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What are the factors that affect the sterility of large injection bottles

Carrie Jun 12,2019 Share this post:
vaccine vials

There are four main aspects to the sterility risk of large volume injection bottles:



vaccine vials

1.Level of microbiological contamination before sterilization

Products before sterilization usually there is a certain degree of microbial contamination, such as microbial content of raw materials;production environment is qualified, whether in line with GMP standard clean area production; production equipment online cleaning, disinfection and other processes;

2.Reliability of sterilization process

Sterilization process can be used with good permeability ethylene oxide sterilization equipment for sterilization, the sterilization thoroughly sterilized.

3.Large volume injection bottle seal integrity

The main need to go through the seal integrity sealing system design, testing qualified seal assembly, sealing is completed, the final tightness testing.

 4.The establishment of a sound management system of sterility assurance

Aseptic assurance management system involves all aspects of GMP concern management, mainly including production management and quality management two major aspects.


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