scholarly journals Distinct and Quantitative Validation for Predictive Process Modelling in Steam Distillation of Caraway Fruits and Lavender Flower Following a Quality-By-Design (QbD) Approach

Processes ◽  
2020 ◽  
Vol 8 (5) ◽  
pp. 594 ◽  
Author(s):  
Thorsten Roth ◽  
Lukas Uhlenbrock ◽  
Jochen Strube
Keyword(s):  
Quality By Design ◽  
Steam Distillation ◽  
Process Development ◽  
Model Development ◽  
Chemical Model ◽  
Maximum Information ◽  
Physico Chemical ◽  
Target Values ◽  
Different Types ◽  
Quantitative Validation

A quality by design (QbD) approach as part of process development in the regulated, pharmaceutical industry requires many experiments. Due to the large number, process development is time consuming and cost intensive. A key to modern process development to reduce the number of required experiments is a predictive simulation with a validated physico-chemical model. In order to expand the process expertise of steam distillation through maximum information, a model development workflow is used in this paper, which focuses on implementation, verification, parametrization and validation of a physico-chemical model. Process robustness and sensitivity of target values can be determined from the developed general model and design of experiments with statistical evaluations. The model validation is exemplified by two different types of plant systems, caraway fruits (Carum Carvi) and lavender flowers (Lavandula).

scholarly journals Distinct and Quantitative Validation Method for Predictive Process Modelling in Preparative Chromatography of Synthetic and Bio-Based Feed Mixtures Following a Quality-by-Design (QbD) Approach

Processes ◽  
2019 ◽  
Vol 7 (9) ◽  
pp. 580 ◽  
Author(s):  
Steffen Zobel-Roos ◽  
Mourad Mouellef ◽  
Reinhard Ditz ◽  
Jochen Strube
Keyword(s):  
Quality By Design ◽  
Process Development ◽  
Model Development ◽  
Process Modelling ◽  
Feed Consumption ◽  
Parameter Determination ◽  
Preparative Chromatography ◽  
Maximum Information ◽  
Target Values ◽  
Quantitative Validation

Process development, especially in regulated industries, where quality-by-design approaches have become a prerequisite, is cost intensive and time consuming. A main factor is the large number of experiments needed. Process modelling can reduce this number significantly by replacing experiments with simulations. However, this requires a validated model. In this paper, a process and model development workflow is presented, which focuses on implementing, parameterizing, and validating the model in four steps. The presented methods are laid out to gain, create, or generate the maximum information and process knowledge needed for successful process development. This includes design of experiments and statistical evaluations showing process robustness, sensitivity of target values to process parameters, and correlations between process and target values. Two case studies are presented. An ion exchange capture step for monoclonal antibodies focusing on high accuracy and low feed consumption; and one case study for small molecules focusing on rapid process development, emphasizing speed of parameter determination.

scholarly journals Physico-chemical evaluation of Rosmarinus officinalis L. essential oils

2005 ◽  
Vol 48 (6) ◽  
pp. 1035-1039 ◽  
Author(s):  
Ana Cristina Atti-Santos ◽  
Marcelo Rossato ◽  
Gabriel Fernandes Pauletti ◽  
Luciana Duarte Rota ◽  
Juarez Ciro Rech ◽  
...  
Keyword(s):  
Steam Distillation ◽  
Optical Rotation ◽  
Volatile Oil ◽  
Rosmarinus Officinalis ◽  
Chemical Compositions ◽  
Chemical Parameters ◽  
Alpha Pinene ◽  
Chemical Evaluation ◽  
Physico Chemical ◽  
Rosmarinus Officinalis L

Nineteen samples of Rosmarinus officinalis were extracted by steam distillation in a pilot plant and evaluated in terms of chemical compositions and physico-chemical characteristics. The volatile oil yields ranged from 0.37% (1999 harvest) to 0.49% (1998 harvest). Twenty components were identified in the oils. The major components were alpha-pinene (40.55 to 45.10%), 1,8-cineole (17.40 to 19.35%), camphene (4.73 to 6.06%) and verbenone (2.32 to 3.86%). The physico-chemical parameters averaged 0.8887 g/cm³ for specific gravity, 1.4689 for refractive index, and +11.82° for optical rotation, and there were no significant variations in either the chemical or physico-chemical data in the different years.

Antioxidants (BHA and BHT) in Breakfast Cereals

1965 ◽  
Vol 48 (4) ◽  
pp. 694-699
Author(s):  
David M Takahashi
Keyword(s):  
Gas Chromatography ◽  
Petroleum Ether ◽  
Chromatographic Method ◽  
Steam Distillation ◽  
Gas Chromatograph ◽  
Breakfast Cereals ◽  
Collaborative Studies ◽  
Different Types ◽  
Gas Chromatographic Method

Abstract Antioxidants (BHA and BHT) in different types of breakfast cereals were studied by argon ionization gas chromatography. Samples containing antioxidants were packed into the column, and antioxidants were eluted with redistilled petroleum ether. EIuates were concentrated under N2 and injected into a Barber-Colman Model 10 gas chromatograph. Recoveries ranged from about 92 to 110%. Results obtained by steam distillation-colorimetry methods were erratic. Colorimetric procedures were not free from interferences and could lead to highly erroneous results at the lower ppm levels. The gas chromatographic method is faster, simpler, and more accurate. Collaborative studies on corn and rice ready-to-eat breakfast cereals are recommended.

