Development of Cross Laminated Timber in the United States of America

This research focuses on the establishment of Cross Laminated Timber (CLT) ventures in the United States of America (USA) and provides interested stakeholders knowledge about the product and the existing CLT industry. This research is designed to improve knowledge of CLT and manufacturing technologies for potential investors of CLT capacities in the USA. The invention of CLT in Austria led to a paradigm change in European wood construction as it allowed the woodworking industry to enter new construction markets such as multi-story residential and non-residential buildings. The CLT industry has experienced tremendous growth in Europe. The United States is a large market for wood construction and CLT expansion in USA is anticipated in the next decade. The thesis summarizes the historical development of CLT, its field of application, and the current status of the industry. Detailed information on the production processes of CLT from the input of raw material to the final product based on the information of the European industry is presented. A possible layout for a CLT mill in the USA is described. The concept of a capability analysis and potential input process parameters for CLT manufacturing are also presented

Current and future trens in the quality control of pharmaceuticals and biopharmaticals : impacts on Cost of Goods Sold (COGS)

[Summary] 2. Roles of quality control in the pharmaceutical and biopharmaceutical industries. - 2.1. Pharmaceutical industry. - 2.2. Biopharmaceutical industry. - 2.3. Policy and regulatory. - 2.3.1. The US Food and Drug Administration (FDA). - 2.3.2. The European Medicine Agency (EMEA). - 2.3.3. The Japanese Ministry of Work, Labor and Welfare (MHLW). - 2.3.4. The Swiss Agency for Therapeutic Products (Swissmedic). - 2.3.5. The International Conference on Harmonization (ICH). - - 3. Types of testing. - 3.1. Microbiological purity tests. - 3.2. Physiochemical tests. - 3.3. Critical to quality steps. - 3.3.1. API starting materials and excipients. - 3.3.2. Intermediates. - 3.3.3. APIs (drug substances) and final drug product. - 3.3.4. Primary and secondary packaging materials fro drug products. - - 4. Manufacturing cost and quality control. - 4.1.1. Pharmaceutical manufacturing cost breakdown. - 4.1.2. Biopharmaceutical manufacturing cost breakdown. - 4.2. Batch failure / rejection / rework / recalls. - - 5. Future trends in the quality control of pharmaceuticals and biopharmaceuticals. - 5.1. Rapid and real time testing. - 5.1.1. Physio-chemicals testing. - 5.1.2. Rapid microbiology method

Seismic Vulnerability of Chemical Racks in the Cross-Aisle Direction

Information on the seismic response of chemical containers located in storage racks is very limited. Unfortunately, no clearly established data and statistics exist related to potential damage of chemical racking systems during earthquakes. Hence, this work presents an approach for developing fragility curves for chemical racking systems in the cross-aisle direction through dynamic non-linear analysis. It aims to simulate the structural behaviour of various racking systems in the cross-aisle direction for the worst-case scenario, in order to quantify the vulnerability of chemical racks in seismic areas and to better understand the associated natech risk. Analytical fragility curves and a fault tree model were derived and used to evaluate the probabilities of chemical containers falling from racks. The damage state limits were considered as four levels of intensity of loss of containment. Three damage modes (overturning, sliding, and buckling), two types of chemical containers (205 l metal drums and 1000 l IBCs), three types of rack base anchoring (unanchored, anchored-brittle, and anchored-plastic), and four rack heights (3, 4.5, 6, 7.5, 9 m) were considered in the analysis. Overall, twenty-four fragility curves were developed based on twenty-six strong motion records from the PEER Strong Motion database. However, the analytical method employed in this study can also be used for deriving fragility curves for other merchandise types of racking structures. In order to assess the natech risk of a chemical rack containing a flammable substance, to test the developed fragility curves, and to illustrate the natech risk assessment and mapping capabilities of RAPID-N, a case study based on the 1786 Olivieri earthquake scenario was conducted. The findings demonstrate that chemical racks loaded with IBCs are more vulnerable than those loaded with drums. Moreover, although a very robust anchorage reduces the probability of collapse of the rack, it increases the probability of chemical containers falling.JRC.G.5-Security technology assessmen

The infrared spectrograph during the SIRTF pre-definition phase

A test facility was set up to evaluate back-illuminated impurity band detectors constructed for an infrared spectrograph to be used on the Space Infrared Telescope Facility (SIRTF). Equipment built to perform the tests on these arrays is described. Initial tests have been geared toward determining dark current and read noise for the array. Four prior progress reports are incorporated into this report. They describe the first efforts in the detector development and testing effort; testing details and a new spectrograph concept; a discussion of resolution issues raised by the new design; management activities; a review of computer software and testing facility hardware; and a review of the preamplifier constructed as well as a revised schematic of the detector evaluation facility

An investigation into the introduction of process analytical technology, using near infrared analysis, to selected pharmaceutical processes

