Required Testing

A trade secret may consist of any formula, pattern, device or compilation of information which is used in one s business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it. It may be a formula for a chemical compound, a process of manufacturing, treating or preserving materials, a pattern for a machine or other device, or a list of customers. 

This definition has been consistently applied in trade secret litigation and was adopted by the Supreme Court for federal patent law. Moreover, courts have explicitly applied the Restatement definition in cases arising under FOIA.  

As is clear from the Restatement definition itself, chemical formulas and process information are classic trade secrets because of their ongoing commercial value to innovators. However, the Restatement definition also extends to any. . . compilation of information that confers a competitive advantage upon those who possess it. To determine whether specific information constitutes a trade secret under this aspect of the definition, courts must consider the following factors set forth in the Restatement  

the extent to which the data is independently known to outsiders or is used by outsiders for similar purposes  

the extent of the measures taken by an owner to guard its secrecy  

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The characteristics of interior paints that require testing and analysis include hiding and appearance, package stabiHty, adhesion, spatter resistance, flow and leveling, color and sheen uniformity, touch-up, stain removal, burnish resistance, and block and print resistance. A popular test that assesses the wet abrasion resistance of an interior paint is to measure its scmb resistance. A mechanical device is used to scmb a paint film of a specified thickness with a standard bmsh and abrasive cleanser suspension. The number of scmb cycles (back and forth movements of the weighted bmsh) at various end points (first cut through, or 50% removal of the film) is then recorded. Scmb resistance usually holds steady or decreases slightly as PVC is increased, but drops quickly once the CPVC is exceeded in a paint formulation. 

Sugar trading is controlled by contractual agreements between buyers and sellers. The contracts set specifications and limits and detail the required tests that must be conducted. In the United States, three parties participate in the analyses of raw sugar the buyer, the seller, and the New York Sugar Trade Laboratory (NYSTL). The settiement value for polarization is determined as the average of the two closest results if all three results are equidistant, all three results are averaged. 

These tests should establish the optimum operating conditions, the ability of the dryer to handle the material physically, product quality and characteristics, and diyer size. The principal manufacturers of diying equipment are usually prepared to perform the required tests on dryers simulating their equipment. Occasionally, simple laboratoiy experiments can serve to reduce further the number of diyers under consideration. 

The tolling team has analyzed the hazards, addressed the risks and modifications using a management of change system, revised and written procedures, trained the workers, performed a PSSR, and completed any required test runs. The pre-startup phase is complete at this point. 

For a switching device having no protection (e.g. an Isolator). The required test cuirenl may be applied for the necessary duration (I or 3 seconds) and the dynamic and thermal strengths should be verified. 

When the required test voltage is not available at site, the reduced voltage power frequency withstand test may be carried out at still lower test voltages, depending upon the voltage availability at site. Then the duration of the test must be increased as shown in Table 14.8, and IS 10118-3 and BS 159. 

Respiratory protective devices - Classification superseded BS 6928 1988 Respiratory protective devices - List of equivalent terms. Supersedes BS 6930 1988 Respiratory protective devices - Full face masks - Requirements, testing, marking. Supersedes BS EN 136-10 1992 and BS 7355 1990... 

AMD 2 Respiratory protective devices - Compressed air line breathing apparatus for use with a full face mask, half mask or a mouthpiece assembly - Requirements, testing, marking (AMD 10774J dated Januai-y 2000. With BS EN 138, BS EN 269 and BS EN 270, superseded BS 4667-3 1974... 

Compressed oxygen escape apparatus - Requirements, testing and marking. Superseded... 

AMD 1 Particulate air filters for general ventilation - Requirements, testing, marking (AMD 8367) dated 15 November 1994. Superseded BS 6540 Part 1 1985... 

Although there is no requirement that the eertifieation be written, the employer should be able to produee a reeord of training provided, the methods provided, how an employee was able to demonstrate understanding of the training, and how the employee s ability to use the PPE was eonfirmed. OSHA may require test results in eases where employee eomprehension is in doubt. 

Existhig equipment that may have been designed and constructed many years ago according to codes and standards no longer in use, requires identifying the codes and standards that were used, and the aspects of the facility and process affected. To justify that it is still suitable for the intended use may require testing, inspection, and demonstration. If the process involves departure from applicable codes and standards, the suitability of the design and construction must be documents. 

Issues for consideration under this element include controls or procedures, utilities, raw materials, equipment, and operating environments. Required tests and inspections as well as critical operating parameters, from an ESH/PSM perspective, would be covered here. 

