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【答案】应助回帖
是这个吗？是的话我可以给你
<381> ELASTOMERIC CLOSURES FOR INJECTIONS
INTRODUCTION
Elastomeric closures for containers used in the types of preparations defined in the general test chapter Injections 1 are made of materials obtained by vulcanization (cross-linking) polymerization, polyaddition, or polycondensation of macromolecular organic substances (elastomers). Closure formulations contain natural or synthetic elastomers and inorganic and organic additives to aid or control vulcanization, impart physical and chemical properties or color, or stabilize the closure formulation.
This chapter applies to closures used for long-term storage of preparations defined in the general test chapter Injections 1 . Such closures are typically used as part of a vial, bottle, or pre-fill syringe package system.
This chapter applies to closures formulated with natural or synthetic elastomeric substances. This chapter does not apply to closures made from silicone elastomer; however, it does apply to closures treated with silicone (e.g., Dimethicone, NF). When performing the tests in this chapter, it is not required that closures be treated with silicone, although there is no restriction prohibiting the use of siliconized closures.
This chapter also applies to closures coated with other lubricious materials (e.g., materials chemically or mechanically bonded to the closure) that are not intended to, and in fact do not provide, a barrier to the base elastomer. When performing the tests, closures with lubricious nonbarrier coatings are to be tested in their coated state. |
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