Introduction: Process analytical technologies are systems for the analysis and control of manufacturing processes to assure acceptable end-product quality. This is achieved by timely measurements of critical parameters and performance attributes of raw material and in-process material and processes. The introduction of process analytical technology using near infrared analysis was investigated in three areas, namely incoming raw material analysis, blend uniformity analysis and moisture determination in the fluid bed dryer. Methodology: Incoming raw material identification - The FOSS XDS rapid content analyzer was used for the development of a NIR method for the identification and material qualification of starch maize and lactose monohydrate. Blend uniformity analysis – The SP15 Laboratory Blender fitted with near infrared probe was utilized for the study. Two types of blend experiments were designed to monitor the distribution of magnesium stearate (lubricant) in the blend, namely, a powder blend utilizing lactose monohydrate and a granule blend utilizing Ridaq® granule. Software methods were developed to monitor the standard deviation of the absorbance at the wavelengths that were specific for lactose monohydrate, Ridaq® granule and magnesium stearate. To confirm the prediction of end-point using near infrared, results were verified using an atomic absorption method for magnesium stearate. The blends were sampled at the selected time intervals corresponding to three states of the blend, namely, before end-point, at end-point and after end-point using a sampling plan. An additional six blends were conducted for the granule blend and sampled when the standard deviation had reached a value below 3 x 10-6 at the magnesium stearate wavelength at four consecutive data points (standard deviation value extrapolated from blends carried out to predetermined time intervals). Moisture determination in the fluid bed dryer – Moisture values for two products (Product A and Product B) were retrospectively collected from past production batches. A process capability study was conducted on the moisture values to determine if the current process was in a state of control. Results and Discussion: Incoming raw material identification – The algorithms used for the spectral library were able to distinguish between the raw materials selected. The spectral library positively identified the starch maize and lactose monohydrate samples that were not present in the library. The negative challenge with pregelatinised starch and tablettose demonstrated that the spectral library was able to differentiate between closely related compounds. Blend uniformity analysis – Blends sampled at the predetermined time intervals demonstrated a homogeneous state when the standard deviation of the absorbance was low and a non-homogeneous state when the standard deviation of the absorbance was high, thus near infrared prediction on the state of the blend was confirmed by the standard analytical methods. The series of Ridaq® granule and magnesium stearate blends sampled when the standard deviation was below 3 x 10-6 were homogeneous with the exception of one blend that was marginally out of specification. Blend durations were significantly lower than the standard blend durations used in the facility and ranged from 112 to 198 seconds. Moisture determination in the fluid bed dryer – From the process capability study of the two products it was noted that Product A is stable but can still be optimized while Product B is at a desirable state. The statistical evaluation of the moisture values for Product A and Product B demonstrated that the use of the product temperature to monitor the moisture gave consistent results. The current process is stable and capable of producing repeatable results although near infrared provides a means for continuously monitoring the product moisture and allows one to take action to prevent over-drying or under-drying. Conclusion: From the investigations conducted, it can be seen that there is definitely a niche for process analytical technology at this pharmaceutical company. The implementation is a gradual process of change, which may take time, probably several years (Heinze & Hansen 2005)

Governance of Dual-Use Technologies: Theory and Practice

The term dual-use characterizes technologies that can have both military and civilian applications. What is the state of current efforts to control the spread of these powerful technologies—nuclear, biological, cyber—that can simultaneously advance social and economic well-being and also be harnessed for hostile purposes? What have previous efforts to govern, for example, nuclear and biological weapons taught us about the potential for the control of these dual-use technologies? What are the implications for governance when the range of actors who could cause harm with these technologies include not just national governments but also non-state actors like terrorists? These are some of the questions addressed by Governance of Dual-Use Technologies: Theory and Practice, the new publication released today by the Global Nuclear Future Initiative of the American Academy of Arts and Sciences. The publication's editor is Elisa D. Harris, Senior Research Scholar, Center for International Security Studies, University of Maryland School of Public Affairs. Governance of Dual-Use Technologies examines the similarities and differences between the strategies used for the control of nuclear technologies and those proposed for biotechnology and information technology. The publication makes clear the challenges concomitant with dual-use governance. For example, general agreement exists internationally on the need to restrict access to technologies enabling the development of nuclear weapons. However, no similar consensus exists in the bio and information technology domains. The publication also explores the limitations of military measures like deterrence, defense, and reprisal in preventing globally available biological and information technologies from being misused. Some of the other questions explored by the publication include: What types of governance measures for these dual-use technologies have already been adopted? What objectives have those measures sought to achieve? How have the technical characteristics of the technology affected governance prospects? What have been the primary obstacles to effective governance, and what gaps exist in the current governance regime? Are further governance measures feasible? In addition to a preface from Global Nuclear Future Initiative Co-Director Robert Rosner (University of Chicago) and an introduction and conclusion from Elisa Harris, Governance of Dual-Use Technologiesincludes:On the Regulation of Dual-Use Nuclear Technology by James M. Acton (Carnegie Endowment for International Peace)Dual-Use Threats: The Case of Biotechnology by Elisa D. Harris (University of Maryland)Governance of Information Technology and Cyber Weapons by Herbert Lin (Stanford University

