Analysis on the application of rubber materials in

Analysis on the application of plastic materials in China's pharmaceutical packaging industry

pharmaceutical plastic materials and products

although pharmaceutical packaging does not directly contact the human body or even be buried inside the human body like medical products, if it does not meet the health and stability requirements, indirect contact will also seriously endanger life safety. Therefore, all plastic materials used for drug packaging must comply with the regulations on drug packaging materials issued by the State Drug Administration. Imported and newly developed drug packaging materials also need to be declared and tested

main plastic drug packaging materials

there are many kinds of plastic materials used for drug packaging, including PVC, PE, PP, PS, pet, nylon, etc. Among them, PE, PP and pet account for the largest proportion, and the amount of PVC is decreasing. The use of rubber materials is less

main plastic drug packaging forms

plastic aluminum composite bags, multi-layer plastic composite bags, blister eye blister packaging, various medicine bottles and infusion bottles containing solid and liquid drugs are the main drug packaging as a social molecular form. Blister eye blister packaging is becoming the most important solid drug packaging. PP, PE and PET bottles are used in solid and liquid drugs

packaging of liquid drugs

liquid drugs are mainly divided into injection, large infusion and oral liquid. Liquid drugs are mainly packaged in bottles and bags

plastic materials have made slow progress in injection packaging. Although it is generally believed that plastic bottles will replace ampoules as the main packaging form of injections in the future, drug administration agencies in various countries are more cautious in managing plastics due to concerns that the ingredients filtered from plastics may pollute products

on the contrary, plastic packaging is making breakthroughs in large infusion drugs. According to incomplete statistics, at present, there are more than 200 infusion enterprises that have passed GMP certification, and the production capacity of infusion is about 3billion bottles. There are more than 100 enterprises with an annual production capacity of more than 10million bottles. Some large infusion drug manufacturers, including Shuanghe pharmaceutical and Tianjin Otsuka, are using plastic bottles or bags to make large infusion packages

although glass bottles still account for more than 80% of China's total infusion packaging, this situation is changing with the rapid development of polyolefin plastic bags and BOPP bottles in this field. In particular, BOPP bottles, because the equipment is produced domestically, have the advantages of high output and low unit cost of products, and are rapidly popularized in large infusion production enterprises in China. Since BOPP bottles cannot be cleaned for the second time, they must be produced in GMP certified workshops, and the storage conditions must also meet the requirements of GMP. Many polyolefin infusion bag production lines have also been introduced in China. However, due to the fact that polyolefin raw materials cannot be produced in China, the cost is high, and there are some difficulties in market development, and the consumption of PVC bags will gradually shrink

soft plastic bottles have been partially used in oral liquids, and their application scope has been gradually expanded. Hard plastic bottles are also slowly replacing glass for packaging large volume liquid drugs such as syrup, which is consistent with the development of Europe. The main reason is that plastic containers often have a wide bottleneck, which makes it easier to fill, and the production process on the filling line is also faster, which is not easy to break, and can provide a larger label area, such as ropes, which are very suitable for the manufacture of such satellites. Other plastic tests carry more information

the biggest disadvantage of plastic in liquid packaging is that the shelf life of drugs will be shortened after changing from glass to plastic bottles. The barrier performance of single-layer plastic containers is limited, while composite plastic containers are restricted by price factors. A compromise currently used in Europe is to add a plastic shrink sleeve to the glass bottle

the materials used in liquid medicine packaging bottles are mainly PP, PE and pet

solid drug packaging

solid drugs, including tablets, granules and powders. Plastic bags, plastic bottles and blister packaging are the main forms of packaging

tablets are the drug dosage forms with the largest variety and sales volume. Large capacity glass bottles are rapidly withdrawing from this field and are replaced by plastic bottles and aluminum-plastic blister packaging

the most common blister packaging is made of polyvinyl chloride sheet (PVC) and composite double aluminum sheet (CFF). PVC sheets have good compatibility, easy to form and seal, and low price, but the moisture barrier is relatively low. CFF has good moisture resistance, but it is easy to distort and cannot see the drugs inside. Therefore, pills are rarely used

in order to solve the problem of poor barrier property of PVC blister and high price of double aluminum sheet Blister, PVDC is widely applied on PVC. Other companies have developed a film coated with fluorinated chloride resin on PVC, which can better improve the barrier and transparency

since most drugs need to be stored away from light, white LDPE bottles are also the most commonly used drug packaging, especially suitable for the packaging of large doses of Chinese and Western medicine pills and tablets. A small number of bottles are also made into transparent brown bottles as needed, which are mainly made of PET material

bottle caps are also mostly made of PE or PP materials

aluminum plastic composite bags have the advantages of good barrier and simple processing. They are widely used. They are the main packaging form of traditional Chinese and Western medicine powders and granules after moderate stretching

generally speaking, the processing methods of bottles and bags for solid drug packaging in China can basically meet the needs, and the existing problem is how to ensure the hygiene and safety of products

Application of rubber in the field of pharmaceutical packaging

rubber materials are less used in pharmaceutical packaging, and are mainly used as seals for pharmaceutical product packaging, such as infusion bottle plugs, lyophilizer bottle plugs, blood test tube rubber plugs, infusion pump rubber plugs, dental anesthesia syringe pistons, pre installed injection syringe pistons, insulin syringe pistons, and seals for various aerosol bottles (aspirators)

good sealing and resealing performance, low air permeability and water permeability, good physical and chemical properties, sterilization resistance and good compatibility of drugs are the most important requirements for bottle closures in pharmaceutical packaging

natural rubber has excellent physical properties and chip resistance, but the permeability and chemical resistance of its vulcanizates cannot meet the requirements of modern pharmaceutical industry. Therefore, natural rubber plugs have been included in the ranks of elimination

at present, more than 90% of the world's Cork manufacturers mostly use pharmaceutical grade peelable butyl rubber or halogenated butyl rubber as raw materials for the production and manufacture of various types of pharmaceutical corks

butyl rubber is a copolymer of isobutene and a small amount of isoprene. It has the characteristics of low permeability to gas, high vibration damping at low frequency, excellent aging resistance, heat resistance, low temperature resistance, chemical resistance, ozone resistance, water and steam resistance, oil resistance and strong resilience. In addition to the above advantages, halogenated butyl rubber has higher vulcanization activity and selectivity. It is easy to co vulcanize with unsaturated rubber, eliminating the disadvantage that ordinary butyl rubber is easy to be polluted by rubber, and has been widely used in the field of pharmaceutical packaging

in order to comprehensively improve the quality level of pharmaceutical packaging in China, the State Drug Administration has decided that "butylation" will be enforced for pharmaceutical rubber plugs in China by the end of 2004