Aseptic drainage tube sealing performance monitoring program

Abstract : Good sealing performance is one of the basic requirements for the drainage tube. This paper 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 process and the principle and parameters of the equipment provide an effective reference method for the enterprise to monitor the sealing performance of the drainage tube.

Key words : drainage tube, sealing performance, seal tester, negative pressure method, leakage

1 , meaning

Sterile drainage tube is a kind of Medical Equipment commonly used in clinical practice. It has various types and functions. It can be used for catheterization, and can also be used for pus accumulation in human tissues or body cavity such as wound, brain cavity, chest cavity, gastrointestinal tract and biliary tract. Blood and liquid are guided to the outside to prevent postoperative infection and affect wound healing. The tube body of the drainage tube and the joints of each component should maintain a high degree of sealing. Otherwise, the drainage may not be smooth, or the aseptic environment of the wound may be damaged to cause wound infection. If the gas is introduced into the human body, It is prone to serious consequences such as pneumothorax, and leakage of fluid such as drainage may lead to cross-infection. Therefore, there is no leakage and good sealing of the components and joints of the drainage tube, which is one of the prerequisites for the normal use of the drainage tube.


Figure 1 various types of drainage tube

2 , reference standard

The product standard that can be referred to for sterile drainage tube is YY 0489-2004 "Single-use sterile drainage catheter and auxiliary equipment". The standard specifies that the sealing of the sterile drainage tube can be tested according to the standard GB/T 15812.1-2005 . Endovascular catheters - Part 1 : General performance test methods.

3 , test samples

In this paper, the aseptic drainage tube produced by a company is taken 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 opened, and the vacuum chamber of the equipment is evacuated, so that the sample immersed in the vacuum chamber generates a pressure difference between the inside and the outside, and the sample is leaked. In this way, the sealing performance of the sample is judged; or by vacuuming the vacuum chamber, the sample is subjected to internal and external pressure difference, and the sealing performance of the sample is judged by observing the expansion of the sample and the recovery of the shape of the sample after releasing the vacuum.

4.2 Scope of application

  • Applicable to the overall sealing test of plastic bags, bottles, tubes, cans, boxes, etc.
  • Applicable to the overall sealing test of glass bottles, tubes, tanks, boxes, etc.
  • Applicable to the overall sealing test of metal bottles, tubes, tanks, boxes, etc.
  • It is suitable for the sealing test of paper-plastic composite bags and box packaging.
  • It meets the requirements of national standard GB/T 15171 and 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 ) , 460 mm ( diameter ) × 330 mm ( height ) .
  • The equipment uses digital preset test vacuum and vacuum hold time to ensure the accuracy of test data.
  • Automatic constant pressure air supply technology further ensures that the test can be carried out under preset vacuum conditions.
  • The equipment adopts a professional software system, which supports the functions of automatic backflushing and unloading and automatic end of the test to ensure the smooth progress of the test process.

5 , the test process

(1) Assemble the sample of the drainage tube as required and seal the open end.

(2) Place the sample in a vacuum chamber.

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

(4) Click the start button, the test starts, and carefully observe whether there are continuous bubbles on the surface of the sample during vacuuming and holding. After the end of the holding time, the test ends automatically.

6 , test results

The sterile drainage tube samples tested herein did not leak 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 It has a high degree of intelligence and accurate and reliable test results. It is a testing device that can quickly and efficiently test the sealing performance of sample parts. Domestic packaging testing equipment manufacturing industry leaders - Labthink Technology Co., Ltd. In addition to providing professional, accurate packaging testing equipment, but also provide caring, quality packaging testing services, packaging performance involves covering the barrier properties, flexibility, Impact resistance, puncture resistance, heat sealing performance, sealing performance, solvent residue, evaporation residue, etc., related equipment information and service content can be viewed at Jinan Languang Company or call for consultation. The more you understand, the more you trust! Labthink is willing to promote technical exchanges and cooperation with enterprises and institutions in the industry.

Health Monitor

Health Monitor (Health Care Monitor) is based on the principle of pulse pressure method, and based on the established theory, the model is divided into compartments, and a series of calculation formulas are deduced by linear correlation algorithm. After these formulas are corrected by nonlinear compensation and clinical experience parameters, a set of reflecting cardiac function, vascular condition, blood state and microcirculation function can be obtained.

The main function:

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use:

It is carefully designed for the urgent needs of the market for Household Breathing Machine, cardiovascular health care and sub-health status detection. It has the function of non-invasive and rapid detection of human heart, blood vessels, blood, microcirculation and pulmonary function parameters, especially suitable for hospitals and community medical care. Health care, health census and selection of medicines and health products, etc.

Health Monitor,Household Breathing Machine,Health Care Monitor,Wearable Pulse Monitor

Haloxylon Ammodendron Medical Equipment Co., Ltd. , https://www.haloxylonhospital.com

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