Testing criteria

Da.ta. Ana.lysls. First, the raw data must be converted to concentrations over an appropriate time span. When sample periods do not correspond to the averaging time of the exposure limit, some assumptions must be made about unsampled periods. It may be necessary to test the impact of various assumptions on the final decision. Next, some test statistics (confidence limit, etc) (Fig. 3) are calculated and compared to a test criteria to make an inference about a hypotheses. 

It is necessary to estabUsh a criterion for microbial death when considering a sterilization process. With respect to the individual cell, the irreversible cessation of all vital functions such as growth, reproduction, and in the case of vimses, inabiUty to attach and infect, is a most suitable criterion. On a practical level, it is necessary to estabUsh test criteria that permit a conclusion without having to observe individual microbial cells. The failure to reproduce in a suitable medium after incubation at optimum conditions for some acceptable time period is traditionally accepted as satisfactory proof of microbial death and, consequentiy, stetihty. The appHcation of such a testing method is, for practical purposes, however, not considered possible. The cultured article caimot be retrieved for subsequent use and the size of many items totally precludes practical culturing techniques. In order to design acceptable test procedures, the kinetics and thermodynamics of the sterilization process must be understood. 

Enclosure for electrical equipment up to lOOOV. Test criteria and design tests Industrial controls and systems. Enclosures... 

The vibration characteristics, determined by use of the instrumentation, will serve as the basis for acceptance or rejection of the machine. API standards generally require that the equipment be operated at speed increments of approximately 10% from zero to the maximum continuous speed and run at the maximum continuous speed until bearings, lube-oil temperatures, and shaft vibrations have stabilized. Next, the speed should be increased to trip speed and the equipment run for a minimum of 15 minutes. Finally, the speed should be reduced to the maximum continuous speed and the equipment should be run for four hours. API does not require that the four hours be uninterrupted however, it is generally interpreted that way. The interpretation is one of the many test criteria to be discussed. It would seem that a break in the test at the midpoint is not the same as having it cut short five minutes from the end because the vendor s boiler took an upset that was not related to the compressor test. The ibration during the shop test is normally specified as the API limit of 1.0 mils peak to peak, or the value from Equation 10.1, unfiltcred. whichever is lower. 

Equipment used to process, store, or handle highly hazardous chemicals must be designed constructed, installed and maintained to minimize the risk of release. A systematic, scheduled, test and maintenance program is preferred over "breakdown" maintenance " that could compromise safety. Elements of a mechanical integrity program include 1) identification and categorization of equipment and instrumentation, 2) documentation of manufacturer data on mean time to failure, 3 ) test and inspection frequencies, 4) maintenance procedures, 5) training of maintenance personnel, 6) test criteria, and 7) documentation of test and inspection results. 

The UL 525 detonation flame arrester test criteria are as follows ... 

Table 8-1 presents a comparison of test requirements in various US and foreign standards and codes for end-of-line and in-line deflagration flame arresters. A comparison of test requirements in various US and foreign standards and codes for in-line detonation flame arresters is similarly presented in Table 8-2. The UL and EM test criteria closely follow the USCG criteria.

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. 

The final result is written in a predefined manner number of decimals, units, number of repeats, relevant test criteria, and a decision statement (fails/passes). 

Requirements for labelling of containers for supply may differ from those for conveyance. Key features of a supply label are to identify the substance (the chemical name in most cases) and any hazards and safety precuations. In Europe the classification, packaging and labelling of dangerous substances is covered by Directive 67/548/EEC as amended. This requires labels to identify appropriate risk and safety phrases (Tables 12.2 and 12.3) depending upon product properties. A substance is considered dangerous if in Part lA of an approved list or if it exhibits hazardous properties as defined in Schedule 1 for supply, or Schedule 2 for conveyance as shown in Tables 12.4 and 12.5. Substances not tested should be labelled Caution — substance not yet fully tested . Criteria for risk phrases are provided, e.g. as in Table 12.6 for toxic compounds. 

