Manufacturing standards for medicinal plastic bottles
In recent years, medical plastic bottle packaging has been rapidly developed. Medical plastic bottles have the characteristics of light weight, no damage, health, etc., plus special requirements for pharmaceutical packaging. At present, pharmaceutical tablets, capsules, and packaging have gradually realized "plastic" instead of "glass".
The varieties of plastic bottles include high-density polyethylene bottles (HDPE), polypropylene bottles (PP), polycarbonate bottles (PC), and polyester bottles (PET). In the early 90s, a naphthalene dicarboxylic acid appeared. Ethylene glycol (PEN) plastic bottles have better properties than PET, high strength, heat resistance, UV radiation resistance, high carbon dioxide and oxygen barrier properties, and good chemical resistance. It is an excellent material for medical plastic bottles.
As there are many specifications, colors and different shapes of medicinal plastic bottles, the following main selection criteria should be grasped:
1. Sealing of the bottle cap, water vapor permeability. Air tightness and moisture permeability play a vital role in the stability of charging
2. Plastic bottle product quality standards. Carry out product quality analysis from the manufacturer’s product quality standards to determine whether it is advisable. Pharmaceutical plastic bottle companies should formulate corporate standards higher than national standards, and industry standards are more stringent.
3. Select the main raw material and auxiliary formulation of plastic bottles: the product standard of solid plastic bottles is the applicable regulations for the main raw materials, and must comply with non-toxic, no odor, etc., because there are many main raw materials, which need to be selected as raw materials Overall performance, tablets generally use high-density polyethylene, polypropylene bottles, such as PET bottles, which can be used for transparency and better barrier properties of PEN bottles. Generally used in liquid pharmaceutical dosage forms, polypropylene or polyethylene bottles are the main raw materials. Made of materials.
4. Stability and compatibility of plastic bottles. The use of plastic bottles, especially the use of new plastic bottles for drugs (or new materials, new processes) should pack advanced drug tests to check the stability and charge of the compatibility of plastic bottles with drugs. The interpenetration, dissolution, adsorption, chemical reaction, and denaturation of pharmaceutical plastic bottles can be determined through scientific testing.
5. Quality assurance system. Supplier audits to purchase plastic bottles have become an essential part. After passing the audit, the factory can make a comprehensive and correct assessment of the overall level of software and hardware facilities, technical equipment, and quality that can be produced.
SANLE's medical plastic bottles use excellent materials to ensure the quality.
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