Medicinal plastic materials and products Although pharmaceutical packaging is not in direct contact with the human body or even inside the human body as in medical products, indirect exposure can seriously endanger life if it does not meet hygiene and stability requirements. Therefore, all plastic materials used for pharmaceutical packaging must comply with the regulations for drug packaging materials issued by the State Drug Administration. Imported and newly developed pharmaceutical packaging materials also need to be declared and tested. The main plastic medicine packaging materials used in pharmaceutical packaging more types of plastic materials, including PVC, PE, PP, PS, PET, nylon and so on. Among them, PE, PP, and PET accounted for the largest proportion, and the amount of PVC was decreasing. The use of rubber materials is even less. The main forms of plastic medicine packaging plastic aluminum composite bags, multi-layer plastic composite bags, blisters blister packaging, a variety of packaging solid, liquid medicine bottles and infusion bottles are the main form of pharmaceutical packaging. Among them, bubble eye blister packaging is becoming the most important solid drug packaging method. PP, PE and PET bottles are used in both solid and liquid medicines. Liquid drug packaging liquid drugs are mainly divided into injections, large infusions and oral liquids. There are two types of liquid medicines: bottle and bag. Plastic materials have made slow progress in injection packaging. Although it is widely believed that plastic bottles may replace Ampoules as the main form of injections in the future, due to concerns that components filtered out of plastics may contaminate the product, drug regulatory agencies in various countries are more prudent in managing plastics. On the contrary, plastic packaging is making breakthrough progress in transfusion medicines. According to incomplete statistics, there are currently more than 200 infusion companies that have passed GMP certification, and the infusion production capacity is about 3 billion bottles. More than 100 companies have annual production capacity of more than 10 million bottles. Some of the large-scale infusion drug companies, including Shuanghe Pharmaceutical and Tianjin Daxuan, are using plastic bottles or bags for large infusion packaging. Although glass bottles still account for more than 80% of China's total infusion packaging volume, the status quo is changing with the rapid development of polyolefin plastic bags and BOPP bottles in this area. Especially BOPP bottles, due to the advantages of high production, low unit cost, etc., due to the domestic production of equipment, are rapidly gaining popularity among domestic large infusion manufacturers. Since the BOPP bottle cannot be processed for secondary cleaning, the bottle must be produced in a GMP-certified factory building, and the storage conditions must also comply with GMP requirements. Polyolefin infusion bag production line has also introduced a lot of domestic, but due to polyolefin raw materials can not be produced domestically, resulting in higher costs, there are some difficulties in the field development, and the use of PVC bags will gradually shrink. In the oral solution, soft plastic bottles have been partially applied, and gradually expand its application. Hard plastic bottles are also slowly replacing glass for packaging larger volumes of liquid drugs such as syrups, which is consistent with European developments. The main reason is that plastic containers often have a wide bottleneck and are easier to fill. The production process on the filling line is also faster, less broken and can provide a larger label area to carry more information. The biggest disadvantage of plastics in liquid packaging is that the shelf life of pharmaceuticals is usually shortened when they are changed from glass to plastic bottles. Single-layer plastic containers have limited barrier properties, while composite plastic containers are subject to price constraints. One of the current trade-offs in Europe is the addition of a plastic shrink sleeve outside the glass bottle. The materials used in liquid medicine bottles are mainly PP, PE and PET. Solid drugs package solid drugs, including tablets, granules, and powders. Plastic bags, plastic bottles and blister packs are their main forms of packaging. Tablets are the largest variety and the largest volume of drugs sold. Large-capacity glass bottles are rapidly exiting the field and replaced by plastic bottles and aluminum-plastic blister packs. The most common blister packs are made of polyvinyl chloride sheets (PVC) and composite double aluminum sheets (CFF). PVC sheets have good compatibility, are easy to form and seal, and are inexpensive, but have relatively low moisture barrier properties. CFF has good barrier properties against moisture, but it is easy to distort and can't see the inner medicine. Therefore, pills are rarely used. In order to solve the problem of poor barrier property of PVC blister, and the high price of double aluminum blister, it is generally used to coat PVDC on PVC. Some companies have also developed films coated with fluorinated chloride resins on PVC to better improve barrier properties and transparency. Since most drugs need to be stored in the dark, the white LDPE bottle is also the most commonly used drug package, and is particularly suitable for large doses of Chinese and Western medicine pills and tablets. A small amount of bottles are also made of transparent brown bottles as needed, and these bottles are mainly made of PET. Bottle caps are also mostly made of PE or PP. Aluminum-plastic composite bag has the advantages of good barrier property, simple processing, etc. It is widely used and is currently the main packaging form of Chinese and western medicine powder and granules. Overall, China's solid pharmaceutical packaging bottles and bags can basically meet the needs of processing methods, the problem is how to ensure product health and safety. Application of rubber in the field of pharmaceutical packaging Rubber materials are used less on pharmaceutical packaging, mainly used as seals for packaging of pharmaceutical products, such as infusion stoppers, lyophilized agent stoppers, blood test tube stoppers, infusion pump stoppers, and teeth Anesthesia syringe pistons, pre-filled syringe pistons, insulin syringe pistons, and various aerosol bottle (aspirator) seals used. Good sealing performance and resealing performance, low air permeability and water permeability, good physical and chemical properties, good resistance to sterilization and good compatibility of medicines are the most important requirements for medical packaging on cork stoppers. Natural rubber has excellent physical properties and resistance to chipping, but its vulcanizate's breathability and chemical resistance can not meet the requirements of the modern pharmaceutical industry. Therefore, natural rubber stoppers have been included in the elimination phase. At present, more than 90% of global cork manufacturers use pharmaceutical grade peelable butyl rubber or halogenated butyl rubber as raw materials for the production and manufacture of various types of pharmaceutical rubber stoppers. Butyl rubber is a copolymer of isobutylene and a small amount of isoprene. It has low permeability to gases, high vibration damping at low frequencies, excellent resistance to aging, heat, low temperature, chemical resistance, ozone resistance, and water resistance. And steam, oil and other properties and strong rebound characteristics. In addition to the above advantages, the halogenated butyl rubber has higher vulcanization activity and selectivity, and is easily co-vulcanized with unsaturated rubber. It eliminates the disadvantages of common butyl rubber that is easily contaminated by rubber and is widely used in the pharmaceutical packaging field. . To comprehensively improve the quality level of pharmaceutical packaging in China, the State Drug Administration decided that by the end of 2004, China's pharmaceutical rubber stoppers will enforce "butylation."
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