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Full-Text Articles in Engineering

Ultra-Rapid Microwave Sintering Of Ceramics And Powder Metals, Kirill I. Rybakov, Yury Bykov, Anatoly Eremeev, Sergei Egorov, Vladislav Kholoptsev, Ivan Plotnikov, Andrei Sorokin Mar 2019

Ultra-Rapid Microwave Sintering Of Ceramics And Powder Metals, Kirill I. Rybakov, Yury Bykov, Anatoly Eremeev, Sergei Egorov, Vladislav Kholoptsev, Ivan Plotnikov, Andrei Sorokin

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

Over the recent years, we have demonstrated ultra-rapid microwave sintering of different ceramic materials, including Al2O3, ZrO2, Y2O3, MgAl2O4, and Yb:(LaO)2O3, using a gyrotron system operating at a frequency of 24 GHz with an output microwave power of up to 6 kW [1-3]. The ceramic pellets were sintered to 98-99.5 % of the theoretical density with the duration of the high-temperature sintering stage not exceeding several minutes. We have shown that the absorbed microwave power required for the ultra-rapid sintering regimes is …


Effect Of The Addition Of Doped-Cobalt On The Properties Of Recycled Tungsten Carbide Powder Sintered By Sps, Alexandre Mégret, Véronique Vitry, Fabienne Delaunois Mar 2019

Effect Of The Addition Of Doped-Cobalt On The Properties Of Recycled Tungsten Carbide Powder Sintered By Sps, Alexandre Mégret, Véronique Vitry, Fabienne Delaunois

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

A key issue that has appeared in the last twenty years is the availability of certain materials. Cobalt is considered as a critical raw material since it is massively used in batteries for electrical cars [1]. Cobalt is also the usual binder in cemented carbides because it gives excellent hardness to toughness ratio at the tungsten carbide parts. There is a tendency to replace cobalt by other binders such nickel or iron [2] but cobalt remains the best one. Recycling old WC parts is a solution to limit the use of raw cobalt powder and to keep the benefits of …


Kinetics Of Liquid-Assisted Densification During Flash Sintering Of Ceramic Nanoparticles, Rachman Chaim Mar 2019

Kinetics Of Liquid-Assisted Densification During Flash Sintering Of Ceramic Nanoparticles, Rachman Chaim

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

The recent liquid film capillary mechanism [1, 2] proposed for the rapid densification during the flash sintering was consistent energetically with the dissipated power during the process. Following this mechanism, melting of contacts with high electric resistance will induce high attractive capillary forces. Wetting of a solid substrate by its own melt is termed homologous wetting with zero wetting (dihedral) angle. Therefore, wetting and spreading of the melt on its own substrate is extremely fast. Here we will show that particle surface softening / melting and the following transient processes associated with it namely local melt wetting and spreading, particle …


Flash Sintering Of Beta-Alumina Solid Electrolytes For Sodium Battery Applications, Gareth Jones, Y. Hu, S. Ghanizadeh, D. Pearmain, S.N. Heavens, J.S. Blackburn, S. Maclachlan Mar 2019

Flash Sintering Of Beta-Alumina Solid Electrolytes For Sodium Battery Applications, Gareth Jones, Y. Hu, S. Ghanizadeh, D. Pearmain, S.N. Heavens, J.S. Blackburn, S. Maclachlan

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

The rechargeable sodium batteries, sodium sulphur (NaS) batteries and molten-salt sodium nickel chloride (Na-NiCl2) are proven commercially available systems, particularly for large-scale energy storage applications and electric vehicle applications respectively. They have attractive properties such as the use of abundant low-cost raw materials, high energy and power density, high faradaic efficiency of charge/discharge, zero self-discharge rate and proven long-term durability. Conventional manufacturing of the core component, the sodium beta”-alumina solid electrolyte, requires a high sintering temperatures, ~ 1600 °C to achieve high density and good ceramic quality, which contributes significantly to battery cost, energy and time consumption in …


Advantages Of The Method Of High-Voltage Consolidation Of Powder Materials, Evgeny Grigoryev, Vladimir Goltsev, Natalya Ermakova, Andrey Osintsev, Aleksandr Plotnikov Mar 2019

Advantages Of The Method Of High-Voltage Consolidation Of Powder Materials, Evgeny Grigoryev, Vladimir Goltsev, Natalya Ermakova, Andrey Osintsev, Aleksandr Plotnikov

