Pharmaceutical Systems, Inc.

Thomas F Cullen

Robert J Thrash

Jimmy Fisher

Davoud Khorzad

Ross A Caputo

Robert R Reich, Jr

Apparatus and method for testing one or more sterilization indicators (e.g., biological indicators or chemical indicators) or other articles by contacting them under controlled sterilization conditions with a flowing antimicrobial gas containing hydrogen peroxide vapor are disclosed. This invention also provides apparatus and method for testing sterilization processes that use a flowing antimicrobial gas containing hydrogen peroxide vapor under controlled sterilization conditions, or for testing materials for such processes under controlled sterilization conditions, or for testing both such processes and such materials under controlled sterilization conditions. There can be an essentially square-wave contact of the sterilization indicators or other articles with the antimicrobial gas (i.e., short rise time to reach full concentration of the antimicrobial gas in contact with the sterilization indicators or other articles and short fall time to remove all of the antimicrobial gas from contact with the sterilization indicators or other articles). A preferred way of generating a substantially constant flow of antimicrobial gas of substantially constant hydrogen peroxide concentration may be used to generate the antimicrobial gas. A preferred way of determining the hydrogen peroxide concentration in the antimicrobial gas may be used.

Apparatus for testing sterilization methods and materials

Methods are disclosed for determining the monotonic functional relationship between (A) the integrated absorbance of spectral energy within a spectral region of interest of an analyte (i) that decomposes during the time experimental spectral data for determining the relationship are being obtained, or (ii) whose spectral data are pressure sensitive at pressures below a given pressure, or (iii) that decomposes during the time the spectral data are being obtained and whose spectral data are pressure sensitive and (B) the concentration of the analyte before decomposition commences. Methods are also disclosed for using the monotonic functional relationship to determine the concentration of the analyte in an unknown from the integrated absorbance of spectral energy within the spectral region of interest for the unknown. The methods are useful for determining the concentration of gaseous analytes, such as hydrogen peroxide, whose concentrations must be accurately and rapidly determined in processes such as sterilization processes at the time the processes are being conducted.

Spectrophotometric determination of gas phase compositions

Apparatus and method for producing at high efficiency vaporization a precisely controllable, continuously adjustable gas-phase flow of a vaporizable liquid (e.g., hydrogen peroxide) in a carrier gas (e.g., air) are disclosed. The gas-phase product flow can be substantially continuous, low-temperature, unsaturated with respect to the vaporized vaporizable liquid, and of substantially constant vaporized vaporizable liquid concentration as a function of time. Fine particles of the vaporizable liquid are produced and introduced into the flow of carrier gas/vapor in a vaporization plenum with a sufficient flow of carrier gas/vapor to provide a curtain of carrier gas/vapor between substantially all of the fine particles of vaporizable liquid and the inner surface of the vaporization plenum.

Growing community of inventors

Des Plaines, IL, United States of America

Thomas F Cullen