Standards product-specific

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. 

Limestone blocks, weighing up to several tonnes, are used as armourstone for coastal and shoreline engineering [8.21]. A CEN product specification standard is in preparation (section 8.8.1). 

Standards, like directives, come in three forms types A, B, and C, otherwise called basic, generic, and product-specific standards. The type C product-specific standards are the top-level standards and take precedence over types A and B standards. Refer to the appropriate standards as needed. 

Product standards (type C). Type C standards address a specific product or related group or range of equipment. The type C standards take precedence over the basics and generics and call up the appropriate A and B standards, when necessary. The type C nomenclature varies slightly between the directives with the term product-specific standard being the most widely recognized for type C s ... 

In addition to these generic standards, there are product specific standards which specify EMC requirements. 

The American National Standards Institute (ANSI) serves as the administrator and coordinator of the US private-sector voluntary standardization system. ANSI oversees the creation, promulgation, and use of product specifications, standards, and guidelines that cover a wide variety of American manufactured products. ANSI facilitates the development of American National Standards (ANS) by accrediting the procedures of standards-devel-oping organizations (SDOs). These groups work cooperatively to develop voluntary national consensus standards. Accreditation by ANSI signifies that the procedures used by the standards body in connection with the development of American National Standards meet ANSI s essential requirements for openness, balance, consensus, and due process. 

Specifications, Standards, Quality Control, and Health and Safety Factors. APA-The Engineered Wood Association represents the softwood plywood and oriented strandboard industries in the areas of specification, standards, and quaHty control (QC). An APA product standard, PSl-95 (6), discusses the above areas in detail. The following listing summarizes plywood characteristics covered in PSl-95. 

Specifications, Standards, Quality Control, and Health and Safety Factors. The hardboard industry is represented by the American Hardboard Association (AHA). Specifications and standards are contained in several ANSI standards (8—11). These standards define the various hardboard product categories as well as specific product qualities required for each group. 

Copper Development Association P.O. Box 1840 Greenwich, Conn. 06836 Standards for wrought and cast copper and copper alloy products a standards handbook is pubUshed with tolerances, alloy data, terminology, engineering data, processing characteristics, sources and specifications cross-indexes for six coppers and 87 copper-based alloys that are recognized as standards. 

Contaminant by-products depend upon process routes to the product, so maximum impurity specifications may vary, eg, for CHA produced by aniline hydrogenation versus that made by cyclohexanol amination. Capillary column chromatography has improved resolution and quantitation of contaminants beyond the more fliUy described packed column methods (61) used historically to define specification standards. Wet chemical titrimetry for water by Kad Eisher or amine number by acid titration have changed Httle except for thein automation. Colorimetric methods remain based on APHA standards. 

Conformance to one of the first three ISO standards is verified by third-party audit for which the auditee pays the auditor a fee. Continued conformance is assured through periodic reaudit by the third party. The ISO 9000 standard is not a product quahty standard. Conformance to ISO 9001 or 9002 ensures that the customer receives product in conformance to mutually agreed-upon specifications. Other agreed-upon requirements are also met. 

Yolk comes from breaking machines at 45% or greater, and this is standardized to 43.5% soHds by adding mix and whites to the Hquid. USDA standards do not allow going below 43.0% soHds for yolk. SoHds to which product is standardized depends on customer specifications. 

The requirements within the product specification need to be expressed in terms that can be verified. Hence you should avoid subjective terms such as good quality components , high reliability , commercial standard parts , etc. as these requirements are not sufficiently definitive to be verified in a consistent manner. (See the later section on Design acceptance criteria and Part 2 Chapter 2 on Clarifying standards of acceptabili-fy-)... 

Acceptance criteria are the requirements which, if met, will deem the product acceptable. Every requirement should be stated in such a way that it can be verified. Characteristics should be specified in measurable terms with tolerances or min/max limits. These limits should be such that will ensure that all production versions will perform to the product specification and that such limits are well within the limits to which the design has been tested (see also Part 2 Chapter 2 under Identifying verification requirements). Where there are common standards for certain features, these may be contained in a standards manual. Where this method is used it is still necessary to reference the standards in the particular specifications to ensure that the producers are always given full instructions. Some organizations omit common standards from their specifications. This makes it difficult to specify different standards or to subcontract the manufacture of the product without handing over proprietary information. 

