TEST DATA SUMMARY

Empty chamber heat distribution test data summaries Copy of appropriate specifications used Test data summary sheets for each function evaluation Test and equipment pre- and postcalibration status listings... 

Review the reactive chemicals test data summaries for exotherms, shock sensitivity or other indicators of instability or energy release potential. 

Table 2. Mini-Pilot Test Data Summary...

A. L. Wright, W. L. Pattison, and J. Y. King, SERIES -2 Aerosol Resuspension Test Data Summary Report, Oak Ridge National Laboratory, Oak Ridge, Tennessee, unpublished. 

Opening segments of the IP2 PRA data analysis section describe the definitions of terms and concepts employed, the assumptions made, and limitations recognized during the data base construction. A set of 39 plant-specific component failure mode summaries established the basis for component service hour determinations, the number of failures, and the test data source for each failure mode given for each component. Generic data from WASH-1400, IEEE Std 500, and the LER data summaries on valves, pumps, and diesels were combined with plant-specific failure data to produce "updated" failure information. All the IP2 specialized component hardware failure data, both generic and updated, are contained in Table 1.5.1-4 (IP3 1.6.1-4). This table contains (by system, component, and failure mode) plant-specific data on the number of failures and service hours or demands. For some components, it was determined that specifications of the system was warranted because of its impact on the data values. 

Melhem, G. A., Croce, P. A., and Abraham, H., Data Summary of the Nabonal Fire Protection Associations BLEVE Tests, Process Safety Prog., V. 12, No. 2, 1993, p. 76. 

Table 2 is a summary of drug discrimination testing data for drugs that completely substitute in rats trained to discriminate saline from (-t-)-MBDB-HCl (1.75 mg/kg 7.19 pmol/kg). These data are arranged in order of decreasing relative potency. 

QA SQPs should specify the amount of data to be audited and how the data points are chosen for audit. An auditor may choose to perform more thorough and more frequent audits on a recently validated system. The validation report can be used to assist in determining what and how much to audit. For example, if data summary printouts from the chromatographic computer system are used in the report, the validation report should be reviewed to verify that this summary function was tested during validation. If this portion of the computer software was successfully validated, verifying a few values from each table in the report may be sufficient. 

Example 4 A Stability/Runaway Hazard Assessment Report In Table 2.3, test data evaluating stability/runaway hazards of a material are presented. This table contains the relevant test data and evaluations in accordance with Section 2.1.5 (Test Strategies) and represents a good model for summary reports of such key information. 

The following list provides a summary of factors that can detract from the value of, or even invalidate, accelerated test data. 

This mechanical performance summary is for recording maximum test levels for each operating region relative to specified values. It is not intended to replace shop test data logs. 

In addition to review of test results, summary data, investigation reports, and other data, the print of the system should be reviewed when conducting the actual physical inspection. As pointed out, an accurate description and print of the system is needed in order to demonstrate that the system is validated. 

For simple analytical instruments, a simple table to summarize the qualification testing, acceptance criteria, results, and pass/fail decision of the tests will be sufficient since there are fewer tests that are required and the tests are usually relatively simple. For complex analytical systems, a more complex table often referred to as a traceability matrix which traces the requirements, testing, acceptance criteria, test results, and storage locations of the validation documents, test data, and other supporting documents is usually included in the summary report for easy reviewing and quick references. 

In summary, from all currently available test data, the four-in-one 33-tnm (1.4-in.] hydrocyclones exhibit high efficiencies over a range of 318 to 1113 m3/d water (2,000 to 7,000 BWPD] per unit, giving a turndown ratio of 3.5 1. The upper limit is considered to be a pressure-drop restriction on available reject rate, not droplet shearing caused by the high flow rate. 

Since the presentation of this model new data have appeared which allow various tests and new conclusions. The diffusion coefficients of Karger (14), together with Equation 1 and the median jump time from the relaxation data at room temperature yield a jump distance of 2.7 A for the zeolitic water as compared with 2.2 A in bulk water (see Table III for a data summary). One might be tempted to explain the jump distance in terms of some geometrical constant of the zeolite structure such as the distance between Sn and Sm ionic sites (40), but with the cages full of... 

Supervision, administration, documentation Data summary, analysis, and conclusions Process validated, further trials, more process design, and testing... 

