Leakage and Sealing Strength Tester HY-LSSD-01

Especificaciones

Introducción detallada

Technical features
1. Equipped with a 5-inch IPS high-definition touch screen, equipped with a silent micro-printer.
2. User hierarchical permission setting, meeting GMP requirements, test record auditing, tracking functions.
3. Intelligent control of pressurization, pressure holding, timing, and pressure relief test process "one-key" operation, high test efficiency.
4. The test range is optional, the test range is wide, and the application field is wide.
5. Double test method of expansion inhibition and expansion non-inhibition.
6. Rupture test, creep test, creep to rupture test, multiple test mode options.
7. Test accessory support, flexible test mode, compatibility and diversification.
8. Pneumatic components imported from world-renowned SMC are used, with durable, stable and reliable performance.

YY/T0681.3 Sterile medical device packaging/unconstrained packaging resistance to internal pressure damage, bursting, creep, creep to rupture test methods

Four-side sealed (full-sealed) aseptic packaging bag adopts inflatable device

Open-type three-side-sealed packaging bag adopts test-sealed inflation device

1. Burst test: pressurize the flexible packaging bag through the test equipment until it ruptures. This test method can measure the maximum bursting pressure of the tested sample (the maximum pressure that the tested sample bears before it ruptures).
2. Creep test: apply a certain pressure to the flexible packaging bag, and maintain this pressure for a specified time, and the sample that can ensure that the package is intact and leak-free is judged as "qualified", otherwise it is judged as "unqualified".
3. Creep to rupture test: pressurize the inside of the flexible packaging bag to a specified pressure, and maintain the pressure until the package leaks. Compared with the creep test, the pressure value here is set higher, to ensure that the package is damaged within a reasonable time.
This method measures the interval time that the package can maintain the pressure until it leaks after the pressure is applied.

YY/T0681.5 Sterile medical device packaging/inner pressure method for detection of gross leakage air bubbles

1. Punch a hole in the package with a perforator. to insert the air source and pressure monitor into the sample. The perforation should be located in the center of the package as much as possible. The holes should be sized to allow insertion of the air source and pressure monitor with a minimum of air leakage. If necessary, seal the insertion site with tape and a rubber pad as a puncture site occluder.
2. Insert the air source and pressure monitor into the test sample. Submerge the package approximately 2.5cm under water. Air is applied to the package.
3. If necessary, adjust the gas and pressure limiting valves, and slowly inflate the package to a pressure greater than or equal to the specified minimum test pressure. If necessary, adjust the pressure limiting valve and pressure regulator to maintain constant pressure.
4. Inspect the entire package for air bubble flow in areas showing damage (channels in the seal, pinholes, ruptures, tears, etc.), and the inspection time depends on the size of the package.
5. Remove the package from the water and mark any areas of damage observed.

YY/T0681.9 Sterile medical device packaging/constraint plate internal pressure method soft packaging seal burst test method

The restraint plate is a sample fixing device. During the pressurization process, the packaging bag is located between two parallel rigid restraint plates to limit the expansion and shape deformation of the package, but the surrounding sealing area is not restricted, as shown in Figure 3.
In the positive pressure sealing test, the package is placed in a restraining plate for internal pressure, and the applied pressure can be evenly distributed in the sealing area around the packaging bag, thereby maintaining the stability of the packaging bag size. The bag seal is usually located around the perimeter of the bag. In this way, the lower pressure sealed area can be tested to the maximum extent, and the pressure required to break the package can be derived.

Technical indicators
Test Range:
0～600kPa; 0～87.0 psi (regular) 0～100kPa; 0～14.5psi (optional)
0～400kPa; 0～58.0psi (optional) 0～250kPa; 0～36.3 psi (optional)
0～1.6MPa; 0～232.1psi (purchased separately) 0～10 KPa; 0～1.45psi (purchased separately)
Accuracy: 0.5 grade
Air source pressure: 0.4MPa～0.9MPa (air source is prepared by the user)
Air source interface: Ф8mm polyurethane tube
Dimensions: 300 mm (L) × 310 mm (B) × 180 mm (H)
Test stand size: 305 mm (L) x 356mm (B) x 325mm (H)
Power supply: AC 220V 50Hz
Net weight: 23kg