TY - JOUR A1 - Bäuerle, Tim A1 - Ostertag, Edwin A1 - Drieschner, Tobias A1 - Lorenz, Anita A1 - Mannhardt, Joachim A1 - Lorenz, Günter A1 - Rebner, Karsten T1 - Cleaning in Place Konzept zum Dauerbetrieb optischer Sonden in der Prozessanalytik der Polymerextrusion T1 - Cleaning in place concept for continuous operation of optical probes in process analytics of polymer extrusion JF - Zeitschrift Kunststofftechnik = Journal of plastics technology N2 - Die kontinuierliche Erfassung von Qualitätsparametern ist eine zunehmende Anforderung in der Polymerextrusion. Die optische Spektroskopie kann diese Anforderung erfüllen, da sie neben der Farbe weitere Parameter wie beispielsweise chemische Eigenschaften, Trübungsgrad oder Partikelgröße erfasst. Dabei werden für Inline-Messungen im Extruder optische Sonden eingesetzt. Im laufenden Betrieb bilden sich Ablagerungen auf den Sondenfenstern. Dieser Beitrag präsentiert ein neues Cleaning in Place Konzept, mit dessen Hilfe die Fenster auch während der Produktion ohne Unterbrechung gereinigt werden können. Auch die Kalibrierung der Messtechnik ist dabei möglich. Das verhindert Rüstzeiten und sichert eine kontinuierliche Inline-Messung. N2 - The continuous monitoring of quality parameters is an increasing requirement in polymer extrusion. Optical spectroscopy can fulfill this requirement as it detects other parameters besides color, such as chemical properties, turbidity or particle size. Here, optical probes are used for inline measurements in the extruder. During operation, material can accumulate on the probe windows (window fouling). This article presents a new cleaning in place concept that allows windows to be cleaned without interruption during production. Additionally, the calibration of the measurement system is possible. This prevents set-up times and ensures a continuous inline measurement. Y1 - 2018 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bsz:rt2-opus4-19240 SN - 1864-2217 VL - 14 IS - 5 SP - 348 EP - 366 PB - Hanser CY - München ER - TY - JOUR A1 - Hitzer, Patrick A1 - Bäuerle, Tim A1 - Drieschner, Tobias A1 - Ostertag, Edwin A1 - Paulsen, Katharina A1 - Lishaut, Holger van A1 - Lorenz, Günter A1 - Rebner, Karsten T1 - Process analytical techniques for hot-melt extrusion and their application to amorphous solid dispersions JF - Analytical and bioanalytical chemistry N2 - Newly developed active pharmaceutical ingredients (APIs) are often poorly soluble in water. As a result the bioavailability of the API in the human body is reduced. One approach to overcome this restriction is the formulation of amorphous solid dispersions (ASDs), e.g., by hot-melt extrusion (HME). Thus, the poorly soluble crystalline form of the API is transferred into a more soluble amorphous form. To reach this aim in HME, the APIs are embedded in a polymer matrix. The resulting amorphous solid dispersions may contain small amounts of residual crystallinity and have the tendency to recrystallize. For the controlled release of the API in the final drug product the amount of crystallinity has to be known. This review assesses the available analytical methods that have been recently used for the characterization of ASDs and the quantification of crystalline API content. Well established techniques like near- and mid-infrared spectroscopy (NIR and MIR, respectively), Raman spectroscopy, and emerging ones like UV/VIS, terahertz, and ultrasonic spectroscopy are considered in detail. Furthermore, their advantages and limitations are discussed with regard to general practical applicability as process analytical technology (PAT) tools in industrial manufacturing. The review focuses on spectroscopic methods which have been proven as most suitable for in-line and on-line process analytics. Further aspects are spectroscopic techniques that have been or could be integrated into an extruder. KW - process analytical technology KW - hot-melt extrusion KW - amorphous solid dispersions KW - pharmaceutical manufacturing KW - vibrational spectroscopy KW - UV/VIS spectroscopy Y1 - 2017 U6 - http://dx.doi.org/10.1007/s00216-017-0292-z SN - 1618-2642 VL - 409 IS - 18 SP - 4321 EP - 4333 PB - Springer CY - Berlin, Heidelberg ER -