Pharmaceutical packaging material testingHow to apply for a report? What items need to be tested? We will conduct testing and evaluation in strict accordance with the standards. We can also provide personalized testing plans and reports according to your needs.

Pharmaceutical packaging material testing is an important part of ensuring the quality and safety of drugs. The following are the main methods for testing pharmaceutical packaging materials:

1. Physical performance testing
Physical performance testing mainly evaluates the mechanical strength, barrier properties, thickness, and other physical properties of pharmaceutical packaging materials.

Thickness testing: Use a thickness gauge to measure the thickness of the packaging material to ensure that its uniformity meets the standard. Thickness uniformity is important for ensuring the barrier properties and mechanical strength of the packaging.
Tensile strength and tear strength testing: Use a tensile testing machine to apply a certain tensile force to the sample, record the force value and elongation at break and other data, and evaluate the integrity of the packaging material during transportation and use.
Barrier performance testing:
Gas barrier performance: Use a gas permeability tester to measure the barrier ability of packaging materials to gases such as oxygen and carbon dioxide. Good gas barrier performance can prevent drugs from deteriorating due to oxidation.
Water vapor barrier performance: Use a water vapor permeability tester to measure the water vapor permeability of packaging materials. Water vapor barrier performance is essential to prevent drugs from getting damp and mildewing.
Sealing performance test: Use a sealing tester or a leakage and sealing strength tester to evaluate the sealing reliability of the packaging bag to ensure that the product will not leak, be contaminated, or deteriorate due to poor sealing.
2. Chemical performance test
Chemical performance test mainly evaluates whether the drug packaging material contains chemical substances that are harmful to the human body and whether these substances will migrate into the drug.

Dissolution test: The packaging material is soaked in a simulated solvent, and then the type and content of the dissolution are detected using analytical instruments such as high-performance liquid chromatography and atomic absorption spectrometer. This helps to ensure that the packaging material does not release harmful substances into the drug.
Heavy metal content detection: Use an atomic absorption spectrometer or an inductively coupled plasma mass spectrometer to detect the heavy metal content in the packaging material. Excessive heavy metal content may cause harm to the human body, so it must be strictly controlled.
Solvent residue detection: A large amount of organic solvents may be used in the production process of drug packaging, and these solvents will remain in the packaging material. If the solvent residue is too high, it may cause pollution to the drug and endanger human health. Therefore, it is necessary to detect the solvent residue.
3. Microbial limit detection
Microbial limit detection mainly evaluates the number of microorganisms on packaging materials that are in direct contact with drugs (such as plastic film and rubber stopper of inner packaging) to prevent contamination of drugs.

Sampling and cultivation: Samples are taken from the surface of the packaging material and then placed in a special culture medium for cultivation.
Counting and identification: Microorganisms are counted and identified by methods such as membrane filtration or plate counting to ensure that the number of microorganisms on the packaging material meets the specified standards.
4. Other testing items
In addition to the above main testing methods, drug packaging material testing may also involve the following items:

Printing quality testing: Exquisite printing is an important means for products to attract consumers, and the quality of printing directly affects consumers' trust in the product. Therefore, it is necessary to control the quality of packaging printing to ensure the bright appearance of the packaging and the accurate communication of information.
Appearance inspection: Check the color, transparency, surface scratches, or damage of the packaging material to ensure that it meets the specified requirements.
Specific performance testing: Specific performance tests such as impact resistance, rubbing resistance, and heat sealing strength to ensure the performance of packaging materials under specific conditions of use.
In summary, the methods for testing pharmaceutical packaging materials include physical properties testing, chemical properties testing, microbial limit testing, and other testing items. By comprehensively applying these methods, the quality and safety performance of pharmaceutical packaging materials can be comprehensively evaluated, providing a strong guarantee for the safety and effectiveness of drugs.

Test report function

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