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

The main features of high-voltage electropulse consolidation (H-VEC) of powder materials and the unique possibilities of the method caused by them are considered. The electro-thermal processes in the H-VEC at the contacts between the powder particles and in the macroscale of the whole consolidated sample are analyzed. The results of calculations of the dynamics of closure (collapse) of interparticle pores in the consolidated material are presented. The experimental results of high voltage consolidation W-based heavy alloys are discussed and a theoretical analysis of the kinetics of compaction of powder materials is made. The results of investigation of the macro- and …


Field Assisted Sintering Of Larger Scaled Ceramic Parts Using Adapted Tool Design And Hybrid Heating, Martin Bram, Moritz Kindelmann, Alexander M. Laptev, Olivier Guillon Mar 2019

Field Assisted Sintering Of Larger Scaled Ceramic Parts Using Adapted Tool Design And Hybrid Heating, Martin Bram, Moritz Kindelmann, Alexander M. Laptev, Olivier Guillon

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

Field Assisted Sintering/Spark Plasma Sintering (FAST/SPS) is a promising technology for the energy efficient sintering of ceramic, composite and metal powders. The combination of direct current heating and applied pressure enables high heating rates, rapid densification and offers the potential to decrease the sintering temperature significantly. FAST/SPS is of special interest for materials, which are difficult to densify by conventional methods like pressure less sintering. To establish this processing technology on industrial scale, fundamental studies are required to better understand the relationship between processing parameters, specific FAST/SPS boundary conditions and resulting material properties. A challenging task – especially for non-conductive …


Hybrid Sintering – The Beneficial Combination Of Sintering Principles, Juergen Hennicke, Tobias Kessel, Sergio Rivera Monte Mar 2019

Hybrid Sintering – The Beneficial Combination Of Sintering Principles, Juergen Hennicke, Tobias Kessel, Sergio Rivera Monte

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

„Hybrid Sintering“ can be defined as a beneficial combination of different sintering principles, e.g. direct and indirect heating, uniaxial and gas pressure, high and low electrical fields (Figure 1). In the technological context this can be completed by debindering, decoupled pre-heating and cooling as well as rate controlled sintering optionally. Hybrid sintering systems enable the development and production of all new material solutions.

Please click Additional Files below to see the full abstract.


3-Point Measurement In Solid State Devices: (Novel) Artifacts And How To Avoid Them, Tobias Huber, Richard Schlesinger, Markus Kubicek, Jürgen Fleig, Alexander Schmid Mar 2019

3-Point Measurement In Solid State Devices: (Novel) Artifacts And How To Avoid Them, Tobias Huber, Richard Schlesinger, Markus Kubicek, Jürgen Fleig, Alexander Schmid

Nonstoichiometric Compounds VII

There are two common methods to measure the impedance response of only one electrode of a solid-state electrochemical cell, microelectrodes or a three-terminal configuration. In aqueous electrochemistry, three-terminal configurations are widely used, however, implementing this method in solid-state electrochemistry is highly non-trivial. This work summarizes, which method is most suitable for different applications. We show potential error sources and evaluate each of them quantitatively with special emphasis on their impact in thin film electrode measurements. Evaluation is done by means of finite elements analysis (FEA), electric circuit simulations and conducted measurements.

Three potential error sources were identified as particularly crucial …


Conference Program, Hitoshi Takamura, Roger De Souza, Ryan O’Hayre Mar 2019

Conference Program, Hitoshi Takamura, Roger De Souza, Ryan O’Hayre

Nonstoichiometric Compounds VII

No abstract provided.


Photoluminescence In Sps-Processed Transparent Ce:Yag Ceramics, Avital Wagner, Nachum Frage, Sergey Kalabukhov, Barak Ratzker Mar 2019

Photoluminescence In Sps-Processed Transparent Ce:Yag Ceramics, Avital Wagner, Nachum Frage, Sergey Kalabukhov, Barak Ratzker

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

Ceramic phosphors display great promise for the realization of high-power lighting devices. Cerium-doped yttrium aluminum garnet (Ce:YAG) is commonly used as a phosphor in white light emitting diodes. Therefore, it was chosen as a case study to investigate photoluminescence of transparent ceramic phosphors fabricated by spark plasma sintering (SPS). In the present work, 0.5 at.% Ce:YAG nano-powder was synthesized by a co-precipitation method and subsequently consolidated by SPS into highly transparent ceramic samples. The effect of varying sintering parameters (temperature and pressure) and post-sintering treatments (hot isostatic pressing and air atmosphere thermal treatment) on optical properties was investigated. Correlations between …


