Aseptic drainage tube sealing performance monitoring program

Abstract : Good sealing performance is one of the basic requirements for the drainage tube. This article uses the MFY-01 Sealing Tester independently developed by Jinan Languang Electromechanical Technology Co., Ltd. to test the sealing performance of a drainage tube, and briefly describes the test. The principle and parameters of the process and equipment, thus providing an effective reference method for the enterprise to monitor the sealing performance of the drainage tube.

Keywords : Drainage tube, sealing performance, seal tester, negative pressure method, leakage

1 , the meaning

Sterile drainage tube is a commonly used clinical medical device. It has a wide range of different functions and can be used for catheterization. It can also be used for the accumulation of pus in wounds, brain cavities, thoracic cavities, gastrointestinal tracts, biliary tracts, or between body tissues. Blood, liquids, and liquids are directed outside the body to prevent postoperative infection and affect wound healing. Drainage tube body and the joints of the components should maintain a high degree of sealing, otherwise it may lead to drainage is not smooth, or the sterile wound environment caused by wound infection, if the gas is introduced into the human body Severe consequences such as pneumothorax are prone to occur, and leakage of the draining fluid causes problems such as cross-infection. Therefore, it is one of the preconditions for the normal use of the drainage tube that the components and connections of the drainage tube have no leakage and good sealing performance.


Figure 1 various types of drainage tube

2 , reference standards

Sterile drainage tube may refer to standard products YY 0489-2004 "Disposable Sterile drainage catheters and accessory devices", the predetermined detection criteria may be sterile drainage tube sealing reference standard GB / T 15812.1-2005 "non Intravascular catheter - Part 1 : General performance test method".

3 , test sample

This article takes a sterile drainage tube manufactured by a company as an example to test its sealing performance.

4 , test equipment

Labthink PARAM MFY-01 seal test device is a test method underpressure principle of detection equipment, the device detects a sterile paper, sealing performance of the drainage tube.


Figure 2 MFY-01 Seal Tester

4.1 Equipment Principle

During the test, the sample is placed in the vacuum chamber of the equipment, the vacuum chamber pump is turned on, and the vacuum chamber of the equipment is evacuated, so that the sample immersed in the vacuum chamber water generates a pressure difference between the inside and outside, and the leakage of the sample is checked. In order to determine the sealing performance of the sample; or through the vacuum chamber vacuum, make the sample produce internal and external pressure difference, by observing the expansion of the sample and release the vacuum after the recovery of the shape of the sample to determine the sealing performance of the sample.

4.2 Scope of application

Applicable to the overall leak test of plastic bags, bottles, tubes, cans, boxes, etc. Applicable to the overall leak test of glass bottles, tubes, cans, boxes, etc. Applicable to the overall leak test of metal bottles, tubes, cans, boxes, etc. Applicable to the sealing test of paper-plastic composite bags and boxes. Meet the requirements of the national standard GB/T 15171 and the American standard ASTM D 3078 .

4.3 Equipment Parameters

The degree of vacuum is 0 ~ -90 KPa . The effective size of the vacuum chamber is available in three options: 270 mm ( diameter ) × 210 mm ( height ) , 360 mm ( diameter ) × 585 mm ( height ) , and 460 mm ( diameter ) × 330 mm ( height ) . The equipment adopts digital preset test vacuum and vacuum holding time to ensure the accuracy of test data. Automatic constant pressure replenishment technology further ensures that the test can be performed under preset vacuum conditions. The equipment uses a professional software system to support automatic backflush unloading and automatic end of test functions to ensure the smooth progress of the test process.

5 , the test process

(1) Assemble the drainage tube assembly as required and close the open end.

(2) Place the sample in a vacuum chamber.

(3) Set the vacuum according to the product requirements and set the pressure holding time to 120 s .

(4) Click the start button to start the test. Observe carefully whether there are any continuous bubbles on the surface of the sample during the vacuum and pressure holding process. After the pressure holding time is over, the test is automatically ended.

6 , test results

The aseptic drainage tube samples tested herein showed no leakage at a vacuum of -90 KPa .

7. Conclusion

Sterile drainage tube sealing performance is related to the use of a safe or not important performance index, using the article of Labthink MFY-01 seal test instrument sterile drainage tube sealing properties were tested, simple operation of the device The high degree of intelligence, accurate and reliable test results, is a test equipment that can quickly and efficiently test the sealing performance of the sample. The leading domestic packaging testing equipment manufacturing industry - Jinan Languang Electromechanical Technology Co., Ltd. can provide professional and accurate packaging testing equipment, and can provide intimate, high-quality packaging testing services, covering the packaging performance of the barrier, flexibility, Impact resistance, puncture resistance, heat sealing performance, sealing performance, solvent residue, evaporation residue, etc., related equipment information and service content You can visit the website of Jinan Languang Company to view or call for consultation. The more you understand, the more trust! Labthink is willing to take this opportunity to increase technical exchanges and cooperation with enterprises and institutions in the industry.

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