In recent years, China's pharmaceutical plastic bottle packaging has experienced rapid development. Medicinal plastic bottles have the characteristics of light weight, no damage, and good health, coupled with special requirements for drug packaging. At present, pharmaceutical tablets, capsules, and packaging have gradually replaced "glass" with "plastic".
The dosage of producing plastic bottles, if used improperly, can cause the migration of trace elements and alter the medicinal efficacy of the medication, which can even endanger life. Drugs are a special commodity, and the manufacturers of plastic pharmaceutical bottles must strictly control each link of production to be healthy and meet the relevant requirements of "GMP", and also master the relevant laws and regulations, such as the "Chinese Pharmacopoeia of the People's Republic of China", "Drug Administration Law of the People's Republic of China", "Good Manufacturing Practices", "Drug Packaging Management Measures" and the standards and requirements of related plastic pharmaceutical bottles. At present, most medicinal plastic bottles are used for packaging tablets, capsules, and drugs. Therefore, the production of plastic bottles must ensure that the drug tablets and capsules are not easily affected by moisture or deterioration, heat-resistant, melted, explosive, and not easily discolored. When exposed to light, they decompose, oxidize, and contaminate.
There are various types of plastic bottles, including high-density polyethylene bottles (HDPE), polypropylene bottles (PP), polycarbonate bottles (PC), and polyester bottles (PET) for medicine granules. However, in the early 1990s, polyethylene naphthalate (PEN) plastic bottles appeared, which have better properties than PET, such as high strength, heat resistance, UV radiation resistance, high carbon dioxide gas and oxygen barrier properties, and good chemical resistance. PEN is an excellent material for medicinal plastic bottles.
Due to the availability of various specifications, colors, and shapes of medicinal plastic bottles, it is important to grasp the following main selection criteria:
1. Sealing of bottle caps and water vapor permeability. Airtightness and moisture permeability play a crucial role in ensuring stable charging
2. Quality standards for plastic bottle products. Conduct product quality analysis based on the manufacturer's product quality standards to determine if it is acceptable. Pharmaceutical plastic bottle enterprises should establish enterprise standards higher than national standards and industry standards more stringent.
3. Choose the main raw materials and auxiliary formula for plastic bottles: The product standard for solid plastic bottles is the applicable regulations for the main raw materials, and must comply with non-toxic, odorless, etc. Because there are also many main raw materials, this needs to be selected as the overall performance of the raw materials. Tablets are generally made of high-density polyethylene and polypropylene bottles, such as PET bottles, which can be used for transparency and better barrier performance of PEN bottles. They are generally made of polypropylene or polyethylene bottle esters as the main raw materials for liquid pharmaceutical formulations.
4. Stability and compatibility of plastic bottles. The use of plastic bottles, especially new plastic bottles (or new materials, new processes) for drug use, should undergo advanced drug testing to check the stability and charge of the compatibility between plastic bottles and drugs. The mutual permeation, dissolution, adsorption, chemical reaction, and denaturation of pharmaceutical plastic bottles can be determined through scientific testing.
5. Quality assurance system. Supplier audits for purchasing plastic bottles have become an essential part. After the audit is approved, the overall level of software and hardware facilities, technical equipment, and quality that the factory can produce will be comprehensively and correctly evaluated.