Β-Sialon-Based Ceramic Composites By Combustion Synthesis And Spark Plasma Sintering, Evgeny Grigoryev, Vladimir Goltsev, Konstantin Smirnov, Dmitriy Moskovskikh, Aleksey Sedegov Mar 2019

Β-Sialon-Based Ceramic Composites By Combustion Synthesis And Spark Plasma Sintering, Evgeny Grigoryev, Vladimir Goltsev, Konstantin Smirnov, Dmitriy Moskovskikh, Aleksey Sedegov

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

Spark-plasma sintering (SPS) of composite ceramics in the β-Si5AlON7– system (SiC, TiN, BN) was studied. An effective mechanism of intensification of sintering processes was revealed due to the introduction of h-BN, having a scaly structure and playing the role of a solid lubricant, which improves the compressibility of the sintered powder mixtures under load. For composites containing 0–30 wt. % h-BN, 0–40 wt.% β-SiC, and 0–40 wt. % TiN, with different character distribution of components by volume (homogeneous, layered and gradient), the optimal parameters of the PCA were established, ensuring the achievement of a high level …


Tensile Strength Of Materials Obtained By Electric Pulse Consolidation Of Powders, Evgeny Grigoryev, Vladimir Goltsev, Andrey Osintsev, Aleksandr Plotnikov Mar 2019

Tensile Strength Of Materials Obtained By Electric Pulse Consolidation Of Powders, Evgeny Grigoryev, Vladimir Goltsev, Andrey Osintsev, Aleksandr Plotnikov

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

A wide range of products of modern technology, obtained by electropulse consolidation of powders, has dimensions that do not exceed 10-15 mm in diameter, and their thickness varies from 1 to 10 mm. Standard mechanical testing methods for such sample sizes are often not applicable.

The article investigates the possibility of determining the resistance to fracture of materials obtained from powders by electric pulse consolidation method using the test method for bending thin disks on an annular support and testing short cylinders according to the "Brazilian test". A numerical simulation of the process of bending a thin disk on an …


Microstructure Evolution During High-Pressure Spark Plasma Sintering (Hpsps) Of Transparent Alumina, Barak Ratzker, Sergey Kalabukhov, Nachum Frage, Avital Wagner Mar 2019

Microstructure Evolution During High-Pressure Spark Plasma Sintering (Hpsps) Of Transparent Alumina, Barak Ratzker, Sergey Kalabukhov, Nachum Frage, Avital Wagner

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

Applying high-pressure during spark plasma sintering (so-called HPSPS) enables rapid densification of a ceramic powder at relatively lower temperatures, limiting grain growth and allowing fabrication of fine-grained highly transparent ceramics. The present work focuses on the fabrication of fine submicron transparent alumina from untreated commercial powder by HPSPS and the microstructure evolution during consolidation under high applied pressure. The sintering was conducted at relatively low temperatures (1000-1100°C) under high pressure varied from 250 to 800 MPa. We review unique sintering phenomena such as stress-enhanced grain growth and de-sintering, which are related to creep taking place during the final stage of …


Conference Program, Rishi Raj, Olivier Guillon, Hidehiro Yoshida Mar 2019

Conference Program, Rishi Raj, Olivier Guillon, Hidehiro Yoshida

Electric Field Enhanced Processing of Advanced Materials II: Complexities and Opportunities

No abstract provided.


Novel Supply Chain And Process Modeling For Cell Therapy Manufacturing And Distribution, Chip White, Ben Wang, Kan Wang, Reid Bishop, Aaron Levine, Brian Liu, Bhavya Divvela, Aubrey Incorvaia, Kris Saha, Tava Das Jan 2019

Novel Supply Chain And Process Modeling For Cell Therapy Manufacturing And Distribution, Chip White, Ben Wang, Kan Wang, Reid Bishop, Aaron Levine, Brian Liu, Bhavya Divvela, Aubrey Incorvaia, Kris Saha, Tava Das

Advancing Manufacture of Cell and Gene Therapies VI [2019]

