The specific requirements for the final processing of sterile drugs and the packaging sealing tester for fused sealed products are as follows:

Article 131: Sterile drugs shall be sealed using validated methods to prevent contamination of the product. The sealing verification of packaging containers should consider transportation conditions (such as pressure reduction orabnormalThe temperature may have adverse effects on the sealing of the container.

Article 132: For products such as blow fill seal (BFS), molded fill seal (FFS), bagged injections, glass or plastic ampoules that use melt sealing, key parameters and factors that affect sealing should be evaluated and determined, and effectively controlled and monitored. Verified methods should be used for sealing testing, with sealed products not exceeding 100ml undergoing 100% sealing testing. For sealed products exceeding 100ml, when historical data proves that process and process control techniques are feasible, the sample size for inspection can be reduced. The method of visual inspection is unacceptable.