Abstract: An apparatus for use with an isolator, including a crown for releasably joining with a beta port of the isolator, wherein the crown includes at least one anchoring support; a spring hook on at least one end of the at least one anchoring support; a needle block including at least one through hole for having a needle positioned therein, wherein the at least one needle is joined with tubing; a yoke; and a biasing element releasably joined with the yoke and the at least one anchoring support; wherein the needle block is releasably joined to the crown.

Abstract: Single-use integral chromatography unit having an inlet and an outlet, and comprising one or more plates or pairs of filter plates interposable between a pair of end plates. In certain embodiments, each of the filter plates comprises a polymeric framework with one or more membranes supported therein. The filter plates and end plates may be assembled to form a substantially fixed, substantially water-tight, integral stack. Fluid entering the unit through a common inlet passes the membrane or membranes of each filter plate substantially contemporaneously prior to exiting the unit through a common outlet (cf, “parallel” flow). The assembly is a modular design, as multiple pairs of plates can be stacked in a suitable holder to form a single chromatography unit.

Abstract: A filtration module is provided, the module including at least one filtration packet containing filtration media or one or more membranes, such as a stack of membranes, the at least one filtration packet having one or more fluid ports, the one or more fluid ports being surrounded by a primary seal and a secondary seal spaced from the primary seal. The secondary seals are designed to maintain sterility of the assembly during shipping, handling and/or installation. A removable film may cover one or more fluid ports to maintain sterility prior to use.

Abstract: A funnel-less filtration device that attaches directly to a storage container such as a cell culture media bottle. The device includes a filter collar containing one or more membranes, an inlet with a coupling device for attaching the filter device to a supply of liquid to be filtered, an outlet at a lower portion of the collar, a vacuum port in the collar below the membrane(s) and a filtered vent in the collar above the membrane(s).

Abstract: Processes and systems for filtering a liquid sample are provided. Batches of a liquid sample can be routed to two or more cycling tanks (e.g., first and second cycling tanks). Upon filling a first cycling tank, a first batch of the liquid sample can be routed to a filtration assembly by a continuous diafiltration process that includes routing produced retentate back to the first cycling tank or to a collection vessel. Upon filling a second cycling tank, a second batch of the liquid sample is routed to the filtration assembly by a continuous diafiltration process that includes routing produced retentate back to the second cycling tank or to the collection vessel. The filling and continuous diafiltration of batches of the liquid sample continues to alternate between the two or more cycling tanks until a total product volume is processed.

Abstract: Port protection device particularly suited for an encapsulated filter unit. In certain embodiments, the protection device comprises a main body defining an internal region configured to receive a port or the like protruding from an encapsulated filter. In certain embodiments, the main body includes a slot that allows for easy removal of the protection device from the port or the like. A tube management system may be provided to receive and hold tubing. One suitable tube management system includes two spaced tangs that extend from the main body of the protection device and are configured to cooperatively receive and hold tubing between them.

Abstract: Depth filters with optimized head space are provided, as well as methods of optimizing the head space in depth filters, and methods of filtration with depth filters having optimized head space, including clarification of flocculated feed streams where pretreatment may include any of lowering cell culture pH, addition of polymers (uncharged or charged), or addition of salts to precipitate out solubilized impurities resulting in high insoluble biomass.

Abstract: A fluid filtration device containing a composite filter media having a coarse porous polymeric nonwoven interlayer located between first and second polymeric fiber containing filter mats. The fiber diameters of the fibers in the first and second filter mats are different from each other, and each filter mat has a different pore size rating. The first and second polymeric fibers in the filter mats can be electrospun nanofibers. The interlayer has a coarser pore size when compared to the either the first or second filter mats, such that the resulting composite media has an increased dirt holding capacity compared to filter layers that are layered directly over each other without the presence of a coarse interlayer therebetween.

Abstract: Treatment methods for reduction of (1?3)-?-D-glucan leachables from cellulose-containing filter materials are described.

Abstract: A testing method that includes the steps of evacuating air from a container to a negative atmospheric pressure, the container being a collapsible, flexible container, and comprising at least two opposing flexible walls, wherein a surface of at least one of the walls internal to the container comprises a plurality of channels or recessed features on said at least one wall and monitoring a mass flow or a state of vacuum so as to determine the integrity of the container. The container can be of any size or conformation, with or without attached fittings.

Abstract: Methods of calibrating a pH sensor fixed within an enclosed vessel are disclosed. The methods include introducing a buffer into the enclosed vessel, introducing a gas mixture comprising CO2 into the enclosed vessel, measuring a pH signal of the solution, measuring a CO2 concentration of a headspace gas of the solution, and calculating a pH value with a buffer calibration curve. The methods include calculating a calibration parameter with a sensor calibration curve and calibrating the pH sensor with the calibration parameter. Reactor systems are also disclosed. The systems include an enclosed reactor, a pH sensor, a CO2 sensor, a temperature control subsystem, and a controller. Methods of facilitating pH sensor calibration without sampling in a bioreactor system are also disclosed. The methods include providing a controller and providing instructions to operably connect the controller to the pH sensor and the CO2 sensor.

Abstract: The present invention provides compact spiral-wound filter elements having cassette-like performance. The invention further provides filtration systems (e.g., TFF systems) and processes (e.g., SPTFF processes) employing compact spiral-wound filter elements having cassette-like performance.

Abstract: Filter elements for perfusion systems and methods are provided. A filter element sheet includes a microporous membrane having a mean pore size of at least about 0.65 ?m and a feed spacer comprising woven fibers and having an open area of at least about 35%. The filter element sheet can be arranged within a filter element, for example, in a spiral-wound format or in a cassette format. A perfusion system includes at least one filter element and a pump configured to control flow of a liquid feed through the at least one filter element.

Abstract: The invention concerns an installation for treating biological liquid by viral inactivation, comprising a main supply valve (4) for suppling biological liquid to treat, a first line (2) downstream of said valve and provided with a first main tank (7), a second line (3) downstream of said valve and provided with a second main tank (14), said second line being in parallel with said first line, and a third main tank (11) disposed at an outlet both from said first line and said second line and configured to be successively supplied by said first main tank and by said second main tank; said installation being configured such that in each of said first, second and third main treatment tanks, a determined volume of acid and a determined volume of base are introduced at least so as to adjust a pH of said biological liquid and to regulate a rate of drainage flow of said third main treatment tank so as to provide a continuous rate of flow of treated biological liquid at an outlet from said installation.

Abstract: A funnel-less filtration device that attaches directly to a storage container such as a cell culture media bottle. The device includes a filter collar containing one or more membranes, an inlet with a coupling device for attaching the filter device to a supply of liquid to be filtered, an outlet at a lower portion of the collar, a vacuum port in the collar below the membrane(s) and a filtered vent in the collar above the membrane(s). Optionally, the device may include a filtrate reservoir attached to the outlet, preferably by a threaded connection. Optionally, the upper opening to the filter collar is selectively and removably sealed with a lid until used. The lid is then removed the filter device inverted over a storage container such as cell culture media bottle and the two are attached via the upper opening of the filter collar. The assembly is then inverted so the supply container is above the filter device.