Abstract:
A method and apparatus for calibrating a sensor for determination of the concentration of a sterilant, e. g., hydrogen peroxide vapor, in a sterilization system. This invention provides a method for calibrating a sensor that is used for measuring the quantity of a sterilant in a system for delivering the sterilant, the method comprising the steps of: (a) generating reference calibration data, the reference calibration data showing a mathematical relationship between a measurable parameter, e. g. voltage, and a quantity of the sterilant, e. g., parts of sterilant per million parts of air (ppm), for a plurality of sensors; (b) generating sensor calibration data, the sensor calibration data showing a mathematical relationship between the measurable parameter and the quantity of the sterilant for an individual sensor; and(c) normalizing the sensor calibration data to compensate for the difference between the measurable parameter for the reference calibration data and the measurable parameter for the sensor calibration data, whereby data obtained by the individual sensor can be used to accurately determine the quantity of sterilant in the system.
Abstract:
A testing apparatus is disclosed which is useful for determining if air filters are providing clean/sterile air within acceptable aseptic processing and/or clean room operation acceptable contaminant levels. The advantage of the disclosed testing apparatus is that air filters may be tested "on-line" during a production process as opposed to the traditional testing methods which included removal of air filter for off-line testing. Less down-time is experienced using the disclosed testing system. A series of valves positioned at the outputs from the air filters, which allow communication with a particle counter, are controlled by a computer which sequentially activates the valves to test the contamination level of the air which passed through an air filter during the production process.
Abstract:
A method and apparatus for determining the dispersibility grade of particulate material by means of an image processing technique that employs machine vision. In one aspect, this invention provides a method for grading the dispersibility of particulate material, the method comprising the steps of: (a) obtaining an image, in digitized form, of a sample comprising reconstituted particulate material; (b) performing a series of image processing steps to determine the presence and magnitude of blobs; (c) performing a blob analysis to obtain data relating to the distribution of the particulate material in the sample; (d) comparing the result of the blob analysis with data in a database; and (e) determining the grade of said particulate material by means of the comparison. The sample of particulate material, which is typically in the form of a powder, is reconstituted preferably by means of agitating a container filled with the sample. The database suitable for use in this invention can be established by recording the results of a large number of tests performed by a powder quality grading authority. The grade levels are ssociated with several ranges that have emerged from the statistical analysis. In another aspect, this invention provides an apparatus suitable for grading the dispersibility of particulate material.
Abstract:
A pad (101) for transmitting acoustical waves between an ultrasound probe (107) and a target surface (105). The pad (101) includes a first layer (102) having a first porous portion which defines first layer pores therethrough. The first layer pores have a first layer pore dimension. The pad (101) further includes a second layer (103) having a first porous portion which defines second layer pores therethrough. The second layer pores have a second layer pore dimension. The second layer (103) is attached to the first layer (102) to define a space (104) therebetween. The first porous portion of the first layer (102) overlies the first porous portion of said second layer (103). An ultrasound couplant (100) is disposed in the space (104) defined between the first (102) and second (103) layers. The ultrasound couplant (100) has a molecule size that is less than or substantially equal to the first layer pore dimension and less than or substantially equal to the second layer pore dimension.
Abstract:
The need for a highly viscous couplant gel or water spray to form an acoustical couple for ultrasound testing is eliminated by employing an ultrasound probe module. A porous membrane (83) and an ultrasound probe (80) cooperate to define a chamber (90) which contains a liquid acoustical couplant. When pressure is applied to the liquid acoustical couplant, it passes through the porous membrane (83). The porous membrane (83) and chamber (90) are disposed such that ultrasound signals going to or away from the ultrasound probe (80) pass through the liquid acoustical couplant and porous membrane (83).
