Catalog excerpts

Appl_PAT_Equipment_for_Inline_Dilution_Processes - 1

sartoriusstedim biotech Process Analytical Equipment for Monitoring, Control and Cost Optimization of Inline Dilution Processes turning science

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Appl_PAT_Equipment_for_Inline_Dilution_Processes - 2

Automated inline dilution is a promising alternative to conventional large-scale pharmaceutical and biopharmaceutical manufacturing of diluted products. The advantages are obvious: Bulky, expensive storage vessels that require extensive maintenance, equipment administration and validation no longer need to be used and the quality of the final product is improved. However, inline monitoring and control of the dilution process is mandatory to ensure the correct product composition. State-of-the-art process analytical tools, such as near infrared spectroscopy (NIR) and refractometry, are...

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Appl_PAT_Equipment_for_Inline_Dilution_Processes - 3

Advantages of Inline Dilution Automated inline dilution provides significant advantages in upstream and downstream biopharmaceutical processes. Over the past decade, fermentation and cell culture yields, as well as production volumes, have been rapidly increasing, creating the need for ever-larger equipment. Processes designed for a certain volume may now require double capacities due to increased product yield. However, doubling the vessel volume is not always easy: Is there room at my manufacturing site for a bigger vessel? Classical Process Ingredients Water | Diluent Mixing tank for...

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Appl_PAT_Equipment_for_Inline_Dilution_Processes - 4

PAT Monitoring and Control Tools for Inline Dilution Ingredients Water | Diluent Process refractometer Monitoring and control of binary solutions Process refractometer | Inline NIR spectrometer Monitoring and control of the dilution process Inline NIR spectrometer – ompleteness C recipe control – oncentration C of ingredients – omogenity H Mixing tank to prepare concentrated solution (500 liter) Water |  Diluent Storage tank (1,000 liter) Inline NIR spectrometer – roduct concentration P – ndpoint determination E – rocess trajectories P Skid for inline dilution Production tank | Fermenter...

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Appl_PAT_Equipment_for_Inline_Dilution_Processes - 5

Process Refractometry Monitoring using process refractometry enables the concentration to be determined and liquid or paste-like product streams to be identified. Typical applications for inline dilution are identification and Process refractometer quality assurance of – Concentration determination stock solutions, as well of binary solutions as determination of the – Sum parameter for complex concentration of the solutions target diluted product in binary processes. In the first case, several ”ideal” stock solutions are employed as references to define the acceptable range of a refractive...

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Appl_PAT_Equipment_for_Inline_Dilution_Processes - 6

The PAT strategy has to be adapted to the complexity of a dilution process. How many streams are combined simultaneously and | or sequentially? How high are the batch-to-batch variations of my stock solution and my diluent? How homogeneous are my stock solution and my target diluted product? However, the most important question to answer is: What do I really need for optimal monitoring and control of my inline dilution process? As every process is different, no general solution can be provided. Risk analysis is often helpful to develop the optimal process control strategy: Which are the...

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Appl_PAT_Equipment_for_Inline_Dilution_Processes - 7

Sartorius Process Analyzers – Integrated Solutions for Inline Dilution Processes All Sartorius process analyzers are specially designed for the continuous use under harsh process conditions, without the need for constant maintenance or vigilance. The BioPAT®Reflex PMD700 process refractometer series enable online and real-time monitoring and control by determining the refractive index of samples. This series delivers the highest accuracy available worldwide. Its field-proven technology in combination with integrated process automation ensures fast response times and the highest precision....

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Appl_PAT_Equipment_for_Inline_Dilution_Processes - 8

For further contacts, visit Europe Germany Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen Phone +49.551.308.0 Fax +49.551.308.3289 Sartorius Stedim Systems GmbH Robert-Bosch-Strasse 5 - 7 34302 Guxhagen Phone +49.5665.407.0 Fax +49.5665.407.2200 France Sartorius Stedim Biotech S.A. ZI Les Paluds Avenue de Jouques- CS 91051 13781 Aubagne Cedex Phone +33.442.845600 Fax +33.442.845619 Italy Sartorius Stedim Italy S.p.A. Via dell'Antella, 76/A 50012 Antella-Bagno a Ripoli (FI) Phone + Fax...

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