The hottest drug packaging system at home and abro

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This paper focuses on the classification of drug packaging and the overview of the standard system. In order to ensure the safe and effective use of drugs, the compatibility test between drug packaging materials and drugs should be carried out to select appropriate drug packaging materials and forms

key words drug packaging standard compatibility test

drug packaging refers to the packaging materials and containers that directly contact drugs. It belongs to the category of special packaging. It has all the properties of packaging and has its particularity: 1. It can protect drugs from the influence of the environment during storage and use, and maintain the original properties of drugs. 2. The properties of drug packaging materials should be stable during storage and use. 3 Drug packaging materials shall not pollute the drug production environment when wrapping drugs. 4. Drug packaging materials shall not contain substances that can not be eliminated in the process of use and have an impact on the packaged drugs. 5. The drug packaging materials and the drugs that the packaging center has led and participated in the formulation of 4 national standards, 5 industrial standards and 9 local standards cannot have chemical and biological reactions. In order to confirm that drug packaging materials can be used to wrap drugs, it is necessary to monitor the quality of these materials

I. drug packaging classification

(I) according to the ingredients used in drug packaging materials and containers, they can be divided into five categories: plastic, rubber (or elastomer), glass, metal and other categories (such as cloth, ceramics, paper, desiccant)

(II) according to the shape of drug packaging materials and containers, they can also be divided into five categories: containers (such as oral solid pharmaceutical high-density polyethylene bottles, etc.), hard pieces or bags (such as PVC solid pharmaceutical hard pieces, composite films for drug packaging, bags, etc.), plugs (such as pharmaceutical chlorinated butyl rubber plugs), covers (such as tear aluminum caps of oral liquid bottles), auxiliary uses (such as infusion interfaces)

II. Standard system of drug packaging materials

in order to ensure the safe and effective use of drugs, all countries carry out quality control on drug packaging materials and containers. The standard system mainly includes

1. Pharmacopoeia system: the technical requirements of drug packaging materials are contained in the Pharmacopoeia appendices of developed countries

2. ISO system: formulate standards according to materials and shapes (such as aluminum caps, glass infusion bottles)

3 Industrial standard systems of various countries: such as British Industrial Standard BS, etc., have been gradually transformed to ISO standard

4. Domestic standard system: industrial standard forms are the same as ISO standard, and the safety items are slightly less than those in the Pharmacopoeia of advanced countries. In order to effectively control the quality of drug packaging materials, the State Food and drug administration has formulated and promulgated corresponding quality standards for drug packaging materials containers since 2002, strengthening the control of physical, mechanical, chemical and safety properties of materials

international standards and pharmacopoeias of various countries are the technical basis commonly followed by the international market of drug packaging. Among them, Pharmacopoeia focuses on the safety evaluation of materials and containers, and international standards play a positive role in promoting human social progress and the environment, focusing on the evaluation of product performance

III. introduction to the quality standard system of drug packaging containers in various countries

1. The items controlled by USP for glass products include: light transmittance test, water resistance test, arsenic leaching test, etc; The control items of PE or pet products (applicable to oral solid preparations) include: infrared measurement, thermal analysis, light transmittance test, water vapor transmission measurement, heavy metal, nonvolatile matter measurement, etc

2. The inspection items of Japan Pharmaceutical Administration for glass containers for injection include: sealing requirements, determination of soluble alkali (water resistance), determination of iron (lightproof container), and determination of light transmittance; The special requirements for plastic containers are (1) the dissolution or migration of the container should be investigated (2) the physical properties of the container should be investigated (3) the barrier performance of the container should be investigated (4) the resistance to adverse weather should be investigated (5) the sterilization resistance of the container should be investigated (6) the evaluation of the toxicity of the container at the design stage. Among them, the test items of rubber stopper for injection include: cadmium, lead, leaching solution test, acute toxicity test, hemolysis test, pyrogen test; The inspection items of containers for PE or PP injections include: transparency, water vapor transmission, heavy metals, cadmium, lead, leaching solution test, cytotoxicity test; The test items of containers for PVC injection include: thickness, transparency, leakage, flexibility, water vapor transmission, cadmium, lead, tin, vinyl chloride monomer, insoluble particles, leaching solution test, cytotoxicity, etc

3. The main plastic materials used in the European Pharmacopoeia are PE (divided into PE without additives and PE with additives), PP and pet. The main control items of the above materials are: identification (using infrared spectrum and density test), leaching solution test, metal ion, ash test, adding agent inspection connected with oil suction chamber and oil discharge chamber respectively in the process of change; Items to be controlled for glass containers include: water resistance, light transmittance, thermal shock resistance, arsenic, etc; PVC materials are divided into PVC for intravenous infusion containers (including plasticizers) and PVC without plasticizers (applicable to liquid bottles for non injections). The control items of the above materials include: infrared identification, leaching solution test, metal ions, ash test, additive inspection, vinyl chloride content determination and vinyl chloride monomer control; The control items of the rubber plug include: identification, leaching solution test, volatile sulfide, puncture force, puncture debris, self sealing, etc

(to be continued)

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