Production quality and safety requirements:
•Prevention of drug attenuation Prevent microbial invasion •Restrict the entry of harmful gases or other substances
FDA industry guide：
USP1207 Regulations
1207: Sterile products package integrity evaluation
The traditional probabilistic leak detection method is the opposite of the deterministic leak detection, which has randomness and great uncertainty in sample size and test results.
USP1207 Regulations
1207.2:Package Integrity Leak Test Technologies
The deterministic and probabilistic method are described. The sample requirement, leakage limit and test time of each method are described
1207.3:Package Seal Quality Test Technologies
Mainly how to improve and characterize the sealing performance of packaging