Lumen sterilization device and method
a sterilization device and lumen technology, applied in the field of sterilization of medical devices, can solve the problems of difficult sterilization of the sterilizing agent to penetrate and sterilize the long narrow tubes of the medical device, and the equipment cannot withstand the heat or moisture of steam treatment, so as to reduce the pressure in the chamber, improve the penetration of antimicrobial vapor or gas, and improve the effect of sterilization
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example 1
Sterilization Results with No Dry Booster on the Lumen
[0089] In Example 1, biological indicators of 1.6×106 B. stearothermophilus spores were placed in the center of lumens of various lengths. The lumens were placed in a 72.5-liter STERRAD 50 sterilizer with a standard STERRAD 50 load double wrapped with CSR wraps. The chamber was evacuated to 0.4 torr, and 740 mg of 59 weight % hydrogen peroxide were injected for 5 minutes to provide 6 mg / L of hydrogen peroxide vapor in the chamber. After 5 minutes of injection and diffusion, the chamber was vented to atmospheric pressure, the lumens were removed, and the sterility results of the biological indicators were determined. The results are shown in Table 1 below.
TABLE 1Sterility Results From Tests with No Dry Booster(No. of Positives / No. of Samples)Lumen SizeSterility Results1 mm × 250 mm0 / 31 mm × 300 mm0 / 31 mm × 350 mm0 / 31 mm × 400 mm1 / 21 mm × 450 mm3 / 31 mm × 500 mm2 / 2
[0090] As shown by the results in Table 1 above, under the test co...
example 2
Sterilization of Lumens With A “Dry Booster”
[0092] In the experiments of Example 2, one end of an adaptor 200 as described in U.S. Pat. No. 5,580,530 was attached to an end of a 1 mm×400 mm stainless steel lumen to be sterilized. A biological indicator as described in Example 1 was placed in the center of each lumen. The second end of the adaptor 200 was attached to a 17 mm ID polyethylene scintillation vial 300 having varying lengths and therefore varying volumes, as shown in FIG. 13. The lumens 100 with the attached boosters comprising an adaptor 200 and vial 300 were exposed to hydrogen peroxide vapor under the conditions described in Example 1, the chamber was vented, and the sterility tests were measured. The results are shown in Table 2 below.
TABLE 2Sterility Results From Tests with a Dry Booster(No. of Positives / No. of Samples)Ratio of Dry Booster Volume / InternalVolume of 1 mm × 400 mm LumenSterility Results20:10 / 315:10 / 314:10 / 313:10 / 312:10 / 311:11 / 310:11 / 3 5:11 / 2
[0093] A 1 ...
example 3
Effects of Varying Evacuation Pressure and Evacuation Time
[0098] A plurality of 1 mm×500 mm stainless steel lumens 100, each containing a biological indicator, were placed in a 72.5 liter sterilization chamber as in Example 1. Dry boosters having various volumes were attached to the ends of certain of the lumens, as shown in FIG. 13. The remainder of the lumens were placed into the chamber without a dry booster. The chamber was evacuated to a pressure of either 0.4 torr or 0.1 torr and was maintained at the pressure of 0.4 torr or 0.1 torr for a time period of between 0 and 20 minutes, as noted in Table 3 below. A total of 740 mg of 59 weight % hydrogen peroxide was injected for 5 minutes to provide 6 mg / L of hydrogen peroxide vapor in the chamber. After 5 minutes of injection and diffusion, the chamber was vented to atmospheric pressure, the lumens were removed, and the sterility results of the biological indicators were determined. The results are shown in Table 3 below.
TABLE 3...
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