Note 1: The Ethylene Oxide sterilization conditions must be obtained through validation confirmation and should be verified with monitoring and routine control during each sterilization cycle. The requirements for validation and routine control are outlined in GB 18279.
Note 2: This testing method is also applicable to A class Ethylene Oxide sterilizers equipped with preset Ethylene Oxide sterilization programs.
E.1 Equipment
E.1.1
Four process challenge devices are required as follows:
- The process challenge device consists of a stainless steel tube and a semi-closed chamber loaded with contaminated carriers. The steel tube and chamber are connected using O-ring seals and threaded connections. The only pathway into the chamber is through the length of the tube.
- The tube length is 4.55 m (nominal), with an inner diameter of 3.0 mm (nominal), giving a length-to-diameter ratio of 1500:1. The total internal volume is approximately 32 mL, of which 0.85 mL is the volume of the chamber.
E.1.2
Eight paper-plastic packaging bags that comply with GB/T19633, YY/T0698.4, and YY/T0698.5.
E.1.3
Contaminated carriers that comply with GB18281.1 and GB18281.2.
E.1.4
Appropriate recovery culture media for the contaminated carriers.
E.1.5
Cultivation pot.
E.2 Testing Steps
E.2.1
Select the Ethylene Oxide sterilization program to be tested.
E.2.2
Place one contaminated carrier in the test chamber of each process challenge device. Wrap each process challenge device with two paper-plastic packaging bags, sealing each bag with a sealing machine.
E.2.3
The process challenge device does not need initialization but should be maintained at 20°C ± 5°C for at least one hour before testing.
Note: This simulates the worst-case conditions.
E.2.4
Raise the Ethylene Oxide sterilizer to the sterilization temperature, load four wrapped process challenge devices into the Ethylene Oxide sterilizer chamber, and start the test cycle within 15 minutes after loading. The exposure time for the sterilant during the test cycle should be half of the time specified for that Ethylene Oxide sterilization cycle.
E.2.5
After the test cycle is complete, remove the process challenge devices from the Ethylene Oxide sterilizer.
E.2.6
Remove the contaminated carriers from the test chamber, culture them according to the manufacturer’s instructions, and verify compliance with the requirements of section 2.13.
E.2.7
Culture one unexposed contaminated carrier from the same batch according to the manufacturer’s instructions; it should show the presence of viable microorganisms. If not, the test is considered invalid, and retesting should be conducted.
E.2.8
Repeat the test two more times.
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