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The final product passed all recommended quality control specifications (pH, sterility, pyrogen test & bubble test).
This includes spots that failed Invitrogen's recommended quality control specifications.
The workflow process was carefully monitored with addition of positive and negative controls at each process step and individual samples were accepted for final analysis after passing quality control specifications (see Supplementary Text S1).
34, 35 The PfSPZ Challenge released for clinical use met quality control specifications including sterility (USP 71 compendial assay), purity (Supplemental Figure S1), and potency (Table 1).
In the ECOG study, 12% of all vaccines failed to meet quality control specifications (in terms of cell number and/or viability), and 15% of the vaccinated patients failed to develop DTH reactions to tumor cells alone.
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Using vialed sporozoites that have met defined lot release specifications should reduce or eliminate these variables, as a defined number of sporozoites with the same quality control release specifications can be used for all comparative studies.
Users should check whether the daily quality control meets the specifications or passed the test correctly.
These also serve for quality control and the specification of diagnostic reference levels (see below, point 8).
The use of fiber reinforced concretes (FRC) as a substitute for reinforcement meshes, particularly in the construction of tunnels, frequently faces quality control problems because the specifications and acceptability criteria are based on parameters obtained from the flexion test of standard EN-14651, which is very difficult to perform at works.
The ESA Laboratories blood lead analysis protocol and quality control and quality assurance specifications are described elsewhere (Hu et al. 1996b).
11 Quality control procedures (Synarc Inc , Hamburg included specifications related to image acquisition and collection (eg, depiction, positioning and beam angle); regular training for radiology technicians; determination of radiographical eligibility; and onsite and centralised digitisation and quality control of radiographs.
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