Compatibility and Packaging Integrity between Human Albumin Injection and Container of Cyclic Olefin Polymer
OBJECTIVE To explore the feasibility of using cyclic olefin polymer(COP)as packaging material for human albu-min products.METHODS Human albumin products were stored in COP bottles.Under the conditions of long-term stability(2-8 ℃ for 24 months)and accelerated stability[(25±2)℃ for 12 months],the key quality indexes of albumin and the probable extracts of COP material were analyzed,and the seal integrity of COP packages was tested.RESULTS Under both test conditions,the appearance,visible foreign matter,numbers of insoluble particles,pH,purity,polymer content,residual aluminum content,pro-tein content,activity of prekallikrein activator and abnormal toxicity of the albumin products all conformed to the quality standards and met the requirements of Chinese Pharmacopoeia.In the products,the contents of molybdenum,nickel,methylbenzene,and cyclohex-ane that may be produced by COP bottles were all lower than the quality standard limits.Moreover,the human albumin packaging con-tainer assembled by COP bottle,halogenated butyl rubber plug and aluminum-plastic combination cap showed excellent package integri-ty.CONCLUSION COP can be used in the storage and transport of human albumin.
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