Characterization Test Plan

Table 12.4 summarizes all of the test procedures. TABLE 12.4 Laminate Characterization Test Plan... 

Bonnett, P.C. 2000. Test Plan Requirements Characterization of an Energetic Hydrolysis Reactor System at Holston Army Ammunition Plant, July 12. Picatinny Arsenal, N.J. U.S. Army Tank-Automotive Armaments Command-Army Research and Development Engineering Center. 

The scope of the system generates many of the support requirements for the operations, usually provided by the system owner. The term requirement defines a bounded characterization of the scope of the system, and contains information essential to support the operation/operators. Some of these requirements include functional capacity, execution capability, operational usability, information needed to support validation, installation, commissioning, SLC documentation required, user s manuals, training, maintenance manual, system maintenance, system test plan, acceptance criteria, and regulatory compliance (e.g., Part 11). 

The norms for medicinal production are particularly stringent. Biological products are composed of complex molecules, produced by cell lines with a relatively recent history, and difficult to characterize. Tests performed only on the final product do not guarantee consistency of production. The purification procedures should be planned and validated for the removal of potential contaminants from diverse sources cells, culture media, equipment, and reagents used in the purification or even degradation products derived from the protein itself. There are examples of products with unexpected risks that have caused serious problems such as blood contamination by HIV-1 virus between 1980 and 1985 (Bloom, 1984) or the presence of residual infectious viruses in the poliomyelitis vaccine due to inefficient inactivation (Lubiniecki et al., 1990). 

Table 4. Mechanical Testing Plan for Mechanical Characterization of Composite for Aeronautical Applications...

Experimental analysis involves the use of thermal hazard analysis tests to verify the results of screening as well as to identify reaction rates and kinetics. The goal of this level of testing is to provide additional information by which the materials and processes may be characterized. The decision on the type of experimental analysis that should be undertaken is dependent on a number of factors, including perceived hazard, planned pilot plant scale, sample availability, regulations, equipment availability, etc. 

Statistical experimental design is characterized by the three basic principles Replication, Randomization and Blocking (block division, planned grouping). Latin square design is especially useful to separate nonrandom variations from random effects which interfere with the former. An example may be the identification of (slightly) different samples, e.g. sorts of wine, by various testers and at several days. To separate the day-to-day and/or tester-to-tester (laboratory-to-laboratory) variations from that of the wine sorts, an m x m Latin square design may be used. In case of m = 3 all three wine samples (a, b, c) are tested be three testers at three days, e.g. in the way represented in Table 5.8 ... 

Characterizing the site. The customized site characterization plan is implemented by conducting a detailed site investigation and rapid testing of the water, air, and soil. 

The design and construction of sample collection and field test kits is a planning activity, since these kits must be ready to go at a moment s notice in response to a possible contamination threat. In addition to improving the efficacy of the site characterization and sampling activities, advance preparation of sample collection and field test kits offers several advantages ... 

Field testing and sampling maybe handled in the generic plan by presenting a menu that covers all potential options available to the utility, based on both internal and external capabilities. In developing a customized plan, the incident commander can simply check off the field tests and sampling requirements that are appropriate for the specific situation. The site characterization plan may also need to be revised in the field based on the observations of the team. 

EDS testing has resulted in adequate resolution of gaseous waste stream characterization issues, as discussed earlier in this chapter. The concentrated brine product from the evaporator blowdown stream has not been characterized, but this is planned. Solid wastes have been shown to be adequately decontaminated to a 5X condition. 

Every clinical trial is carefully designed to answer certain research questions. A trial plan called a protocol maps out what study procedures will be done, by whom, and why. Products are often tested to see how they compare to standard treatments or to no treatment. The FDA often provides extensive technical assistance to researchers conducting clinical trials, helping them design better trials that can characterize effects of a new product more efficiently, while reducing risks to those participating in the trials. 

Field Locations. For each field test location a variety of information is collected and recorded in addition to the samples which are collected. Seven general categories of information can be defined. Three simple ones are 1) test design or plot plan, 2) location and 3) field use history for several years. Field soil characterization 4) includes screen analysis (soil type), pH measurement, and organic matter content. Weather information 5) includes daily temperatures and rainfall and/or irrigations during the test. Application related data 6) consists of dates, application modes, weather conditions at application, calculations and calibrations. Harvest information 7) includes crop name, part, amount, date, and collector. 

Many different test methods are used to measure the reactivity or cure rate of the epoxy adhesive. Some of these, such as working life or pot life, are very practical and are used to plan the production process. Others, such as exotherm, are used to determine reaction kinetics. Still others are used to characterize the epoxy network as it cures for the purposes of determining the degree of crosslinking and the rheological properties of the curing adhesive. 

Planning for clinical testing involves defining the unmet medical need (disease characterization), determining how the intended use of the neo-organ product addresses the need, and defining processes that yield reproducible production of a safe and efficacious product for placement into patients. Developing a... 

At the Pine Bluff Chemical Agent Disposal Facility (PBCDF), process knowledge, quality assurance data, and analytical data are used to make waste characterization decisions. Under the PBCDF RCRA permit, the term chemical agent free refers to contaminated or potentially contaminated solid materials that have been tested per the PBCDF waste analysis plan and found to be below the WCL or to have been thermally treated for 15 minutes at 1000°F. Under the waste analysis plan, waste may be shipped off-facility for treatment and/or disposal only if... 

The analytical protocols used to characterize hazardous wastes are primarily the EPA-approved methodologies found in their publication Test Methods for the Evaluation of Solid Waste, Physical/Chemical Methods, SW-846. Because these methodologies are a part of the waste analysis plan and the feed-stream analysis plan, they are required by the facility s RCRA permit. In the case of the feedstream analysis plan and the LDRs, adherence is required to meet specific regulatory requirements. Occasionally, DuPont will analyze streams for hazardous constituents or properties other than those required under the permit or regulations in order to address a specific issue (e.g., to determine if the stream can be recycled). Analyses like these should be considered not as an industrial best practice but only as an internal planning aid. 

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