Test equipment needed

The PI must demonstrate that they have acceptable and adequate resources available to manage the trial, including access to or control over clinical space such as beds and clinics, if needed. The facilities must have appropriate staff and other resources to conduct the research and to protect the subjects. Specialized testing equipment needed for the experiments must be available, either in the form of genera testing purchased from the health system or in the PTs own laboratory. 

Bosch and co-workers devised laboratory reactors to operate at high pressure and temperature in a recycle mode. These test reactors had the essential characteristics of potential industrial reactors and were used by Mittasch and co-workers to screen some 20,000 samples as candidate catalysts. The results led to the identification of an iron-containing mineral that is similar to today s industrial catalysts. The researchers recognized the need for porous catalytic materials and materials with more than one component, today identified as the support, the catalyticaHy active component, and the promoter. Today s technology for catalyst testing has become more efficient because much of the test equipment is automated, and the analysis of products and catalysts is much faster and more accurate. 

The development of a continuous grinding index was the focus of work in the late 1970s (59). The laboratory test equipment used is similar to that for the Hardgrove test but permits classifying the product and recycling the oversize material. An improved correlation is obtained that may, however, need to be corrected for the relative sizes of the test grinding balls versus those used in commercial-scale equipment. The continuous grinding index is especially useful for lower rank coals. 

When maldug any economic analysis, care should be taken to be certain that the efficiency ratings of all motors being considered are on the same basis. While this should not be a problem for motors rated 1 to 500 horsepower as covered by the NEMA Standards for efficiency marldug, it is common practice for several different test methods to be used when measuring the efficiency of motors rated over 500 horsepower. A particular test method may need to be selected by the test facility on the basis of available test equipment and power supply. All test methods that may be used to test any one motor will not necessarily give the same result for efficiency. 

Definition of the test equipment, support equipment, and facilities needed to carry out the verification activities. 

Define the inspection aids and test equipment to be used. There may be jigs, fixtures, gages, and other aids needed for inspection. Standard measuring equipment would not need to be specified as your inspectors and testers should be trained to select the right tools for the job. Any special test equipment should be identified. 

Procedures are required for the control and maintenance of inspection, measuring, and test equipment and to cover test software, not only for calibration. This section of the standard is often referred to as the calibration requirement but it goes far beyond mere calibration. In assessing compliance with section 4.11, there are at least 30 requirements to check (see the questionnaire at the end of this chapter) and calibration is only one of them. Figure 11.2 shows the processes needed to control, calibrate, and maintain inspection, measuring, and test equipment. The shaded boxes indicate interfaces with other processes. 

There are two categories of equipment which determine the selection of equipment general-purpose and special-to-type equipment. It should not be necessary to specify all the general-purpose equipment needed to perform basic measurements, which would be expected to be known by appropriately trained personnel. You should not need to tell an inspector or tester which micrometer, vernier caliper, voltmeter, or oscilloscope to use. These are the tools of the trade and they should select the tool which is capable of measuring the particular parameters with the accuracy and precision required. However, you will need to tell them which device to use if the measurement requires unusual equipment or the environmental conditions prevailing require that only equipment be selected that will operate in such an environment. In such cases the particular devices to be used should be specified in the test or inspection procedures. In order to demonstrate that you selected the appropriate device at some later date, you should consider recording the actual device used in the record of results. With mechanical devices this is not normally necessary because wear should be detected well in advance of there being a problem by periodic calibration. 

This requirement hides an important provision. It not only applies to inspection, measuring, and test equipment but to the measurements that are performed with that equipment. Anywhere you intend performing product verification or monitoring processes you need to ensure that the environmental conditions are suitable. By environmental conditions is meant the temperature, pressure, humidity, vibration, lighting, cleanliness, dust, acoustic noise, etc. of the area in which such measurements are carried out. To avoid having to specify the conditions each time, you need to establish the ambient conditions and write this into your procedures. If anything other than ambient conditions prevail, you may need to assess whether the measuring devices will perform adequately in these conditions. If you need to discriminate between types of equipment, the ones most suitable should be specified in the verification procedures. 

