scholarly journals mAb Production Modeling and Design Space Evaluation Including Glycosylation Process

Processes ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 324
Author(s):  
Ou Yang ◽  
Marianthi Ierapetritou
Keyword(s):  
Product Quality ◽  
Design Space ◽  
Kriging Model ◽  
High Productivity ◽  
Process Understanding ◽  
Different Temperatures ◽  
Model Training ◽  
Dynamic Kriging ◽  
Limited Input Data ◽  
Production Modeling

Due to high demand, monoclonal antibodies (mAbs) production needs to be efficient, as well as maintaining a high product quality. Quality by design (QbD) via predictive process modeling greatly facilitates process understanding and can be used to adjust process parameters to further improve the unit operations. In this work, mechanistic and dynamic kriging models are developed to capture the protein productivity and glycan fractions under different temperatures and pH levels. The design of experiments is used to generate input and output data for model training. The dynamic kriging model shows good performance in capturing the dynamic profiles of cell cultures and glycosylation using only limited input data. The developed model is further used for feasibility analysis, and successfully identifies the operating design space, maintaining high productivity and guaranteed product quality.

Studi Kualitas Puding Melalui Pendekatan Six Sigma Studi Kasus Di Pt. Keong Nusantara Abadi

2019 ◽  
Vol 1 (1) ◽  
pp. 44
Author(s):  
Rony Trizudha ◽  
Sri Rahayuningsih ◽  
Ana Komari
Keyword(s):  
Quality Control ◽  
Quality Improvement ◽  
Production Process ◽  
Product Quality ◽  
Six Sigma ◽  
Improve Quality ◽  
High Productivity ◽  
Fierce Competition ◽  
And Control ◽  
Technology Advances

As technology advances at this time, players in business are aware of the importance of product quality in the increasingly fierce competition in the industrial world due to the emergence of many similar companies. Therefore, companies must be able to compete to meet customer desires and try to retain customers. To maintain customers and their marketing areas, companies must have high competitiveness in order to survive by prioritizing quality improvement, increasing efficiency and increasing productivity to improve quality because by increasing quality, products can be accepted among consumers so that company goals can be fulfilled. Therefore, the company must carry out effective quality control which will result in high productivity, lower overall cost of making goods and the factors that cause production failure to be minimized. To improve quality, use the six sigma method, DMAIC and seven tools so that it can be known the cause of the damage and what actions are taken so that there needs to be a controversy to stabilize the processes of the production process so that we can know what percentage of damage and what factors cause damage, therefore there must be measurements and recommendations for improvement and control to reduce the causes From the analysis, it was found that the dent cup was 20.36%, the lid was 21.36% less dense, the lid was damaged in the finished product 18.72%, the cup was 19.28% less thick, the packaging was flexible 20.55%Seiring kemajuan teknologi pada saat ini pelaku di bisnis menyadari akan pentingnya kualitas produk dalam persaingan dunia industri yang semakin ketat karena banyak bermunculan perusahaan-perusahaan sejenis. Oleh sebab itu perusahaan harus dapat bersaing untuk memenuhi keinginan  pelanggan dan berusaha dapat mempertahankan pelanggan. Untuk mempertahankan pelangan dan wilayah pemasaranya perusahaan-perusahaan harus mempunyai daya saing yang tinggi untuk dapat bertahan dengan mengutamakan peningkatan mutu, peningkatan efisiensi dan peningkatan produktivitas untuk meningkatkan kualitas karena dengan peningkatan kualitas, produk dapat diterima di kalangan konsumen sehingga tujuan perusahaan dapat terpenuhi. Maka dari itu perusahaan harus melakukan pengendalian kualitas yang efektif akan menghasilkan produktivitas yang tinggi, biaya pembuatan barang keseluruhan yang lebih  rendah serta  faktor-faktor yang menyebabkan kegagalan produksi akan dapat ditekan sekecil mungkin. Untuk meningkatkan kualitas mengunakan metode six sigma, DMAIC dan seven tools agar dapat diketahui penyebab  kerusakan  dan  tindakan  apa  saja  yang dilakukan sehingga perlu ada kontror untuk menstabilkan  peoses proses produksi sehinga dapat di ketahui berapa persen  kerusakan dan faktor-faktor apa saja yang menyebabkan  kerusakan maka dari itu harus ada pengukuran dan  rekomendasi perbaikan serta melakukan kontrol untuk mengurangi penyebab kerusakan. Dari hasil analisis  di ketahui cup  penyok 20,36%, lid kurang  rapat  21,36%, lid  rusak  pada produk jadi 18,72%,cup kurang tebal 19,28 %kemasan lentur 20,55%

