Specifications Production tests

It is satisfactory in many cases for a flame-retarded polymer to be rated into classes V-2, V-1, or V-0 according to UL (94 cf. Section 3.1.5.2) by testing as a vertical rod specimen. Sometimes specific product test requirements have to be met (e.g. DIN 4102 or ASTM D 84, cf. Section 3.2.1) when flame-retarded plastics are used. 

Table 7.9 Specifications and test methods for naphthas. These products are industrial intermediates and are not subject to ...

Specifications and test methods for paraffins and waxes. There are no French specifications for these products, but only the customs ... 

Specifications for the principal LPG products are summarized in Table 4. Detailed specifications and test methods for LPG are pubHshed by the Gas Processor s Association (GPA) (3) and ASTM (4). The ASTM specification for special-duty propane and GPA specification for propane HD-5 apply to propane that is intended primarily for engine fuel. Because most domestic U.S. LPG is handled through copper tubing, which could fail if corroded, all products must pass the copper strip corrosion test. A test value of No. 1 represents a LPG noncorrosive to the copper. 

Tar. Before the development of gas chromatography (gc) and high pressure Hquid chromatography (hplc), the quantitative analyses of tar distillate oils involved tedious high efficiency fractionation and refractionation, followed by identification or estimation of individual components by ir or uv spectroscopy. In the 1990s, the main components of the distillate fractions of coal tars are deterrnined by gc and hplc (54). The analytical procedures included in the specifications for tar bulk products are given in the relevant Standardi2ation of Tar Products Tests Committee (STPTC) (33), ISO (55), and ASTM (35) standards. 

Product Specifications and Testing. Nutrients and diet supplements without claims are considered foods, and thus are regulated by the U.S. Food and Dmg Administration and are further subject to specific food regulations. Specifications for the hydrochloride (2) and the mononitrate (3) for foods are given in the Food Chemicals Codex (62) and for pharmaceuticals in the US. Pharmacopeia (63). General test methods have been summarized (64). 

Equipment—client may not have the equipment required to manufacture a specific product. It may be that available capital and installation time are limited such that they simply can not design, acquire, install and test the process equipment to reach the desired capacity within the available budget and time. If a product is in the early stages of its life cycle, the capital required may be hard to justify. This could be based upon the low initial volume anticipated while developing the market or the need to take advantage of a time-sensitive business opportunity. Tolling can provide a means to safely produce introductoiy, short-term, or small volume products that would otherwise be uneconomic. 

Obtain all available information about the material. If it is a surplus or off-specification product, obtain an analysis or a Material Safety Data Sheet. If it is a waste, check for previous analyses, and if none exists, obtain one. (Even if a previous analysis exists, consider running a few screening-type field analyses for confirmation of important properties such as pH, redox potential, or other oxidizer test such as cyanide, sulfide, and flashpoint.)... 

You can gain an assurance of quality by testing the product/service against prescribed standards to establish its capability to meet them. However, this only gives confidence in the specific product or service purchased and not in its continuity or consistency during subsequent supply. Another way is to assess the organization that supplies the products/services against prescribed standards to establish its capability to produce products of a certain standard. This approach may provide assurance of continuity and consistency of supply. 

Establish standards for preparation of development and production test specifications and procedures. 

The quality of a drug substance is controlled by its specification. An internationally harmonized guideline on specifications and tests for chemical substances as active ingredients and in drug products makes reference to chiral compounds. This has recently been finalized and is discussed in Section 13.5.2. 

For drug substances and drug products, applications for enantiomers and racemates should include a stereochemically specific identity test and/or a stereochemically selective assay. The choice of control tests should be based on the method of manufacture and stability characteristics and, in the case of the finished product, its composition. 

Guidance on specifications is divided into universal tests/criteria which are considered generally applicable to all new substances/products and specific tests/criteria which may need to be addressed on a case-by-case basis when they have an impact on the quality for batch control. Tests are expected to follow the ICH guideline on analytical validation (Section 13.5.4). Identification of the drug substance is included in the universal category, and such a test must be able discriminate between compounds of closely related structure which are likely to be present. It is acknowledged here that optically active substances may need specific identification testing or performance of a chiral assay in addition to this requirement. 

