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Importance of drug packaging materials and standardization of testing
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As an integral part of drugs, drug packaging materials are an important guarantee to ensure the safety and effectiveness of drugs. Drug packaging materials have always been considered as a part of drugs, and the materials used in packaging will also affect the effectiveness, safety and stability of drugs, which is also the purpose of drug packaging testing.
Commonly used drug packaging materials
We often see paper products, plastic, glass, metal, wood, recheck materials, rubber products, etc. From the development trend, packaging materials are developing in the direction of replacing wood with paper, replacing paper with plastic, or composing various composite materials with paper, plastic, aluminum foil, etc.
Composite material is a new type of packaging material, which is made of multi-layer composite of plastic, paper, aluminum foil, etc. Commonly used are paper plastic composite, aluminum foil polyethylene composite, aluminum foil polyester ethylene, etc. The inspection data of drug packaging shows that these composites have good mechanical strength, biological corrosion resistance, vacuum retention performance and compressive resistance, which are a collection of many favorable factors.
Performance testing of drug packaging materials
In addition to certain mechanical properties, barrier properties and good safety performance, packaging materials should also have appropriate processing properties and better economic performance. For the drug packaging testing of the drug packaging material performance, we also attach great importance to the test specifications of the performance from the perspective of national supervision.
The 2020 edition of the Chinese Pharmacopoeia, officially implemented on December 30, 2020, has added 16 general drug packaging testing methods, elaborated the drug packaging testing specifications in terms of barrier performance, physical and mechanical properties, biosafety performance, etc., and helped the development of drugs through continuous improvement of the drug packaging standard system.
On September 1, 2021, the official website of China Pharmaceutical Packaging Association released the Research Guide on the Self Stability of Plastic and Rubber Drug Packaging Materials (T/CNPPA317-2021), which was implemented from the date of release. The guide was called the first research guide on the self stability of plastic and rubber drug packaging materials in China by industry insiders.
With the reform of domestic drugs, the corresponding regulatory model of drug packaging has also undergone tremendous changes, from no restrictions on drug packaging to the implementation of the manufacturing enterprise licensing system, to the "registration management system" of drug packaging, and then to the "related review and approval system". It can be seen that the supervision of drug packaging materials is more detailed and clear.
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