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Quality requirements of drug packaging materials

Date: 2021-12-24 02:50
Views: 466
Abstract: Quality requirements of drug packaging materials According to the characteristics of drug packaging materials, the quality standards of drug packaging materials mainly include the following items: 1. Material identification (identification) mainly confirms the characteristics of materials, prevents doping, and confirms the consistency of material sources. 2. Check the chemical properties of the materials. Extract the materials in various solvents (such as water, ethanol and n-hexane) (mainly check harmful substances, low molecular weight substances, unreacted substances, substances brought in during production, additives, etc.), reducing substances, Huo metals, evaporation residue, pH, UV absorption, etc; Check the specific substances in the materials, such as vinyl chloride monomer in PVC hard sheet, catalyst in polypropylene infusion bottle and solvent residue in composite materials; Check material processing additives, such as sulfide, polychlorinated rubber

Quality requirements of drug packaging materials


According to the characteristics of drug packaging materials, the quality standards of drug packaging materials mainly include the following items:
    1. Material identification (identification) mainly confirms the characteristics of materials, prevents doping, and confirms the consistency of material sources.
    2. Check the chemical properties of the materials. Extract the materials in various solvents (such as water, ethanol and n-hexane) (mainly check harmful substances, low molecular weight substances, unreacted substances, substances brought in during production, additives, etc.), reducing substances, Huo metals, evaporation residue, pH, UV absorbance, etc; Check the specific substances in the materials, such as vinyl chloride monomer in PVC hard sheet, catalyst in polypropylene infusion bottle and solvent residue in composite materials; Check additives during material processing, such as sulfide in rubber, plasticizer in PVC film (dioctyl phthalate), antioxidant in polypropylene infusion bottle, etc.
    3. The use performance of materials and containers shall be checked for tightness, water vapor permeability, anti drop property and drip volume (if there is a quantitative function of the container), etc; The water vapor permeability, tensile strength and elongation of the sheet should be checked; If the material and container need to be used in combination, the heat sealing strength, torque and size of the combined parts should be checked.

    4. The biosafety inspection items of materials and containers are microbial count inspection, and the amount of various kinds of microorganisms is determined according to the dosage forms used by the materials and containers. According to the dosage form of the material and container used, the items of abnormal toxicity, hemolytic cytotoxicity, eye irritation and * * internal * * need to be tested.

Jinan Chenchi instrument is specialized in the production and sales of medical packaging material physical performance testing equipment. For more details, please call 0531-58788753-58188952-58782853

Quality requirements for drug packaging materials Quality requirements for drug packaging materials Quality requirements for drug packaging materials