Application of hottest rubber in pharmaceutical pa

  • Detail

The application of rubber in pharmaceutical packaging

analysis of the current situation

the history of using rubber in the pharmaceutical industry is as old as the rubber industry. From the early rubber industry to the modern rubber industry, rubber products are widely used in medicine. Among them, butyl rubber, halogenated butyl rubber, nitrile rubber, ethylene propylene rubber, natural rubber and cis-1,4-polybutadiene rubber can be used to manufacture the basic element of pharmaceutical packaging system - pharmaceutical bottle stopper. The inherent characteristics of rubber are: high elasticity, good sealing performance and resealing performance can be obtained; Low air permeability and water permeability; Good physical and chemical properties; Sterilization resistance; Good compatibility with drugs. These are the most important requirements of pharmaceutical packaging for corks

application of rubber bottle stopper in the field of pharmaceutical packaging

in order to prevent drugs from being polluted and leaking during storage, transportation and use, rubber bottle stopper is generally used as the seal of pharmaceutical product packaging, such as liquid handling bottle stopper, lyophilizer bottle stopper, blood test tube rubber stopper, infusion pump rubber stopper, dental anesthesia syringe piston, pre installed injection syringe piston, insulin syringe piston and seals used in various aerosol bottles (aspirators)

the correct selection of packaging materials for drug containers is an important means to ensure the quality of drugs, and most of the experimenters lack experience in the maintenance and protection of instruments. The materials of rubber bottle stopper, glass or plastic container may produce harmful substances, which may leak into the drug solution, causing the drug solution to precipitate, exceed the standard of particles, change the pH value, change color, etc. The ideal cork should have the following properties: low permeability to gas and water vapor; Low water absorption; Capable of needling without chip falling; It has enough elasticity and good sealing property after puncture; Good aging resistance and color stability; Resistant to steam, oxyethylene and radiation disinfection, etc

at present, there is no material that can meet the requirements of the pharmaceutical packaging industry for the combination of chemical inertia and good physical properties of its materials. Although people can meet the relevant materials in the last century, and although people have improved the relevant materials in the last century, they can not meet the ideal requirements at present

in the last century, the pharmaceutical industry passed strict production specifications and quality control regulations to meet the strict requirements of bottle stopper products on their physical and chemical properties, that is, through extensive research and analysis of basic collagen materials, improve the formula, production process and post-treatment methods of rubber, and implement GMP (good manufacturing Practice for drugs) and white workshop production method, so as to meet the requirements of drugs on the physical and chemical properties of bottle stopper. But so far, only a few manufacturers in the world can provide bottle stopper products that can meet the highest quality standards of drugs

the types of pharmaceutical corks, such as glue

the requirements of drugs on corks in terms of low permeability, low extraction rate and low absorption, determine that rubber corks are very demanding in the production process. People have conducted extensive research on the application of various types of rubber in pharmaceutical bottle stoppers, and achieved a series of important results

natural rubber is the first generation of rubber used for pharmaceutical corks. It has excellent physical properties and chip resistance, but the permeability and chemical resistance of its vulcanizate can not meet the requirements of modern pharmaceutical industry. Because natural rubber needs high content of vulcanizing agent and antioxidant to prevent aging, it will produce extractables with high residue that are not needed by drugs, and its absorption rate is not ideal. Therefore, natural rubber plugs have been included in the ranks of elimination

neoprene is rarely used in the pharmaceutical industry. Its high permeability and high water absorption are the main reasons for its performance greatly exceeding the type of raw fiber itself

ethylene propylene rubber is formulated by peroxide vulcanization without any plasticizer. However, the analysis of ethylene propylene rubber corks and gaskets shows that there are often some catalyst residues from rubber. Therefore, this rubber is generally only used for corks in contact with high pH solutions or some aerosols

nitrile rubber has excellent heavy sealing performance, oil resistance and various solvent resistance, and is widely used in pharmaceutical propulsion rubber parts, such as metering valve of aerosol pump, oil resistant bottle stopper of veterinary medicine, etc

butyl rubber has high content of vulcanizing agent in the formula, long vulcanization time, low permeability, low water permeability and excellent chemical resistance. It was widely used in the production of special rubber corks by foreign pharmaceutical cork manufacturers in the 1960s. However, since then, the production and application of chlorinated butyl rubber stopper have appeared. In the 1970s, brominated butyl rubber with higher reactivity than butyl rubber appeared. 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 and halogenated butyl rubber

butyl rubber is a copolymer of isobutene and a small amount of isoprene. With the addition of isoprene, there are double bonds on the molecular chain of butyl rubber that can be vulcanized with sulfur or other vulcanizing agents. It has the characteristics of low permeability to gas, high shock absorption at low frequency, excellent aging resistance, heat resistance, low temperature resistance, chemical resistance, ozone resistance, water and steam resistance, oil resistance and strong resilience. These characteristics are necessary for an ideal pharmaceutical rubber stopper, which is also the main reason why butyl rubber is widely used in the field of pharmaceutical packaging

halogenated butyl rubber and butyl rubber have common properties and characteristics, but due to the existence of halogen element chlorine or bromine, the vulcanization activity and selectivity of the compound are higher, and it is easy to co vulcanize with unsaturated rubber, eliminating the disadvantage that ordinary butyl rubber is easy to be polluted by rubber; In the vulcanization process, a variety of vulcanization systems can be selected, which can be vulcanized without sulfur or with a sulfur system with less water in the oil, and can be vulcanized without or with a small amount of ZnO. Thus, halogenated butyl rubber is more widely used in the field of pharmaceutical packaging

The characteristics of halogenated butyl rubber determine that it is the most ideal material for pharmaceutical corks at present. In order to comprehensively improve the quality level of pharmaceutical packaging in China, the State Drug Administration decided to enforce the "butylation" of pharmaceutical rubber plugs in China by the end of 2004

Copyright © 2011 JIN SHI