A method and device for the automated non-destructive single inspection of solutions in transparent containers for particle contamination, in injectable pharmaceutical solutions, with commercially viable acceptance percentages, while maintaining security within guidelines based on skilled human inspection. The containers are fully illuminated with forward scatter lighting with total light flux for detection of low contrast particles, with the size of the particles being evaluated by the maximum instantaneous increase of detector current as the particle moves through the detection zone. Simultaneously therewith, narrow detection volumes are back lighted with collimated light flux for detection of high contrast or dark particles, within the detection volume, by light extinction with a decrease of detector current from the normal non-particle illumination. The maximum pulsatile current decrease is used to determined the size of the particle. Separate illumination elements provide the forward scatter light and the back lighting, and separate, non-overlapping detector areas capture the separate increase and decrease of detector current. Either separate detectors with separate lenses are utilized for detection of the increase and decrease of detector current or mirrors are utilized to reflect the respective images through a single lens onto separated sections of a single detector element.
A method for the quantitative acquisition of flow patterns in fluid flows in which a medium (e.g., a gas or a liquid) and the particles contained therein and carried in the flow are set in motion in a transparent flow object. The method provides that a flow object is transilluminated by a laser light fanned out on a plane parallel to the longitudinal axis of the flow object. A scattering of the laser light by the particles is detected by a camera positioned at a right angle to the longitudinal channel axis and moving in the vertical and horizontal directions, and can be analyzed with an analysis unit connected downstream from the camera. The analysis unit is calibrated by quantitatively comparing an image, which has an object-to-image ratio and which is recorded inside the flow object by the camera, to an image having an object-to-image ratio and recorded outside the flow object.
A method for the substantially complete detection of all particles, within a predetermined size range, contained in an injectable solution comprising the steps of: a) pre-positioning particles in the container whereby rotation of the container causes substantially all of the particles in the injectable solution in the container to rotate in a shell volume adjacent the inner walls of the container, with said shell volume having a predetermined thickness; b) illuminating all the particles rotating within the shell volume with light; and c) detecting at least one of light scatter, light reflection and light extinction caused by said particles, with detectors having a depth of focus of detection in opposite volumes of the shell along a cross sectional diameter of the container perpendicular to the sensing array. Wherein the detectors are positioned, relative to the container whereby a focal point of detection which initially coincides with a focused plane through the vertical axis of the container, whereby the size of detected particles in the opposite volumes is accurately adjusted to an actual size by either calculation or by calculated offset of the focused planes; and wherein there are at least two directed lights, spaced 120.degree. from each other, with said containers being masked relative to each of said lights whereby each light illuminates different opposite volumes of the shell, with each of said volumes being bounded by a 90.degree. arc segment of the container, which is symmetrically disposed around the principal optical plane of the system.
A method, and device for automated non-destructive deterministic inspection of solutions in transparent containers for particle contamination, comprising the steps of pre-positioning particles in a zone distant from the vertical spin axis, specifically by tilting of the container; rapidly rotating the solution container; suddenly stopping the container, wherein particles within the solution, continue in motion; illuminating the container, while the particles are in motion, whereby particles within the container detectably reflect or block light. The container is tilted, prior to the spinning, by an acute angle ranging from 5.degree. to 85.degree., from a normal concentric vertical spin axis of the container, whereby effects of gravity are utilized to affect settling of particles to provide improved uniformity of spin energy transfer to the contaminating particles within the container, wherein tilting of the container, results in gravity providing sectoral positioning of the contaminating particles to the lowest portion of the container. Settling of particles is estimated according to Stokes Law, prior to illumination inspection. Spinning of the container is either while the container is in the vertical or tilted position.
A method to minimize noise is used to analyze data generated from a measurement system such as a flow cytometer. One embodiment of a computer-implemented method includes determining sums of different subsets of sample values. The method also includes determining the subset of the sample values having the largest sum. In addition, the method includes designating the subset of the sample values having the largest sum as a peak sum of the sample values. Such a peak sum minimizes the impact of noise leading to better determinations of particle identity, reaction identity, and the like.
A method of detecting unwanted objects or faults in containers containing a fluid or liquid includes: (a) moving the containers along a path of travel; (b) providing; a light source emitting light of a specific spectral distribution, wherein the containers and their contents are at least partly transparent or translucent at the specific spectral distribution; (c) providing a camera for detecting light at the specific spectral distribution, wherein (1) the path of travel intersects a field of view defined by the camera, and (2) the camera registers a sequence of digital images as the containers pass between the light source and the camera; (d) selecting a part of each of the digital images that corresponds to the outline of a specific container; and (e) processing a sequence of the parts of the digital images so as to detect the unwanted objects or faults in the specific container.