Method for testing liquid storage bags

Abstract

An embodiment of the present invention relates to a method (50) for testing a liquid storage bag (10). The liquid storage bag (10) includes: a bag body (12) having a storage space (14) therein; an interface portion (16); and a connecting portion (18) connecting the bag body (12) and the interface portion (16). The method (50) includes the following steps: (52) separating the bag body (12) and the interface portion (16) from the same side of the connecting portion (18) to obtain a first force-applying portion (20) of the bag body (12) and a second force-applying portion (22) of the interface portion (16) extending from the connecting portion (18) in opposite directions (A); and (54) applying a pulling force in the opposite directions (A) to the connecting portion (18) at the first force-applying portion (20) and the second force-applying portion (22) to test the connection strength of the connecting portion (18).

Description

Technical Field

[0001] The present application relates to biopharmaceuticals, and in particular to a method for detecting a liquid storage bag. Background Art

[0002] With the development of the biopharmaceutical industry, liquid storage bags are rapidly gaining widespread application. However, many liquid storage bags that pass inspection using existing methods exhibit leakage and other issues, failing to meet quality requirements. Therefore, improved methods for inspecting liquid storage bags are needed. Summary of the Invention

[0003] One object of the present application is to provide an improved method for detecting a liquid storage bag.

[0004] To achieve the above objectives, one aspect of an embodiment of the present application relates to a method for testing a liquid storage bag. The liquid storage bag includes: a bag body portion, which is provided with a storage space; an interface portion; and a connecting portion, which connects the bag body portion and the interface portion. The method includes the following steps: separating the bag body portion and the interface portion from the same side of the connecting portion to obtain a first force-applying portion of the bag body portion and a second force-applying portion of the interface portion extending from the connecting portion in opposite directions; and applying a pulling force in the opposite directions to the connecting portion at the first force-applying portion and the second force-applying portion, respectively, to perform a connection strength test on the connecting portion.

[0005] In some embodiments, the method is performed at room temperature and indoor humidity.

[0006] In some embodiments, the bag body and the interface portion are made of different materials.

[0007] In some embodiments, the bag body is made of plastic film material.

[0008] In some embodiments, the interface portion is made of polyethylene material or polyethylene-octene co-elastomer material.

[0009] In some embodiments, the interface portion includes an accessory matching portion, which matches with at least one of the accessories for liquid inlet, liquid outlet, stirring and mixing, feeding, and detection.

[0010] In some embodiments, the connecting portion is a welding layer of the bag body and the interface portion.

[0011] In some embodiments, before the step of separating the bag body and the interface portion from the same side of the connecting portion to obtain a first force-applying portion of the bag body and a second force-applying portion of the interface portion extending from the connecting portion in opposite directions, a sample to be tested including the bag body, the interface portion and the connecting portion is prepared from the liquid storage bag.

[0012] In some embodiments, before the step of separating the bag body and the interface portion from the same side of the connecting portion to obtain a first force-applying portion of the bag body and a second force-applying portion of the interface portion extending from the connecting portion in opposite directions, the bag body and the interface portion on the same side of the connecting portion are stacked on each other.

[0013] In some embodiments, the step of applying tension in opposite directions to the connection portion by the first force applying portion and the second force applying portion respectively to detect the connection strength of the connection portion includes obtaining a tension value corresponding to a peak value of the tensile strength.

[0014] If technical conditions permit, the technical solutions of the above embodiments can be combined arbitrarily.

[0015] The present application will be further described below with reference to the accompanying drawings. The drawings may use the same or similar reference numerals to refer to the same or similar elements, devices, shapes, structures, steps, features, etc. in different embodiments, and the descriptions of the same or similar elements, devices, shapes, structures, steps, features, effects, etc. in different embodiments, as well as the descriptions of the elements, devices, shapes, structures, steps, features, effects, etc. in the prior art, may be omitted. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 This is a perspective diagram of a liquid storage bag in use according to an embodiment of the present application;

[0017] Figure 2 is a flow chart of a method for detecting a liquid storage bag according to some embodiments of the present application;

[0018] Figure 3 A schematic diagram of a structure for detecting a liquid storage bag according to some embodiments of the present application;