Abstract:
A method for conducting an ultrasound procedure on an object having a target surface. The method includes the step of providing an ultrasound probe having an acoustical wave emitting end portion. A pad for transmitting acoustical waves between the ultrasound probe and a target surface of an object also is provided. The pad includes a first layer having a first porous portion which defines first layer pores therethrough. The first layer pores have a first layer pore dimension. The pad further includes a second layer having a first porous portion which defines second layer pores therethrough. The second layer pores have a second layer pore dimension. The second layer is attached to the first layer so as to define a space therebetween. The first porous portion of the first layer overlies the first porous portion of the layer. An ultrasound couplant is disposed in the space defined between the first layer and the second layer. The ultrasound couplant has a molecule size which is less than or substantially equal to the first layer pore dimension, and which is less than or substantially equal to the second layer pore dimension. The method further includes the steps of placing the first porous portion of the second layer in contact with a target surface and placing the acoustical wave emitting end portion of the ultrasound probe in contact with the first porous portion of the first layer. The ultrasound probe is then activated.
Abstract:
The method includes the steps of providing a means for generating and receiving ultrasonic waves, a processing unit, and a means for agitating the flowable product. The means for generating and receiving ultrasonic waves is placed in ultrasonic contact with the flowable product and ultrasonic waves are directed into the flowable product. Ultrasonic waves are received using the means for gnerating and receiving ultrasonic waves and the received waves are transmitted to the processing unit where they are processed by establishing respective vectors for a plurality of reflective contents of the flowable product and by comparing the respective vectors to a predetermined, acceptable statistical range of vectors. The system includes a means for conveying a flowable product where the means for conveying includes an agitating means for agitating the flowable product.
Abstract:
The need for a highly viscous couplant gel or water spray to form an acoustical couple for ultrasound testing is eliminated by employing an ultrasound probe module. A porous membrane (83) and an ultrasound probe (80) cooperate to define a chamber (90) which contains a liquid acoustical couplant. When pressure is applied to the liquid acoustical couplant, it passes through the porous membrane (83). The porous membrane (83) and chamber (90) are disposed such that ultrasound signals going to or away from the ultrasound probe (80) pass through the liquid acoustical couplant and porous membrane (83).
Abstract:
A rnethod for calibrating a portable unit for measuring the concentration of a sterilant, e.g., hydrogen peroxyde vapor, said method comprising the steps of: (a) passing a sterilant vapor through a vessel, said vessel being submerged in a water bath, said portable unit being installed within said vessel, said portable unit responsive to the concentration of sterilant, the temperature, and the relative humidity for a test run; and (b) additionally determining the concentration of said sterilant by a titration method. Furthermore, a method for verifying that a sensor for measuring the quantity of sterilant in a system for delivering said sterilant has been calibrated accurately is disclosed, wherein said sterilant delivered in a stream of flowing air, said method comprising the steps of: (a) performing at least two static and (b) at least two dynamic test runs for said sensor to obtain readings of concentration of sterilant vapor; (c) comparing the results of said at least two static and (d) at least two dynamic test runs; (e) concluding that (1) the flow rate of air has changed or (2) the rate of addition of sterilant to the system has changed or (3) said sensor is unreliable if (i) if said readings of concentration of sterilant vapor determined in said static test runs remain substantially constant, but said readings of concentration of sterilant vapor deterrnined in said dynamic test runs vary substantially or (ii) if said readings of concentration of sterilant vapor determined in said static test runs vary substantially, but said readings of concentration of sterilant vapor determined in said dynamic test runs rernain substantially constant.
Abstract:
A sterilant monitoring assembly including an external housing defining an inlet and an outlet, and an internal flow path extending therethrough. An internal housing is located within the external housing and substantially surrounded by the internal flow path. The internal housing defines an interior sensor chamber therein. A sterilant sensor is positioned within the interior sensor chamber and is constructed to provide output signals corresponding to detected levels of sterilant within the interior sensor chamber. In one embodiment, a sterilant monitoring assembly includes an external housing defining an inlet and an outlet, and an internal flow path extending therethrough. An internal housing is located within the external housing and substantially surrounded by the internal flow path. The internal housing defines an interior sensor chamber having a sterilant sensor positioned therein, the sterilant sensor constructed to provide output signals corresponding todetected levels of sterilant within the interior sensor chamber.