scholarly journals Design Space and QbD Approach for Production of Drug Nanocrystals by Wet Media Milling Techniques

Pharmaceutics ◽  
2018 ◽  
Vol 10 (3) ◽  
pp. 104 ◽  
Author(s):  
Leena Peltonen
Keyword(s):  
Process Parameters ◽  
Design Space ◽  
Milling Process ◽  
Production Chain ◽  
Media Milling ◽  
Process Understanding ◽  
Poorly Soluble ◽  
Critical Process Parameters ◽  
Input Variables ◽  
Definition Of

Drug nanocrystals are nanosized solid drug particles, the most important application of which is the improvement of solubility properties of poorly soluble drug materials. Drug nanocrystals can be produced by many different techniques, but the mostly used are different kinds of media milling techniques; in milling, particle size of bulk sized drug material is decreased, with the aid of milling beads, to nanometer scale. Utilization of Quality by Design, QbD, approach in nanomilling improves the process-understanding of the system, and recently, the number of studies using the QbD approach in nanomilling has increased. In the QbD approach, the quality is built into the products and processes throughout the whole production chain. Definition of Critical Quality Attributes, CQAs, determines the targeted final product properties. CQAs are confirmed by setting Critical Process Parameters, CPPs, which include both process parameters but also input variables, like stabilizer amount or the solid state form of the drug. Finally, Design Space determines the limits in which CPPs should be in order to reach CQAs. This review discusses the milling process and process variables, CPPs, their impact on product properties, CQAs and challenges of the QbD approach in nanomilling studies.

A Model for Feeder-Extruder Interactions

1993 ◽  
Vol 115 (1) ◽  
pp. 118-123
Author(s):  
J. H. Conner ◽  
D. I. Bigio
Keyword(s):  
Product Quality ◽  
Extrusion Process ◽  
Theoretical Description ◽  
Transfer Model ◽  
Fluid Composition ◽  
Fluid Element ◽  
Twin Screw Extrusion ◽  
Process Understanding ◽  
Screw Extrusion ◽  
Twin Screw

In the field of plastic extrusion, the accurate feeding of materials to the extrusion process is an important issue. The end product quality is partially dependent upon the extruder receiving feed materials in the correct proportions. Therefore, the understanding of the relationship between the feeder and the extruder is very important. This paper presents and analyzes this relationship. The feeder is usually a separate and distinct item from the extruder. The feed materials and the environmental conditions may affect the flow rate of the reaction or blending process of the extrusion process. The variation of this feed material may cause the quality of the overall product to be beyond an acceptable quality. This paper shows that two feeder parameters, the period and amplitude of the feeder error, affect the composition of the materials throughout the extrusion process. Understanding the effect of these parameters will allow for the overall improvement in product quality. This paper also shows that the extrusion process is able to dampen the error of the feeder. In other words, by mixing a fluid element the average fluid composition will tend towards a nominal value. The fluid composition error associated with the fluid element will decay exponentially. This paper presents two models to describe phenomena described above. The first model is a theoretical description of an idealized mixing process with a time varying feeder error. The second model is an iterative mass transfer model representing a nonintermeshing twin screw extrusion process. An analysis of each of these models will demonstrate how the error of fluid composition reduces as a function of the amount of mixing.

