濟南歐凱測試技術有限公司
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<ul id="qqie6"></ul> 濟南歐凱測試技術有限公司
閱讀：72發布時間：2024-7-29
With the development and progress of the pharmaceutical industry, the safety and quality of pharmaceutical packaging have become increasingly important topics. The design and manufacture of pharmaceutical packaging must comply with a series of standards and requirements to ensure the safety and effectiveness of pharmaceuticals during transportation, storage and use. The following are the main items for pharmaceutical packaging testing:
1. Mechanical properties: The mechanical properties of pharmaceutical packaging materials are important indicators for evaluating their strength and durability. Common mechanical property tests include tensile strength, elongation at break, peel strength, heat sealing strength (film/bag), bursting strength, etc. These tests can help determine whether packaging materials can withstａnd the stress during transportation and use, and ensure the stability and protection of pharmaceutical products.
2. Barrier properties: The barrier properties of pharmaceutical packaging materials are very important to protect pharmaceuticals from external substances and environmental influences. Common barrier performance tests include water vapor transmission, nitrogen transmission, etc. These tests can evaluate the barrier effect of packaging materials on moisture, oxygen and other gases, ensuring the stability and preservation of medicines inside the packaging.
3. Usability: The usability of pharmaceutical packaging is directly related to the convenience and safety of drugs. Common usage performance tests include differences in protective layer adhesion, adhesive coating amount, moisture content, environmental moisture absorption rate, drop performance, etc. These tests can evaluate the adhesive properties, water resistance and impact resistance of packaging materials to ensure the safety and stability of pharmaceuticals during use.
4. Material identification: Material identification of pharmaceutical packaging materials is one of the important steps to ensure packaging quality and safety. Common material identification methods include infrared spectroscopy, density and other tests. These tests can help confirm the composition and properties of materials to avoid contamination and damage to pharmaceutical products caused by the use of substandard materials.
5. Safety performance: The safety performance of pharmaceutical packaging is an important factor in ensuring drug quality and patient medication safety. Common safety performance tests include paper bag fluorescence, ignition residue, leachable test, solvent residue, metal ions, etc. These tests are designed to detect the presence of contaminants and harmful substances in packaging materials and to ensure that packaging materials do not negatively affect the quality and safety of pharmaceutical products.
6. Microbial limit: The microbial limit of pharmaceutical packaging is an important indicator for evaluating its hygienic status and protective performance. Common microbial limit tests include bacterial count, mold count, yeast count, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, etc. These tests can ensure that pharmaceutical packaging does not become a breeding environment for microorganisms and ensure the purity and sterility of pharmaceuticals.
In addition to the above test items, compatibility research on pharmaceutical packaging is also very important. Compatibility studies evaluate the interaction between packaging and drug products primarily through turnover device testing. These tests include the inspection of pallets and turnover boxes, and are fully tested according to relevant standards to ensure the compatibility and stability of the packaging and the drug.
The basis for drug packaging testing mainly includes the Pharmacopoeia of the People's Republic of China, the YBB series of pharmaceutical packaging standards, and the United States Pharmacopoeia USP. These standards provide detailed inspection methods and specifications to ensure that the quality and safety of pharmaceutical packaging meet international standards.
In short, pharmaceutical packaging testing projects involve many aspects, from the mechanical properties of materials to barrier properties, usability performance, material identification, safety performance and microbial limits, etc. Through item-by-item testing and evaluation, the quality and safety of pharmaceutical packaging can be guaranteed, providing reliable protection for the transportation, storage and use of pharmaceuticals.
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