There are destructive and nondestructive tests (NDTs) (2). Most important, they are essential for determining the performance of plastic materials to be processed and of the finished fabricated products. Testing refers to the determination by technical means properties and performances. This action, when possible, should involve application of established scientific principles and procedures. It requires specifying what requirements are to be met. There are many different tests (thousands) that can be conducted that relate to practically any material or product requirement. Usually only a few will be applicable to meet your specific application. Examples of these tests will be presented. 

Choosing and testing a plastic when only a few existed that could be used for specific products would prove relatively simple if the selection were limited, but the variety... 

There are other types of impact tests for shock loading where energy is required to cause complete failure is reported. Each has their specific behaviors that can be related to specific product performance requirements. Tests include ball burst, ball or falling dart using different weights and heights, bag drop, bullet-type instantaneous impact, Charpy, dart drop, Mullen burst, tear resistance, and tub (2). 

Changes to specifications or test methods intended to provide increased assurance as regards product quality... 

Impurities like chlorine are effectively re-used. At an input of 1% of chlorine in the MPW (2% PVC), the products will contain around 10 ppm Cl. This is somewhat higher than the specifications of 5 ppm typical for refinery use. However, in view of the high dilution likely in any refinery or petrochemical application, BP assumes that this is acceptable (a.5). Also, metals like Pb, Cd and Sb can be removed to very low levels in the products. Tests have shown that all the hydrocarbon products can be used further in refineries. 

Investigating Out of Specification (005) Test Results for Pharmaceutical Production, FDA Draft Guidance for Industry (J IGUIDANC 121DFT.WPD) dated 9/4/98. 

It is important to emphasize that often — but not always — the performance of a product with a chemical depends heavily on the manufacturer and a specific product model. A model that performs well with one chemical may perform poorly with another chemical, even when the chemicals are in the same chemical class. This is illustrated by the Edmont Model 37-165 glove which was tested against all five acids. This glove shows good protective properties with hydrochloric, perchloric, and phosphoric acids, but exhibits degradation in nitric and sulfuric acids. 

Many sea trials of dispersant chemicals to demonstrate the effectiveness of specific products or to elucidate the processes of oil dispersion into the water column have been described. Most tests have proved inconclusive, leading many to believe that dispersant chemicals are only marginally effective. Tests in a wave basin have been conducted to measure dispersant effectiveness under closely controlled conditions [261]. These tests show that dispersed oil plumes may be irregular and concentrated over small volumes, so extensive plume sampling was required to obtain accurate dispersant effectiveness measurements. In large-scale sea trials, dispersants have been shown effective, but only when sufficient sampling of the water column was done to detect small concentrated dispersed oil plumes and when it was known that the dispersant was applied primarily to the thick floating oil. 

At least one test shall be conducted to verify the identity of each component of a drug product. Specific identity tests, if they exist, shall be used. 

One of the unique issues in the development of advanced-performance materials is that they are very product-specific, and their development requires expensive prototype iteration and performance testing. The product development is people- and design-intensive and usually results in a niche market for the material that is, the specific product slate for which the material has been designed and tested. Many of the applications are in high-tech industrial products like aerospace components, so the total volume of material used will be small. Thus, attractive commercialization schemes require that the material have intrinsic value that will justify a high margin, or there must be a product application for which the value can be captured in the end product. 

The active ingredient specification may need to include specific relevant tests that relate to the use of the material in particular products. These may be in addition to any relevant pharmacopeial monograph specifications. 

For pharmacopeial materials scientific data are not normally required in the application provided that the method of production is such that uncontrolled impurities will not be present in the material. Otherwise the impurities concerned should be declared and appropriate specifications and test methods put forward. 

R D. Returning to our examples, The R D lab, contributes to the long term profitability of the firm (rather than the short term cash flow) by developing and perfecting products and processes. While controlling the costs of R D as a whole is important, the speed at which a specific analytical test can be completed is less important than the speed and success at which a project as a whole can be completed. This relates to the effectiveness of the lab at its overall mission. The ability of a R D lab to quickly and successfully develop products and/or processes and if necessary to protect them through patent actions, may ultimately impact the firm s market share and its profitability. 

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