Discussion on the most popular drug packaging syst

2022-07-25
  • Detail

Discussion on drug packaging system at home and abroad (Part I)

Abstract 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, select appropriate drug packaging materials and forms, and carry out the compatibility test between drug packaging materials and drugs

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 shall not react with the packaged drugs in a chemical or biological sense. In order to confirm that drug packaging materials can be used to wrap drugs, it is necessary to carry out quality monitoring on 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 and 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 pull aluminum caps of oral liquid bottles), and auxiliary uses (such as infusion interfaces)

II. Standard system for 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 systems mainly include

1. Pharmacopoeia system: the technical requirements for 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 and glass infusion bottles)

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

4. Domestic standard system: industrial standards are the same as ISO standards in form, 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, since 2002, the State Food and drug administration has formulated and promulgated corresponding quality standards for drug packaging materials containers to strengthen the control over the 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 focus 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 items to be controlled for PE or pet products (applicable to oral solid preparations) include: infrared measurement, no thermal damage; The package shall be printed with the product name, manufacturer name and address, production date, product grade (excellent product, first-class product, qualified product), adopted standard number, implemented health standard number and other information analysis, light transmittance test, water vapor transmission measurement, heavy metal, nonvolatile matter measurement, etc

2. The inspection items of the Japanese pharmaceutical administration on the glass containers for injection include: sealing requirements, determination of soluble alkali (water resistance will also be further expanded), determination of iron (lightproof container), and determination of light transmittance; The special requirements for plastic containers are (1) the dissolution or migration of the containers should be investigated (2) the physical properties of the containers should be investigated (3) the barrier properties of the containers should be investigated (4) the resistance to adverse weather should be investigated (5) the sterilization resistance of the containers should be investigated (6) the evaluation of the toxicity of the containers 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 and pyrogen test; The inspection items of containers for PE or PP injection include: transparency, water vapor transmission, heavy metals, cadmium, lead, leaching solution test, and cytotoxicity test; The inspection 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 plastic film mainly used in the European Pharmacopoeia is excluded from the domestic waste recycling project. The plastic materials include PE (including PE without additives and PE with additives), PP and pet. The main control items of the above materials include: identification (inspection by the flexible packaging manufacturer using infrared spectrum and density test), leaching solution test, metal ion, ash test and additive inspection; 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 plasticizer) and PVC without plasticizer (applicable to liquid bottles for non injection). 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 for the rubber plug include: identification, leaching solution test, volatile sulfide, puncture force, puncture debris, self sealing, etc

4. ISO standards: the international standards formulated by the international organization for standardization are the technical guarantee for the smooth progress of international trade. Among them, iso/tc76 focuses on the formulation of standards for pharmaceutical packaging materials and containers. The standards for pharmaceutical packaging materials included in ISO include: ISO injection containers and accessories - Part 1: controlled glass injection bottles, ISO injection containers and accessories - Part 4: molded glass injection bottles, ISO medical infusion sets - Part 3: glass infusion bottles, ISO ampoules for injection, ISO point marking ampoules, ISO dropping bottles, ISO spiral bottles for syrup, ISO spiral bottles for solid and liquid drugs, ISO tablet bottles ISO injection containers and accessories - Part 3: aluminum caps for injection bottles, ISO medical infusion sets - Part 3: aluminum caps for infusion bottles, iso8872 blood transfusion, infusion and injection bottles - General requirements and test methods, ISO injection containers and accessories - Part 6: aluminum plastic composite injection bottle caps, ISO medical infusion sets - Part 7: aluminum plastic composite infusion bottle caps, iso10985 infusion bottles and injection bottle aluminum plastic composite bottle caps - Requirements and test methods ISO injection containers and accessories - Part 2: injection bottle closures, ISO injection containers and accessories - Part 5: freeze-dried injection bottle closures, ISO medical infusion sets - Part 2: infusion bottle closures, ISO medical infusion sets - Part 6: infusion bottle freeze-drying bottle closures, iso8871 elastomers for parenteral water preparations, iso15747:2003 plastic containers for intravenous injection, etc

5. YBB standard: in order to strengthen the quality control of drug packaging containers, the State Food and Drug Administration (SFDA) formulated, promulgated and implemented the national drug packaging container standard (YBB standard) in 2002 on the basis of full investigation on product quality in the early stage. Among them, 34 standards in the second series were issued in 2002; In 2003, the second series of 40 standards were issued. There are 47 product standards involved, including 2 general product rules in

and 45 specific product standards; There were 26 method standards and 1 guiding principle for compatibility test between drug packaging materials and drugs. Including 19 plastic products, including infusion bottles (bags), eye drops bottles, oral solid (or liquid) bottles, composite films (bags), hard films, etc; 5 metal products, including aluminum foil, aluminum tube, aluminum cover, etc; 2 rubber products, all of which are butyl rubber products; There are 19 glass products, including ampoules, infusion bottles, oral liquid bottles, etc. Another 41 standards were issued in 2004. There are 25 product standards and 16 method standards involved. It includes 4 plastic products, including composite films (bags), al/pe cold formed composite hard tablets for suppositories, oral solid moisture-proof composite bottle caps, etc; 2 metal products, including aluminum cover for pen syringe, injection needle, etc; 7 rubber products; The types include polyisoprene gasket, oral liquid silicone rubber plug, pen syringe piston and pre filling syringe piston; There are 8 glass products, including medicine bottles, infusion bottles, oral liquid bottles, etc; 1 capsule gelatin; There are 3 combined products, including combined caps for infusion containers, sealing gaskets, pre filled syringes, etc

sfda formulates and issues the standard for drug packaging materials, which is the national legal standard to ensure the quality of drug packaging materials and the safety and effectiveness of drugs. It is also the legal standard for the use of drug packaging materials by Chinese drug manufacturers, the production of drug packaging materials by drug packaging materials enterprises and the inspection of drug packaging materials by drug supervision departments. YBB standard controls different materials, including identification test, physical test, mechanical property test, chemical test, microbial and biological test. These projects provide a basic guarantee for the safe and reasonable selection of drug packaging materials and containers, and also provide technical support for the implementation of the national registration system for drug packaging containers

Copyright © 2011 JIN SHI