[0019] Figure 4 yes Figure 1 The storage status of the liquid storage bag and the schematic diagram of sample preparation;

[0020] Figure 5 Schematic diagram of the detection structure in Comparative Example 1;

[0021] Figure 6 is the curve graph generated in Comparative Example 1; and

[0022] Figure 7 The curve graph generated in Example 1. DETAILED DESCRIPTION

[0023] Figure 1 This is a perspective diagram of a liquid storage bag in use according to an embodiment of the present application. Figure 1In some embodiments, a liquid storage bag 10 includes: a bag body 12 having a storage space 14 therein; an interface portion 16 ; and a connecting portion 18 connecting the bag body 12 and the interface portion 16 .

[0024] The terms "inside", "outside", "upper", "lower" and the like in this document may refer to the directions and relationships in the accompanying drawings, or may refer to the directions and relationships in the implementation scenarios of the embodiments of the present invention.

[0025] The liquid storage bag 10 can be a disposable liquid storage bag. The liquid storage bag 10 can be used to store liquid in the biopharmaceutical process in the storage space 14. The liquid storage bag 10 can be called a disposable biological storage and transportation bag and can be used in various disposable biopharmaceutical functional products.

[0026] Figure 2 It is a flowchart of a method for detecting a liquid storage bag according to some embodiments of the present application. Figure 3 This is a schematic diagram of the structure of the detection method for the liquid storage bag according to some embodiments of the present application. Figure 2 、 3 As shown, a method 50 for testing a liquid storage bag includes the following steps: 52. Separating the bag body 12 and the interface portion 16 from the same side of the connecting portion 18 to obtain a first force-applying portion 20 of the bag body 12 and a second force-applying portion 22 of the interface portion 16 extending from the connecting portion 18 in opposite directions A respectively; and 54. Applying a pulling force in the opposite directions A to the connecting portion 18 at the first force-applying portion 20 and the second force-applying portion 22 respectively to perform a connection strength test of the connecting portion 18.

[0027] The embodiments of the present invention can help to accurately measure the connection strength of the liquid storage bag.

[0028] For example, the first force-applying portion 20 and the second force-applying portion 22 extending from the same side of the connecting portion 18 respectively apply a pulling force to the connecting portion 18 in the opposite direction A to perform a connection strength test on the connecting portion 18. This can facilitate directly applying the pulling force measurement position to the connecting portion 18, thereby obtaining accurate data reflecting the actual connection strength, thereby reducing or eliminating the possibility of leakage in the liquid storage bag 18 that has passed the test, thereby better meeting quality requirements.

[0029] The terms "first" and "second" in this document are not used to represent importance, priority, etc., but are intended to distinguish the devices, elements, shapes, structures, parts, etc. they modify.

[0030] The method 50 can be performed at room temperature, such as 23° C. The method 50 can be performed under indoor humidity, such as 50% humidity, to facilitate detection.

[0031] In some embodiments, the bag body 12 and the interface portion 16 are made of different materials.

[0032] In this way, the method 50 can be helpful in accurately detecting the connection strength between the bag body 12 and the interface portion 16 made of different materials.

[0033] In some embodiments, the bag body 12 is made of plastic film material.

[0034] In this way, the method 50 can be helped to accurately detect the connection strength between the bag body 12 and the interface portion 16 made of plastic film material.

[0035] The plastic film material may be a medical film material. The plastic film material may be a multi-layer co-extruded film. Examples of the plastic film material may include, but are not limited to, a multi-layer co-extruded film with the brand number 9101 from RENOLIT.

[0036] The bag body 12 can be 2-dimensional or 3-dimensional. Correspondingly, the storage space 14 can be 2-dimensional or 3-dimensional. Figure 1 The bag body 12 is three-dimensional, and the storage space 14 can be roughly square when in use.

[0037] In some embodiments, the interface portion 16 is made of polyethylene material or polyethylene-octene co-elastomer material.

[0038] In this way, the method 50 can be facilitated to accurately detect the connection strength between the interface portion 16 and the bag body 12 made of polyethylene material or polyethylene-octene co-elastomer material.

