029] Any feature disclosed in this specification (including any additional claims, abstract and drawings), unless otherwise stated, may be replaced by other equivalent or alternative features with similar purposes. That is, unless otherwise stated, each feature is only an example of a series of equivalent or similar features.

[0030] Combine the following Figure 1-3 The present invention is described in detail. For the convenience of description, the directions mentioned below are defined as follows: the up, down, left, right, front, and back directions mentioned below are the same as Figure 1 The view direction is consistent in front, back, left, right, up and down directions. Figure 1 is a front view of the device of the present invention, Figure 1 The directions shown are consistent with the front, back, left, right, up and down directions of the device of the present invention when viewed from the front.

[0031] See also Figure 1-3 , an embodiment provided by the present invention: a purified water detection process in pharmaceutical engineering, comprising a liquid taking device 1 and a water bath device 2, and the following steps:

[0032] Step 1: Preparation of the test solution: use the liquid taking device 1 to measure three portions of 5 ml of the test solution and place them in three different test tubes, and then seal and cool them separately;

[0033] Step 2: Add 0.4 ml of 10% potassium chloride solution and 0.1 ml of 0.1% diphenylamine sulfuric acid solution to the test tube cooled in step 1, shake well and let stand;

[0034] Step 3: placing the test tube after standing in step 2 in the water bath device 2 for fifteen minutes and observing the color change;

[0035] Step 4: Preparation of control solution: use the liquid taking device 1 to measure three portions of 0.3 ml of standard nitrate solution and place them in three different test tubes, and add 4.7 ml of nitrate-free water to each of them, and seal them and cool them down respectively;

[0036] Step 5: Add 0.4 ml of 10% potassium chloride solution and 0.1 ml of 0.1% diphenylamine sulfuric acid solution to the three test tubes cooled in step 4 respectively, and slowly add 5 ml of sulfuric acid while shaking;

[0037] Step 6: Place the three test tubes shaken in step 5 in the water bath device 2 for 15 minutes and observe the color change;

[0038] Step 7: Place the test solution and control solution in step 3 and step 6 respectively under fluorescent light for observation.

[0039] In addition, in one embodiment, the liquid collection device 1 includes a liquid collection tube 10, wherein a liquid collection tube inner cavity 11 is provided in the liquid collection tube 10, a liquid suction cavity 13 is provided in communication with the lower side wall of the liquid collection tube inner cavity 11, a switch valve is provided in the liquid suction cavity 13, a metering scale plate 15 is fixedly provided on the right end face of the liquid collection tube 10, a fixed sleeve block 17 is fixedly provided on the outer end face of the liquid collection tube 10, a vacuum generator 16 is fixedly provided in the fixed sleeve block 17, an energy module 18 is provided on the right side of the vacuum generator 16, an air suction hood 19 is provided on the upper side of the liquid collection tube inner cavity 11, a sterile air pipe is connected between the air suction hood 19 and the vacuum generator 16, and an arc-shaped electric heating plate 12 is fixedly provided on the lower outer end face of the liquid collection tube 10 The arc-shaped electric heating plate 12 is electrically connected to the energy module 18, and a control switch 14 is provided on the fixed sleeve 17 at the left side of the liquid taking tube 10. The control switch 14 is electrically connected to the vacuum generator 16. When the liquid taking device 1 is used to measure the solution, the control switch 14 is pressed to control the suction hood 19 to suck air so that the inner cavity 11 of the liquid taking tube forms a vacuum, so that the liquid suction cavity 13 absorbs the solution. The control switch 14 is released by observing the scale on the measuring scale plate 15. At the same time, after use, the arc-shaped electric heating plate 12 can be started to perform high-temperature heating and sterilization on the suction head position of the liquid taking device 1 to avoid cross infection during the next use.

