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Production standard of medical plastic bottle

2020-07-31  Visits:20

     In recent years, the packaging of medical plastic bottles in China has been developing rapidly. Medical plastic bottle has the characteristics of light weight, no damage, health and so on, in addition to the special requirements of drug packaging. At present, pharmaceutical tablets, capsules, packaging, has gradually realized "plastic" instead of "glass".            

     If the dosage of plastic bottles is not used properly, the migration of trace elements will change the medicinal efficacy of drugs, and even life-threatening. Drug is a kind of special commodity. The manufacturer of plastic bottle for medicine must strictly control every link of production, in order to meet the requirements of GMP, and master relevant laws and regulations, such as "Chinese Pharmacopoeia of the people's Republic of China", "Drug Administration Law of the people's Republic of China", "good manufacturing practice", "drug packaging management measures" and related medicines Standards and requirements for plastic bottles. At present, most of the medical plastic bottles, tablets, capsules, drug packaging, so the production of plastic bottles must ensure that the drug tablets, capsules are difficult to damp deterioration, heat-resistant melting, explosion, not easy to change color, when exposed to light, decomposition, oxidation and pollution. 

    The varieties of plastic bottles include high density polyethylene (HDPE), polypropylene (PP), polycarbonate (PC) and polyester (PET) bottles. In the early 1990s, ethylene naphthalene dicarboxylate (pen) plastic bottles appeared with better properties than pet, high strength, heat resistance, UV radiation resistance, high carbon dioxide gas and oxygen barrier, good chemical resistance, and is an excellent material for medical plastic bottles Materials.            

     As there are many specifications, colors and shapes of plastic bottles for medicine, the following main selection criteria should be grasped: 

1.Sealing of bottle cap, water vapor permeability. Air tightness and moisture permeability play an important role in the stability of charging           

2. Quality standard of plastic bottle. Conduct product quality analysis from the manufacturer's product quality standards to determine whether it is desirable. Pharmaceutical plastic bottle enterprises should formulate enterprise standards higher than national standards, and industry standards should be more stringent.                

3. Selection of main raw materials for plastic bottles, formula of additives: the product standard of solid plastic bottles is the applicable provisions of main raw materials, and must meet the requirements of non-toxic, no odor, etc., because there are many main raw materials, which need to be selected as the overall performance of raw materials. Tablets generally use high-density polyethylene, polypropylene bottles, such as PET bottles, can be used for transparency, better barrier performance of pen bottles, It is usually made of polypropylene or polyethylene bottle ester as the main raw material in liquid drug formulation.            

4. Stability and compatibility of plastic bottles. The use of plastic bottles, especially the use of new plastic bottles (or new materials, new technology) should be packed up with advanced drug testing to check the stability and charge of the compatibility between plastic bottles and drugs. The mutual penetration, dissolution, adsorption, chemical reaction and denaturation of drug plastic bottles can be determined by scientific detection.            

5. Quality assurance system. Supplier audit purchase of plastic bottles has become an essential part. After the audit, the factory can make a comprehensive and correct assessment of the overall level of software and hardware facilities, technical equipment and quality.


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