[0039] The interface portion 16 may be a polyethylene (PE) disc interface. Accordingly, the connecting portion 18 may be annular. The connecting portion 18 may be close to the outer edge of the interface portion 16.

[0040] In some embodiments, the interface portion 16 includes an accessory matching portion 24, which matches with at least one of the accessories for liquid inlet, liquid outlet, stirring and mixing, feeding, and detection.

[0041] In this way, the method 50 can be helped to accurately detect the connection strength between the interface portion 16 and the bag body portion 12 that cooperates with at least one of the accessories for liquid inlet, liquid outlet, stirring and mixing, feeding, and detection.

[0042] The liquid storage bag 10 may be a disposable biological storage and transportation bag formed by connecting the bag body 12 and the interface 16 and cooperating with at least one of accessories for liquid inlet, liquid outlet, stirring and mixing, feeding, and testing.

[0043] The accessory fitting portion 24 may be located in the middle of the interface portion 16. The accessory fitting portion 24 may protrude from the interface portion 16 toward one or both of the outside and the inside of the liquid storage bag 10.

[0044] In some embodiments, the connecting portion 18 is a welding layer of the bag body 12 and the interface portion 16 .

[0045] In this way, the method 50 can be used to accurately detect the welding strength between the interface portion 16 and the bag body portion 12, thereby reducing or avoiding the possibility of poor welding or leakage in the liquid storage bag 10 that has passed the inspection.

[0046] The connecting portion 18 can be formed by heating and welding the bag body 12 and the interface portion 16. The liquid storage bag 10 can be a multi-layer co-extruded film bag body 12 with a brand number of 9101 from RENOLIT and a polyethylene (PE) disc interface portion 16, which are welded after being heated by a disc sealing machine.

[0047] In some embodiments, before step 52 , a sample to be tested 26 including the bag body 12 , the interface portion 16 and the connecting portion 18 is prepared from the liquid storage bag 10 .

[0048] In this way, it is helpful to sample and detect the connection strength of the connection portion 18 in a targeted manner.

[0049] Figure 4 yes Figure 1 The storage status of the liquid storage bag and the sample preparation diagram are shown in the figure. Figure 4 During storage and transportation, when no liquid is stored in the storage space 14, the liquid storage bag 10 can be folded to reduce the volume of the space occupied. At this time, the liquid storage bag 10 can be two-dimensional.

[0050] The sample 26 to be tested, including the bag body 12, the interface 16, and the connecting portion 18, can be cut from the liquid storage bag 10 along the dotted line 30. The sample 26 to be tested can be centered at the center 28 of the interface 16. The sample 26 to be tested can be generally in the shape of a long strip. The center 28 of the interface 16 can be the center of the accessory fitting portion 24.

[0051] Please continue to refer to Figure 3 In some embodiments, before step 52 , the bag body portion 12 and the interface portion 16 on the same side of the connecting portion 18 are stacked on each other.

[0052] In this way, the connection between the bag body 12 and the interface portion 16 can be reliable, and the possibility of poor welding and leakage of the liquid storage bag 10 can be reduced or avoided.

[0053] Figure 3 The sample 26 to be tested has a connecting portion 18 on both the upper and lower sides of the accessory fitting portion 24. The connecting portion 18 located above the accessory fitting portion 24 is clamped on the upper portion of the clamp 32. The bag body 12 and the interface portion 16 on the side of the connecting portion 18 near the accessory fitting portion 24 are stacked and not separated. The connecting portion 18 located below the accessory fitting portion 24 has the bag body 12 and the interface portion 16 stacked on the side of the connecting portion 18 near the accessory fitting portion 24 separated, so that the first force-applying portion 20 of the separated bag body 12 is clamped by the lower portion of the clamp 32 and extends in the opposite direction A from the second force-applying portion 22 of the separated interface portion 16 clamped by the upper portion of the clamp 32. When the first force-applying part 20 and the second force-applying part 22 respectively apply pulling forces in the opposite directions A, the connection strength of the connecting part 18 located below the accessory fitting part 24 is tested. This can help to directly apply the pulling force to the connecting part 18 located below the accessory fitting part 24 through the measuring position, thereby obtaining a more accurate connection strength value.