Experimental and Numerical Investigations for Quantifying Variability of NR Mechanical Properties after Thermal Aging

2020 ◽  
pp. 000-000
Author(s):  
Andrés Malo Estepa ◽  
Franck Massa ◽  
Adnane Boukamel ◽  
Thierry Tison ◽  
Philippe Champagne ◽  
...  
Keyword(s):  
Mechanical Properties ◽  
Carbon Black ◽  
Numerical Simulations ◽  
Thermal Aging ◽  
Kriging Model ◽  
Dynamic Simulations ◽  
Numerical Investigations ◽  
Different Temperatures ◽  
Hyperelastic Model

ABSTRACT The evolution of mechanical properties of NR with carbon black fillers was examined after a thermal aging step through both experimentation and non-deterministic numerical simulations. A quantification of mechanical properties and associated variability is first proposed for a set of specimens exposed at different temperatures and exposure times. Second, a family of stretch–stress laws is numerically built with a James' hyperelastic model. Next, the whole of the behavior evolution is modeled with a Kriging model to quantify the effects of properties on a macroscopic stiffness, useful in dynamic simulations, and the least-favorable scenario is so determined. Finally, Arrhenius method is performed to numerically draw the evolution bounds of macroscopic stiffness as a function of aging exposure, followed by a comparison with a naturally aged suspension component. To our knowledge, the methodology developed has not already been proposed in this area.

Kriging Modeling for Engine Mount Optimization in Motorcycles

2009 ◽  
Author(s):  
Sudhir Kaul ◽  
Anoop K. Dhingra
Keyword(s):  
Correlation Function ◽  
Theoretical Model ◽  
Optimization Problem ◽  
Design Space ◽  
Substantial Reduction ◽  
Kriging Model ◽  
Surrogate Models ◽  
Fractional Factorial ◽  
Engine Mount ◽  
Selection Of

This paper addresses two critical aspects associated with the successful use of a Kriging model for solving the engine mount optimization problem. The two aspects are the selection of an appropriate correlation function and the use of a suitable governing design for sampling within the design space. The selection of a correlation function is critical in building a Kriging model since the function should accurately represent the behavior of the response over the entire design space. Whereas the Gaussian correlation function is most commonly used for building Kriging models, it is generally suitable for only those processes or systems which have a relatively smooth response within the entire design space. The correlation functions that have been evaluated in this paper for building the Kriging models for solving the engine mount optimization problem are as follows: Exponential, Linear Spline, Matern’s 3/2, Matern’s 5/2 and Gaussian. Three types of experimental designs – Fractional Factorial, D-optimal and Latin Hypercube, have been used to select the sampling points for making simulation runs in order to build the Kriging models. A theoretical model that represents the dynamics of the engine mount system in a motorcycle application has been used to build all the surrogate models. The Kriging models are then used to solve the engine mount optimization problem for enhanced vibration isolation with mount stiffness, mount orientation and mount location as the design variables. The optimization results of the Kriging models are compared to the results of the theoretical model. It is found that the D-optimal design in conjunction with Matern’s 3/2 correlation function provides the best results. This can be attributed to the high irregularity of the response function in the design space, especially due to the influence of orientation variables. The use of the surrogate Kriging model simplifies the governing model and leads to a substantial reduction in computational effort for solving the optimization problem. Based on the results, it can be concluded that the Kriging modeling technique can be successfully used to build surrogate models for the engine mount problem for design iterations as well as for design optimization if the correlation function and the governing design are judiciously chosen.

scholarly journals Influence of ultrasound assist during combined drying on ceramic materials quality and drying kinetics

2018 ◽  
Author(s):  
Andrzej Pawłowski ◽  
Weronika Trawińska
Keyword(s):  
Mechanical Properties ◽  
Product Quality ◽  
Ceramic Materials ◽  
Quality Parameter ◽  
Materials Processing ◽  
Strength Parameter ◽  
Material Strength ◽  
Drying Rate ◽  
Different Temperatures ◽  
Ultrasound Application

Presented in this article studies show the investigation of ultrasound application as a new method for improvement of ceramic materials processing and their influence on mechanical properties of dried samples. Ultrasound were applied during convective and convective-microwave processes carried out in two different temperatures. Obtained results indicate increase of drying rate due to sonification and what’s more interesting they affect the material strength parameter. The experiments indicate that the effectiveness of ultrasound assist depends on the drying temperature and such dependency is observed mainy when considering dry product quality parameter. Keywords: ceramics; hybrid drying; material strength

scholarly journals DIGITAL ELECTRONICS PRODUCTION MODELING AND PRODUCT QUALITY ASSURANCE

