Sartorius Stedim Biotech Gmbh

G-con Manufacturing, Inc.

Sartorius Biotech Gmbh

Sartorius Ag

Maik Jornitz

Oscar-Werner Reif

Christian Oldendorf

Reinhard Baumfalk

Ralf Lausch

Stefan Schlack

Troy Arledge

Jens Meyer

Sidney Backstrom

A method for the preparing mixtures of pharmaceutical or biopharmaceutical substances (&#x2033;) includes arranging a preparation container (&#x2033;) already made up with ingredients in a receptacle () of a device (&#x2033;) feeding a fluid () from a storage container (&#x2033;) into the preparation container (&#x2033;) via a feed line (), preparing the ingredients with the fluid (&#x2033;) into a substance mixture (&#x2033;), and removing the substance mixture (&#x2033;) from the preparation container (&#x2033;) into a receiving container via a discharge line (&#x2033;). A device also is provided for carrying out the method.

Use of a device and a method for preparing mixtures of pharmaceutical substances

The present invention includes a removable utility unit and/or removable utility room for providing one or more utilities to at least one of a controlled air, a sealable, a sterilizable, a sanitizable cleanroom comprising: at least one of a utility connection selected from air, water, gas, or electricity; and a substantially hermetic connector between the removable unit and the cleanroom, wherein the at least one of air, water, gas, or electricity are connectable to matching utility inputs in the cleanroom.

Modular parts that supply utilities to cleanroom, isolation or containment cubicles, pods, or modules

A method and a connector unit for connecting two or more structures wherein at least one of the two or more structures being connected is a mobile structure validatable for pharmaceutical manufacturing or patient care. The connector unit comprises of an alignment system, a sealing, and a fixation system. The method for using the connector unit comprises of aligning the two or more structures to dock the two or more structures together, sealing the two or more structures, or one or more structures and an environment air tight with a seal or a sealing system, and affixing the two or more structures together to prevent relative movement of the two or more structures, or breakage of the seal or seal system.

Method for connecting modular mobile rooms

A method and an apparatus are provided for carrying out integrity tests of at least one filter element, arranged within a filter housing, with porous filter materials. Sensors are provided for measuring the sound generated by a test fluid when it flows through the filter element. The method includes applying a test fluid to a first side of the filter materials of the filter element while maintaining a constant fluid pressure, measuring the body-borne sound and/or the vibrations caused by test fluid flowing through the filter materials by sensors, and comparing the body-borne sound and/or the vibrations with the body-borne sound and/or the vibrations of an integral, identical filter element, measured under identical conditions.

Method and apparatus for carrying out integrity tests of a non-wetted filter element

The invention relates to a filtration system and method for carrying out a process for the filtration of fluids, comprising at least one filtration device with at least one filtration element comprising readable data and a check and/or test apparatus to which the filtration device may be connected, by means of data and testing means lines. The check and/or testing device is connected to a process controller, by data exchange means, for regulation and control of the filtration process and the process controller is connected to a filtration databank, by means of data exchange means, which comprises data sets for at least one filter element and/or for each filtration device and/or for the filtration process. The invention further relates to a computer program product for carrying out a filtration process on fluids whereby program components may be called up from a program memory which support the carrying out of the filtration process.

Device, method and computer program product for carrying out a process for the filtration of fluids

The invention relates to a device for carrying out integrity tests on filter elements by means of test gases, comprising a device housing (), with an electronic controller (), arranged therein for regulation and control of the progress of a test programme for filter elements, a filter housing (), for housing a filter element () under test, a pneumatic unit (), connected to the controller () and the filter housing (), in particular for the generation and measurement of gas pressures, an electronic memory unit (), which may be connected to the filter element () under test and a communication unit ('), connected to the controller (), for the exchange of data between the controller () and the electronic memory element (). The communication unit (&#x2032;) is preferably embodied as an antenna (&#x2032;) and the electronic memory element () as a transponder (). In addition to the device a method for carrying out integrity tests and a computer programme product are also disclosed.

Device, method and computer programme product for carrying out integrity tests on filter elements

Device, method and computer program product for carrying out integrity tests on filter elements

The invention concerns a device and method for monitoring the integrity of filtering installations consisting of a filter housing () designed to perform integrity tests and for filtration, equipped with a plurality of filter elements () and an electronic testing and monitoring unit () designed for monitoring and performing integrity tests, said filter elements () having each a storage element and a communicating part () being connected to the monitoring and testing unit arranged in the filtering housing, whereon data of said electronic storage elements can be read. The invention also concerns a method for monitoring the integrity of filter installations by means of a plurality of filter elements () in a filter housing () and of an electronic testing and monitoting unit designed to monitor and perform integrity tests, data stored by electronic storage elements () arranged on the filter elements () capable of being exchanged with the monitoring and testing unit, identification data and other data concerning the filter elements derived from the electronic storage elements () capable of being selected and of constituting the basis for integrity monitoring and testing.

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Manorville, NY, United States of America

Maik Jornitz