Comparison and Optimization of Dye Ingress Method for Package Integrity Assessment of Small Volume Injection Packaging System
A dye ingress method was established to assess the package integrity of prefilled syringes and vials.On the basis of setting rational parameters as well as preparing negative and positive samples,the vacuum,negative pressure holding time and the processing method of the prefilled syringe packaging system were optimized,and the method was verified.The results showed that the sensitivity of this method for assessment the integrity of the prefilled syringe packaging system and the vial packaging system was 10-15 μm,and was better than those in the USP,EP and International Organization for Standardization under the same conditions.This method could effectively assess the integrity of the prefilled syringe packaging system and the vial packaging system,which provided a reference for establishing the test standard for the prefilled syringe packaging system and the vial packaging system by dye ingress method.