A procedure to enable hardness measurements to be made on specimens much thinner and smaller than those needed for the standard test. Normally the whole test equipment is scaled own to l/6th of its original dimensions. 

In some cases, the exam question will request a list of the equipment needed, while in other cases you will get a list from which to choose the items you need. Certain items appear in many experiments. These include the analytical balance, beakers, support stands, pipets, test tubes, and Erlenmeyer flasks. Burets, graduated cylinders, clamps, desiccators, drying ovens, pH meters, volumetric flasks, and thermometers are also commonly used. If you are not sure what equipment to choose, these serve as good guesses. Most of the remaining equipment appears in three or fewer experiments. 

Due to the nature of the test method, quality by design is an important qualification aspect for in vitro disolution test equipment. The suitability of the apparatus for the dissolu-tion/drug-release testing depends on both the physical and chemical calibrations which qualifies the equipment for further analysis. Besides the geometrical and dimensional accuracy and precision, as described in USP 27 and Ph.Eur., any irregularities such as vibration or undesired agitation by mechanical imperfection are to be avoided. Temperature of the test medium, rotation speed/flow rate, volume, sampling probes, and procedures need to be monitored periodically. 

Validation of automated systems must demonstrate a lack of contamination or interference that might result from automated transfer, cleaning, or solution preparations procedures. Equivalency between the results generated from the manual method and the data generated from the automated system should be demonstrated. Since sensitivity to automated dissolution testing may be formulation related, qualification and validation of automated dissolution equipment needs to be established on a product-by-product basis (8,13) (see also Chapter 12 for a more detailed description of automation issues). 

However, these stringent new requirements created a need to accelerate the development of specifically targeted catalysts. Ashland decided to initiate its own catalyst preparation program, coupled with installation and development of advanced testing equipment, to speed the evolution of advanced catalysts. 

Additionally, what is a company s commitment to technology and engineering support before and after start-up Who provides the training costs Who pays what Are the in-process testing equipment and necessary analytical equipment operational, qualified, and ready when needed Who will perform the validation requirements (equipment and process) These are some of the key questions and concerns that go beyond the hardware issues and technology that must be addressed prior to the project start-up. 

When inspection, measuring, or test equipment is found to be out of calibration, an evaluation is made to determine the validity of previous inspection or test results and a decision is made as to the need for reinspection or retest. 

Calibration is based on the principle of traceability from a primary standard through intermediate standards to the test equipment, with estimates of the uncertainty which increases at each step in the chain. Wherever possible, bought in calibrations should be carried out by an accredited laboratory. It is perfectly acceptable for the test laboratory to do its own calibration but then they must maintain appropriate calibration standards and operate a measurement management system in accordance with IS01001213. One factor which has hindered full appreciation of the detailed needs of... 

The basic requirement for test equipment is that it is adequate for its purpose - it needs to comply exactly with any standard test method being used, be in good working order and be properly calibrated. However, there is then scope for a considerable range of level of sophistication, ease of use etc. 

What kind(s) of product)s) will be processed by the equipment What kind of retention testing is needed to prevent compromising the process ... 

For example, the requirements for tracking the receipt and use of the test substances and test animals are the same. The need for the calibration of the test equipment, storage, and archives are the same. 

If surface scums or precipitates are observed in an acute study or the protocol requires it, the test concentrations need to be measured and documented. This requires taking appropriate samples. The investigator must have considerable expertise in taking and analyzing the samples if the concentrations are low or if sophisticated analytical techniques and/or equipment are needed. In a renewal-study or a chronic study requiring a flow-through system, it is important to take and measure test concentrations on a daily... 

IPCR is not for everyone, as there are many well-established ELISA tests with sufficient sensitivity. A certain degree of handling experience and equipment needed for ultrasensitive analysis will certainly rule out applications in quick-testing, outdoor kits, or test-stripes. 

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