Handling, testing integrity

The data handling or integration software can also cause peak distortion if the settings are altered throughout the lifetime of the method and it is often necessary to test these for ruggedness. 

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. 

For catalyst testing, conventional small tubular reactors are commonly employed today [2]. However, although the reactors are small, this is not the case for their environment. Large panels of complex fluidic handling manifolds, containment vessels, and extended analytical equipment encompass the tube reactors. Detection is often the bottleneck, since it is still performed in a serial fashion. To overcome this situation, there is the vision, ultimately, to develop PC-card-sized chip systems with integrated microfluidic, sensor, control, and reaction components [2]. The advantages are less space, reduced waste, and fewer utilities. 

The movement of the test substance during the course of a Held residue study must be tracked to assure that the integrity of the test substance is maintained [40 CFR 160.185(a)(10)]. The COC can be accomplished in a number of ways. In the simplest situation, every person signs their name on a piece of paper that accompanies the test substance when they handle the test substance. Eventually the COC will list the names of all those who handled the test substance during the course of the study. Shipment, receipt, weighing, and final disposition of the test substance container must all be tracked and promptly recorded if an unbroken COC is to be present at the end of the trial. The completed COC becomes an essential part of the field residue trial record. 

One advantage of the initial rate method is that complex rate functions that may be extremely difficult to integrate can be handled in a convenient manner. Moreover, if one uses initial reaction rates, the reverse reactions can be neglected and attention can be focused solely on the reaction rate function for the forward reaction. More complex rate functions may be tested by the choice of appropriate coordinates for plotting the initial rate data. For example, a reaction rate function of the form... 

The LC control software, either stand-alone or as part of an overall data-handling system, should be tested by means of a separate OQ protocol. This protocol only needs to address the communica-tions/control integrity of the hardware (e.g., setting up a run/sequence with the proper instrument parameters, the ability to start and stop the pump, etc.). It should cover all the required instrument control functions listed as part of the protocol s functional specifications. It does not need to include specific hardware performance testing, such as linearity or flow rate. The latter tests are performed separately, as part of the individual hardware validation described below. 

In addition to testing the system components, a test of software functionality would be performed to test the system software operation and electronic records and electronic signatures (ERES) compliance (security, data integrity, data backup, and archive). In order to test the software functionality, a predetermined set of instructions can be entered step by step into the system. The system responses are then compared to the expected outcomes of the instruction and any problems with the execution are determined. Some vendors will provide a standard set of data which can be processed by the system to verify the data-handling capability of the system. 

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