Environmental Performance Test Procedure

The purpose is to describe the environmental performance test criteria. 

It is the responsibility of validation team members to follow the procedures. The quality assurance (QA) manager is responsible for SOP compliance. 

Controlled environments should generally be subjected to the following set of performance tests related to environmental control  

The preceding tests are required for the final certification and validation of the environment (where applicable). The instruments used for these tests should be calibrated reports should be available. The qualification shall include conditions at rest, dynamic, and or under stress (as applicable). 

Tests performed under at-rest conditions to serve as baseline information are needed to determine the degree by which the environmental parameters are affected by the process after they are repeated at dynamic conditions (simulated fully operational conditions). After this analysis, review procedures, equipment, methods, etc. and change if necessary. Performance tests executed at dynamic conditions are the only way to obtain a clean representation of the prevailing environmental conditions. 

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Although cyclic environmental chamber test procedures may suffice for failure processes Involving, for example, mechanical stress, kinetic controlled processes dependent upon time and temperature such as oxidation and diffusion do not lend themselves to adequate Identification and analysis based solely on number of cycles. Thus Sandia National Laboratories developed an accelerated aging protocol for environmental testing which (1) identifies material incompatibilities and subsequent failure modes in Phase I and (2) proceeds with kinetic analysis of the Arrhenius type of failure mode processes which allow extrapolation necessary for lifetime prediction of components in Phase II. Thus two phases are necessary in a complete analysis to accurately predict system lifetimes. The accelerated aging protocol requires the Identification of the stresses that are most likely to damage the performance of the component under test. However, data is frequently not available on the performance of a system under a particular stress. When this is the case, it becomes necessary to make predictions of those stresses most likely to cause degradation and then test to see if the stresses selected are dominant. 

Developing the System Functional Performance Testing Procedures. The development of system functional performance testing procedures is crucial to proper performance of the commissioning process. In order to develop these procedures, the TC must have reviewed the design criteria, the construction documents, and the approved environmental control and building automation systems. Based on this information, written testing procedures and test... 

SAE has established a Fuel Cells Standard Forum that is chartered with the establishment of standards and test procedures for fuel cell powered vehicles. The committee was established in 1999. The standards will cover the safety, performance, reliability and recyclability of fuel cell systems in vehicles with emphasis on efficiency and environmental impact. The standards will also establish test procedures for uniformity in test results for the vehicle/systems/components performance, and define interface requirements of the systems to the vehicle. Task Groups have been formed in the areas of safety, performance, reliability, emissions, recyclability, interface and miscellaneous. 

Environmental Tests. It is desirable to know the rate at which an adhesive bond will lose strength due to environmental factors in service. Strength values determined by short-term tests do not give an adequate indication of an adhesive s performance during continuous environmental exposure. Laboratory-controlled aging tests seldom last longer than a few thousand hours. To predict the permanence of an adhesive over a 20-year product life requires accelerated test procedures and extrapolation of data. Such extrapolations are extremely risky because the causes of adhesive bond deterioration are complex (see Sec. 15.2.2). Unfortunately no universal method has yet been established to estimate bond life accurately from short-term aging data. 

Third, many times the toxicity tests are selected on the basis of cost, and this is a valid parameter. A FIFRA mesocosm may cost as much as 750,000 compared to as little as 500 for a D. magna acute toxicity test. The danger is from both ends of the spectrum. The more expensive multispecies test is not necessarily better unless it answers specific questions left unanswered by the simpler tests. In fact, the large multispecies tests are performed only after a thorough review and evaluation of simpler testing procedures. Likewise, the simpler and less costly toxicity tests may not adequately address the fate and effects of a xenobiotic, leaving a great deal of uncertainty in the prediction of environmental effects. 

An abbreviated version of the test procedure, incorporating an additional safety factor is used for routine product quality control and for the screening of development products. With this test, a reliable prediction of the enzyme s column performance can be made from a small sample in about an hour. It is important to realise that the hydraulic properties of the enzyme bed are related to the enzyme particle size distribution and rigidity. These properties in turn can be influenced by environmental factors, e.g. pH, ionic concentration, temperature and these effects have been studied extensively. 

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. 

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