Technical Specialist SME, PFS, CZ and Combination Products
二月 13, 2018
E-beam sterilization has many advantages; it is convenient, gentle and effective. E-beam sterilization can be performed continuously on product in its final package (e.g., product supplied in nests used in flexible fillers). Compared to steam sterilization, it operates at a much lower temperature, and is suitable for products having hard-to-reach areas (e.g., capped cartridges). Compared to gamma irradiation, it poses a much lower risk of degradation (due to shorter exposure times); compared to ethylene oxide exposure, it eliminates the risk of ethylene oxide absorption and subsequent leaching into drug product.
A point to note is that e-beam sterilization can cause a temporary discoloration (yellowish tint) in polymer products, including Daikyo Crystal Zenith® cyclic olefin polymer products. This is due to the presence of short-lived free radicals. However, after the quenching of these radicals, there is no resultant risk to drug product, and in particular, biologic products.
For more information on West products, or how e-beam sterilization can be successfully employed for packaging products, visit the Knowledge Center or contact your Account Manager, or Technical Customer Support representative.
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Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.