Sartorius Stedim Biotech Gmbh

Magnus Andreas Stering

Nicolas Voute

Martin Dahlberg

Kai Gloth

Hartmut Langer

A method for quality assurance of filtration processes includes inserting a filter element () into a filtration device () in which filter elements () can be subjected to integrity tests. The method further includes associating the integrity information with each filter element () in a filter element database () connected to a shared data network () and saving the number of failed integrity tests performed on each filter element () as integrity information associated with that filter element. The saved tolerance setting has an auxiliary limit value, which when exceeded in a defined manner by the queried number of failed integrity tests performed on the identified filter element (), causes a warning message to be sent to a predetermined monitoring unit () and the resulting blocking of the selected integrity testing device () is maintained until a release message is received from the predetermined monitoring unit ().

Method for quality assurance of filtration processes

A method for improving reliability of an integrity or leak test includes determining at least one first parameter indicative of: a first volume of a sample, a first temperature of the sample, a first pressure of the sample and/or a first assessment of integrity of the sample. The method further determines at least one second parameter indicative of a deviation from the first parameter and at least one third parameter indicative of a second assessment of the integrity of the sample. The second assessment provides an indication of a passed or failed test. The method further determines whether the deviation has an impact on the indication of the second assessment. When the deviation is determined to have an impact on the indication of the second assessment, the method comprises identifying a possibility that the indication of the second assessment is incorrect.

Reliability of an integrity or leak test of a sample

A method of determining an internal volume (V) of a filter or bag device includes pressurizing the device to a first pressure (p) lower than a proof pressure by supplying a test gas, pressurizing the device to proof pressure (p), and at the same time, measuring the mass flow (m) or the volumetric flow of test gas, determining the gas temperature (T), and determining the internal volume (V) based on the equation for ideal gases, such that: V=m&#xd7;R&#xd7;T/(p&#x2212;p) where V is the internal volume, m is the mass flow, R is the gas constant, T is the gas temperature, pis the proof pressure and pis the first pressure. A computer program product and a testing apparatus for performing the above-mentioned method also are provided.

Method of determining an internal volume of a filter or bag device, computer program product and a testing apparatus for performing the method

A method for calibrating a pressure sensor includes connecting the pressure sensor to first and second fluid storage vessels; providing an initial fluid pressure at the pressure sensor and at the fluid storage vessels; and carrying out a pressure measurement of the initial fluid pressure at a time t. The method then disconnects the second fluid storage vessel from the pressure sensor and the first fluid storage vessel; provides a first fluid pressure at the second fluid storage vessel; and carries out a pressure measurement of the first fluid pressure at a time t. The method then connects the second fluid storage vessel with the pressure sensor and the first fluid storage vessel, so that a second fluid pressure between the initial and first fluid pressures is provided at the pressure sensor; and carries out a pressure measurement of the second fluid pressure at a time t.

Method and device for verification and/or calibration of a pressure sensor

An apparatus automatically carries out an integrity test on a filter device having a fluid inlet, a fluid outlet and a venting port. The apparatus includes a filter integrity testing device having a pressure sensor and/or a flowmeter. An inlet connector is connectable to the fluid inlet, is connected via a wetting liquid supply valve to a wetting liquid supply, and is connected via a drainage valve to a first drain. An outlet connector is connectable to the fluid outlet and via an outlet valve to the first or a second drain. A venting port connector is connectable to the venting port and via a measurement valve to the pressure sensor and/or flowmeter. The venting port connector also is connected via a venting valve to a venting pipe, and via a measurement gas valve to a measurement gas source. The valves are controlled by the filter integrity testing device.

Filter device test apparatus, filter integrity testing method and computer program product

There is a bag () that has at least one lateral gusset () and at least one port (), a source () of pressurized gas, elements () for measuring the pressure of the gas; &#x2014;there are two restraining plates and spacer strips. The bag is placed flat between the two restraining plates (). At least one spacer strip () is inserted between the two small walls of each gusset in order to prevent these walls from resting on one another. The port is connected to the gas source and the pressure measuring elements. The gas is sent under pressure into the bag, the expansion of the bag being limited by the restraining plates; then, the pressure drop in the bag is compared to a predefined threshold.

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Le Mesnil Le Roi, France

Magnus Andreas Stering