Life-Cycle Test Conditions

If reliable test data as a function of charge current and duration, discharge current, and terminal voltage are of prime importance, then life-cycle test conditions must be strictly followed. Discharge-cycle test conditions are defined in terms of 

Discharge-Cycle Test Conditions Charge-Cycle Test Conditions Rest Duration (h) 

Source Vutetakis, D. C., and H. Wu, The effect of change rate and depth of discharge on the cycle life of sealed lead-acid aircraft batteries, Proceedings of the IEEE, 1992 IEEE. With permission. 

For a 20% DOD cycle test condition, a current of 20 A over a 9 min. duration is involved. For the charge-cycle test, a current of 50 A over 51 min. is involved with no rest duration. When these test conditions are satisfied, the SLABs are fully qualified for their specific application and are ready for deployment in a specified electrical system. 

6 Thermal Battery for Aircraft Emergency Power and Low-Earth-Orbiting Spacecraft 

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A thermomechanical fatigue screening test for the remaining 13 alloys was performed utilizing 44 I/O and 20 I/O leadless ceramic chip carriers (LCCC) on FR-4 PWB substrates under the thermal cycling test conditions of —55 to + 160°C, with a ramp rate of 10°C/min, temperature dwell of 10 min at each temperature extreme for a total cycle duration of 1 hr. The WeibuU results for the various alloys are presented in Figure 29. The seven alloys determined to be the best performers based on mean life are listed in Table 41 The alloy Sn-A.8Bi-3.3Ag... 

Each qualification must be formally reported to ensure an approved and audit-able transition to subsequent life-cycle phases. Qualification summary reports for the system must be prepared by the pharmaceutical manufacturer and should be kept in the validation file. Each qualification report should confirm the qualification test acceptance and review associated change control records. The report must present a documented record that clearly states the basis for concluding that the qualification is acceptable, particularly if there are any minor conditions or actions outstanding. 

VMP for its successful execution. Reference the location of each deliverable and provide the detail necessary for retrieval at a later date (e.g., SOP and protocol numbers). Identify any conditions surrounding the use of the system. Were some features of the system found to be unsatisfactory for use Clearly state what aspects of the CRS are not approved for use until they are re-engineered and tested and what formal controls are in place to enforce this (SOPs, security programming, etc.). Design the VMP so that approval of the MVS document is the end point that releases the CRS for GMP use by appropriately trained users. This end point is called system acceptance and signals the transition to the validation maintenance phase of the system life cycle. 

These segments can be tested separately or in a combined manner. All stages of development from conception to maturity and the detection of acute and delayed effects of exposure through one complete life cycle should be examined. The standard species are rodents, rats as the preferred rodent species for all study types and, the rabbit as the second nonrodent species for the embryo-toxicity studies. In some rare cases mice or monkeys are used too, if special conditions - usually kinetic data - justify such species. 

Each requirement must be written so that it can be tested if required. According to IEEE standard 1233, a well-defined requirement must address capability, condition, and constraint. Remember, as shown in Figure 20.6, that the URS functions are related to the tests carried out in the qualification phase of the life cycle. If the requirements are not specified, how can they be tested Further discussion on CDS user requirements can be found in McDowall. ... 

In practice, perfumery companies test all products at 0-4 °C, 20 or 25 °C and 37 °C (or 40 °C) for 12 weeks as a minimum standard. In addition, tests at 45 or 50 °C may be used (except for aerosols, which could explode) if quick results are required, or if it is likely that the product will experience these sort of conditions during its life-cycle. Stability for 4 weeks at 50 °C is considered acceptable in many instances, but signs of instability should be taken as precautionary only, particularly if the samples still appear satisfactory at 37 or 40 °C. This is because certain chemical reactions could occur at these high temperatures that could not happen at ambient temperatures or even at 37 °C. Note that 37 °C has become an accepted standard because many cosmetic chemists believe there is a temperature barrier , corresponding to the heat of the human body, above which chemical reactions are accelerated beyond that predicted by the Arrhenius equation. 

Thus, it is no longer acceptable for the formulator to delay this compatibility testing until later in the development programme. The key message is for the formulator to test early and ensure equivalence of the whole product throughout the development cycle. Leachables are specifically mentioned data on their identity and concentration in the product and placebo are required through the shelf life and also under accelerated stability test conditions. Information should be submitted on source, chemical composition and physical dimensions of the container closure system, together with control and routine extraction tests. Acceptance criteria are also required. 

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