Abstract: A method of reducing resource utilization for sterile filter validation includes obtaining historical datasets that each include respective values of a plurality of parameters associated with a respective sterile filtration process for a respective protein molecule, and generating, by processing the plurality of historical datasets, a PCA model. Vectors of the PCA model correspond to differently weighted combinations of the plurality of parameters, and collectively define a model space. The method also includes obtaining a target dataset that corresponds to a sterile filtration process for a target protein molecule, and includes target values of the plurality of parameters. The method also includes mapping the target values onto the model space, determining whether the mapped target values fall within a normal operating region of the model and error space, and causing sterile filter validation to be selectively bypassed or not bypassed accordingly.

Abstract: The present invention is directed to methods for filling a container wherein the filled container has no headspace. The present invention is further directed to methods for stabilizing an aqueous drug substance solution by filling a container with the aqueous drug substance solution wherein the filled container has no headspace. The present invention is further directed to methods for detecting headspace in a container.

Abstract: The present invention is directed to methods for filling a container wherein the filled container has no headspace. The present invention is further directed to methods for stabilizing an aqueous drug substance solution by filling a container with the aqueous drug substance solution wherein the filled container has no headspace. The present invention is further directed to methods for detecting headspace in a container.

Abstract: The present invention is directed to methods for filling a container wherein the filled container has no headspace. The present invention is further directed to methods for stabilizing an aqueous drug substance solution by filling a container with the aqueous drug substance solution wherein the filled container has no headspace. The present invention is further directed to methods for detecting headspace in a container.

Abstract: The present invention is directed to methods for reducing immunogenicity of a drug product, utilizing filling a container wherein the filled container has no headspace. The present invention is further directed to methods for stabilizing an aqueous drug substance solution by filling a container with the aqueous drug substance solution wherein the filled container has no headspace. The present invention is further directed to formulations of drug substances with reduced immunogenicity.

Abstract: The present invention is directed to methods for filling a container wherein the filled container has no headspace. The present invention is further directed to methods for stabilizing an aqueous drug substance solution by filling a container with the aqueous drug substance solution wherein the filled container has no headspace. The present invention is further directed to methods for detecting headspace in a container.

Abstract: A process for enriching a crude ammonia stream having moisture and/or metal impurities and/or gas impurities therein. The crude ammonia stream is condensed to form a crude liquid ammonia stream. A distillation membrane or pervaporation membrane is contacted with the crude liquid ammonia stream to form an enriched ammonia vapor stream, which is removed as a permeate. When the crude ammonia stream originates from a manufacturing tool, the enriched ammonia vapor stream may be recycled to the manufacturing tool. There is also an apparatus for enriching a crude ammonia stream.

Abstract: Improved methods for recovering helium gas from a multiple-stage consolidation furnace are disclosed. It has been discovered that a multi-valve can be actuated to respond to each of the stages of the consolidation furnace and their corresponding exhaust gases. By using this valve, the various exhaust gases can be directed to membrane separation units, PSAs, scrubbers and GRCs to remove, N2, O2, HCI, Cl2 and H2O from the gas streams and recover the helium gas.

Abstract: The present invention provides an improved cold gas-dynamic spraying process utilizing a carrier gas and small-diameter particulates whereby the particulate-laden carrier gas is directed to a ceramic filter unit where the particulates are separated out and the particulate-free carrier gas is analyzed and returned to the spraying process or to other gas purification systems.

Abstract: An ozone-oxygen gas stream produced by passing oxygen into an ozone generator is introduced into a membrane separation unit containing an ozone-permeable membrane. Ozone-enriched gas passes through the membrane and is recovered or it contacts a liquid or gas stream which contains ozone-reactive substances, thereby oxidizing the substances. The oxygen-enriched gas stream produced on the feed side of the membrane by permeation of ozone through the membrane is recycled to the ozone generator. Prior to being recycled, the oxygen-enriched stream may be purified to remove gaseous impurities which permeate through the membrane from the liquid or gas stream being treated.

Abstract: An ozone-oxygen gas stream is introduced into feed side of a membrane separation unit containing an elastomeric polymer membrane. Ozone-enriched gas passes through the membrane to a permeate zone and is contacted with an ozone-reactive substance-containing gas stream in the permeate zone, thereby oxidizing the substances or is removed from the permeate zone. Removal of the ozone-enriched gas from the permeate zone may be effected by purging the permeate zone with an inert gas and/or evacuating the permeate zone. Ozone-enriched gas removed from the permeate zone may be mixed with a liquid or gas stream which contains ozone-reactive substances in, for example, a venturi device, thereby oxidizing the substances.

Abstract: Hot optical fiber being drawn from a preform is cooled in a helium cooled heat exchanger by a two-stage process. In the first stage, in which the rate of draw of fiber through the heat exchanger is increased to the design draw rate, the rate of flow of helium to the heat exchanger is increased as the rate of draw of fiber is increased. Helium is withdrawn from the heat exchanger by a variable speed blower, and during the first stage the rate of withdrawal of helium from the heat exchanger is controlled primarily by the rate of flow of helium into the heat exchanger, and during the second stage, the rate of flow of helium to the heat exchanger is maintained constant and the rate of withdrawal is determined primarily by the pressure in the heat exchanger.

Abstract: Pervaporation membranes are used for removing volatile organic compounds from wastewaters. These pervaporation membranes are prepared by dispersing at least one hydrophobic adsorbent such as activated carbon uniformly into a polymer matrix.

Abstract: Ammonia is purified by a membrane unit to concentrate ammonia and/or ammonia and moisture. Moisture is removed in a temperature-swing adsorption unit. The resultant product of such purification is then partially condensed to remove light components of other impurities and then partially vaporized to produce a pressurized ammonia product lean in heavy components. If the feed stream is processed through the membrane unit first, the permeate stream will be lean in such impurities as carbon dioxide, nitrogen and methane. Moisture and any carbon dioxide not removed in the membrane unit is then removed by the adsorption unit. The resultant stream produced by action of the membrane and adsorption units is then partially condensed to produce a liquid lean in light impurities. Such liquid is then partially vaporized within a product pressure vessel to produce ammonia vapor lean in heavy impurities and at a required operational pressure.

Abstract: A method of processing semiconductor manufacturing exhaust gases for recovering at least hexafluoroethane in which a feed stream composed of the exhaust gases is passed through an adsorbent bed selected to adsorb oxygen, and also nitrogen if present, but not to appreciably adsorb the hexafluoroethane. As a result, a product stream, discharged from the adsorbent bed, has a higher concentration of hexafluoroethane than in the feed stream. In one embodiment, only a single adsorbent such as carbon molecular sieve is provided to adsorb the oxygen or a modified 4A zeolite could be used to adsorb both oxygen and nitrogen. When nitrogen is a potential constituent, layers of carbon molecular sieve and zeolite are provided to adsorb the oxygen and then the nitrogen, respectively. A third adsorbent, preferably 5A zeolite may be provided in addition to the foregoing two adsorbents to also adsorb any carbon tetrafluoride produced as a by-product.