公开(公告)号：US5824553A

公开(公告)日：1998-10-20

申请号：US193712

申请日：1994-02-09

申请人： Patrick J. McCormick ,  James Jay Kaiser ,  Paul M. Eckardt

发明人： Patrick J. McCormick ,  James Jay Kaiser ,  Paul M. Eckardt

IPC分类号： C12Q1/22 ,  G01N31/22

CPC分类号： G01N31/226 ,  A61L2/206 ,  A61L2/28 ,  C12Q1/22

摘要： Structure for evaluating the efficacy of sterilization apparatus using either steam or ethylene oxide as sterilant is disclosed. The structure includes an insert of porous material having a cavity formed therethrough for retaining a biological or chemical indicator. The porous material has homogeneous porosity throughout. The insert of porous material and indicator are enclosed within an outer covering which is relatively impervious to penetration of gases and which provides restricted pathways to air and sterilant. The outer covering is provided with removable portions which are removed when the structure is used to evaluate ethylene oxide sterilization. Removal of the portions enlarges the existing pathways for ingress and egress of gases which may be appropriate in certain efficacy testing.

摘要翻译： 公开了用于评估使用蒸汽或环氧乙烷作为灭菌剂的灭菌装置的功效的结构。 该结构包括具有穿过其形成的空腔的多孔材料的插入物，用于保持生物或化学指示剂。 多孔材料贯穿整个孔隙。 多孔材料和指示剂的插入物封闭在相对不透气体的外覆盖物内，并且向空气和灭菌剂提供限制的途径。 外覆盖层设置有可移除部分，当该结构用于评估环氧乙烷灭菌时，该部分被移除。 这些部分的去除扩大了在某些功效测试中可能适合的气体进入和排出的现有途径。

公开(公告)号：US5968807A

公开(公告)日：1999-10-19

申请号：US837666

申请日：1992-02-14

申请人： James Jay Kaiser

发明人： James Jay Kaiser

IPC分类号： C12M1/20 ,  C12M1/28 ,  C12N1/20 ,  C12M1/34 ,  C12Q1/22

CPC分类号： C12M37/06 ,  C12M23/08 ,  C12M23/22 ,  C12M23/24 ,  C12M23/32 ,  C12M23/38 ,  C12M41/26 ,  C12M41/36

摘要： A heat stable culture medium is prepared by substituting glycerol for carbohydrate components such as dextrose that are prone to Maillard reactions. A preferred medium contains pancreatic digest of casein, soytone, soluble starch, a phosphate buffer system, a salt, a pH indicator, and glycerol as a primary carbon source. The culture medium is pH and color stable when exposed to steam sterilization, including post-manufacture steam sterilization when used as the medium of a self-contained biological indicator. A self-contained sterility indicator device contains a flexible cylindrical tube having an opening at one end. The tube contains a submicron screen as a gas transmissive, bacteria impermeable window, an adsorbent wick bearing at one end viable microorganisms, and a frangible glass ampule containing the culture medium. The end of the wick containing microorganisms is located away from the ampule and adjacent the screen. A cap that seals the tube opening has an open position, and a closed position that seals the window and prevents media evaporation. During sterilization, the microorganisms adjacent the screen are exposed directly to sterilant. After sterilization, the cap is moved to the closed position, and the ampule is broken by applying pressure to sides of the flexible tube to release the culture medium. The medium is adsorbed by the wick and transported to the end containing microorganisms. After incubation, the device is examined to determine from the color of the indicator whether or not microorganism growth has occurred.

摘要翻译： 用甘油代替倾向于美拉德反应的葡萄糖等碳水化合物成分制备热稳定的培养基。 优选的培养基包含酪蛋白，大豆油，可溶性淀粉，磷酸盐缓冲体系，盐，pH指示剂和作为主要碳源的甘油的胰酶消化。 当暴露于蒸汽灭菌时，培养基的pH值和颜色稳定，包括用作独立生物指示剂的培养基的后制造蒸汽灭菌。 独立的无菌指示器装置包含一端具有开口的柔性圆柱形管。 该管包含亚微米屏幕作为气体透过的细菌不渗透窗口，一端承载活菌的吸附芯，以及含有培养基的易碎玻璃安瓿。 包含微生物的芯的末端位于远离安瓿和邻近筛网的位置。 密封管开口的盖子具有打开位置，并且封闭位置，其密封窗口并防止介质蒸发。 在灭菌过程中，屏幕附近的微生物直接暴露于消毒剂中。 灭菌后，盖子移动到关闭位置，并通过向柔性管的侧面施加压力来破坏安瓿，以释放培养基。 介质被芯吸附并运送到含有微生物的末端。 孵育后，检查该装置以根据指示剂的颜色确定微生物生长是否发生。