We present a two-level hierarchical supply chain model of (autologous) CAR-T cell therapy that serves as the basis for the development of strategies to: 1) deliver cell therapy products that are safe and have a high level of efficacy, 2) minimize fulfillment time and variability, and 3) reduce total manufacturing and logistics costs while reducing the risk of patient morbidity and mortality. The model consists of two integral components: (1) an agent-based program for a “single manufacturing facility” that simulates the manufacturing and quality control process of cell therapy; and (2) a supply chain network program that evaluates different supply …


Key Engineering Challenges In The Biomanufacturing Of Lentiviral Viral Vectors, Peter Jones Jan 2019

Key Engineering Challenges In The Biomanufacturing Of Lentiviral Viral Vectors, Peter Jones

Advancing Manufacture of Cell and Gene Therapies VI [2019]

No Abstract.


Tangential Flow Filtration And Scalability In Viral Vector Purification, Eni Sterjanaj, Heather Mall, Rachel Legmann, Jacky Dang Jan 2019

Tangential Flow Filtration And Scalability In Viral Vector Purification, Eni Sterjanaj, Heather Mall, Rachel Legmann, Jacky Dang

Advancing Manufacture of Cell and Gene Therapies VI [2019]

Pall Biotech has linearly scalable tangential flow filtration technology that can cover processing volume ranges from less than a liter to over 2000 liters. Manual assemblies can be used with Pall TFF filters in scales under 20L and programmable skids are available for larger scales. In this document TFF linear scalability of up to 200 liters is covered starting from a 7L initial volume and maintaining similar pressures, processing times and yields at all scales. Using this scalable technology Pall biotech can help biologics companies go to clinical trials and to commercial scale manufacturing successfully.

Please click Additional Files below …


Conference Program, Dolores Baksh, Rod Rietze, Ivan Wall Jan 2019

Conference Program, Dolores Baksh, Rod Rietze, Ivan Wall

Advancing Manufacture of Cell and Gene Therapies VI [2019]

No abstract provided.


Workshop Agenda, Fernanda Masri Jan 2019

Workshop Agenda, Fernanda Masri

Advancing Manufacture of Cell and Gene Therapies VI [2019]

No abstract provided.


Development Of A Closed Car-T Manufacturing Process, Loo-Yong Steven Kee, Calley Hirsch, Devina Ramsaroop, Elizabeth Csaszar, Danylo Sirskyj, Aaron Dulgar-Tulloch Jan 2019

Development Of A Closed Car-T Manufacturing Process, Loo-Yong Steven Kee, Calley Hirsch, Devina Ramsaroop, Elizabeth Csaszar, Danylo Sirskyj, Aaron Dulgar-Tulloch

Advancing Manufacture of Cell and Gene Therapies VI [2019]

The field of immunotherapy has emerged as a promising new type of treatment for cancer with the approval of the first two CAR-T therapies. The clinical success of T-cell based immunotherapies necessitates a robust manufacturing process for these products to be consistently produced at commercial scale. Our CAR-T workflow combines unit operation specific solutions for thaw of an apheresis unit, wash, CD3 selection, T-cell activation, lentiviral transduction, incubator- and reactor-based expansion culture, harvest, formulation, cryopreservation and thaw of CAR-T product. We have evaluated the impact of both serum-containing and xeno-free culture media, commercially available T-cell selection and activation reagents, closed …


Scale-Up Study For Ex-Vivo Expansion Of Allogeneic Natural Killer Cells In Stirred-Tank Bioreactor, Juyoung Kim, Hyung Jin Nam, Sang Hyun Lee, Jong Beom Ku, Seung Ryel Han, Hye Jin Shin, Yu Kyeong Hwang, Sang Hoon Paik Jan 2019

Scale-Up Study For Ex-Vivo Expansion Of Allogeneic Natural Killer Cells In Stirred-Tank Bioreactor, Juyoung Kim, Hyung Jin Nam, Sang Hyun Lee, Jong Beom Ku, Seung Ryel Han, Hye Jin Shin, Yu Kyeong Hwang, Sang Hoon Paik

Advancing Manufacture of Cell and Gene Therapies VI [2019]

