The varieties of plastic bottles include HDPE bottles, polypropylene bottles and polyester bottles. Due to the different specifications, colors and shapes of many medical plastic bottles, the following main selection criteria should be well 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 quality analysis from manufacturer's product quality standards to determine if it is desirable. Pharmaceutical plastic bottle enterprises should formulate enterprise standards higher than national standards, and the industry standards should be more strict.
3. Selection of raw materials for plastic bottle and formula of additives: the product standard of solid plastic bottle does not meet the applicable regulations of main raw materials, and must meet the requirements of non-toxic and odorless, etc., because there are many main raw materials, which need the overall performance of raw materials not selected. Tablets generally use high-density polyethylene, polypropylene bottles, such as PET bottles, which need good transparency, Generally used in liquid pharmaceutical dosage form of polypropylene or polyethylene bottles are not made of the main raw materials.
4. Stability and compatibility of plastic bottles. The use of plastic bottles, especially the use of new plastic bottles for drugs, should be tested first to check the stability and charge of compatibility between plastic bottles and drugs. Mutual penetration, dissolution, adsorption, chemical reaction and deformation of drug plastic bottles can be determined by scientific detection.
5. Quality assurance system. Supplier audit purchasing plastic bottles has become an essential part. After passing the audit, the factory can make a comprehensive and correct evaluation of the overall level of software and hardware facilities, technical equipment and quality. |