Study on Container Closure Integrity of Packaging System of Levofloxacin Sodium Chloride Injection by Mass Extraction Method

OBJECTIVE To establish a complete set of quality extraction methods, and study the container-closure integrity of the packaging system of levofloxacin sodium chloride injection.

METHODS  By testing negative samples, negative control samples, and large leakage samples, optimize the time test parameters of pre-vacuuming, detecting large leakage samples and micro-leakage samples, complete methodological validation, three batches of stored samples of 0, 3, 6 month and long-term samples of 6, 12, 24 month were tested for container-closure integrity. Long-term conditions: temperature is (25±2)℃, relative humidity is (40±5)%; acceleration conditions: temperature is (40±2)℃, relative humidity is (75±5)%.

RESULTS  The detection limit of the method was 5 μm, which was convenient and sensitive, and the sealing property of the product meets the requirements.

CONCLUSION  The method can be used to study the sealing property of levofloxacin sodium chloride injection in three-layer co-extruded infusion bag packaging system.