The pre-filling of medical packaging should be able to […]
The pre-filling of medical packaging should be able to have a good seal during the validity period of the drug, and prevent the intrusion of microorganisms from causing the deterioration of the drug, which will bring danger to the user. The most ideal solution to verify the sealability of prefilled pharmaceutical packaging is to test the seal integrity of each bottle.
From a practical point of view and time cost, it is not yet realistic to test the application of products one by one. The quality assurance process based on container sealing system design, sealing component production, sealing completion, and sealing integrity verification is generally accepted internationally, so as to ensure the tightness of the finished product. Then the main factors affecting the sealing of medical packaging pre-filling are as follows:
First, the design of the sealing system is flawed, causing the sealing performance to fail to meet the requirements;
Second, there are quality deviations in containers or sealing components;
Third, there are problems in the sealing process;
Fourth, the seal integrity verification scheme is unreasonable;
The solution is as follows:
In view of the design defects of the pre-filling and sealing system for medical packaging, a rigorous design plan should be formulated in advance, and sealing components that meet international standards should be used as much as possible to effectively avoid the risk of leakage.
In view of the problems of containers and sealing components, suppliers of rubber stoppers and medical packaging prefilling should be audited regularly to ensure that their quality is stable and reliable.
In view of the problems in the sealing process, a sampling test plan should be formulated to standardize the sealing process.
In view of the unreasonable sealing integrity verification scheme, the integrity of the sealing system should be verified.