Specifications Routine tests

The adhesives are routinely tested for specific performance and compliance to many user specifications with different requirements. Government purchases are covered in the Mil Standard A-46050C (12). 

When all equipment has been listed, the total number of running feet needed can be added up. How much more will be required This will vary from one laboratory to another. In an industrial laboratory where both routine testing and product development work are to be performed, this figure can safely be multiplied by four for a realistic estimate. In some laboratories used exclusively for specific types of work with no other types contemplated, this figure may be lower. It should be kept in mind, however, that expanding an existing laboratory is an extremely expensive... 

The commonly used hybridization technique (Kafatos et al. 1979, Martin 1985) for sequence-specific detection of DNA is sensitive to 10 pg of DNA. However, several factors render hybridization impractical for routine testing for DNA contaminants, since it is labor intensive, time consuming, and strongly semiquantitative and usually requires a radioisotope. In addition, the specificity of the method means that some contaminating DNA may be missed. 

Where there is a Ph Eur or national pharmacopeial specification for the excipient, this should be applied. Third country pharmacopeial specifications may also be acceptable. Routine tests and specifications should be stated. Function-related specifications should be included. 

For nonpharmacopeial materials a full specification should be included in the application. This should include appropriate tests and requirements for physical characteristics, identification, relevant purity tests, and performance-related tests. Characteristics likely to influence bioavailability of the finished product should be controlled. Routine tests and specifications should be described. Methods should be validated. The material should be fully characterized, with full data on the chemistry concerned and including consideration of the safety of the excipient. Any relevant European Directive requirements or other international specifications should be met, but additional requirements might apply depending on the intended use of the product—e.g., for materials to be used in sterile products. 

The homogeneity of the product should be addressed. The adequacy of mixing processes should be shown (and confirmed with appropriate process validation data) and potential segregation discussed (as affected by surface properties, crystallinity, particle size, etc.). The Ph Eur uniformity of content requirements should apply to the dosage forms and uniformity of distribution needs to be shown between batches and within batches. The need for appropriate routine tests as part of the release specification should be discussed. 

The QA/QC lab, then, would particularly benefit from LIMS technology which would mechanize the collection and analysis of data from routine tests, which would assure and document adherence to appropriate test methods and specifications, and which would include automatic limit checking and pass/fail determination. 

Uses of Specific Laboratory Tests to Discover, Confirm, and/or Exclude a Disease. Some tests can confirm the diagnosis of a disease (e.g., tissue histology from a broncho scopic biopsy to confirm lung cancer), but cannot be used to exclude the disease or discover the disease in routine screening. Other tests can be used both to confirm and to exclude the diagnosis of a disease (e.g., glucose tolerance test for diabetes mellitus), but are too inconvenient to be used to discover the disease in routine screening. The uses of each laboratory test to discover, confirm, or exclude a disease should be considered before a test is simply added to a clinical trial protocol. This ensures that the test is appropriate in the context of the planned clinical trial. 

Those parameters that are not directly evaluated by system suitability testing during routine analysis must be checked periodically or the risk mitigated in some other way to ensure that the instrument is maintained in a qualified state. However for some critical parameters evaluation as part of the system suitability testing may not be sufficient and specific periodic testing may also be required. 

Identifying pharmaceuticals, whether APIs or excipients used to manufacture products, and the end products themselves is among the routine tests needed to control pharmaceutical manufacturing processes. Pharmacopoeias have compiled a wide range of analytical methods for the identification of pharmaceutical APIs and usually several tests for a product are recommended. The process can be labor-intensive and time-consuming with these conventional methods. This has raised the need for alternative, faster methods also ensuring reliable identification. Of the seven spectroscopic techniques reviewed in this book, IR and Raman spectroscopy are suitable for the unequivocal identification of pharmaceuticals as their spectra are compound-specific no two compounds other than pairs of enantiomers or oligomers possess the same IR... 

Some of these government agencies and private companies, because of the nature of their business, will utilize the services of an analytical chemistry laboratory as part of their overall need to assure the required quality operation. For example, municipal governments will employ the use of an analytical chemistry laboratory to test their water supply on a regular basis to make sure it is free of toxic chemicals. The pharmaceutical company will house an analytical chemistry laboratory within its facility to routinely test the products it produces and the raw materials that go into these products to make certain that they meet the required specifications. A fertilizer plant will utilize an analytical chemistry laboratory to confirm that the composition of its product meets the specifications indicated on the individual bags of fertilizer. Companies that produce a food product, such as snack chips, cheese, cereal, or meat products, will have an analytical chemistry laboratory as part of their operation because they want to have the assurance that the... 

