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Introduction of pharmaceutical packaging materials
Pharmaceutical packaging materials refer to materials used to manufacture packaging containers, packaging and decoration, packaging and printing, packaging and transportation to meet product packaging requirements, including metals, plastics, glass, ceramics, paper, bamboo, wild mushrooms, natural fibers, chemical fibers, composite materials and other main packaging materials, as well as auxiliary materials such as coatings, adhesives, straps, decoration, and printing materials.
Classification of packaging materials: blister film, co-extruded film, packaging film, packaging tape, packaging tape, plastic packaging tape, plastic packaging tape, winding film, PE winding film, PE stretch film and other packaging materials.
Requirements for pharmaceutical packaging materials
1. With certain mechanical properties, the packaging material should be able to effectively protect the product, so it should have certain strength, toughness and elasticity to adapt to the influence of static and dynamic factors such as pressure, shock and vibration.
2. Barrier performance. According to the different requirements for product packaging, packaging materials should have certain barriers to moisture, water vapor, gas, light, aroma, odor, heat, etc.
3. Good safety performance, the toxicity of the packaging material itself should be small, so as not to contaminate the product and affect human health; the packaging material should be non-corrosive, and have the properties of insect-proof, moth-proof, rodent-proof, and microbial inhibition to protect product safety.
4. Suitable processing performance, packaging materials should be suitable for processing, easy to make various packaging containers should be easy to mechanize and automate packaging operations, so as to adapt to large-scale industrial production should be suitable for printing, easy to print packaging signs.
5. Better economic performance, packaging materials should have a wide range of sources, convenient materials and low cost, and the packaging materials and packaging containers after use should be easy to handle without polluting the environment and causing public harm.
Classification of pharmaceutical packaging materials
Class ⅰ pharmaceutical packaging materials refer to pharmaceutical packaging materials and containers that are in direct contact with and used directly.
Class II drug packaging materials refer to drug packaging materials and containers that are in direct contact with drugs, but are easy to clean. In the actual use process, they are required after cleaning and can be disinfected and sterilized.
Class III drug packaging materials refer to other drug packaging materials and containers other than Class I and II that may directly affect the quality of drugs.
The classification catalogue of drug packaging materials shall be formulated and published by the State Drug Administration.
Quality Management of Pharmaceutical Packaging Materials
The quality management department of the pharmaceutical packaging material production enterprise shall be responsible for the quality management and inspection of the whole process of product production, and shall be directly led by the person in charge of the enterprise. The quality management department shall be equipped with a certain number of quality management and inspection personnel, and have venues, instruments and equipment suitable for the production scale, variety and inspection requirements of the pharmaceutical packaging material.