[0054] The fixture 32 may be a component of a material testing machine, examples of which include, but are not limited to, a QT-6203 desktop servo-type universal material testing machine.

[0055] In some embodiments, step 54 includes obtaining a tensile force value corresponding to the peak tensile strength.

[0056] In this way, the method 50 can be helped to obtain the connection strength of the connection portion 18 under the extreme state, thereby reducing or avoiding the possibility of the liquid storage bag 10 that has passed the inspection having a cold weld or leakage.

[0057] The following experimental examples may be used to help understand the embodiments of the present invention and are not intended to be used as limitations on the claims.

[0058] Experimental Example

[0059] Comparative Example 1

[0060] like Figure 4As shown, referring to the industry standards QB / T2358-98 and ASTM D882, a strip 10 cm long and 1.5 cm wide, including at least a portion of the interface 16, the bag body 12, and the connecting portion 18, was cut along the dashed line 30, centered at the center 28 of the interface 16 of a liquid storage bag 10. This strip, i.e., the test sample 26, was cut. The liquid storage bag 10 was made by welding a multi-layer co-extruded film (RENOLIT brand 9101) to a polyethylene (PE) disc interface using a disc sealer after heating. Specifically, the bag body 12 was made of the multi-layer co-extruded film, and the interface 16 was made of PE. The connecting portion 18 was a welded layer formed by welding the interface 16 and bag body 12 together at 140°C and 0.15 MPa for 5.5 seconds.

[0061] See Figure 5 Continuing to refer to the two standards "QB / T2358-98" and "ASTM D882", the test sample 26 was fixed with the fixture 32 of the QT-6203 desktop servo universal material testing machine, and the connection strength of the connection part 18 located below the accessory fitting part 24 was tested at a speed of 30 cm / min. In particular, the interface part 16 on the side of the connection part 18 close to the accessory fitting part 24 and the bag part 12 on the side of the connection part 18 away from the accessory fitting part 24 were respectively applied to the connection part 18 in opposite directions A to test the connection strength of the connection part 18, record the data, and generate the following data: Figure 6 The graph shown has the value of the force applied to the sample 26 as the vertical axis and the corresponding deformation of the sample 26 as the horizontal axis. The ambient temperature during the test was 23° C. and the ambient humidity was 50%.

[0062] Combine Figure 6 It can be concluded that the tensile force corresponding to the peak tensile strength of the sample 26 to be tested is 64.96N.

[0063] After inspection, it was observed that the connecting portion 18 was torn, but the bag body 12 and the interface portion 16 connected thereto had not yet been completely separated.

[0064] Example 1

[0065] Another test sample 26 was prepared in the same manner as in Comparative Example 1 from another liquid storage bag 10 used in Example 1. Specifically, the bag body 12 was made of a multi-layer co-extruded film, and the interface 16 was made of PE. The connecting portion 18 was also a welded layer formed by welding the interface 16 and bag body 12 together at 140°C and 0.15 MPa for 5.5 seconds.

[0066] The same QT-6203 desktop servo universal material testing machine used in Comparative Example 1 was used to fix the sample 26 to be tested, and the connection strength of the connection portion 18 located below the accessory fitting portion 24 was tested at a speed of 30 cm / min. Figure 3 During the fixing process, the sample to be tested 26 is bent, and the stacked bag body 12 and the interface portion 16 are separated from the side of the connecting portion 18 located below the accessory matching portion 24 and close to the accessory matching portion 24, so as to obtain the first force-applying portion 20 of the bag body 12 and the second force-applying portion 22 of the interface portion 16 extending from the connecting portion 18 in opposite directions A respectively.

[0067] Then, the first force applying portion 20 and the second force applying portion 22 apply a pulling force in the opposite direction A to the connecting portion 18, and record the data to generate the following equation: Figure 7 The graph shown has the value of the force applied to the sample 26 as the vertical axis and the corresponding deformation of the sample 26 as the horizontal axis. The ambient temperature during the test was 23° C. and the ambient humidity was 50%.

