How To Ensure The Sterility Of Medicinal Glass Bottles

The quality assurance of medicinal glass bottles mainly focuses on sterility, in this regard, a good sterile packaging is essential.For more medicinal bottles, click here

The risks associated with sterility of medicinal glass bottles generally stem from the following:

First, the level of microbial contamination of raw materials;

Second, the reliability of sterilization process;

Third, whether the sealing of large volume injection is good;

Fourthly, whether a complete asepsis assurance management system has been developed;

So to ensure the asepsis of medicinal glass bottles, the following points should be started:

1. Test the microbial contamination level of raw materials. Generally speaking, the distribution of microorganisms in solid raw materials may be uneven, so the sample test results may not represent the overall situation of the whole batch of raw materials. Relevant procurement standards for raw and auxiliary materials should be formulated, specifying the corresponding microbial limits.

2. Reasonable sterilization method should be adopted to achieve thorough sterilization effect. Generally speaking, ethylene oxide sterilization or cobalt 60 sterilization method should be used for sterilization treatment.

3. Adopt advanced technology for production, to ensure good sealing of the bottle body, with good sealing cap, so as to effectively ensure the sealing of the sealing.

4. Develop a complete asepsis management system to ensure that the production environment of the workshop and the relevant standards of the clean workshop meet the requirements of GMP and the enterprise's own standards.