Background
To guarantee the safety of medicine while being transported and stored, it is paramount to assess the intactness of the sealed pharmaceutical packaging. This procedure contributes to ongoing enhancements in pharmaceutical packaging materials and techniques. Preserving a secure seal is fundamental to ensure medicine quality and safety. Through the implementation of seal integrity tests, we can confirm that the pharmaceutical packaging effectively protects the medicine from harm or contamination, irrespective of the surrounding conditions. These tests aid in the identification of potential packaging issues and prompt actions can be taken to prevent any losses or hazards during the packaging process. Seal integrity testing plays a crucial role in ensuring that the medicine retains its desired qualities and delivers an exceptional experience for consumers.
Test Description:
In this test, a pharmaceutical packaging sample is placed into a chamber filled with water, and the lid is tightly closed. The control unit then activates, extracting air from the chamber until a predetermined level of vacuum is achieved. Due to the pressure difference between the inside and outside of the pharmaceutical packaging sample, even a small leak will cause air within the pharmaceutical packaging sample to escape. If a leak exists, bubbles of gas will rise, indicating the location of the leak. This bubbling phenomenon is often visible to the naked eye.
Standard
ASTM D4991 Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method
Features
The LT-02 Leak Tester, developed by Cell Instruments, represents the initial release of automated vacuum testing devices. The ASTM D3078 is the designated test method for detecting notable leakage in flexible packages that contain headspace gas, utilizing the bubble release technique. To conduct the test, a sample is submerged in a vacuum chamber filled with a soaking solution.
- To achieve stable vacuum and considering the fact that compressed air is easier to be obtained at user facility, we use Venturi tube for a high level of vacuum up to –90KPa.
- Precious and long test time setting.
- SMC branded vacuum pressure switch.
- Strong and clear chamber provided, and different sizes and shapes could be customized
- It could be modified to work with vacuum pump, to achieve higher vacuum (for ASTM D4991)
Main Parameters
Test Range 0~-90 KPa
Chamber Acrylic cylinder shape
Test Space Φ270*H210mm (internal usable)
Compressed Air 0.7MPa (Prepared by user)
Electricity Not Needed
