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Introduction to the coated rubber plug

2005The elimination of natural rubber plug so far10In 2005, the pharmaceutical rubber plug industry in China had a great development, and made due contribution to the pharmaceutical industry。Medicinal rubber plug products have also changed greatly from the original halogenated butyl rubber plug to the current coated rubber plug。Although Chinese medicinal rubber plug, especially coated rubber plug, has made great progress in recent years, it still faces some practical difficulties in the actual production, application and use。In order to meet the safety of rubber plug and film coated material on the basis of making the varieties of film coated rubber plug get healthy development, in order to meet the actual demand of the domestic drug market, the application of film coated rubber plug and film material safety characteristics are summarized。

 First, the concept of coated rubber plug

        The coated rubber plug refers to the local contact surface between the rubber plug (naked plug) and the drug"Coated" with a solid "film" of rubber plug products, such as fluorine coated rubber plug。The rubber plug formed by dipping and spraying technology can be called coating rubber plug, such as the coating rubber plug formed by coating polydimethylsiloxane film。

        When using a common rubber plug, because the rubber plug is in direct contact with the sensitive drug, it may cause compatibility problems due to the interaction between the rubber plug and the drug。The film-covered rubber plug can block the contact between the rubber plug and the drug by adding a blocking plastic film on the surface of the rubber plug, which can effectively reduce the absorption, adsorption, leaching and penetration between the rubber plug and the drug, so as to effectively reduce or delay the occurrence and development of compatibility problems and improve the long-term stability of the drug。

Second, the production and use of coated rubber plug at home and abroad

        Abroad, Japan1957The year began to produce butyl rubber bottle stopper, Europe and the United States each economically developed countries are also in1970年初实现批量生产药用丁基橡胶瓶塞;在国内,直到1992We started mass production of medicinal butyl rubber bottle stoppers in 2000。At the same time, the coating technology of butyl rubber plug developed earlier in foreign countries, and the technology is relatively mature, such as the United States West Company, Japan Daxie Nitrate Company, BelgiumHelvoetCompanies, etc., have a variety of different specifications of coated butyl rubber plug, and all have the capacity of mass production。早在20世纪80In the 1990s, Japanese Ojo Seiko (Daikyo Seiko) on the first development of coated rubber plug, and apply for a patent。At present, some domestic butyl rubber plug manufacturers technical personnel after a lot of tests, constantly explore communication, but also can mass production of relatively stable quality coated butyl rubber plug。Approved at the national Office35A kind of coated rubber plug is available18The fluorine containing film material is used, which is the main form of film material used in the domestic coated rubber plug。

Because of its excellent chemical properties, it has been widely used in a variety of sensitive drugs, such as antibiotics and biochemical preparations。In response to the widespread use of coated rubber plugs, the new edition of the United States Pharmacopoeia has rewritten the chapter on medicinal rubber seals。It is specially stipulated that even if the adhesive plug with barrier film (such as fluorine film) is used, the adhesive plug part must still meet the relevant requirements of medicinal adhesive plug, mainly in order to control the quality of the adhesive plug itself。Therefore, the film coating process is only a process to further optimize the quality of qualified medicinal rubber plugs to meet the higher requirements of sensitive drugs, rather than to cover up the unqualified quality of low quality rubber plugs through film coating。This also reflects the international recognition of rubber plug film technology and fluorine film material, although at the same time, there is no application for any kind of rubber plug fluorine film materialDMFAnd be activated。

Iii. Commonly used fluorine film materials and their suppliers

      "Teflon" (Teflon"Is often used to refer to fluorinated resins and their products, but in fact"Teflon"Is a registered trademark used by DuPont in a line of fluoropolymer products。Dupont started out as"Teflon"As a trade name for teflon resin, and later developed to includeTeflon AF (amorphous fluoropolymer),Teflon FEP (polyperfluoroethylene propylene resin),Teflon FFR (fluoropolymer foam resin),Teflon NXT(fluoropolymer resin)Teflon PFA (perfluoroxy resin) and other products, while forETFE(乙烯-Tetrafluoroethylene copolymer), whose registered trademark is"Tefzel”。