Cutting Tool Temperatures in Contour Turning: Transient Analysis and Experimental Verification

1997 ◽  
Vol 119 (4A) ◽  
pp. 494-501 ◽  
Author(s):  
D. A. Stephenson ◽  
T.-C. Jen ◽  
A. S. Lavine
Keyword(s):  
Transient Analysis ◽  
Cutting Tool ◽  
Process Development ◽  
Thermal Contact ◽  
Model Development ◽  
Cutting Speed ◽  
Depth Of Cut ◽  
Transient Conditions ◽  
Trouble Shooting ◽  
Model Predictions

This paper describes a model for predicting cutting tool temperatures under transient conditions. It is applicable to processes such as contour turning, in which the cutting speed, feed rate, and depth of cut may vary continuously with time. The model is intended for use in process development and trouble shooting. Therefore, emphasis is given in the model development to enable rapid computation and to avoid the need to specify parameters such as thermal contact resistances and convection coefficients which are not known in practice. Experiments were conducted to validate the predictive model. The model predictions with two different boundary conditions bound the experimental results. An example is presented which shows the utility of the model for process planning.

scholarly journals Relaxometry Models Compared with Bayesian Technique: Ganglioside Micelle Example

2020 ◽  
Author(s):  
Pär Håkansson
Keyword(s):  
Model Comparison ◽  
Spin Dynamics ◽  
Model Development ◽  
Relaxation Dispersion ◽  
Site Model ◽  
Research Areas ◽  
Bayesian Model Comparison ◽  
Physico Chemical ◽  
Complex Liquids ◽  
Bayesian Evidence

<div> <div> <div> <p>In this work a methodology to perform Bayesian model-comparison is developed and exemplified in the analysis of magnetic relaxation dispersion (NMRD) experiments of water in Ganglioside micelle system. The NMRD powerful probe of slow dynamics in complex liquids is obtained. There are many interesting systems to study with NMRD, such as ionic and Lyotropic liquids or electrolytes. However, to progress in the understanding of the physical chemistry of studied systems relatively detailed theoretical NMRD-models are required. To improve the models they need to be carefully compared, in addition to physico-chemical considerations of molecular and spin dynamics. The comparison is performed by computing the Bayesian evidence in terms of a thermodynamic integral solved with Markov chain Monte Carlo. The result leads to a conclusion of two micelle water sites, and rules out lower and higher complexity level, i.e., one and three sites. In contrast, and provided only with the quality of best fit, suggest a three site model. The two approximate selection tools, Akaike and Baysian information criterions, may lead to wrong conclusions compared to the the full integration. The methodology is expected to be one of several important tools in NMRD model development, however, is completely general and should find awakened use in many research areas. </p> </div> </div> </div>

scholarly journals HYPERGLYCEMIA IN ACUTE MYOCARDIAL INFARCTION: PROGNOSTIC MEANING AND NUTRITIVE CORRECTION

2018 ◽  
Vol 19 (1) ◽  
pp. 20-24
Author(s):  
O. V. Аlekseenko ◽  
V. M. Luft
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Intensive Care Unit ◽  
Emergency Medicine ◽  
Intensive Care ◽  
Target Values ◽  
Different Types

Currently the emergency medicine turned on the wide use of the special enteral nutritional cocktails like “Diabetes” to manage different types of hyperglycemia under various acute disorders. Under the conditions of resuscitation and intensive care unit (RICU) there looked into the possibility and efficacy of early monitoring of the hyperglycemia target values using the special enteral nutritional cocktails with the MI patients.

scholarly journals An improved physico-chemical model of hybridization on high-density oligonucleotide microarrays

2008 ◽  
Vol 24 (10) ◽  
pp. 1278-1285 ◽  
Author(s):  
N. Ono ◽  
S. Suzuki ◽  
C. Furusawa ◽  
T. Agata ◽  
A. Kashiwagi ◽  
...  
Keyword(s):  
High Density ◽  
Chemical Model ◽  
Oligonucleotide Microarrays ◽  
Physico Chemical

Process development in the Quality by Design paradigm: Modeling of Protein A chromatography resin fouling

2018 ◽  
Vol 1570 ◽  
pp. 56-66 ◽  
Author(s):  
Lalita Kanwar Shekhawat ◽  
Mili Pathak ◽  
Jayati Sakar ◽  
Anurag S. Rathore
Keyword(s):  
Quality By Design ◽  
Process Development ◽  
Protein A ◽  
Design Paradigm
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