Making standards for pharmaceutical plastic bottles

2022/04/19

Author: mgg-Plastic bottle manufacturer

In recent years, pharmaceutical plastic bottles have been developed rapidly. The pharmaceutical plastic bottle has the characteristics of light, no damage, health, and special requirements for pharmaceutical packaging. At present, medical tablets, capsules, packaging have gradually achieved "plastic" "glass".

The dose of the plastic bottle is produced, and if the use of improper use, the migration of trace elements will change the pharmaceutical effects, and it will even endanger life. Drug is a special commodity, and the medicinal plastic bottle producers produced from production must strictly control, health and comply with "GMP" related requirements, such as the "People's Republic of China" "China Pharmaceutical Management Law" "Pharmaceutical Management Law" "Good Production Regulations" and the Standards and Requirements of Drug Packaging Management and Related Medicine Plastic Bots. At present, most pharmaceutical plastic bottle tablets, capsules, drug packaging, the production of plastic bottles must guarantee drug tablets, capsules, calendering, heat resistance, burst, not easy to discolor, when exposed to light, decompose, Oxidation and pollution.

Plastic bottles have a high-density polyethylene bottle (HDPE), polypropylene bottle (PP), polycarbonate (PC), polyester bottle (PET), and a naphthalic acid in the 1990s The nature of the ethylene glycol (PEN) plastic bottle is better than PET, high strength, heat resistance, ultraviolet radiation, high carbon dioxide gas and oxygen barrier properties, good chemical resistance, is a pharmaceutical plastic bottle excellent material. Since there are currently many pharmaceutical plastic bottles, color and different shapes, the following major selection criteria are grasped: 1. Sealing of the cap, water vapor permeability. The airtightness and moisture permeability play a stability of charging. 2. Plastic bottled product quality standards.

Product quality analysis from the manufacturer's product quality standards to determine if it is preferable. Medicinal plastic bottle companies should formulate corporate standards higher than national standards, and industry standards are more stringent. 3. Select the plastic bottle master raw material, the auxiliary formula: the product standard for solid plastic bottles is the applicable provisions of the main raw materials, and must be in line with non-toxic, no different taste, because of the main raw materials, there are many, this needs to be selected as raw materials. Overall performance, tablets generally use high-density polyethylene, polypropylene bottles, such as PET bottles, can be used in the need to transparency, better PEN bottles, generally used in liquid pharmaceutical dosage forms, polypropylene or polyethylene bottles, ester Material made.

4. Stability and compatibility of plastic bottles. Using plastic bottles, especially drugs, new plastic bottles (or new materials, new processes) should be collected advanced drug tests to examine the stability and charge of plastic bottles and drug compatibility. Drug plastic bottles penetrate, dissolve, adsorb, chemical reactions, and denaturation can be determined by scientific detection.

5. Quality assurance system. Supplier audit purchases plastic bottles have become an essential part. After the approved, the factory can produce a comprehensive and correct assessment of software and hardware facilities, technical equipment, and quality.

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