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Despite the fact that the operating characteristic (OC) curve of the USP 905 test guarantees a signi cant portion of each batch will have poor quality before batch rejection is probable [42, 43], companies have become comfortable with their odds. Process analytical monitoring tools such as NIR spectroscopy, which are capable of high-speed sampling in line, online, or at line, have been perceived as an additional burden on the rate of successful batch release. By forgoing real-time, pervasive quality monitoring, however, companies incur signi cant opportunity costs in at least three ways. First, without continuous monitoring there are few feasible opportunities for implementing RTR; time delays related to of ine release testing are one of the most signi cant factors limiting supply chain velocity in pharmaceutical manufacturing. Second, while there is some potential for discovering a greater number of batches which do not meet release criteria, statistical simulations suggest that potentially fewer batches will be rejected when larger sample sizes are considered. In other words, when the impact of measurement imprecision and the true distribution of quality characteristics are considered, traditional release testing methods pose nite risks of failing passable batches (which otherwise should have passed) because the limited sample does not adequately represent the characteristics of the population (Figure 4). Finally, and perhaps most importantly, traditional sampling techniques are an effective barrier to continuous improvement; based on fundamentals of statistical theory, it can be shown that samples of at least hundreds of individuals are required to detect incremental changes in process capability (Figure 5). Hence, even if a company were to investigate potential process improvements, only process capability changes of improbable magnitude would be recognized with statistical con dence.

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TABLE 8.2. Relevant Parameters for BaTiO3:Rh Crystals Characterized at 1.06 mm with CW Illumination (Ordinary Polarized Beams and Counterpropagating Geometry) X16-45 (0.06 + 0.02) cm21 (2.8 + 0.2) m21 (11 + 3) m21 s21 (11 + 1)s 90 + 15 2.6 cm21 X17 6/3 X17 6/4 (0.05 + 0.02) cm21 (3.6 + 0.2) m21 (13 + 4) m21 . s21 (8 + 1)s 390 + 70 2.5 cm21

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Using and acting on information Generating and updating the right information retrieving information Figure 10.1: The information life cycle Reviewing and analysing information

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Combinations of Stabilizers Combinations of different types of stabilizers are often used to reduce degradation through protection by more than one mechanism. In many cases, the combination gives synergistic protection, that is, it provides better protection than the sum of the effects of each when used alone. The combination of HALS with a UV absorber, such as a benzophenone or benzotriazole type, was an important new development in stabilization of polyole ns and has since been used for other polymers. However, the effect of combining a UV absorber with HALS cannot be predicted. It depends on the mechanism of degradation of the polymer, which can vary with the manufacturing process, and the mechanism(s) of protection by the stabilizer. In some cases, antagonism results so that the effectiveness of one of the stabilizing additives is diminished by the presence of the other. For example, the combination of a benzophenone-type UV absorber with a low-molecular-weight HALS was shown to be antagonistic in one type of HDPE but synergistic in another type of HDPE [76]. The effectiveness of the combination also depends on thickness. Synergism is almost never manifested in very thin lms. For example, synergism was exhibited in 0.1-mm lms of LDPE and PP but not in tapes of PP, which are only 0.05 mm thick [76]. The combination of UV absorbers, each acting only by a screening mechanism, can be expected to have just an additive effect. However, synergism has been exhibited by combinations of UV absorbers from different classes due to the simultaneous protection by other mechanisms. For example, combinations of oxanilides with either the benzophenones, benzotriazoles, or hydroxyphenyltriazines are strongly synergistic in polyole ns. Combinations of benzophenones and benzotriazoles can be synergistic or antagonistic, or just additive, depending

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Residuals. (Problem 6.19)

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