The product specification should provide all necessary processing requirements that need to be implemented when carrying out particular processes however, some of the requirements may need to be defined in separate process specifications which are invoked by reference. You may need to develop your own process specifications, but there are many national standards that may suit your needs and they come with the added benefit that they have been proven to work. The quality plan or procedures should not contain any further product requirements but may provide the verification methods to be employed, the precautions to be observed and the recording requirements to be met. You need to identify in your production plans each of these documents at the stage at which they should be applied, otherwise there is the possibility that they may be overlooked. 

Vor-norm, /, tentative standard, -ozydation, /. previous oxidation, -polieren, n. roughpolishing, first polishing, -posten, m. out post, -praparation,/. previous or preliminary preparation or treatment, -probe, /. preliminary test, -produkt, n. initial (or primary) product crude product, specif, crude benzol intermediate, -produktkiihler, m. (Coal Tar) crude benzol condenser, -priifung, /. previous or preliminary examination, -pumpe, /. auxiliary pump (as for vacuum) (Brewing) circulator, wort pump. 

This illustrates the need for an agreed national standard for product specification, which provides assurance of the highest pressure likely to be attained in service from knowledge of ambient conditions. Against this knowledge. 

Firstly, there are technical reasons concerning catalyst and reactor requirements. In the chemical industry, catalyst performance is critical. Compared to conventional catalysts, they are relatively expensive and catalyst production and standardization lag behind. In practice, a robust, proven catalyst is needed. For a specific application, an extended catalyst and washcoat development program is unavoidable, and in particular, for the fine chemistry in-house development is a burden. For coated systems, catalyst loading is low, making them unsuited for reactions occurring in the kinetic regime, which is particularly important for bulk chemistry and refineries. In that case, incorporated monolithic catalysts are the logical choice. Catalyst stability is crucial. It determines the amount of catalyst required for a batch process, the number of times the catalyst can be reused, and for a continuous process, the run time. 

There are many products based on these life sciences standards, such as the aforementioned gene expression standard that is used in Rosetta Merck s Resolver product and the European Bioinformatics Institute s (EBI) Array-Express database. The LECIS (Laboratory Equipment Control Interface Specification) standard is used by Creon as part of their Q-DIS data standard support (note that one of the authors was the finalization task force chairperson for this standard). 

The backbone of the laboratory control system rests on the philosophy used to establish sound and appropriate specifications, standards, and test procedures to ensure drug product quality. Some of the components of this section of the law are as follows ... 

An international committee (ISO/TC45) deals with the standardisation of test methods for rubber and the standardisation of rubber product specifications. There is a parallel committee for plastics, materials and products ISO/TC61. Individual countries also have standard setting bodies such as BSI and ASTM. 

Catalysis has been central to the component-specification standards defined by Texas Instruments and Microsoft, the CBD-96 standards from Tl/Sterling, and services and products from Platinum Technology it has been adopted by several companies as their standard approach for UML-based development. It fits the needs of Java, JavaBeans, COM+, and CORBA development and supports the approach of RM-ODP. It also supports systematic development based on use cases. 

There are clear advantages in obtaining direct evidence of performance by exposing the total component or product. This is particularly so in cases involving complex degrading environments and critical applications. Unfortunately this is rarely possible, particularly for accelerated tests, due to limitations of exposure space and costs. When it is possible, it is better to use functional tests on the product to assess the environmental effects, rather than the standard material methods. Increasingly, product specifications include such tests but in many cases it would be necessary to devise methods for the product in question (see Chapter 5). 

Part—I has three chapters that exclusively deal with General Aspects of pharmaceutical analysis. Chapter 1 focuses on the pharmaceutical chemicals and their respective purity and management. Critical information with regard to description of the finished product, sampling procedures, bioavailability, identification tests, physical constants and miscellaneous characteristics, such as ash values, loss on drying, clarity and color of solution, specific tests, limit tests of metallic and non-metallic impurities, limits of moisture content, volatile and non-volatile matter and lastly residue on ignition have also been dealt with. Each section provides adequate procedural details supported by ample typical examples from the Official Compendia. Chapter 2 embraces the theory and technique of quantitative analysis with specific emphasis on volumetric analysis, volumetric apparatus, their specifications, standardization and utility. It also includes biomedical analytical chemistry, colorimetric assays, theory and assay of biochemicals, such as urea, bilirubin, cholesterol and enzymatic assays, such as alkaline phosphatase, lactate dehydrogenase, salient features of radioimmunoassay and automated methods of chemical analysis. Chapter 3 provides special emphasis on errors in pharmaceutical analysis and their statistical validation. The first aspect is related to errors in pharmaceutical analysis and embodies classification of errors, accuracy, precision and makes... 

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