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Therefore, the integrity of pharmaceutical packaging is not only the focus of each manufacturer, but also an important checkpoint required by the state. For example, the 2010 edition of GMP stipulates that “the sealing of sterile pharmaceutical packaging containers should be verified to avoid product contaminationâ€. The State Food and Drug Administration's "Standards for Packaging Materials and Containers for Direct Contact with Drugs" also contains provisions for the testing of the sealing properties of pharmaceutical packaging.
Analysis causes the poor sealing of the package, from the packaging material itself to the production process to the transportation link, there are influencing factors, such as uneven thickness of the package, localized pinholes; the joint between the packaging components is not tight; the plastic heat sealing is unevenly welded. There is a phenomenon of virtual welding and leakage; the package is pierced by sharp objects, and micropores appear.
At present, commonly used packaging sealing verification methods include vacuum differential pressure method, extrusion visual inspection method, methylene blue dyeing method, microbial infiltration method, vacuum attenuation method and the like. The vacuum differential pressure method has a wide range of applications and a fast detection speed, and has a wide range of applications in the pharmaceutical industry. Such as YBB20102012 "oral liquid pharmaceutical high-density polyethylene bottle", YBB20122012 "external liquid pharmaceutical high-density polyethylene bottle", YBB20132012 "oral solid pharmaceutical polypropylene bottle" and other standards require vacuum negative pressure test packaging Sealing.
The vacuum differential pressure test method is as follows: by vacuuming the vacuum chamber, the sample immersed in water is subjected to internal and external pressure difference, and the gas escape condition in the sample is observed; or the vacuum chamber is evacuated to generate internal and external pressure of the sample. Poor, observe the sample expansion and release the vacuum shape of the sample to determine the sealing performance of the sample.
The test method is as follows: an appropriate amount of distilled water is placed in a vacuum chamber, and the sample to be tested is immersed in water. Cover the vacuum chamber with a sealing cover. Adjust the vacuum of the test instrument to the required value and evacuate the vacuum chamber. The vacuum is stopped when the set vacuum is reached, and the vacuum is maintained for a while. Observe the sample expansion, water ingress or bubble escape during evacuation and vacuum maintenance.
The adjusted vacuum value and vacuum retention time are determined according to the characteristics of the sample (such as the packaging materials used, the sealing conditions, etc.) or the relevant product standards.
Jinan Languang Electromechanical Technology Co., Ltd. Packaging Safety Testing Center has been committed to providing professional materials physical testing solutions and services to customers around the world, and accumulated a lot of valuable experience and data in actual testing. If you have related product quality problems or want to know more test details, or you can send an email consultation, we will consult you on product quality problems that are easy to occur in production, transportation, sales, etc. We will be happy to provide you with technical services.
The drug has therapeutic and diagnostic effects, and the stability of the drug in physical, chemical, microbiological, biological, etc. must be ensured during the period of validity. Common medicines are packaged in plastic composite bags, glass bottles, and blister capsules. Medical packaging is a closed system that provides adequate protection of the contents while carrying the effects of packaging and transporting the drug. If the packaging containment system is incomplete, even if high barrier materials are used, the drug may be deteriorated due to adverse factors (such as exposure to oxygen and water vapor), and may even be contaminated to cause unacceptable quality degradation, which may not only cause medical treatment. Accidents cause economic losses to manufacturers and also damage the image of manufacturers.