Table 4-1 provides a list of cement facilities in the United States that have been reported to be burning tires or to have burned tires in the past. Test data on air emissions while burning tires were obtained for three cement facilities and one lime plant. These facilities comprised both wet and dry process plants, and plants that burned whole tires and TDF. A summary of this test data is presented in this report in section 4.3 below. 

Air emissions testing data from five facilities were evaluated for this report. The results are summarized here, by pollutant. The most extensive testing was performed by WP L, who tested criteria pollutants, heavy metals, dioxins and furans, and other organic compounds. Table 6-2 summarizes test data for all criteria pollutants at WP L.18 Ohio Edison tested particulate, S02, NOx, and lead emissions results from this whole tire test are provided in Table 6-3.12 Illinois Power tested PM, metals, and S02 their emissions data are summarized in Table 6-4.4 In 1979, United Power Association performed two TDF tests at their Minnesota facility, and conducted air emissions tests during the first test burn for particulate, NOx, SOz, sulfuric acid, and chloride.17 These emission results are summarized in Table 6-5.17 Northern States Power tested TDF in their wood-fired utility boiler in 1982, without much success.9 Their emissions data are summarized in Table 6-6.9 Comparisons of the data from these plants are provided in the pollutant specific discussions that follow the Northern States Power data are not included with graphical summaries of the other four facilities, because its boiler is wood fired, while the other four co-fire the TDF with coal. 

Table 7 -3. Summary of Air Emissions Test Data While TDF at Saginaw Steering and Gear7,8,9 Saginaw, MI Burning...

Table II. Average Stack Gaseous Emissions Data Summary For Full Engine Tests (From Reference 6)...

The results from each study are considered on a case by case basis and the subsequent analysis and interpretation will be dependent on the type of study and the data collected. Generally, data comparison is made between test and control substances. Standard analysis for the majority of skin irritation studies includes a breakdown of the range of assessment grades elicited by each substance tested, a summary of subjective comments and some form of statistical analysis. 

Two resins were used to do the first study on laminate construction. The first was a brominated epoxy vinyl ester resin with antimony pentoxide and the second was a brominated unsaturated polyester resin. They were both promoted to cure at room temperature with methyl ethyl ketone peroxide catalyst. The panels were then postcured at 250°F (121°C) for 8 h. Panels were prepared that varied in glass content from 25% to 70% and panel thickness varying from 0.05 in. to 0.25 in. and were tested at the same testing facility. A summary of the FSI test data for the first set of panels tested are shown in Figures 23.1 and 23.2. This graph in Figure 23.1 plots the FSI value versus the panel thickness. This data would indicate that the thickness of the test panel has no effect on the measured... 

Other important parameters that affect the detonation velocity and performance of ANFO are charge diameter and confinement. The detonation velocity of ANFO will increase by about 300 m/s when the charge confinement is changed from a PVC tube to a Schedule 40 steel pipe. A summary of test data on ANFO velocity versus confinement and diameter is shown in Fig. 37.5. 

The summary s importance cannot be overstated. In this section, the sponsor can state and argue its case for the product s approval. A well-prepared summary includes a straightforward description of the product and its manufacturing technology, testing data, nonclinical data, clinical data, and adverse and beneficial effects. Such a summary can build CBER s confidence in the applicant, the validity of the BLA s information, and the product itself. In addition, because the summary is one of the few sections reviewed by all members of the BLA licensing committee, it can be pivotal in establishing a foundation for product approval. 

Upon arrival, the sample should be logged in the laboratory record book indicating time of arrival, sample temperature, and pH. The sample should in all cases be analyzed for residual chlorine and, if present, oxidized with sodium thiosulfate before it is employed for toxicity evaluation. A portion of the sample should also be removed for alkalinity and hardness analyses. Often it is necessary to coarse filter the sample to remove floe or suspended debris before testing however, this practice may reduce the sample s toxicity. The remainder of the sample should be kept at 4°C for a period not exceeding 72 h after initial sample collection. It is desirable to employ two separate 24 h composite samples for performing a 96 h acute larval fathead minnow test. This would allow renewal after 48 h exposure. In the 7 day tests with Ceriodaphnia and Pimephales, three separate 24 h composite samples should be employed for daily renewal of the various exposure solutions. Toxicity data summary sheets should include daily routine physico-chemical measurements and sample information. It is essential that good laboratory practices be used in all aspects of sample collection, treatment, and analysis to obtain quality and defensible results. 

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