        International manufacturers of fluorine plastics mainly include Dupont, Clariant, Ciba Refined,3MArkema, Daikin, Asahi Glass, Solvay, etc., and the fluorine film suppliers for rubber plug coating mainly include Dupont, Saint-Gobain and Asahi glass。

Four, the performance of fluorine film material
Structure and chemical stability of fluorine membrane materials
        The fluorinated plastic film used for the coated rubber plug contains a polymer of tetrafluoroethylene, which is produced after fluorine atoms replace hydrogen atoms in ethylene。

      Carbon with high bond energy in its molecular structure-Fluorine bonds, the substitution of fluorine atoms gives the molecule a helical configuration, and fluorine atoms form a cylindrical shell。The inert spiral shaped perfluorinated shell makes fluorine plastics have a series of outstanding properties, excellent chemical stability and biological inertia, resistance to strong acid, strong alkali and various organic solvents, heat resistance, dielectric property, self-lubricating and aging resistance, even at high temperature, it does not work on the king water。Meanwhile, fluorinated materials have extremely low surface free energy, only0.019N/m, is known to be the smallest surface free energy among solid materials, so almost all solid materials can not adhere to its surface, which is one of the main reasons that it is widely used in food and drug production pipelines and containers。

        Fluorine plastic film for coated rubber plug, not only stable to other substances, stable to the environment, and its film formation process without the use of any processing additives, the fluorine resin composition100%

 2 Heat resistance of fluorine film material
        Fluorine material is the highest high temperature resistant polymer material。The fluorine material is saturated because of its main chainC-CThe bond and the branch chain are saturated with high bond energyC-FBonds, meanwhile, large functional groups-FTherefore, the fluorine materials show high temperature resistance。如FEPLong-term use temperature (perfluorinated ethylene propylene) (long-term use temperature refers to the maximum temperature that lasts more than half a year and the material properties are basically unchanged, is an important index to measure the stability of the material。)为205℃,ETFE(乙烯-Tetrafluoroethylene) long-term use temperature is165Therefore, the sterilization temperature of the rubber plug generally will not have any effect on the fluorine film rubber plug, but it should be considered that the effect of extreme temperature should be taken into account in the experiment because of the high vulcanization temperature of the rubber plug。
        According to DuPont,ETFEFilm in260There will be weightlessness only when the temperature is higher than260Under the condition of ℃, the escape products can be produced. The escape products are analyzed as tetrafluoroethylene and trifluoromethane。FEP膜在400Weightlessness begins at about ° C, at121-300No precipitates were found in the range of constant weight at ℃。The sterilization temperature of the coated rubber plug used by the pharmaceutical factory is generally121℃, the vulcanization temperature of the manufacture of the coated rubber plug is generally at150-160The temperature indicates that there will be no weight loss during the production and use of the laminated rubber plug。

V. Conclusion
        To sum up, the conclusion can be drawn as follows1Fluorinated plastic film material with high bond energy carbon-Fluorine bonds, the substitution of fluorine atoms gives the molecule a helical configuration, and fluorine atoms form a cylindrical shell。Therefore, coated rubber plug film material has strong stability, excellent chemical stability, heat resistance, dielectric property, self-lubrication and aging resistance, does not dissolve or swell in any known solvent。(2The molding process of film material is not like rubber products need to be filled with fillers, antioxidants, curing agents and other additives, also do not need curing reaction process, and its fluorine resin composition100%。(3FEP膜在400Weightlessness begins at about ° C, at121-300No precipitates were found in the range of constant weight at ℃。The sterilization temperature of the coated rubber plug used by the pharmaceutical factory is generally121℃, the vulcanization temperature of the manufacture of the coated rubber plug is generally at150-160℃。It indicates that there will be no weightlessness in the production and use of the laminated rubber plug。(4) Coated rubber plug commonly used film materialFEPThe long-term use temperature of (perfluorinated ethylene propylene) is205℃,ETFE(乙烯-Tetrafluoroethylene) long-term use temperature is165Therefore, the sterilization temperature of the rubber plug generally will not have any influence on the fluorine film rubber plug。


The above article is quoted from China Pharmaceutical Packaging Association




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