Natural killer (NK) cells are a type of lymphocyte in the blood that are responsible for innate and adaptive immune response, and they mature in the liver and bone marrow. Being a key role in host defense system with direct and indirect killing of virus-infected cells or cancer cells, NK cell has been considered an attractive candidate for cancer therapy. Peripheral blood shows the low frequency of NK cells, so ex vivo expansion method is important to obtain sufficient NK cells for therapeutic use. Currently, we successfully developed bioreactor process for NK cell expansion on lab-scale. Stirred-tank bioreactor could be …


Single Use Disposable Biosettler Removes The Dead Cells And Cell Debris Selectively To Increase The Viability Percentage Of Mammalian Cells (E.G., Car-T) During Expansion, Dhinakar Kompala Jan 2019

Single Use Disposable Biosettler Removes The Dead Cells And Cell Debris Selectively To Increase The Viability Percentage Of Mammalian Cells (E.G., Car-T) During Expansion, Dhinakar Kompala

Advancing Manufacture of Cell and Gene Therapies VI [2019]

Current challenge in a FDA approved cell therapy product for adult B-cell leukemia is reported to be the percentage of viable cells after manufacturing is sometimes out of specified range. As the head of a large contract development and manufacturing organization observed, this fall in viability percentage during CAR-T cell manufacturing is a challenge to the whole industry.

We present a simple and powerful off-the-shelf solution to this big challenge in all mammalian cell culture expansion bioreactor system. Our single use disposable BioSettler has been demonstrated to be uniquely capable of removing dead cells and cell debris selectively from the …


Multi-Layer Shotcrete Design For Tunnel Construction, Bruno Mattle, Wolfgang Summerer, Sebastian Höser, Vladimír Bartoš Dec 2018

Multi-Layer Shotcrete Design For Tunnel Construction, Bruno Mattle, Wolfgang Summerer, Sebastian Höser, Vladimír Bartoš

Shotcrete for Underground Support XIII: New Developments in Rock Engineering, Tunneling, Underground Space and Deep Excavation

No abstract provided.


Single-Use And Sustainability: Continued Studies Using Lca Tools, William Whitford Sep 2018

Single-Use And Sustainability: Continued Studies Using Lca Tools, William Whitford

Single-Use Technologies III: Scientific and Technological Advancements

The issue of plastic materials in our environment has been of recent interest. The biotechnology community has responded by examining the effects of single-use systems employed in biomanufacturing. It is natural to emphasize a particular set of environmental concerns over others, and especially the more visible ones. But, in supporting truly sustainable manufacturing systems, it is important to consider all relevant types of pollution or environmental stress. The Life Cycle Assessment (LCA) is a science-based approach for evaluating the environmental impacts, benefits, trade-offs, and burden shifts of a process in an objective format. It considers production process’ materials, equipment and …


Comparison Of Single-Use And Steel Fermenters For Kla And Aggressive Microbial Cultures, Jason Brown, Christopher Brau, Nephi Jones Sep 2018

Comparison Of Single-Use And Steel Fermenters For Kla And Aggressive Microbial Cultures, Jason Brown, Christopher Brau, Nephi Jones

Single-Use Technologies III: Scientific and Technological Advancements

Purpose built single-use fermenters enable production facilities to utilize the single-use technologies instead of traditional stainless steel fermentor vessels without modifying their existing procedures. The manufacture lead time of the single-use fermentor hardware is a fraction of traditional vessels. As each single-use bioprocess container ships sterile and validated, reducing down time between cultures and allowing for more production volume in less space. Here we demonstrate kLa studies and aerobic cultivations with up to 2vvm gas flow in comparison of the single-use fermentors to traditional stainless steel fermenters. These single-use fermentors covering 6L-300L working volumes are specifically designed to meet the …


Polymer Interfaces And Biopharmaceuticals: Chemistry, Designs And Challenges, David W. Grainger Sep 2018

Polymer Interfaces And Biopharmaceuticals: Chemistry, Designs And Challenges, David W. Grainger

Single-Use Technologies III: Scientific and Technological Advancements

The complex interactions between biological components and polymer materials has an extensive technical history. Virtually every surface property has been invoked as being important to biological interfacial response: texture, roughness, topology, porosity, hydrophilic, hydrophobic, polar, apolar, (non)-wettable, non-fouling brushes, surface mobility, rigidity, flexibility, crystalline versus amorphous, aspect ratio. Few surface properties alone, however, provide consistent, global technical solutions to vexing biomedical technology problems, particularly with cell culture, blood, plasma, microbial milieu, and protein solutions. Bio-interface materials performance must therefore be tailored specifically to each application. Short-term contact use (minutes/hours) has different materials interface requirements than long-term (days) use; globular proteins …