[0068] Combine Figure 7 It can be concluded that the tensile force corresponding to the peak tensile strength of the sample 26 to be tested is 48.18N.

[0069] After the inspection, the bag body portion 12 and the interface portion 16 at the corresponding connection portion 18 are completely separated, that is, the welding layer is completely separated.

[0070] As can be seen from the above, under the same parameter combination conditions, the tensile test value of 64.96N can be obtained for Example 1 using the industry standard, while the tensile test value corresponding to Example 1 is only 48.18N, and there is a phenomenon of complete separation of the welding layer. There is a risk of data inaccuracy in the confirmation of the product process of the liquid storage bag corresponding to the original industry standard. If the parameter combination of the original industry standard is adopted, there may be hidden dangers of leakage during the use of the liquid storage bag. The method of the embodiment of the present invention can more accurately measure the welding strength of the liquid storage bag, is more instructive for the production practice of the liquid storage bag, and can help reduce and avoid the possibility of cold welding and leakage in the liquid storage bag that has passed the inspection.

[0071] The various specific embodiments described above and shown in the drawings are only for illustrating the present invention and are not exhaustive. Within the scope of the basic technical concept of the present invention, any form of modification made by a person skilled in the relevant art to the present invention is within the scope of protection of the present invention.

Claims

1. A method (50) for detecting a liquid storage bag (10), characterized in that: The liquid storage bag (10) comprises: a bag body (12) having a storage space (14) therein; an interface portion (16); and a connecting portion (18) connecting the bag body (12) and the interface portion (16); the method (50) comprises the following steps: (52), separating the bag body (12) and the interface portion (16) from the same side of the connecting portion (18) to obtain a first force-applying portion (20) of the bag body (12) and a second force-applying portion (22) of the interface portion (16) extending from the connecting portion (18) in opposite directions (A); and (54) The first force applying portion (20) and the second force applying portion (22) respectively apply a pulling force to the connecting portion (18) in the opposite direction (A) to perform a connection strength test of the connecting portion (18).

2. The method (50) according to claim 1, characterized in that Perform at room temperature.

3. The method (50) according to claim 1, characterized in that The bag body (12) and the interface portion (16) are made of different materials.

4. The method (50) according to claim 1, characterized in that The bag body (12) is made of plastic film material.

5. The method (50) according to claim 1, characterized in that The interface portion (16) is made of polyethylene material or polyethylene-octene co-elastomer material.

6. The method (50) according to claim 1, characterized in that The interface portion (16) comprises an accessory matching portion (24) which matches at least one of the accessories for liquid inlet, liquid outlet, stirring and mixing, feeding, and detection.

7. The method (50) according to claim 6, characterized in that The step (52) includes separating the bag body portion (12) and the interface portion (16) stacked on each other from a side of the connecting portion (18) close to the accessory fitting portion (24).

8. The method (50) according to claim 1, characterized in that The connecting portion (18) is a welding layer of the bag body portion (12) and the interface portion (16).

9. The method (50) according to any one of claims 1 to 8, characterized in that Before the step (52), a sample to be tested (26) comprising the bag body (12), the interface portion (16) and the connecting portion (18) is prepared from the liquid storage bag (10).

10. The method (50) according to claim 9, characterized in that The step (52) includes bending the sample to be tested (26) before separating the bag body (12) and the interface (16).

11. The method (50) according to claim 9, characterized in that The sample to be tested (26) is centered at the center (28) of the interface portion (16) and is roughly in the shape of a long strip.

12. The method (50) according to any one of claims 1 to 11, characterized in that The bag body portion (12) and the interface portion (16) are stacked on each other before separation in the step (52).

13. The method (50) according to any one of claims 1 to 11, characterized in that The step (54) includes obtaining a tensile force value corresponding to the peak value of the tensile strength.

14. The method (50) according to any one of claims 1 to 11, characterized in that The liquid storage bag (10) is a disposable biological liquid storage bag.

15. The method (50) according to any one of claims 1 to 11, characterized in that The interface portion (16) is a polyethylene disc interface, and the connecting portion (18) is close to the outer edge of the interface portion (16) and is annular.

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