Effect of Different Sterilization Methods on Properties of Rubber Plungers for Prefilled Syringe |
Received:August 11, 2020 Revised:August 11, 2020 |
DOI:10.12136/j.issn.1000-890X.2022.03.0218 |
Key Words: BIIR;BIMSM;rubber plunger;prefilled syringe;high-pressure steam sterilization;γ ray radiation sterilization |
Author Name | Affiliation | E-mail | LIU Haihong* | 1.Zhengzhou University;2.Henan Key Laboratory of Advanced Nylon Materials and Applications | bestlhh@126.com | CUI Zhe | 1.Zhengzhou University;2.Henan Key Laboratory of Advanced Nylon Materials and Applications | | FU Peng | 1.Zhengzhou University;2.Henan Key Laboratory of Advanced Nylon Materials and Applications | |
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Abstract: |
Using brominated butyl rubber(BIIR) and brominated poly(isobutylene-co-p-methylstyrene)
(BIMSM) as the main materials,two kinds of vulcanizates and rubber plungers for prefilled syringe were
prepared according to appropriate formulas. The Effects of high-pressure steam sterilization and γ ray
radiation sterilization on the properties of BIIR and BIMSM vulcanizates and plungers were studied. The
results showed that,BIIR and BIMSM vulcanizates both had good physical properties after sterilization by the
two methods,and the high-pressure steam resistance and the radiation resistance of the BIMSM vulcanizate
were better than those of the BIIR vulcanizate. Within 180 days after high-pressure steam sterilization,the
physical and chemical properties of BIIR plungers met the requirements of YBB 00082004—2015. It was
found that right after the 40 kGy dose γ ray radiation sterilization,the properties of BIIR plungers also met
the requirements of YBB 00082004—2015. BIMSM was a better main material for making rubber plungers
for prefilled syringe. |
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