Production process, assessment

BE-3743 On-line quality control, production process assessment and tracking system for mechanical Darts ProT. Cerloa Fernandea UnN. Pol. Madrid... 

The virus reduction factor of an individual purification or removal—inactivation step is defined as the log10 of the ratio of the virus load in the pre-purification material divided by the virus load in the post-purification material. A clearance factor for each stage can be calculated and the overall clearance capacity of the production process assessed. Total virus reduction is calculated as the sum of individual log reduction factors. Individual manufacturing steps must possess fundamentally different mechanisms of virus removal or inactivation in order for values to be considered cumulative. Additionally, because viruses vary greatly with regard to inactivation or removal profiles, only data for the same model virus can be cumulative. 

Canoira, L., Galean, J.G., Alcantara, R., Lapuerta, M., Garcia-Contreras, R., 2010. Fatty acid methyl esters (FAMEs) from castor oil production process assessment and synergistic effects in its properties. Renewable Energy 35, 208-217. 

In the United States, through the NDA review process, pharmaceutical companies that seek FDA approval for new dmg products are assessed user fees by FDA to gain faster approval, by virtue of the U.S. Prescription Dmg User Fee Act of 1992. These assessments are used to increase the new dmg review staff of the FDA, which has agreed to reduce the NDA review time to 12 months by 1997 (6). 

A pesticide manufacturing plant should prepare a hazard assessment and operability study and also prepare and implement an emergency preparedness and response plan that takes into account neighboring land use and the potential consequences of an emergency. Measures to avoid the release of harmful substances should be incorporated in the design, operation, maintenance, and management of the plant. Implementation of cleaner production processes and pollution prevention measures can yield both economic and environmental benefits. 

This would check the products, processes, or services to establish they are what the subcontractor claims them to be. Assessment of design and production capability may be carried out at this stage or be held until the pre-qualification stage when specific contracts are being considered. 

A failure modes and effects analysis is a systematic analytical technique for identifying potential failures in a design or a process, assessing the probability of occurrence and likely effect, and determining the measures needed to eliminate, contain, or control the effects. Action taken on the basis of an FMEA will improve safety, performance, reliability, maintainability and reduce costs. The outputs are essential to balanced and effective quality plans for both development and production as it will help focus the controls upon those products, processes, and characteristics that are at risk. It is not the intention here to give a full appreciation of the FMEA technique and readers are advised to consult other texts. 

Herrchen, M. Klein, W. (2000) Use of the Life-Cycle Assessment (LCA) Toolbox for an Environmental Evaluation of Production Processes. Pure Applied Chemistry, 72(7), 1247-1252. 

FIGURE 3.3 Copper production process. (From U.S. Congress, Copper Technology and Competitiveness, Congress of the United States, Office of Technology Assessment, Washington, DC, 1994.)... 

Most processes operate in the context of an existing site in which a number of processes are linked to the same utility system. The utility systems of most sites have evolved over a period of many years without fundamental questions being addressed as to the design and operation of the utility system. The picture is complicated by individual production processes on a site belonging to different business areas, each assessing investment proposals independently from one another and each planning for the future in terms of their own business. Yet, the efficiency of the site infrastructure and the required investment is of strategic importance and must be considered across the site as a whole, even if this crosses the boundaries of different business areas. 

INERAS (1998) LCA graphic paper and print products (Part 2 Report on the industrial processes assessment). An environmental project of Axel Springer Verlag, STORA and CANFOR. Scientific consultant INFRAS, Zurich... 

In general, quality is assessed by quantifiable traits that are more or less related to specific attributes of the product and the production process. Moreover, the assessment depends on the information delivered by the sensory organs. Information is filtered and evaluated by the brain depending on the specific information provided but also on the concept of understanding that already exists in the cerebral cortex (Singer, 2000). A mental representation of a sensory event can shape neural processes that underlie the formulation of the actual sensory experience. Thus, the subjective sensory experience is shaped by interactions between expectations and incoming sensory information. 

Pork is the product of a very complex process. All the various characteristics of pork quality cannot be assessed directly in each carcass because these measurements and assessments would be too expensive. Therefore, previous scientific quality assessment of meat is primarily an indirect approach based on a few easily detectable quantitative traits and on the prescription of minimal standards in relation to the product in terms of size or composition and in relation to the production process. The prescriptions and the exclusion criteria vary between countries or between labelling programmes. The most encompassing prescriptions are enshrined in the EC regulation on organic livestock production (EEC No. 2092/91). Owing to this approach, extreme deviations in quality traits and deleterious effects are prevented. However, there is still space left within these framework conditions for huge variability in pork quality. 

Tsuj i and Robertson achieved the separation of neomycin B, neomycin C and neamine as the trimethylsilyl ethers on a 6ft. column of 0.75% OV-1 on Gas Chrom Q at a temperature of 290°C. The same conditions have also been shown to separate neobiosamine B, neosamine and deoxystreptamine from neomycin and neamine. Hence the method could be used to study the stability of neomycin or to monitor the biosynthetic production process. Use of the procedure to assess the stability of neomycin in pharmaceutical formulations has been demonstrated by Van Giessen and Tsuji237 with trilaurin as internal standard. However,these authors recommended a 2ft. column packed with 3%... 

The starting point in the development and designing of a closed water loop system is an inventory of the amounts and the quality of the process and transport water flows which are needed for the various steps in the production process. Each production step where process or transport water is involved causes a certain amount of wastewater. The pollution of this water is strongly dependent on the process step. The selection of separate treatment steps which, together, comprise a closed loop water system is complex. As already mentioned, various complete treatment scenarios can be developed and designed to satisfy the requirements set for process and transport water and treatment of wastewater. A technical and economic evaluation, in combination with environmental sustainability assessment, is necessary to determine the treatment system which is most appropriate. 

Closing the water loop is, in general, a first important step to achieve more sustainable production processes. A further improvement of the environmental sustainability of the production process can be obtained by an environmental assessment of all material and energy flows in the production process. This gives a more complete picture of possible ways to save on materials and energy use, and also how to minimise the amount of final wastes from the production process. 

To understand how product safety and toxicity data are used and how the data generation process might be changed to better meet the product safety assessment... 

Finally, alternatives of both in vitro and in vivo types are in the process of development for almost all the different endpoints of concern in safety assessment. Many of these have promise and could be used as screens for many of the uses presented here or as mechanistic tools, but complete replacement is clearly not near at hand, particularly for the more complicated endpoints. How these tests can (and should) be integrated into strategies for product safety assessment is the key... 

Over the last quarter century the dissolution test has emerged as a most powerful and valuable tool to guide formulation development, monitor the manufacturing process, assess product quality, and in some cases to predict in vivo performance of solid oral dosage forms. Under certain conditions, the dissolution test can be used as a surrogate measure for bioequivalence (BE) and to provide biowaivers, assuring BE of the product. Dissolution test has turned out to be a... 

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