[0040] In addition, in one embodiment, the water bath device 2 includes a bottom plate 21, a water bath housing 22 is fixedly provided on the upper end surface of the bottom plate 21, and a water bath chamber 24 is provided in the water bath housing 22. A heating plate 23 is fixedly provided on the lower side wall of the water bath chamber 24, and an open slide 25 is respectively provided on the left and right side walls of the water bath chamber 24, and a first test tube placement tray 26 is slidably connected between the two slides 25, and a fixed column 27 is fixedly connected to the upper end surface of the first test tube placement tray 26, and a second test tube placement tray 29 is slidably connected to the fixed column 27, and the second test tube placement tray 29 is on the left side of the second test tube placement tray 29. The right sides are respectively slidably connected with the corresponding slide grooves 25, and the second test tube placement plate 29 is evenly distributed with test tube placement holes 30. The lower end surface of the second test tube placement plate 29 is evenly distributed with four supporting slide columns 28, and the lower end of each supporting slide column 28 slides through the first test tube placement plate 26, and a block is fixedly provided to abut against the lower end surface of the first test tube placement plate 26. The test tube is passed through the test tube placement hole 30 and placed on the upper end surface of the first test tube placement plate 26, and the first test tube placement plate 26 is sunk into the water bath cavity 24 for water bath heating.

[0041] In addition, in one embodiment, both left and right end surfaces of the first test tube placement tray 26 and the second test tube placement tray 29 are provided with protrusions that are embedded in the corresponding slide grooves 25 for sliding. The outer end surface of the protrusion in the first test tube placement tray 26 is smooth, and the outer end surface of the protrusion on the second test tube placement tray 29 is rough, so that the test tube can be pulled out of the water for observation by pulling the fixing column 27.

[0042] In addition, in one embodiment, a sponge layer is provided in the side wall of each test tube placement hole 30, thereby effectively preventing the test tube from colliding.

[0043] In addition, in one embodiment, in step one and step four, sterile pads are used for sealing, and the cooling environments are respectively -5°C, 0°C, and 5°C.

[0044] In addition, in one embodiment, in step seven, the color depth of the test solution and the control solution at the three groups of temperatures is observed, and the test solution is unqualified if the color is darker.

[0045] In addition, in one embodiment, when the test solution in step seven is qualified and the colors in the three test tubes are the same, there is no need to adjust the storage temperature of the purified water. As the cooling environment temperature increases and the color becomes darker, the storage temperature of the purified water needs to be lowered, and vice versa.

[0046] When it is necessary to detect nitrate in purified water, first prepare the test solution, measure three 5ml test solution by the liquid taking device 1 and place them in three different test tubes, seal them with sterile pads and place them in -5°C, 0°C and 5°C environments for cooling, add 0.4ml of 10% potassium chloride solution and 0.1ml of 0.1% diphenylamine sulfuric acid solution to the cooled test tubes, shake well and let stand, then place them in the water bath device 2 for fifteen minutes, and observe the color change, and at the same time prepare the control solution, measure three 0.3ml standard nitrate solutions by the liquid taking device 1 and place them in three different test tubes, add 4.7ml of nitrate-free water, seal them with sterile pads and place them in -5°C, 0°C and 5°C environments for cooling, then add 0.4ml of 10% potassium chloride solution and 0.1ml of 0.1% diphenylamine sulfuric acid solution, shake well, slowly add 5ml of sulfuric acid, shake well, place the test tubes in the water bath device 2 for fifteen minutes, and observe the color change.

[0047] The above is only a specific implementation of the invention, but the protection scope of the invention is not limited to it. Any changes or substitutions that are not conceived through creative work should be included in the protection scope of the invention. Therefore, the protection scope of the invention should be based on the protection scope defined in the claims.

