During the lyophilization process, freeze-dried powder can remove up to 97% of its water content, allowing it to be stored for long periods without spoilage. However, if the packaging is compromised due to poor sealing, external gases and moisture can quickly infiltrate the freeze-dried powder. This increases the water content, leading to the immediate release and volatilization of internal oxides, microbial growth, loss of enzymatic activity, and ultimately, the loss of its original properties. This may result in irregular phenomena such as concentration or expansion.

According to Article 78 of the new GMP guidelines, sterile pharmaceuticals must undergo vacuum level inspections after a predetermined period when sealed under vacuum. As a typical packaging form for infusions, freeze-dried powder injections are considered high-risk products. Therefore, during drug registration and evaluation, systematic assessment of packaging and drug compatibility is required, and the entire process must *comply with testing standards.

For vacuum sealing tests of freeze-dried powder injections, the Vial Seal Tester LT-02P, developed by Shandong Puchuang, can be selected. It is primarily used for testing the sealing and tightness of pharmaceutical packaging. It can create a vacuum environment of up to -90 kPa and automate the entire testing process, including pressure extraction, pressure holding, pressure replenishment, timing, reverse blowing, and printing. This ensures testing accuracy while improving efficiency and saving human resources.

Vial Seal Tester

Vial Seal Tester LT-02P Key Parameters

Common Name: Seal Tester

Vacuum Level: 0 to -90 kPa
Sensor Accuracy: ≤0.5 grade
Pressure Adjustment Range: 0.2-0.7 MPa
Vacuum Chamber: Φ270 mm x 210 mm (H)
Φ360 mm x 585 mm (H)
Φ460 mm x 330 mm (H) (Other sizes customizable)

Response Time: 5 ms
Built-in Modes: Single-point mode, Incremental mode
Interface Size: Φ6
Resolution: 0.01 kPa
Pressure Holding Time: 0-999,999 s
Display: 7-inch touchscreen
Air Source: Compressed air (user-provided)
Device Dimensions: 420 (L) x 300 (B) x 165 (H) mm

Testing Principle:
By evacuating the vacuum chamber, a pressure difference is created between the inside and outside of the sample immersed in water. The escape of gas from the sample is observed to determine its sealing performance. Alternatively, by evacuating the vacuum chamber, a pressure difference is created, and the expansion of the sample and its recovery after vacuum release are observed to evaluate its sealing performance.

Applicable Standards:
GB/T 15171 Test Method for Seal Performance of Soft Packaging Bags, ASTM D3078 Test Method for Leaks in Flexible Packaging by Bubble Emission, and other relevant standards.