Supercritical Fluid Sterilization Method

Supercritical Fluid Sterilization Method

US6149864
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A method is provided for sterilizing materials, particularly polymers, for drug delivery and implantation, wherein the material is treated with supercritical fluid carbon dioxide at pressures in the range of 2000 to 3000 psi (140 to 210 bar) and temperatures preferably between 30 and 45.degree. C. for periods between 20 minutes and six hours, more preferably between 0.5 and 2 hours. Agitation, pressure cycling, and the presence of water were found to enhance the sterilization method, which promotes diffusion of the supercritical fluid carbon dioxide into the cells of the microorganism to thereby alter the pH within the cells, killing them. The magnitude and frequency of the pressure cycling, as well as the process time and temperature, may vary according to the type and form of the material to be sterilized and the type of organisms to be killed.

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US006149864A United States Patent [19] [11] Patent Number: 6,149,864 Dill0w et al. [45] Date of Patent: Nov. 21, 2000 [54] SUPERCRITICAL FLUID STERILIZATION FOREIGN PATENT DOCUMENTS METHOD 39 04 513 A1 8/1990 Germany . . . . . WO 97/48848 [75] Inventors: Angela K. Dill0W, Minneapolis, Minn.; A1 12/1997 WIPO . Robert S. Langer, Newton, Mass.; Neil Foster, Ortarmon, Australia; J efi'rey S. OTHER PUBLICATIONS Hrkach> S0merVfl1e> M355 Lin et al. “Inactivation of Saccharomyces cerevisiae by . _ supercritical and subcritical carbon dioxide,” Biotechnol. [73] Assignee: Massachusetts Institute of Pmg. 8:458_461 (1992). Technology, Cambridge, Mass. Primary Examiner—Krisanne Thornton [21] Appl. No‘: 09/104,775 Attorney, Agent, or Firm—Arnall Golden & Gregory, LLP [22] Filed: Jun. 25, 1998 [57] ABSTRACT [51] Int Cl 7 A61L 2/00 A method is provided for sterilizing materials, particularly [52] U.s. Cl. ................................ .. 422/28, 422/32, 422/33 Iggafiyeggfesfig;afgggwfifglggI1rgggigfg;P;§5a;1;g>0;Vg§;;;g;gj [58] Field of Search .................................. .. 422/4, 28, 29, P pressures in the range of 2000 to 3000 psi (140 to 210 bar) and temperatures preferably between 30 and 45° C. for . periods between 20 minutes and six hours, more preferably [56] References Clted between 0.5 and 2 hours. Agitation, pressure cycling, and the Us, PATENT DOCUMENTS presence of water were found to enhance the sterilization method, which promotes diffusion of the supercritical fluid 422/32, 33, 38, 292, 295, 305, 307 4,263,253 4/1981 et al. .................................. .. 422/1 b ~ t th ~ ~ t th b 4348357 9/1982 Bithe“ ~~~~~~~~ ~~ ~~ 422/33 tf1:eC:elSl: k1fif§1Cf§§fa?§2”m°a iiiidi 4,687,635 8/1987 Kaehleretal. .. 422/33 P ’ g " g 5,073,203 12/1991 A1_Ghatta . . . . . . . . . . . . . N 422/33 and frequency of the pressure cycling, as well as the process 5,213,660 5/1993 Hossain et al. .. 162/5 time and temperature, may Vary according t0 the type and 5,723,012 3/1993 pages et a], N 523/15 form of the material to be sterilized and the type of organ- 5,725,579 3/1998 Fages et al. .. 623/16 isms to be killed. 5,869,123 2/1999 Osajima et al. . 426/330 5,877,005 3/1999 Castor et al. ...................... .. 435/286.1 5 Claims, 3 Drawing Sheets 6,149,864 otmzoum ®>_._._mOn_ C._U._O \\ Sheet 1 of 3 .z ._._mo 8_n._._o:amo:n: mz
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