Asp Global Manufacturing Gmbh

Doug Vo Truong

Todd Morrison

Lawrence Y Mok

A sterilization system includes a sterilization chamber, a processor, and a sterilization module. The sterilization module includes a frame assembly, an extraction assembly, and a carriage assembly. The extraction assembly is configured to extract a sterilant fluid from a cartridge and transfer the sterilant fluid to the sterilization chamber. The carriage assembly includes a motor, a carriage body, and a translating flag. The carriage body is configured to receive the cartridge. The translating flag is configured to move from a first position to a second position relative to the carriage body in response to the carriage body receiving the cartridge. The sensor is configured to detect movement of the translating flag from the first position to the second position.

Apparatus and method for detecting improper positioning of removable component of sterilizing system

A method of using a vacuum chamber to assist in detecting and removing moisture from an instrument having a lumen, e.g., an endoscope is disclosed. Second derivatives of pressure with respect to time are calculated and differences therebetween summed. These summations may be compared to a threshold value to determine whether residual moisture remains on the instrument in the chamber. The vacuum chamber may include a rack for hanging instruments having lumens, such as endoscopes.

Apparatus and method for detecting moisture in a vacuum chamber

A self contained biological indicator is disclosed having a housing and an ampule disposed within the housing, the ampule having a first dome, a second dome and a sidewall. A cap may be coupled to the housing. The cap may include a projection that may be coupled to the ampule by, e.g., a friction fit. An insert may be disposed within the housing. The insert may include a well within which at least a portion of the bottom dome of the ampule may be disposed. The insert may also include a ramp that is angled relative to the central longitudinal axis of the ampule. The second dome of the ampule may contact the ramp. The insert may also include an arm or finger that extends above the well and has a stress concentrator disposed thereon such that it is also disposed above the second dome of the ampule and adjacent to the sidewall of the ampule. In use, the SCBI generates therein a first reaction force between the second dome of the ampule and the ram having a component directed transverse to a central longitudinal axis of the ampule. The component of the first reaction force causes a second reaction force between the sidewall of the ampule and the stress concentrator. The second reaction force breaks the ampule.

Self-contained biological indicator

A method of sterilizing medical instruments using a vacuum chamber connected to reservoir by a valve in a closed state is disclosed that includes placing instruments in a non-sterile state into a sterilization pack, opening a chamber, placing the pack into the chamber, closing the chamber, withdrawing a first volume of air from the chamber, changing a volume of liquid water into vapor, opening the valve, introducing sterilant into the chamber, introducing a second volume of air into the chamber, opening the chamber, removing the pack from the chamber, and removing the instruments in a sterile-state from the pack. The process may further include the steps of repeatedly determining pressure within the chamber, calculating second-derivative values of pressure with respect to time, and determining whether any local maxima exist in a plot of second derivative values that correspond to pressures above and/or below the triple-point pressure of water.

A method of using a vacuum chamber to assist in detecting moisture on an instrument, removing moisture from the instrument, and confirming dryness of the instrument is disclosed. The method may include the steps of opening a vacuum chamber; placing an instrument into the chamber, closing the chamber, withdrawing a first volume of air from the chamber; changing a volume of liquid water into vapor, introducing a second volume of air into the chamber, withdrawing the second volume of air from the chamber, changing a second volume of liquid water into vapor, introducing a third volume of air into the chamber, opening the chamber, and removing the instrument from the chamber in a dry state. This method may also include the steps of collecting pressure data corresponding to the pressure within the chamber while withdrawing the second volume of air from the chamber, calculating a first second-derivative value of pressure with respect to time corresponding to a pressure greater than approximately the triple-point pressure of water, calculating a second second-derivative value of pressure with respect to time corresponding to a pressure greater than approximately the triple-point pressure of water and a time subsequent to the time corresponding to the first second-derivative value, calculating a third second-derivative value of pressure with respect to time corresponding to a pressure less than approximately the triple-point pressure of water and a time subsequent to the time corresponding to the second second-derivative value, calculating a fourth second-derivative value of pressure with respect to time corresponding to a pressure less than approximately the triple-point pressure of water and a time subsequent to the time corresponding to the third second-derivative value, determining that the fourth second-derivative value is less than or equal to the third second-derivative value, determining that the second second-derivative value is less than or equal to the first second-derivative value. The vacuum chamber may include a rack for hanging instruments having lumens, such as endoscopes.

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Irvine, CA, United States of America

Doug Vo Truong