Continuous Process Performance Enhancements For 50-500 L S.U.B.S, Ben Madsen, Jordan Cobia, Nephi Jones, Kevin Mullen Sep 2018

Continuous Process Performance Enhancements For 50-500 L S.U.B.S, Ben Madsen, Jordan Cobia, Nephi Jones, Kevin Mullen

Single-Use Technologies III: Scientific and Technological Advancements

Improvements in single-use systems have allowed implementation of high-density cultures in emerging bioprocess workflows while progressive advances in media optimization and improved clone genetic selection have underscored the perceived performance limitations of single-use bioreactors (S.U.B.s). This study presents how strategic enhancements to the sparge and agitation systems of Thermo Scientific™ HyPerforma™ S.U.B.s have revealed the potential for a three- to four-fold improvement of mixing and mass transfer performance compared to legacy SUB designs. This study investigates the following:

  • Bioreactor characterization, TruBio™ DeltaV™ controller optimization, online process analytics, and scalability analysis of the S.U.B. when targeting perfusion applications from 50 L …


Automated Foam Control In Single-Use Bioreactors Using The Single Use Foam Probe, Jordan Cobia, Ben Madsen, Emilee Madsen, Alex Hodge Sep 2018

Automated Foam Control In Single-Use Bioreactors Using The Single Use Foam Probe, Jordan Cobia, Ben Madsen, Emilee Madsen, Alex Hodge

Single-Use Technologies III: Scientific and Technological Advancements

Headspace foam in bioreactors can cause significant issues to a biological process among which are unfavorable metabolic conditions for cells, increased shear from bursting bubbles, cell death/entrainment, mass transfer interference and potential fouling of exhaust filters which can allow a point of entry for contamination or lead to pressure build-up and possible failure of the bioprocess container. This study investigates the efficacy of using a single use foam probe coupled with an automated response of an antifoam addition with an integrated DeltaV controller. Two 50L S.U.B.s run in parallel clearly illustrate differences; the first employing foam control using the foam …


Ph Evolution In Solution After Contact With Multilayer Films After Different G- Irradiation Doses And Thus Reconciliation Of Ph And Toc With Carboxylic Acids Detected By Ion Chromatography, Samuel Dorey, Fanny Gaston, Nathalie Dupuy, Magali Barbaroux, Sylvain R.A. Marque Sep 2018

Ph Evolution In Solution After Contact With Multilayer Films After Different G- Irradiation Doses And Thus Reconciliation Of Ph And Toc With Carboxylic Acids Detected By Ion Chromatography, Samuel Dorey, Fanny Gaston, Nathalie Dupuy, Magali Barbaroux, Sylvain R.A. Marque

Single-Use Technologies III: Scientific and Technological Advancements

For a number of various uses (storage, mixing, freezing, transportation, formulation, and filling) biopharmaceutical solutions are stored in sterile single-use plastic bags. Material transfers can then occur between containers and contents. These migrations, of different types, depend on the physicochemical characteristics of the material (composition, pH, solubility, viscosity, molecular weight, etc.), the nature of the product (solid, semi-solid and liquid) and the conditions of the material utilization. In the case of single-use polymers, γ-irradiation sterilization of the polymer is often carried out. The interactions could be therefore influenced by the dose and the contact time between the container and the …


The Proper Use Of Extractables Data - Aspects Beyond Extractables-Measurment, Samuel Dorey, Armin Hauk, Roberto Menzel, Thomas Loewe, Ina Pahl Sep 2018

The Proper Use Of Extractables Data - Aspects Beyond Extractables-Measurment, Samuel Dorey, Armin Hauk, Roberto Menzel, Thomas Loewe, Ina Pahl

Single-Use Technologies III: Scientific and Technological Advancements

Appropriate extraction techniques for SUS/SUT and methods for analysis of extractables have been intensively discussed over the last years. Today, several proposals for common methods are available and used to conduct extractables studies in the bio-pharmaceutical industry. Therefore it is expected that the number of available extractables data will significantly rise over the next years and it is worth to (re-)consider their proper use for materials and device qualification and risk assessment. While this exercise is straightforward for container closure systems (CCS), for SUS/SUT the situation is more complex. In CCS applications, a single drug product, in contact with a …