Abstract: New methodology, realizable with both manual and new semi-automatic imaging technology, has transformed both the inspection and the batch release Attribute Sampling Inspection for contaminating visible particles in injectable solutions into statistically replicable procedures. In this new non-destructive inspection procedure, a calibration curve relates NIST traceable measurement of maximum particle size to the rejection probability of the particle. Data for this calibration curve is determined with a graduated set of single durable stainless steel and glass microspheres that are sized with NIST traceability. Use of the calibration curve transforms the probabilistic variability of visible particle inspection data described by Knapp into the ‘simply replicable form’ required by the Attribute Sampling Tables. The present invention uses cutting edge imaging technology to achieve 1% sizing accuracy within 10 ?m from 50 to 1,000 ?m.

Abstract: Essential prerequisites for any injectable product are its sterility, its freedom from pathogens and its freedom from visible particle contamination . . . . These requirements must be satisfied prior to the release of an injectable product batch for sale and use. A major difficulty in responding to these assay requirements is the need for a size sensitivity difference of 100 or greater in determining the presence of viable pathogenic organisms and of non-viable random particle contaminants. The wide dynamic testing range cannot be satisfied in current art with a single non-destructive testing station. The present invention uses a special agitation procedure to generate separate liquid volumes containing the small viable and larger non-viable particle contaminants. This separation makes possible the introduction of sensing systems that have been optimized for each size range and that can operate in parallel without interference.

Abstract: A method and device for cleaning small volume pharmaceutical containers, comprising the simultaneous introduction of air and cleaning fluid as a moving film on the interior of said container, particularly in a neck region, to prevent re-deposit of contaminants thereon. The device comprises a nozzle for introduction of fluid such as water into the container and a tube within or otherwise juxtaposed with said nozzle for the simultaneous introduction of air. Cleaning is effected before initial medical application use.

Abstract: 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.

Abstract: A method for cleaning small volume pharmaceutical containers of particulate contamination, which includes the simultaneous introduction of air and cleaning fluid as a moving film on the interior of the container, particulary in a neck region, to prevent re-deposit of contaminant particulates thereon. A nozzle is used for introduction of fluid such as water into the container and a tube within or otherwise juxtaposed with the nozzle is used for the simultaneous introduction of air. Cleaning is effected before initial medical application use.

Abstract: A method and device for the accurate manual illumination inspection of transparent containers, such as pharmaceutically injectable vials, for particle contamination with light and dark particles. Opposing positioned and spaced first and second illumination sources are provided on opposite lateral sides of the container, with the container being positioned in an inspection volume at the illumination and physical midpoint (lumen light balance) between the illumination sources. A third illumination source with a diffusion screen is provided behind the inspection volume and container. Light from the opposing first and second light sources lateral to the container effects light reflection and scattering from white or light colored particles within the container and light from the third illumination source is visibly extinguished or blocked from reaching the inspector by black or dark colored particles.

Abstract: A method and device for the accurate manual inspection of three-dimensional (not flat) samples, such as pharmaceutically injectable vials, for particle contamination, which samples are illuminated with diffused (non-point) light. Opposing vertically positioned and spaced illumination sources are provided above and below the vial, with the vial being positioned in an inspection volume at the illumination midpoint (lumen light balance) between the illumination sources. The illumination midpoint, for light sources of equal intensity, is also the physical midpoint therebetween. Though the mid-point is not the position of maximum illumination for light sources, normal variation in manual inspections, e.g., variations in inspector height and deviations caused by manual handling of the vial, at the mid-point, result in minimal deviations in illumination, with resulting greater accuracy and replicability of inspection results.

Abstract: 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.

Abstract: 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.

Abstract: A process for manufacturing colored contact lenses and the lens manufactured by the process. A transparent contact lens having a central pupil section and a surrounding iris section has a colorant applied in a pattern to the entire iris section such that at least about ten percent of surface of the iris section is covered by colorant. The produced lens is capable of coloring the iris of the wearer, yet permits visualization of the structure of the iris. A fundamental color change, e.g. from brown to blue, is possible, yet the colored iris has a natural appearance.

Abstract: A process for manufacturing colored contact lenses and the lens manufactured by the process. A transparent contact lens having a central pupil section and a surrounding iris section has a colorant applied in a pattern to the entire iris section such that at least about ten percent of surface of the iris section is covered by colorant. The produced lens is capable of coloring the iris of the wearer, yet permits visualization of the structure of the iris. A fundamental color change, e.g. from brown to blue, is possible, yet the colored iris has a natural appearance.

Abstract: A method and apparatus for lighting a container which is to be inspected for particulate contamination comprising a first lighting means consisting of two angularly displaced light beams which create an angular shadow zone, a second lighting means of significantly lower intensity than said first lighting means and positioned intermediate the two light beams and a viewing means positioned in the shadow zone.

Abstract: A stopper for holding fluid in a container comprising a body of vulcanized elastomer having a convex surface, and, laminated to the convex surface without adhesive, a thin layer of thermoplastic, which forms a surface intended to contact the fluid and a side of an opening in the container.

Abstract: A colored contact lens comprising a pupil section and an iris section. A colored, opaque, intermittent pattern is deposited over the entire iris section, but a substantial portion within the interstices of the pattern is left uncolored. The lens is capable of coloring the iris of the wearer, yet permitting visualization of the structure of the iris. A fundamental color change, e.g. from brown to blue, is possible, yet the colored iris has a natural appearance.

Abstract: A molding process for manufacturing laminated stoppers having an elastomer core and thin thermoplastic liner where a sheet of thermoplastic liner material having an elongation of at least 450% and the vulcanizable elastomer core material are placed in a mold and molded at a temperature above the vulcanization temperature of the elastomer core but below the crystalline molding point of the thermoplastic liner.

Abstract: A pilfer-proof container for injectable fluid. An inner seal having an opening is fixedly secured to the neck of a bottle to hold a stopper. An outer seal covers the opening and is removably attached to the inner seal with non-flaking, non-rebondable adhesive.The sealing system allows inspection of the stopper after the inner seal has been attached.

Abstract: A method and apparatus for automatically inspecting liquid filled containers for particulate contaminants in relative size. The method comprising the steps of illuminating the liquid with a constant intensity light source, imaging the entire illuminated liquid volume, including the meniscus, into a plurality of image planes with fiber optic bundles, and monitoring the fiber optic bundles with an array of constant sensitivity photo transducers. Each photo transducer continually translates the illumination value of the vial image of an assigned and separate unit volume of the liquid-filled container into a voltage signal and each signal is monitored for a signal change indicative of particulate movement. The interfering output signal due to the meniscus decay is corrected, and the accept/reject decision is based upon a composite signal representative of all the differentiated signals received from the array of photo transducers.

Abstract: A method and apparatus for automatically inspecting liquid filled containers for particulate contaminants in relative size. The method comprising the steps of illuminating the liquid with a constant intensity light source, dissecting the image of the entire illuminated liquid volume, including the meniscus, with fiber optic bundles and monitoring the fiber optic bundles with an array of constant sensitivity photo sensors. Each photo sensor continually translates the illumination value of an assigned and separate cross sectional unit area of the vial image into a voltage signal and monitors each signal for a signal change indicative of particulate movement. The interfering output signal due to the meniscus decay is corrected, and the accept/reject decision is based upon a composite signal representative of all the differentiated signals received from the array of photo sensors.