The main concept addressed in this new multi-part series is the idea of correlation. Correlation may be referred to as the apparent degree of relationship between variables. The term apparent is used because there is no true inference of cause-and-effect when two variables are highly correlated. One may assume that cause-and-effect exists, but this assumption cannot be validated using correlation alone as the test criteria. Correlation has often been referred to as a statistical parameter seeking to define how well a linear or other fitting function describes the relationship between variables however, two variables may be highly correlated under a specific set of test conditions, and not correlated under a different set of experimental conditions. In this case the correlation is conditional and so also is the cause-and-effect phenomenon. If two variables are always perfectly correlated under a variety of conditions, one may have a basis for cause-and-effect, and such a basic relationship permits a well-defined mathematical description. 

Hill, R. G., Eklund, T. I., Sarkos, C. P., Aircraft Interior Panel Test Criteria Derived from Full-Scale Fire Tests. DOT/FAA/CT-85/23, September 1985. 

As shown in Table 1, many FMs meet the biodegradation criteria of a ready or inherent test. If a FM meets the criteria of a ready test, with or without acclimation, a first-order biodegradation rate of 3 h 1 in activated sludge can be assumed [ 1 ]. For FMs that show extensive biodegradation but fail the ready test criteria, a first-order rate of 0.3 h 1 can be assumed for activated sludge treatment [1]. 

Explosion blast ratings are taken as the maximum peak overpressure that may be expected to occur. Commonly industry rating requested are listed below. No standardized test criteria has been adopted by the industry or regulating bodies, rather the operator is required analyse the exposures and demostrate adequate protection is afforded where required. 

XRPD identity test criteria for mandelic acid... 

Queshi SA, McGilveray IJ. Impact of different deaeration methods on the USP dissolution apparatus suitability test criteria. Pharm Forum 1994 20(6) 8565-8566. 

Several in vitro tests are currently employed to assure drug product quality. These include purity, potency, assay, content uniformity, and dissolution specifications. For a pharmaceutical product to be consistently effective, it must meet all of its quality test criteria. When used as a QC test, the in vitro dissolution test provides information for marketing authorization. The dissolution test forms the basis for setting specifications (test, methodology, acceptance criteria) to allow batch release into the market place. Dissolution tests also provides a useful check on a number of physical characteristics, including particle size distribution, crystal form, etc., which may be influenced by the manufacturing procedure. In vitro dissolution tests and QC specifications should be based on the in vitro performance of the test batches used in in vivo studies or on suitable compendial specifications. For conventional-release products, a single-point dissolution... 

For any new excipients, APIs or drug products (where new does not necessarily mean novel, but new to the receiving site) there are additional testing criteria, e.g. supplier audits, third-party contract laboratory audits, analytical method transfers, sample management/tracking, etc. For those key excipients, where there is on-site historical experience, it still behoves both parties to check whether the local grade/supplier used by the CMO is equivalent to that used by the supplier (Worsham, 2010). There are many examples of differences in excipient physical properties, e.g. particle size, which have been attributed to different excipient sources that could ultimately impact on the performance of those excipients in formulated products (Frattini and Simioni, 1984 Dansereau and Peck, 1987 Phadke et al., 1994 Lin and Peck, 1994). 

A miniaturized version of the conventional flask method with S. capricomutum has been developed by Blaise et al [136]. In this assay the algae are exposed to the toxicant in 96-well microplates for a period of 96 hours, after which the cell density is determined using a hemocytometer or electronic particle counter. ATP content measurements [136] or chlorophyll fluorescence [141,142] have also been proposed as test criteria. Compared to the flask method, the main advantages of the microplate assay are (a) the small sample volumes and reduced... 

In Ireland, compliance with toxicity limits for selected industries is ascertained by annual or biannual test on representative samples of effluent. The test species most commonly used is the rainbow trout (Salmo gairdneri). Control authorities normally require results from 96-hour tests. The toxicity values are expressed as the minimum acceptable proportion of effluent (as a percentage) in a test resulting in 50% fish mortality after 96 hours of exposure. The toxic units (TU) are defined as the maximum number of times an effluent may be diluted to produce the test criteria (TU = 100/96-hour LC50, with LC50 expressed as the percentage of effluent in the test) (Fig. 5). 

Interventions and measurements Adverse events and laboratory safety tests Criteria for assessment... 

Formal written acceptance test criteria should be developed and reviewed before systems are used in production mode. 

The purpose is to describe the environmental performance test criteria. 

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