Good rhodium retention results were obtained after several recycles. However, optimized ligand/metal ratios and leaching and decomposition rates, which can result in the formation of inactive catalyst, are not known for these ligands and require testing in continuous mode. As a reference, in the Ruhrchemie-Rhone-Poulenc process, the losses of rhodium are <10 g Rh per kg n-butyraldehyde. 

After obtaining the prototypes, tests must be made to determine the utility. Generally these include a short time destructive test to determine the strength and to check out the basic design. Another test that is done is to use the product in the projected environment with stress levels increased in a rational manner to make for an accelerated life test. Other tests may include consumer acceptance tests to determine what instructions in proper use are required, tests for potential safety hazards, electrical tests, self-extinguishing tests, and any others that the product requires. In the case of high risk products, the test program is continued even after the product enters service. 

The application area is so large that no cookbook advice would be useful. Each type of application must have the potential failure evaluated, the economics calculated, the degree of assurance of performance set, the extent of required testing determined, and the product designed and evaluated to meet the criteria established. There are sources of data available on which to base the approaches to the requirements, but the final combination of factors must be determined by the designer. 

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). 

Major limitations in fission product decontamination will require tests with mixer-settlers. However, we anticipate from the distribution ratio measurements that Tc, Ru, and Pd will limit the overall decontamination from beta activity (other than from lanthanides). ... 

The physical detergency and biodegradation characteristics of primary alcohols are affected by the carbon chain length distribution. Therefore each new supply may require testing to determine whether the desired properties in the chosen application can be achieved. Examples of guideline specifications are presented in Table 10. 

Situation A cream that contains two active compounds was investigated over 24 months (incomplete program if today s ICH standards are applied, which require testing at 0, 3, 6, 9, 12, 18, and 24 months). The assays resulted in the data given in file CREAM.dat. Program SHELFLIFE performs a linear regression on the data and plots the (lower) 90% confidence limit for the regression line. For each full time unit, here months, it is determined whether this CL drops below levels of y = 90% resp. y = 95% of nominal. Health authorities today require adherence to the 90% standard for the end-of-shelf-life test, but it is to be expected that at least for some products the 95% standard will be introduced. 

Requires a federal inventory of existing chemicals in commerce, notification for hsting of new chemicals or new uses for existing chemicals, and can require testing of chemicals for toxicity prior to approval for listing. 

AMD 1 Particulate air filters for general ventilation - Requirements, testing, marking (AMD 8367) dated 15 November 1994. Superseded BS 6540 Part 1 1985 Natural gas - Determination of sulfur compounds. Determination of hydrogen sulfide, mercaptan sulfiir, and carbonyl sulfide sulfur by potentiometry. Also BS 3156 Subsection 11.4.3 1994 Natural gas - Determination of sulfur compounds. Lingener combustion method. Also BS 3156 Subsection 11.4.5 1994... 

As projects approach decision points regarding oral absorption solubihty assays must change towards the traditional thermodynamic equilibrium solubihty assay. Stated again for emphasis - the early discovery kinetic solubihty assay is not a replacement for a traditional thermodynamic equilibrium solubihty assay. Accurate oral absorption requires testing of crystalline materials and corresponding accurate solubihty testing of crystalline materials. 

A quantity sufficient to carry out the required tests, generally in duplicate, are filled into the containers. Most substances for which there are no concerns for either toxicity or stability are filled by weighing the appropriate quantity into antibiotic vials in a horizontal laminar flow work station. These operations are carried out in a self-contained cubicle to avoid cross-contamination. The vials are then closed with butyl rubber stoppers and sealed with an aluminium crimp seal using an automatic crimping and labelling machine. 

As mentioned previously (and discussed in detail in Sec. IX), contact lens products have specific guidelines that focus on compatibility with the contact lens and biocompatibility with the cornea and conjunctiva [75], These solutions are viewed as new medical devices and require testing with the contact lenses with which they are to be used. Tests include a 21-day ocular study in rabbits and employ the appropriate types of contact lenses with which they are to be used and may include the other solutions that might be used with the lens. Additional tests to evaluate cytotoxicity potential, acute toxicity, sensitization potential (allergenicity), and risks specific to the preparation are also required [75-77], These tests are sufficient to meet requirements in the majority of countries, though testing requirements for Japan are currently much more extensive. 

A specific statement then is given that requires that a reserve sample be retained for all required tests and that it should be available for at least 2 years after distribution of the last drug lot that utilized the components or 1 year after a stated expiration date of the finished product. 

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