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Sterilization Technology

Sterilization Technology

Ethylene oxide sterilization

Since 1950s, ethylene oxide (EO) has been used for medical sterilization. Researches of many scientists demonstrated that ethylene oxide was considered as a low-temperature chemical sterilization agent. EO has a good penetration performance at room temperature and not damage to the articles so that it is widely used in sterilization medical devices which can’t stand high temperature and high moist. EO is a simple epoxy compounds having a greater vapor pressure and strong penetration for articles. The sterilization principle is that EO combines to the bacterial protein amino, hydroxyl and carboxyl to react alkylation. As a result, proteins will loss of response genes and be interfered with normal chemical reactions and metabolism, which then lead to the death of microorganisms.

Ethylene oxide Sterilization validation technical process
1
  • Test before sterilization (bioburden, packaging fest and performance test of products)
  • 15days
2
  • Temperature modeling test and Fractional cycle( IPCD, EPCD and product sterility test)

  • 25-30 days
3
  • Three half cycles(IPCD, EPCD test)
  • 21 days

 

4
  • The 1st full cycle and test (EPCD test, EO/ECH test,packaging test and performance test of products)
  • 7days
5
  • The 2nd full cycle and test (EPCDtest, EO/ECH test,packaging test and performance test of products)
  • 7days
6
  • The 3rd full cycle and test (EPCDtest, EO/ECH test,packaging test and performance test of products)
  • 7days

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