Specification-based standards

The fermentation-derived food-grade product is sold in 50, 80, and 88% concentrations the other grades are available in 50 and 88% concentrations. The food-grade product meets the Vood Chemicals Codex III and the pharmaceutical grade meets the FCC and the United States Pharmacopoeia XK specifications (7). Other lactic acid derivatives such as salts and esters are also available in weU-estabhshed product specifications. Standard analytical methods such as titration and Hquid chromatography can be used to determine lactic acid, and other gravimetric and specific tests are used to detect impurities for the product specifications. A standard titration method neutralizes the acid with sodium hydroxide and then back-titrates the acid. An older standard quantitative method for determination of lactic acid was based on oxidation by potassium permanganate to acetaldehyde, which is absorbed in sodium bisulfite and titrated iodometricaHy. 

Fumaric acid is shipped ia soHd form, the particle size varying based upon the specification. The standard shipping containers are 50-lb bags (25 kg bags outside the United States), supersacks containing up to 2500 lbs, and occasionally bulk hopper tmck. 

Specifications and Standards. Typical properties of pyromeUitic acid are given in Table 38 (154,155). In many cases, specifications are negotiated between manufacturer and customer based on the needs of the final product. 

This chapter explores the design of stacks from the point of view of the downwind observer whose task is to determine the connection between stack design, process emissions, meteorology, and, most important, environmental effects. Stacks must be designed to specifications based on meteorological conditions and environmental air quality standards, which may be quite umelated to process requirements... 

Process Detailed Design Detailed specification based on concept design Minimize number of possible leak paths Make plant friendly to control, operate, and maintain Avoid or simplify hazardous activities such as sampling, loading and unloading Process conceptual design and codes/standards and procedures Experience on past projects/designs... 

The 510(k) pre-market notification process is not as onerous as the pre-market approval procedure, as clearance to market a device is not based on actual assessment of the safety and effectiveness of the particular device in question. Instead, devices can be cleared on the basis that they are substantially equivalent to existing devices that have been recognised as safe and effective, or that they conform to specific device standards promulgated or recognised by the FDA. There are four procedural variations to the 510(k) notification process. 

The exact composition and proportion of these additives in a certain type of fluid depends on the intended use. Hydraulic fluids are compounded to conform to performance-based standards such as Military or ASTM (American Society for Testing and Materials) specifications. Some examples of Military specifications are shown in Table 3-2. Many different formulations can be compounded to conform to one performance standard. It should be noted that the variability among these products or even within products with the same trade names may confuse efforts to determine environmental and health effects of hydraulic fluids at hazardous waste landfills since hydraulic fluids that are currently used may or may not contain the same components present in old products of the same name. 

Limit tests have a long standing in pharmacopeias. For some, heavy metals for example, the sensitivity of the method was the basis for the standard. Modem limits in the USP-NF are toxicity based. There is divergence in harmonization because of toxicity-based rather than method-based standards. The modem basis avoids the exclusion of safe products from the marketplace, whereas the older approach could lead to lock-out specifications known as technical barriers to trade. 

Figure 2. Ultrastyragel GPC column specifications based on polystyrene standards, toluene as mobile phase (iml/min).

We now consider the abstract presented in excerpt 8G, which reverses the emphases observed in excerpts 8C-8F. In excerpt 8G, moves 1 and 2 comprise the bulk of the abstract, and move 3 is just a single sentence. Much of the abstract is used to elucidate important gaps in the field that (1) a size-based standard for regulating atmospheric particulate matter is inadequate because it does not take into account chemical composition, and (2) compositional analyses are difficult, especially for metals, because they often exist in multiple oxidation states. These gaps help to establish the relevance of the authors work. Only in the last sentence do the authors mention their work specifically (move 3). Here, they identify their method (micro-XANES) and tell readers what results will be presented at the conference. 

Current quality system models call for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications. International standards provide guidance on auditing [13]. Audit procedures should be developed and documented to ensure that the planned audit schedule takes into account the relative risks of the various quality system activities. Factors that can be incorporated into a risk-based approach to planning audit frequency and scope include the following [6] ... 

Note Specifications for various adapters are listed in the, Index of Specifications and Standards, Dept of the Army, Washington, DC, vol 2, Oct 1958, pp 1-2 Adapter Boosts , A device which consists of a bushing contg a booster charge, usually tetryl pellets. The adapter-booster is screwed deep into the nose or base plug of a bomb. The device is threaded on its protruding end to seat a standard nose or tail bomb fuze... 

When ASTM, followed by ISO and others, started conducting systematic interlaboratory trials to obtain precision data for test methods, the true state of affairs became apparent15. For many standards the variability was worse than realised and in some cases was so bad as to question whether the tests were worth doing at all or whether specifications based on them could be considered valid. The general advance of the quality movement prompted these investigations and have ensured that reproducibility has continued to occupy one of the top spots for attention in recent years. 

Compare sample results against expectations and compare control sample results against the acceptable range (see Critical Parameters). Evaluate replicate results and recoveries for acceptability. Expectations are based upon historical data with a specific matrix, standard references, or expected results (e.g., claims). Acceptable ranges are determined during method validation. 

In order to harmonize SPS measures on as wide a basis as possible, the SPS agreement encourages members to base their SPS measures on international standards, guidelines, or recommendations. Thus, the SPS agreement, like the new TBT agreement, encourages use of international standards. The SPS agreement refers specifically to standards established by the Codex Alimen-tarius Commission, as discussed below. 

Thus, the monolith approach is highly customisable for a particular need or application. It is an important area in column technology development with the number of publications in CEC, pLC and even monolith based standard LC increasing dramatically. Details and specific application examples of the use of these various monolith technologies in CEC will be discussed in a later chapter. 

In the past, different countries had their own textile standard testing methods.79 Since 1990 within EU, there has been an attempt to normalize these standards. In the United Kingdom, for example, most new British Standards are prefixed by BS EN or BS EN ISO. Most of the test methods are based on the principle that test should be straightforward and easy to apply, and are application specific. The standard test methods usually involve pass-fail or performance rating criteria10 and are mostly product application specific. Some selective and more relevant test methods are discussed here in brief, and for detailed information the reader is referred to a recent review by Nazare and Horrocks.11... 

The Biodiesel Stability (BIOSTAB) project, supported by the European Commission, was initiated in 2001 to establish clear criteria and analytical methods for the monitoring biodiesel fuel stability (Various, 2003 Prankl, 2002). The resulting unified method, EN 14112 (Anon., 2003c) established a means for measuring oxidative stability utilizing the Rancimat or oxidation stability instruments. This test method was essentially developed from standards employed in the fats and oils industry to measure isothermally the induction period for oxidation of fatty derivatives. At present, both biodiesel fuel standards ASTM D 6751 (Anon., 2007a) and EN 14214 (Anon., 2003b) include an oxidative stability specification based on measurement by method EN 14112. 

Many standard specifications have been laid down for the more important uses of ZnO (rubber, paints, and the pharmaceutical industry). For standards, see Table 1.1 ( Zinc oxide pigments Methods of analysis and Specification ). Various methods of classification are used, often based on the production process and the chemical composition. The most well known are pharmacopeias (USP, BP DAB, Ph. Eur.) ISO 9298, T31 006 NF, ASTM D79 - 86 and ASTM D 4295 - 89. Table 2.13 shows a classification with typical data for commercially available zinc oxide grades (more detailed standard specifications see standards mentioned above). 

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