Current status and future trends for disposable technology in the biopharmaceutical industry

Single use technology (SUT) is in widespread use throughout the biopharmaceutical industry where it is replacing traditional stainless steel plant particularly for the manufacture of small volume, high value products. The key drivers for SUT uptake include reduction of regulatory risk, lower capital and energy costs and increased facility flexibility. Disposable technology is now well established for cell culture, liquid handling and storage but its application to some downstream operations is proving more intractable. Single‐use chromatography resins are generally uneconomic at process scale and there are limitations on large‐scale tangential flow filtration capacities. The development of disposable sensor technology is lagging behind that of bioreactors and capacities for microbial culture are presently limited to 2000 litres. Concerns regarding compatibility of equipment from different suppliers and extractable and leachable testing are being addressed but continue to influence uptake of SUT by traditional manufacturers. Complete ‘plug and play’ disposable process trains, however, are becoming increasingly available and are being embraced by Contract Manufacturing Organisations (CMOs) with multiproduct facilities. © 2013 Society of Chemical Industry     

Influence of annealing temperature on the structural and anti-corrosion characteristics of sol–gel derived,spin-coated thin films

Recently, an aqueous particulate sol–gel process using metallic chloride precursors was introduced to synthesize zirconium titanate. In this paper, the effect of annealing temperature on the structural and corrosion protection characteristics of spin-coated thin films obtained from this sol–gel system was investigated. Based on scanning electron microscopy, transmission electron microscopy, atomic force microscopy, and spectroscopic reflectometry studies, it was found that the flatness and thickness of the thin films were decreased by increasing the annealing temperature. Also, the corrosion protection of stainless steel AISI 316L provided by the prepared coatings, as analyzed by electrochemical potentiodynamic polarization experiments in a simulated body fluid, was improved in this order: 500 °C-annealed sample<900 °C-annealed sample<700 °C-annealed sample, attributed to a compromise between the defect density and the adhesion of the films to the substrate.     

Real-time monitoring of events applied to syndromic surveillance

Abstract

This article focuses on monitor plans aimed at the early detection of the increase in the frequency of events. The literature recommends either monitoring the time between events (TBE) if events are rare or counting the number of events per unit non-overlapping time intervals otherwise. Some authors advocate using the Bernoulli model for rare events, applying presence or absence of events within non-overlapping and exhaustive time intervals. This Bernoulli model does improve the real-time monitoring assessment of these events compared to counting events over a larger interval, making them less rare. However this approach became inefficient if more than one event starts occurring within the intervals. Monitoring TBE is the real-time option for outbreak detection, because outbreak information is accumulated when an event occurs. This is preferred to waiting for the end of a period to count events. If the TBE reduces significantly, then the incidence of these events increases significantly. This article explores this TBE option relative to using the monitoring of counts when the TBEs are either Exponentially, Gamma or Weibull distributed for moderately low count scenarios. The article will discuss and compare the approaches of using an Exponentially Weighted Moving Average (EWMA) statistic for the TBEs to the EWMA of counts. Several robust options will be considered when the future change in event frequency is unknown. Our goal is to have a robust monitoring plan which is able to efficiently detect many different levels of shifts. These robust plans are compared to the more traditional event monitoring plans for both small and large changes in the event frequency.     

Catalytic Evaluation of CuO/[Si]MCM‐41 in Fenton‐like Reactions

CuO/[Si]MCM‐41 catalysts with various Si/Cu molar ratios were prepared and characterized by X‐ray diffraction, nitrogen physisorption, temperature‐programmed reduction by H₂, and UV‐vis and Raman spectroscopy. The effects of copper loading and pH on their activity in the decolorization of methyl orange were studied in a heterogeneous Fenton‐like process. With decreasing Si/Cu ratio, dye decolorization increased from 18 to 75 % at pH 3. CuO/[Si]MCM‐41 catalysts showed 75, 50, and 40 % conversion of methyl orange at pH 3, 5, and 7, respectively. This is a significant improvement to Fenton‐like reactions involving copper, and thus CuO/[Si]MCM‐41 catalysts are quite promising for pollutant degradation.     

Process capability analysis chart with the application of Cpm

Process capability analysis (PCA) is a highly effective means of assessing the process ability of product that meets specifications. The process capability analysis chart (PCAC/C_pk ) evaluates the capabilities of multiprocess products together with nominal-the-best specifications, larger-the-better and smaller-the-better specifications. This study proposes process capability analysis chart (PCAC/C_pm ) to consider process yield and expected process loss. A new generated estimator for C_pm is proposed and the properties of statistical estimator and hypothesis test are discussed. A practical example was given for application.     

The method of separation for evolutionary spectral density estimation of multi-variate and multi-dimensional non-stationary stochastic processes

The method of separation can be used as a non-parametric estimation technique, especially suitable for evolutionary spectral density functions of uniformly modulated and strongly narrow-band stochastic processes. The paper at hand provides a consistent derivation of method of separation based spectrum estimation for the general multi-variate and multi-dimensional case. The validity of the method is demonstrated by benchmark tests with uniformly modulated spectra, for which convergence to the analytical solution is demonstrated. The key advantage of the method of separation is the minimization of spectral dispersion due to optimum time- or space–frequency localization. This is illustrated by the calibration of multi-dimensional and multi-variate geometric imperfection models from strongly narrow-band measurements in I-beams and cylindrical shells. Finally, the application of the method of separation based estimates for the stochastic buckling analysis of the example structures is briefly discussed.     

Experimental evaluation of the impact of b-learning methodologies on engineering students in Spain

The aim of this article is to highlight the importance of an active learning methodology in engineering degrees in Spain. We present the outcomes of an experimental study carried out during the academic years 2007/2008 and 2008/2009 with engineering students at the University of Salamanca (Spain). In the present research, as we have done in previous ones, we have selected a subject which is common to the four degrees under consideration: Computer Science. This study explores in greater depth the validity of experimental designs coming from educational research and the impact of innovative teaching methodologies. The hypothesis that impulses this research is formulated to ascertain that the learning level and the satisfaction of students will be higher after the implementation of new teaching methodologies (based on constructive learning, collaborative work, and blended learning resources), than in more traditional teaching contexts. The obtained results partially confirm this hypothesis. The ultimate purpose of this work is that of providing evidence that contributes to the improvement of education and teaching methods for a better performance of students in engineering.     

Six Sigma experience as a stochastic process

This study empirically investigates the states of Six Sigma from a stochastic point of view. By the means of an advanced survey, 97 respondents are asked to rate the effect of Six Sigma on different performance categories, the cost of implementing Six Sigma, the level of enthusiasm and expectations from Six Sigma over 20 years. The autocorrelation and cross-correlation functions of these processes are analyzed to investigate the stages of Six Sigma. Consequently, new concepts namely steady state of Six Sigma and Six Sigma experience functions are introduced which shed light on the life cycle of Six Sigma within the companies.     

Ion Exchange Technology in Spent Fuel Reprocessing

Solvent extraction is the major unit operation employed in spent nuclear fuel reprocessing. The operation yields three streams; fission product waste, uranium product and plutonium product. Ion exchange is primarily used in reprocessing as a tail-end method to concentrate and isolate the plutonium product stream. This review will describe the details of plutonium recovery and purification by both cation- and anion-exchange processing. A brief overview of miscellaneous uses of ion-exchange employed in reprocessing will also be given.