SSDs are being routinely used for the display and interpretation of effects data (Parkhurst et al. 1996 Posthuma et al. 2002). An SSD for atrazine (shown in Figure 7.3) displays the typical S-shaped curve associated with many chemical dose-response relationships. Each point on the curve represents an LC50 for a particular species exposed to atrazine under standard toxicity test protocols. The SSD approach uses only a single statistically derived endpoint from each available toxicity test (e.g., the LC50 or EC50). In contrast, all data collected during any specific toxicity test can be used in a hierarchical model. The ability to use all available data to make inferential decisions is a marked improvement over the standard SSD effects distribution. 

Specific tests of the detonation sensitivity of LP are not very different from those used with liq explosives, but the interpretation of LP sensitivity tests is subject to large uncertainties. This is so, because practical considerations dictate that relatively small amounts of LP be tested, but for many LP systems the increase in sensitivity with increasing test sample amount is not known Tannenbaum Beardell (Ref 30, p 344) suggest the following routine tests ... 

The BurStds thermometer and other thermometers calibrated for total immersion should be used only for detn of sp of TNT by the Specification Method, while for routine tests the thermometers calibrated to partial immersion should be used. F or calibration of such thermometers proceed as follows a)Make a mark ca 5cm from the bottom of the bulb and at least lcm above the upper (small) mercury bulb on each special thermometer graduated in 0.1 or 0.05° b)Tie thermometers together in pairs (with a strip of rubber tubing) and be ready for calibration by custard cup method c)Wash and dry a Pyrex custard cup ca 2.5 in diam and ca 2.5 deep. In order to hold the cup and thermometers in place, use a wooden stand as shown in Fig... 

Both academic and technical aspects must be covered (academic = foundation of good recognised knowledge for some routine testing plus extra input to allow data/responses to be assessed for future needs technical = testing designed specifically for the objective in hand). 

A routine method for determining relative crystallinity based on the amorphous bands in the spectrum has proved more rapid and precise than the x-ray method. In practice, the ratio of the 778 cm-1 (12.85 ft) and 2367 cm-1 (4.22 ft) band intensities is measured. Use of a ratio eliminates the thickness measurement and increases precision to about 1% at 50% crystallinity and considerably better at higher levels. A density measurement and an infrared crystallinity determination when combined give an estimate of the fraction of microvoids which can occur in molded specimens of polytetrafluoroethylene. The density of a sample is predicted on the basis of its crystallinity as measured by the infrared method and the difference between this density and the actual density measured by displacement in water is a measure of the microvoid content. This determination is precise to about 0,2% voids by volume. By the use of confirmatory infrared measurements, it is possible to check the possibility that the presence of a substantial percentage of voids may have led to erroneous indications of the molecular weight in the standard specific gravity test discussed earlier. 

To satisfy specific needs with regard to the type of petroleum to be processed, as well as to the nature of the product, most refiners have, through time, developed their own methods of petroleum analysis and evaluation. However, such methods are considered proprietary and are not normally available. Consequently, various standards organizations, such as the American Society for Testing and Materials (ASTM, 1995) in North America and the Institute of Petroleum in Britain (IP, 1997), have devoted considerable time and effort to the correlation and standardization of methods for the inspection and evaluation of petroleum and petroleum products. A complete discussion of the large number of routine tests available for petroleum fills entire books (ASTM, 1995). However, it seems appropriate that in any discussion of the physical properties of petroleum and petroleum products reference should be made to the corresponding test, and accordingly, the various test numbers have been included in the text. 

The specific-locus test is not intended for human risk estimation. The seven loci sampled may not be representative of the whole genome. To continue the example of the appendix to this chapter, a mutation rate of 0.000003 per seven loci corresponds to 0.009 for 20,000 loci, if this is taken as the haploid gene number. This is nearly 1% per zygote, not a negligible number. It would be desirable to have methods to measure mutations in the entire genome, or in an entire chromosome, such as are used in Drosophila. Such methods are being developed in mice, but cure not yet suitable for routine use. 

Although these studies are designed to specifically assess the effects of developmental exposures on nervous system structure and function, they are limited in the extent to which this complex system can be evaluated as part of routine testing. For example, assessment of... 

All patients and control subjects were first routinely tested as follows SPT was performed with a standard panel of aeroallergens (including 5 molds) and blood samples were taken for total and specific IgE determination. RAST for IgE antibodies to A. altemata (Pharmacia, Uppsala, Sweden) was performed by using the allergen-specific CAP system with results converted into RAST classes from 0 to 4 according to the manufacturer s instructions. No antihistamine medication was used by any subject. Six of the 7 patients (but no control subjects) were RAST positive with a RAST class greater than 2. One patient was negative, but this person still showed a positive skin reaction to mf A. altemata enolase (see below). 

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