Does the packaging container for storing pharmaceutical hard gelatin empty capsules need to be sterilized?

The packaging container for storing pharmaceutical hard gelatin empty capsules needs to be sterilized under specific circumstances. This mainly depends on the usage status and storage environment of the packaging container. The following is a detailed analysis of this issue:
1、 The necessity of sterilization treatment
Preventing bacterial contamination:
The hygiene quality of pharmaceutical hard gelatin empty capsules, as a component of drugs, directly affects the overall safety of the drugs.
If the packaging container is kept sealed before use, it can to some extent isolate external pollution. But once the packaging is opened, the interior of the container may be exposed to the threat of bacteria and other microorganisms.
Therefore, to ensure the sterile state of the drug, the opened packaging container should be sterilized before reuse.
Compliance with regulatory requirements:
Drug production must comply with strict quality standards and regulatory requirements. Authoritative documents such as the Chinese Pharmacopoeia have clear regulations on the storage and sterilization of medicinal hollow capsules.
Production enterprises must comply with these regulations to ensure the quality and safety of their products.
2、 Method of sterilization treatment
The common sterilization methods for packaging containers of pharmaceutical hard gelatin empty capsules include the following:
Ethylene oxide sterilization:
Ethylene oxide is a broad-spectrum and highly efficient sterilizing agent commonly used for sterilization of medical devices and pharmaceutical packaging.
When using ethylene oxide for sterilization, it is necessary to strictly control the sterilization conditions (such as temperature, humidity, gas concentration, etc.) to ensure sterilization effectiveness and avoid residual problems.
After sterilization, the packaging container should be adequately ventilated and analyzed to remove residual ethylene oxide.
Other sterilization methods:
In addition to ethylene oxide sterilization, there are various methods to choose from, such as ultraviolet sterilization, ozone sterilization, and irradiation sterilization.
The choice of method depends on the specific packaging materials, product characteristics, and sterilization requirements.
In summary, packaging containers for storing pharmaceutical hard gelatin empty capsules need to be sterilized under specific circumstances, such as when the packaging has been opened or suspected of contamination. Through reasonable sterilization methods and strict storage management, the hygiene quality and safety of drugs can be ensured.