Batch and continuous blending of particulate material studied by near-infrared spectroscopy

Background: Pharmaceutical manufacturing is moving towards real-time release of the products. This objective can only be achieved by clearly understanding the process and by implementing suitable technologies for manufacturing and for process control. Near-infrared (NIR) spectroscopy is one technology that has attracted lot of attention from the pharmaceutical industry since it can analyze bulk solids without any pretreatment, therefore reducing or eliminating wet chemistry analysis. NIR spectroscopy is a powerful tool for the monitoring unit operations were bulk material is involved i.e. blending of powders. Blending of powders is a complex and poorly understood unit operation. In the pharmaceutical industry blending has been performed batchwise and controlled by thief sampling. Thief sampling is an invasive process which is tedious and tends to introduce bias; therefore an alternative sampling method was highly needed. Here is where NIR found a perfect match with blend uniformity monitoring, thus NIR implementation offers several advantages: thief sampling is avoided, the process is continuously monitored, detection of blend-end point, and fast identification of process deviations. NIR spectral data need to be correlated with the parameter of interest (physical or chemical). These computations are done by multivariate data analysis (MVDA). MVDA and NIR are a powerful combination for in-process control and their use has been promoted by the health authorities through the Process Analytical technology (PAT) initiative by the FDA. Purpose: This thesis is focused on the study of powder blending, which is an essential unit operation for the manufacture of solid dosage forms. The aim was to develop two quantitative methods for the monitoring of the active ingredient concentration. One method was developed for blend uniformity monitoring of a batch mixing process, and a second method for a continuous mixing process. This study also tackles the relevance of the physical presentation of the powder on the final blend quality, by studying the influence of the particle size and the effect of the previous manufacturing steps on the NIR spectral data. Methods: Particle size was studied by NIR in diffuse reflectance mode, using Kubelka-Munk function and the transformation of reflectance of absorbance values, in order to focus the analysis on the physical properties. Furthermore, an off-line NIR model was developed for the quantification of the mean particle size. Segregation tendencies due to particle size incompatibilities were studied. Blend uniformity monitoring of a batch pharmaceutical mixing was achieved through a NIR off- line calibration method, which was used for the in-line drug quantification of a production scale mixing process. NIR in diffuse reflectance mode was used in the study of a continuous blending system. The effect of the process parameters, i.e. flow rate and stirring rate, was analyzed. Moreover, a NIR method for the in-line drug quantification was developed. NIR was implemented in a powder stream, in which the mass of powder measured by NIR was estimated. Results and discussion: Regarding particle size, incompatibilities due to different particle size ranges between the formulation ingredients lead to severe segregation. Particle size and cohesion determined the quality of the powder blend; slight cohesion and broader particle size distribution improved the robustness of the final blend. NIR showed high sensitivity to particle size variations, thus it was possible to develop a quantitative model for the mean particle size determination with a prediction error of 16 micrometers. Concerning batch mixing, an off-line calibration was generated for the quantification of two active ingredients contained in the formulation. The prediction errors varied from 0.4 to 2.3% m/m for each of the drugs respectively. Special emphasis was given on the proper wavelength selection for the quantitative analysis in order to focus the analysis on the active ingredients quantification. In relation to continuous blending of particulate material, a quantitative NIR model was developed for the in-line prediction of the active ingredient concentration. The NIR model was tested under different process conditions of feeding rate and stirring rate. High stirring rates produce higher scattering of the NIR predictions. This was directly associated with the acceleration of the particles at the outlet of the blender affecting the dwell time of the particles with the NIR probe. The NIR model showed to be robust to moderate feed rate increments; however the NIR model under-predicted the drug concentration under moderate feed rate reductions of 30 kg/h. Furthermore, the continuous blending phases were clearly identified by principal component analysis, moving block of standard deviation, and relative standard deviation, all of them giving consistent results. NIR measurements in a powder stream involved the scanning of powder flowing in a chute. The flow of bulk solids is a complex phenomenon in which powder moves at a certain velocity. The motion of particles produces changes in the density and distribution of the voids. In this study, the velocity of the powder sliding down an inclined chute was measured and used for the estimation of the NIR measured mass. The mass observed during one NIR measurement was estimated to be less than one tablet. Conclusions: This study proved the feasibility of applying NIR spectroscopy for the blend uniformity monitoring of batch and continuous powder mixing. Understanding the critical parameters of powder mixing lead to a robust process and reliable analytical methods. NIR proved to be a valuable and versatile analytical tool in the measurement of bulk solids