What's the Difference between Bromobutyl versus Chlorobutyl Rubber
There are two common halogenated butyl rubbers used for manufacturing Pharmaceutical Stoppers, including chlorobutyl rubber and bromobutyl rubber.
Rubber components are essential for the safe containment and delivery of parenteral drug products. Many rubber formulations used in the pharmaceutical industry are based on halobutyl rubbers. Halobutyl rubbers, typically bromobutyl or chlorobutyl, are made by the halogenation of butyl rubber, which is a copolymer of isobutylene and isoprene (to a smaller extent). Key features of halobutyl rubbers that make them suitable for the pharmaceutical industry are that they typically have lower levels of extractables compared to other rubbers, and they have excellent resistance to permeation by water and oxygen.
The question is often raised as to when to choose a bromobutyl- versus a chlorobutyl-based component. The answer is - it depends. They are comparable in terms of permeability for oxygen and water. Primary differences will be found in their extractables profiles, as different compounds are employed for curing, stabilization, etc.
Many Europeans and Americans usually manufacture Pharmaceutical Stoppers by bromobutyl rubber. However, In Asia, chlorobutyl rubber is main material of Pharmaceutical Stoppers in earlier period.
Comparisons of chlorobutyl rubber stopper and bromobutyl rubber stopper
1. Bromobutyl rubber stoppers are generally vulcanized with sulfur, which has poor heat resistance. Because bromine is more active, it is easy to produce a smell similar to rotten eggs (suspected as HBr or H2S gas) during high temperature sterilization. At the same time, the system needs to use a vulcanizing agent, which has a greater impact on the hemolysis test of the rubber stopper.
2. The chlorinated butyl rubber stopper generally adopts a non-sulfur vulcanization system, and the product has good heat resistance and low odor during high temperature sterilization; because the rubber does not contain epoxy soybean oil, it is not easy to cause wall hanging, opalescence, etc. after contacting the product phenomenon.
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