Custom plastic bottle manufacturer's standards and requirements
In recent years, medical plastic packaging has developed rapidly in our country.
Medical plastic has the characteristics of light weight, no damage, health, combined with the special requirements of pharmaceutical packaging.
At present, pills, glue, and packaging has gradually realize the 'glass' instead of 'plastic'.
If the dose of plastic bottles to use undeserved, trace element migration will change the efficacy of drugs, and even endanger the life of the drug.
Drug is a special kind of commodity.
Pharmaceutical plastic bottles production enterprises must strictly control each production link, to meet the requirements of GMP and health.
To master the law of the People's Republic of China pharmacopoeia, the pharmaceutical administration law of the People's Republic of China and the drug production quality management ordinance and other relevant laws and regulations.
The measures for the administration of the drug packaging and related medical plastic bottle of the standards and requirements.
Currently, medicinal plastic bottles, plastic lang, medicines, mostly in the form of packing, so must ensure that the production of plastic tablets and glue, not easy be affected with damp be affected with damp, deterioration, thermal resistance, explosion-proof is not easy to change, is exposed to light, plastic bottle is broken down, oxidation, pollution.
Plastic bottles variety with high density polyethylene bottle (
And polypropylene bottles (
, polycarbonate bottles (
, polyester bottle (
In the early 1990 s, there was a better performance than the PET, high strength, heat resistance, resistance to ultraviolet radiation, high carbon dioxide gas and oxygen polyethylene naphthalate formic acid glycol ester (
Is a kind of excellent medical plastic material, with good barrier property and chemical resistance.
The current specifications of medicinal plastic bottles, color and shape each are not identical, should grasp the following key selection criteria: 1.
Sealed and water vapor permeability.
The stability of air tightness and moisture permeability of charge plays an important role.
Plastic bottle quality standards.
From the manufacturer of the product quality standard in the analysis of product quality, to determine whether the preferable.
Pharmaceutical plastic bottles enterprises should formulate enterprise standards higher than the national standard, industry standard is more strict.
Choose the main raw material of plastic bottles, auxiliary formula: solid plastic product standards is the main raw material of provisions shall be applicable, and must comply with non-toxic, no smell, etc. , as the main raw material, there are also many, this need to select as the comprehensive performance of the raw material, tablets in using high density polyethylene, polypropylene bottles, etc, can be used for transparent PET bottles, blocking performance good pen bottle, commonly used in polypropylene or polyethylene bottle of ester liquid in drug formulations.
The stability of plastic bottles and compatibility.
The use of plastic bottles, especially the new plastic bottles (
Or new material, new process)
Use, shall be clean, so that advanced drug test, to check for plastic bottles and the stability of the compatibility of medicines and charges.
Medicine SuPing can mutual penetration, dissolved, adsorption and reaction.
Degeneration can through scientific testing to determine.
Quality assurance system.
Supplier audit has become an important part of procurement of plastic bottles.
After review, the factory can produce the overall level of the quality of software and hardware facilities, technical equipment, make a comprehensive and correct assessment.