Principles for Selection of Pharmaceutical Packaging Materials – Plastic Bottle Packaging
The packaging materials used for pharmaceutical tablets are in direct contact with the drug and therefore belong to the pharmaceutical packaging. Medicine is a special commodity whose efficacy and quality are directly related to human health and safety. The packaging materials and structural forms used must ensure the efficacy and convenience of the drug. Therefore, as a pharmaceutical manufacturing enterprise, when selecting packaging materials, it is necessary to understand some properties and characteristics of packaging materials and containers, in order to combine certain special requirements of pharmaceuticals, and to rationally and accurately select pharmaceutical packaging materials.
The biggest feature of medicinal plastic bottles is that they are light in weight, not fragile and beautiful. Pharmaceutical manufacturers can use them directly without washing and drying. Some of its technical indicators and a large number of data show that its chemical resistance, water vapor permeability and sealing performance are excellent, so it can fully protect the installed drug during the effective period.
Among the materials used are high density polyethylene bottles (HDPE), polypropylene bottles (PP), polycarbonate bottles (PC), and polyester bottles (PET). There are also PEN plastic bottles that are superior in quality to PET. It has high strength, good heat resistance, ultraviolet radiation resistance, excellent barrier properties against carbon dioxide gas and oxygen, and good chemical resistance.
Due to the large number of medicinal plastic bottles, as a pharmaceutical manufacturer, the following principles should be grasped when selecting plastic bottles:
Select the main raw material and additive formula of plastic bottleThe product standards for solid plastic bottles stipulate different applicable main raw materials, and must meet the requirements of non-toxic, no odor and so on. Since there are many different main materials available, it is necessary to select the comprehensive properties of the raw materials. Generally, high-density polyethylene and polypropylene bottles are used for tablets. If you need transparency, you can use PET bottles. If the drug needs higher barrier properties, and needs to be light-blocking and opaque, use brown PET bottles or better PEN bottles. Liquid dosage forms generally use polypropylene or polyester bottles as the main raw material.
Sealing and water vapor permeability between bottle and lidSealability and water vapor permeability are two important technical indicators for pharmaceutical plastic bottles, which play an important role in the stability of the charge.
Plastic bottle product quality standardsFrom the product quality standards of the production plant, the quality of the product can be analyzed and judged. Pharmaceutical plastic bottle enterprises should set enterprise standards that are stricter than national standards and industry standards.
Plastic bottle's charge stability and compatibilityThe selection of plastic bottles, especially new drugs using new plastic bottles (or new materials, new processes) should first carry out a charge test to examine the stability of the charge and the compatibility between the plastic bottle and the drug. The penetration, dissolution, adsorption, chemical reaction and denaturation of drugs and plastic bottles must be determined by scientific testing.
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