Process-Analysis Tools

Fortunately, for those facing similar seemingly insuperable problems, the story is actually true. Not only is this specific story true, but also there are many more like it. Virtually every major biopharmaceutical company in the world has its own case study. These solutions were achieved thanks to a few simple process analysis tools and a systematic structured approach to visualizing data-rich experiments. 

The importance of this information as a process analysis tool is clearly shown if we look at how these distributions can be altered. Figure 9.14 shows these same distribution ranges and how they change under the effects of temperature. As temperature decreases the number of fine particles (0-10 pm and 10-50 pm) increases, however warming the mixture then re-cooling, generates a final distribution with far fewer fine particles. 

Process analysis tools are used to enter, view, and track the process inputs. These tools, like modeling tools, must show different views of the results. Most process analysis tools are packaged with modeling tools. Process analysis tool selection considerations are basically the same as those of modeling tools. Typically, process modeling and analysis tools (Yu and Wright 1997) ... 

Fig. 7.2. Selected references to in-process analysis tools in polymer production. Source Scientific and patent literature...

ABSTRACT This paper illustrates the main features of the MUlti-STAte DEgradation Process analysis Tool (MUSTADEPT), a new software tool which allows quantitatively describing the evolution of the degradation process of an industrial equipment, modeled as a discrete-state transport process. Two different, complementary approaches are offered. One is based on statistics, specifically the Maximum Likelihood Estimation (MLE) technique to estimate the parameters of the degradation process model and the Fisher Information Matrix for evaluating the uncertainty associated to the estimates. The other approach relies on information elicited from experts and describes and propagates the associated uncertainty within the DSTE framework. In both cases, the probabilities that the component occupies the different degradation states over time are estimated with the associated uncertainties. 

ASQ. Failure Mode Effects Analysis. http //asq.org/learn-about-quality/process-analysis-tools/overview/fmea.html, 2014 Quality Associate International. History of FMEA. http //quality-one.com, 2014 see also Fadlovich, Erik. Performing Failure Mode and Effect Analysis (Embedded Technology), 2007. 

Unlike the conservation guaranteed by the first law, the second law states that every operation involves some loss of work potential, or exergy. The second law is a very powerful tool for process analysis, because this law tells what is theoretically possible, and pinpoints the quantitative loss in work potential at different points in a process. 

In the field of in-process analysis, analytical NMR applications also constitute a growth area - and also in relation to additives. This stems from the fact that the method makes it possible to use chemical analytical data in polymer quality control. Robust tools for hostile chemical plant environments are now available. The field of process analytical chemistry has been pushed to the forefront of the partnership between industry and academia. 

Table II demonstrates how NPV would be calculated for a hypothetical LIMS, purchased as a package with negligible site preparation and with installation costs included in the purchase. It is to be acquired for a service laboratory primarily supporting R D activities but with some minimal process monitoring responsibilities. The IRR for this project could be found by trial and error determination of the yearly discount rate which results in a zero NPV. A succinct discussion of these financial management analysis tools can be found in two works by Weston and Brigham. The first (9) presents theoretical and detailed analytical expositions the second OO) is a more practical, applications oriented presentation.

Adhesion of non-polar polymers is sometimes improved by oxidation, so essentially what is normally thought of as degradation may be used to introduce an enhancing surface property. Nevertheless, in both cases the oxidation process modifies the polymer surfaces, and the analysis tools can be rather similar, see, e.g., Ref. [101]. 

There seems to be plenty of evaluation methods for inherent safety. Unfortunatelly they are not directly suitable safety analysis tools to be used with novel design systems in preliminary process design. Most existing safety analysis methods need detailed process information and are not directly applicable in early design stages. On the other hand all methods are not suitable for computerized use with optimization and simulation tools. 

By employing a laser for the photoionization (not to be confused with laser desorption/ ionization, where a laser is irradiating a surface, see Section 2.1.21) both sensitivity and selectivity are considerably enhanced. In 1970 the first mass spectrometric analysis of laser photoionized molecular species, namely H2, was performed [54]. Two years later selective two-step photoionization was used to ionize mbidium [55]. Multiphoton ionization mass spectrometry (MPI-MS) was demonstrated in the late 1970s [56—58]. The combination of tunable lasers and MS into a multidimensional analysis tool proved to be a very useful way to investigate excitation and dissociation processes, as well as to obtain mass spectrometric data [59-62]. Because of the pulsed nature of most MPI sources TOF analyzers are preferred, but in combination with continuous wave lasers quadrupole analyzers have been utilized [63]. MPI is performed on species already in the gas phase. The analyte delivery system depends on the application and can be, for example, a GC interface, thermal evaporation from a surface, secondary neutrals from a particle impact event (see Section 2.1.18), or molecular beams that are introduced through a spray interface. There is a multitude of different source geometries. 

The confirmation of structure is essentially the same as that described in the previous section, but because of the systematic way in which the well contents are derived, other less demanding analysis tools may be appropriate. One approach is to utilize the spectra of the individual sub-structures. In Bruker s AutoDROP (Automated Definition and Recognition Of spectral Patterns, contained within the AMIX suite of software ) these can derive from spectra (most commonly HSQC two-dimensional spectra) of the reactants or from a basis set of product spectra containing sufficient combinations. The process by which the spectra of the sub-structures are... 

This chapter introduced application of simple variographic experiments as a basis for problem-dependent deliberations as to an optimal deployment of increment/sample sampling rate, r, and/or compositing using Q increments/sample. The variographic experiment constitutes the most powerful process sampling data analysis tool available. 

K. Pollanen, A. Hakkinen, S-P. Reinikinen, J. Rantanen, M. Kaijalainen, M. Louhi-Kultanen and L. Nystrom, IR spectroscopy together with multivariate data analysis as a process analytical tool for in-hne monitoring of crystallization process and solid-state analysis of crystalline product, J. Pharm. Biomed. Anal., 38, 275-284 (2005). 

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