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The compatibility test between the packaging material and the drug is to investigate whether there will be mutual or unilateral migration between the packaging material and the drug, which will affect the quality of the drug, and its purpose is to confirm that the quality of the drug in the selected packaging container is stable and controllable, and the safety and effectiveness of its use can be maintained through the compatibility test. Qingdao Kechuang Quality Inspection**** focuses on the compatibility test of pharmaceutical packaging materials.
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Third-party testing institutions with corresponding qualifications can do it, and it depends on the test samples and test items you need to do.
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You can find a third-party testing agency with relevant qualifications to take a look, and STD Testing will conduct strict testing on pharmaceutical packaging materials according to the corresponding testing standards.
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Commonly used types of pharmaceutical packaging materials are plastic, glass, metal and rubber. Due to the different types, compositions and formulations of pharmaceutical packaging materials, their physical and chemical properties are very different, and the impact on various drugs after packaging drugs is also different. Qingdao Stander Testing will conduct strict testing on pharmaceutical packaging materials according to the corresponding testing standards.
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Test itemsAccording to your testing needs, the test items of conventional pharmaceutical packaging materials mainly include the following points:
Barrier properties: gas (oxygen, nitrogen, carbon dioxide, etc.) and water vapor permeability mechanical properties: tensile strength and elongation, heat sealing strength, peel strength, thermal shrinkage, puncture force, puncture retention, insertion point impermeability, injection point sealing, suspension force, aluminum-plastic composite cover opening force, impact resistance, tear resistance, rubbing resistance.
Others: thickness, solvent residue, sealing performance, cap torque, headspace gas analysis capsule testing items: chromium (CR), ethylene oxide, chloroethanol, heavy metals (as lead).
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Want to know what items are tested for pharmaceutical packaging materials? It is necessary to first lock in the specific drug packaging material to be tested, and then find the test items according to the testing standards of the drug packaging material.
The state has issued 130 testing standards for pharmaceutical packaging materials, including testing standards for glass pharmaceutical packaging materials, metal pharmaceutical packaging materials, plastic pharmaceutical packaging materials, rubber pharmaceutical packaging materials, and testing methods and inspection methods for pharmaceutical packaging materials.
For example, YBB00032005-2015 "Soda-lime Glass Infusion Bottle" stipulates that the testing items of soda-lime glass infusion bottles mainly include: appearance, closing line, scale mark, word, mark, thermal stability, thermal shock resistance, 121 degrees Celsius particle water resistance, internal pressure resistance, internal stress, vertical axis deviation, arsenic, antimony lead, cadmium leaching, marking capacity and other items.
The common testing items of pharmaceutical packaging materials mainly include:
1. Barrier performance: gas (oxygen, nitrogen, carbon dioxide, etc.) and water vapor permeability.
2. Mechanical properties: tensile strength and elongation, heat sealing strength, peel strength, heat shrinkage, puncture force, puncture retention, insertion point impermeability, injection point sealing, suspension force, aluminum-plastic combination cover opening force, impact resistance, tear resistance, rubbing resistance.
3. Others: thickness, solvent residue, sealing performance, cap torque, headspace gas analysis.
4. Capsule testing items: chromium (CR), ethylene oxide, chloroethanol, heavy metals (lead).
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Pharmaceutical packaging material testing items.
Barrier properties: gas (oxygen, nitrogen, carbon dioxide, etc.) and water vapor permeability mechanical properties: tensile strength and elongation, heat sealing strength, peel strength, thermal shrinkage, puncture force, puncture retention, insertion point impermeability, injection point sealing, suspension force, aluminum-plastic composite cover opening force, impact resistance, tear resistance, rubbing resistance.
Others: thickness, solvent residue, sealing performance, cap torque, headspace gas analysis capsule testing items: chromium (CR), ethylene oxide, chloroethanol, heavy metals (as lead).
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