Aseptic medical device packaging internal pressure testing method for detecting large leakage bubbles testing method

Aseptic medical device packaging (final sterilization device packaging) is crucial for sterile medical devices. It is the basic guarantee of the safety of sterile medical devices, and together with the sterile device components themselves, it constructs the safety and effectiveness of the product, ensuring that sterile devices can be effectively used in the hands of users. Aseptic medical device packaging has been marked as *“Part of medical equipment composition”In many parts of the world, pre formed sterile barrier systems sold to medical institutions and used for sterilization within institutions are treated as medical devices for management. Aseptic medical device packaging has the following purposes:①Protecting products from environmental pollution and maintaining them in an acceptable small environment, in short: protecting products. This is the most basic function of packaging.②Allowing and withstanding the sterilization process is also a basic requirement.③Maintain the sterility and integrity of the equipment before use.④Aseptic opening for the use of instruments.⑤Convenient for storage and transportation.⑥Easy to identify products and facilitate sales.

This article is based on《YY/T 0681.5-2010Test Methods for Aseptic Medical Device Packaging5Part: Internal pressure method for detecting large leaks (bubble method) ", detecting large leaks in medical packaging. Method sensitivity250MmThe detection probability of the above aperture is81%This method can be used for tray and combination bag packaging.

The sensitivity of this experimental method depends on the pressure difference and pressurization method. The determination of experimental pressure for each packaging material and specification is crucial for achieving reproducible results. Improper pressurization of packaging can significantly reduce the sensitivity of this test method. Increasing the pressure difference will improve the experimental sensitivity. However, excessive pressure can cause the seal to crack or bubbles to be ejected from the breathable material, leading to confusion with defective bubbles, which may result in incorrect conclusions about the existence of defects.

Experimental Method

1、 Experimental methodsA---Procedure for non breathable packaging

1Use a puncher (such as a small slotted screwdriver or other suitable device) to pierce an empty space on the packaging. In order to insert the air source and pressure monitor into the sample. Perforation should be located in the center of the packaging as much as possible. The size of the hole should be suitable for inserting an air source and pressure monitor, and minimize air leakage. If necessary, use tape and rubber pads as a plug for the perforated area to seal the insertion site.

2Insert an air source and pressure monitor into the test sample. Immerse the packaging underwater for approximately2.5cmApply air to the packaging. (Using a limiter will help keep the entire package at the appropriate depth)

3If necessary, adjust the gas and pressure limiting valve and slowly inflate the packaging to a level greater than or equal to that specified in the appendixAThe minimum experimental pressure determined. If necessary, adjust the pressure limiting valve and pressure regulator to maintain a constant pressure.

4Inspect the bubble flow in areas showing damage (sealed passages, pinholes, ruptures, tears, etc.) on the entire packaging, and the inspection time depends on the size of the packaging.

5Remove the packaging from the water and mark all observed damaged areas.

2、 Experimental methodsB---Procedure for breathable packaging

1Use a puncher (such as a small slotted screwdriver or other suitable device) to pierce an empty space on the packaging. In order to insert the air source and pressure monitor into the sample. Perforation should be located in the center of the packaging as much as possible. The size of the hole should be suitable for inserting an air source and pressure monitor, and minimize air leakage. If necessary, use tape and rubber pads as a plug for the perforated area to seal the insertion site.

2Insert an air source and pressure monitor into the test sample. Immerse the packaging underwater for approximately2.5cmAnd maintain at least5sApply air to the packaging. (Using a limiter will help keep the entire package at the appropriate depth)

3If necessary, adjust the gas and pressure limiting valve and slowly inflate the packaging to a level greater than or equal to that specified in the appendixAThe minimum experimental pressure determined. If necessary, adjust the pressure limiting valve and pressure regulator to maintain a constant pressure.

4Inspect the bubble flow in areas showing damage (sealed passages, pinholes, ruptures, tears, etc.) on the entire packaging, and the inspection time depends on the size of the packaging.

5Remove the packaging from the water and mark all observed damaged areas.

Experimental apparatus

Test method for sterile medical device packaging - Internal pressure method for detecting large leakage bubbles - TesterLSST-01A

Based on《YY/T 0681.5-2010Test Methods for Aseptic Medical Device Packaging5Part: Internal pressure method for detecting large leaks (bubble method) ", professionally applicable for testing sterile medical device packaging.

Technical advantages of the internal pressure method for detecting large leakage bubbles using the bubble testing instrument

PLCIndustrial control programs ensure accurate control of pressure and time

Automatically complete the experiment after setting the test pressure and time

Automatic constant pressure compensation during the experimental process

7inchTFTThe full touch screen facilitates the setting of experimental parameters and operation

Multiple sets of experimental parameters can be saved, saving time for repeated settings

Automatic statistics and saving of time results

Technical parameters of the internal pressure method for detecting coarse leakage bubbles using the bubble method tester

Test scope:0 -600 KPa; 0 -87.0 psi(Standard)

Test error:±1%

Constant pressure time:1-9999s

Gas source interface: Φ6 mmPolyurethane pipe

Overall dimensions:400 mm (L)×270 mm (W)×180 mm (H)

Standard configuration: host, puncture device, testing container

Optional devices: standard testing rack, three edge sealing testing fixture, restraint plate testing fixture, anti-theft bottle cap release fixture, non-standard device

Note: Theo Electromechanical has always been committed to innovation and improvement of product performance and functionality, and for this reason, product technical specifications will also change accordingly. The above situation will not be notified separately, and our company reserves the right to modify and interpret.