Drug packaging refers to the packaging materials and containers used in drug preparations that come into direct contact with the drug. Drug packaging is directly related to drug quality, safety, and shelf life.
RLD is the benchmark for generic drug consistency evaluation. Generic drug manufacturers need to choose a packaging system that can guarantee the quality of the drug based on the packaging material of RLD and the characteristics of the declared product. In principle, the quality and performance of generic drugs packaging shall not be lower than RLD to ensure consistency with RLD.
Our Service
Our company provides end-to-end consistency evaluation of generic drug quality and efficacy. Our professional services cover the entire process of pharmaceutical equivalence and bioequivalence evaluation of generic drugs. We undertake testing services for drug packaging for pharmaceutical companies around the world, including the research of RLD packaging, and Packaging Compatibility Testing of Generic Drug.
When declaring generic drugs, it is necessary to state the packaging used by the RLD, and whether the packaging of the declared drug is consistent with the RLD. In case of inconsistency, detailed information on the compatibility study between the declared drug and the packaging material should be provided. Fully studying the properties of RLD packaging is critical for the selection of reasonable and functional packaging.
Our company is committed to providing affordable solutions for the testing of multiple types of RLD packaging through chromatography, mass spectrometry, spectroscopy and a variety of testing methods.
Packaging Test Type
Our packaging material testing scope covers common drug packaging on the market.
- Blister packaging
- Strip packaging
- Bag packaging
- Double aluminum packaging
- Water injection plastic packaging
- Soft bottle packaging
Packaging Test Project
Barrier properties refer to the barrier effect of packaging materials on gas, liquid and other penetrants. Our barrier performance tests include gas (oxygen, nitrogen, carbon dioxide, etc.) and water vapor permeability tests. Barrier performance is an important factor affecting the quality of products during shelf life.
- Physical and mechanical properties
Physical and mechanical properties are indicators to measure the protection strength of the contents of packaging in the production, transportation, shelf display period and use of drugs. Our physical and mechanical properties tests include tensile strength and elongation, thermal bonding strength, peel strength, thermal shrinkage, puncture force, puncture retention, penetration point impermeability, injection point sealing, suspension force, aluminum-plastic cap opening force, impact resistance, tear resistance, and rubbing resistance.
The thickness of the packaging material is related to the quality of the drug preparation and total costs. The uneven thickness of the packaging material can affect the properties of the barrier and its tensile strength.
In the production of drug packaging, organic solvents such as toluene, xylene, and ethyl acetate are used extensively. High residues of organic solvents will harm people's health.
Sealing performance refers to the reliability of container sealing. Through the test, we can ensure the integrity of the entire product packaging seal, which will prevent the product sealing performance is not good, resulting in leakage, pollution, deterioration and other problems.
Bottle packaging is one of the commonly used packaging forms. Whether the torque value of the bottle cap is appropriate has a significant impact on the intermediate transportation of the product and the final consumer experience.
From the completion of production to the opening of the package before use, the gas composition inside the package directly affects the shelf life of the product. Through detection, the oxygen and carbon dioxide gas content at the top of the container can be evaluated, as well as the mixing ratio, so as to guide production and ensure the shelf life and quality of the product.