Claims

1. A purified water detection process in pharmaceutical engineering, comprising a liquid taking device (1) and a water bath device (2), characterized in that: Follow these steps: Step 1: preparing the test solution, using the liquid taking device (1) to measure three portions of 5 ml of the test solution and place them in three different test tubes, and then sealing and cooling them separately; Step 2: Add 0.4 ml of 10% potassium chloride solution and 0.1 ml of 0.1% diphenylamine sulfuric acid solution to the test tube cooled in step 1, shake well and let stand; Step 3: placing the test tube after standing in step 2 in the water bath device (2) for 15 minutes and observing the color change; Step 4: Preparation of control solution: using the liquid taking device (1), three portions of 0.3 ml of standard nitrate solution are measured and placed in three different test tubes, and 4.7 ml of nitrate-free water is added to each of the three test tubes, and the three test tubes are sealed and cooled respectively; Step 5: Add 0.4 ml of 10% potassium chloride solution and 0.1 ml of 0.1% diphenylamine sulfuric acid solution to the three test tubes cooled in step 4 respectively, and slowly add 5 ml of sulfuric acid while shaking; Step 6: Place the three test tubes shaken in step 5 in the water bath device (2) for 15 minutes and observe the color change; Step 7: Place the test solution and control solution in step 3 and step 6 respectively under a fluorescent lamp for observation; The liquid collection device (1) comprises a liquid collection tube (10), wherein a liquid collection tube inner cavity (11) is provided in the liquid collection tube (10), a liquid suction cavity (13) is provided in communication with the lower side wall of the liquid collection tube inner cavity (11), a switch valve is provided in the liquid suction cavity (13), a metering scale plate (15) is fixedly provided on the right end surface of the liquid collection tube (10), a fixed sleeve block (17) is fixedly provided on the outer end surface of the liquid collection tube (10), a vacuum generator (16) is fixedly provided in the fixed sleeve block (17), and an energy module (16) is provided on the right side of the vacuum generator (16). A group (18), an air suction hood (19) is arranged on the upper side of the inner cavity (11) of the liquid collection tube, and a sterile air pipe is connected between the air suction hood (19) and the vacuum generator (16); an arc-shaped electric heating plate (12) is fixedly sleeved at the outer end surface of the lower side of the liquid collection tube (10), and the arc-shaped electric heating plate (12) is electrically connected to the energy module (18); a control switch (14) is arranged on the fixed sleeve block (17) at the left side of the liquid collection tube (10), and the control switch (14) is electrically connected to the vacuum generator (16); The water bath device (2) comprises a bottom plate (21), the upper end surface of the bottom plate (21) is fixedly provided with a water bath shell (22), and a water bath chamber (24) is arranged in the water bath shell (22). A heating plate (23) is fixedly arranged on the lower side wall of the water bath chamber (24), and open slide grooves (25) are respectively arranged on the left and right side walls of the water bath chamber (24), and a first test tube placement plate (26) is slidably connected between the two slide grooves (25), and a fixing column (27) is fixedly connected to the upper end surface of the first test tube placement plate (26), and the fixing column (27) A second test tube placement plate (29) is slidably connected to the upper surface of the test tube placement plate (27); the left and right sides of the second test tube placement plate (29) are slidably connected to the corresponding slide grooves (25); the second test tube placement plate (29) is provided with test tube placement holes (30) at equal intervals; four supporting slide columns (28) are fixedly provided at equal intervals on the lower end surface of the second test tube placement plate (29); the lower end of each supporting slide column (28) slides through the first test tube placement plate (26) and is fixedly provided with a block abutting against the lower end surface of the first test tube placement plate (26).

2. The method for detecting purified water in pharmaceutical engineering according to claim 1, characterized in that: The left and right end surfaces of the first test tube placement tray (26) and the second test tube placement tray (29) are both provided with protrusions which are embedded in the corresponding slide grooves (25) for sliding; the outer end surface of the protrusion in the first test tube placement tray (26) is smooth, while the outer end surface of the protrusion on the second test tube placement tray (29) is rough.

3. The method for detecting purified water in pharmaceutical engineering according to claim 1, characterized in that: A sponge layer is respectively arranged in the side wall of each test tube placement hole (30).

4. The method for detecting purified water in pharmaceutical engineering according to claim 1, characterized in that: In the step 1 and the step 4, sterile pads are used for sealing respectively, and the cooling environments are respectively -5°C, 0°C, and 5°C.

5. The method for detecting purified water in pharmaceutical engineering according to claim 1, characterized in that: In the step 7, the color depth of the test solution and the control solution of the three groups of temperatures is observed. If the test solution has a darker color, it is unqualified.

6. A purified water detection process in pharmaceutical engineering according to claim 5, characterized in that: In the step 7, if the test solution is qualified and the colors in the three test tubes are the same, there is no need to adjust the storage temperature of the purified water. As the cooling environment temperature increases and the color becomes darker, the storage temperature of the purified water needs to be lowered, otherwise the storage temperature of the purified water needs to be increased.

7. The method for detecting purified water in pharmaceutical engineering according to claim 1, characterized in that: The upper end surface of the fixing column (27) is provided with an arc-shaped handle and is covered with a heat-insulating rubber layer.

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