Standard for the production of medicinal plastic bottles


In recent years, China's medicinal plastic bottle packa […]

In recent years, China's medicinal plastic bottle packaging has developed rapidly. Medicinal 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 the "plastic" generation of "glass".

The dose of plastic bottles produced, if used improperly, the migration of trace elements will change the medicinal efficacy of the drug, and even taking drugs may be life-threatening. Drugs are a special commodity, and the manufacturers of medicinal plastic bottles produced by them must be strictly controlled from every stage of production, in order to meet the requirements of health and compliance with "GMP", and also to master relevant laws and regulations, such as "the People's Republic of China Chinese Pharmacopoeia "Good People's Republic of China Drug Administration Law" "Good Manufacturing Practices" "Pharmaceutical Packaging Management Measures" and related pharmaceutical plastic bottles standards and requirements. At present, most medicinal plastic bottles, tablets, capsules, pharmaceutical packaging, so the production of plastic bottles must ensure that pharmaceutical tablets, capsules are difficult to be deteriorated by moisture, heat-resistant melting, explosion, not easy to change color, when exposed to light, decomposition, Oxidation and pollution.

Plastic bottles are available in high-density polyethylene bottles (HDPE), polypropylene bottles (PP), polycarbonate bottles (PC), and polyester bottles (PET). In the early 1990s, a naphthalenedicarboxylic acid appeared. Ethylene glycol (PEN) plastic bottles are better than PET, high strength, heat resistance, UV radiation resistance, high carbon dioxide gas and oxygen barrier properties, good chemical resistance, and are excellent materials for pharmaceutical plastic bottles.

Since there are many medicinal plastic bottle sizes, colors and shapes, it is important to grasp the following main selection criteria:

1. Cap seal, water vapor permeability. Air tightness and moisture permeability play a vital role in the stability of charging

2. Plastic bottle product quality standards. Product quality analysis is performed from the manufacturer's product quality standards to determine if it is desirable. Pharmaceutical plastic bottle enterprises should set corporate standards higher than national standards, and industry standards are more stringent.

3. Select the main raw material of plastic bottle, additive formula: The product standard of solid plastic bottle is the applicable rule of main raw material, 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 can be used for transparency, better PEN bottle barrier properties, generally used in liquid pharmaceutical dosage forms of polypropylene or polyethylene bottle esters as the main raw material Made of materials.

4. Stability and compatibility of plastic bottles. The use of plastic bottles, especially drugs, using new plastic bottles (or new materials, new processes) should be packed with advanced drug testing to check the stability and charge of the plastic bottle with drug compatibility. Drug plastic bottles interpenetrate, dissolve, adsorb, chemically react, and denature can be determined by scientific testing.

5. Quality assurance system. Supplier audits have become an essential part of buying plastic bottles. After the approval, the factory can produce a comprehensive and correct assessment of the overall level of software and hardware facilities, technical equipment, and quality.