2019 ◽  
pp. 46-50
Author(s):  
A. A. Petrushevskaya
Keyword(s):  
Product Quality ◽  
Printed Circuit Boards ◽  
Quality Level ◽  
Circuit Boards ◽  
Electronic Products ◽  
Structural Framework ◽  
Digital Production ◽  
Production Concept ◽  
System Properties ◽  
Production Modeling

The introduction of elements of the concept of digital production is especially important in enterprises manufacturing electronic products that are in demand in all spheres of human activity. To create new objects representing the digital production concept, it is necessary to introduce technological innovations in the production of electronics. This is achieved by solving actual analyzing problems system properties means of production and ensuring product quality. Therefore, the article purpose is to ensure the quality of electronic products based on models and methods for analyzing the means and processes of electronic production. To achieve the goal, the digital production development in a structural framework, functional and informational description are considered. The results of the simulation stages of the production life cycle allowed us to estimate the achieved product quality level while improving the subsystems of automatic installation of printed circuit boards.

The influence of blanching pretreatments on the quality of dehydrated broccoli stems/ Influencia del tipo de escaldado en la calidad de tallos de bróculi deshidratados

2000 ◽  
Vol 6 (3) ◽  
pp. 227-234 ◽  
Author(s):  
N. Sanjuan ◽  
J. Benedito ◽  
G. Clemente ◽  
A. Mulet
Keyword(s):  
Experimental Data ◽  
Diffusion Equation ◽  
Product Quality ◽  
Chlorophyll Content ◽  
Improve Product Quality ◽  
Chemical Additive ◽  
Different Temperatures ◽  
High Chlorophyll Content ◽  
Good Agreement

Different blanching treatments were applied to sliced broccoli stems prior to dehydration in order to improve product quality. The pretreatments used were a conventional blanching in water at 100°C, and a stepwise blanching using different temperatures for the first step (50, 55, 60, 65 and 70°C). Five rehydration temperatures were used (25, 40, 55, 65 and 80 °C). Rehydration rate, chlorophyll content and texture of the rehydrated product were evaluated. Rehydration was modeled based on Fick's diffusion equation. A good agreement between the model and the experimental data was obtained when D eff and W e values were identified for each temperature (average percent variation 99.3). Samples stepwise blanched at 60 °C showed, on average, the lowest We and Ea values. Stepwise blanching at 60 and 65 °C and rehydration at 25, 40 and 55 °C were the combinations that gave the firmest product. Stepwise blanching at 50 °C and rehydration between 25 and 65 °C was the combination that preserved the highest chlorophyll content. From these results, it seems difficult to obtain firm samples with high chlorophyll content without any chemical additive.

Study on Ethanolamine Heat Sensitivity and Seperation Process

2011 ◽  
Vol 233-235 ◽  
pp. 165-170
Author(s):  
Jin Cai Yue ◽  
Na Li ◽  
Ling Qi Kong ◽  
Shi Qing Zheng
Keyword(s):  
High Temperature ◽  
Product Quality ◽  
High Purity ◽  
Process Simulation ◽  
Heat Sensitivity ◽  
Sensitive Material ◽  
Different Temperatures ◽  
Separation Equipment ◽  
The Relationship

Ethanolamine (EA, including MEA, DEA and TEA) is a kind of heat sensitive material. It is easy to be colored at high temperature which influences the product quality and its application. This paper studies the relationship between color number and time of MEA, DEA, TEA and their mixtures at different temperatures. The result shows that MEA is most sensitive to high temperature, TEA take the second place, DEA is almost unaffected. DEA can protect TEA and MEA from being colored, the more DEA content, the better effect. According to the results of tests and process simulation, optimized parameters of separation equipment and operation are put forward which can provide guidance for the production of high purity, low color number of TEA.

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