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Test attributes, procedures, and

Test attributes procedures and acceptance criteria selection of batches testing frequency storage containers, conditions, and period, as well as data evaluation are discussed in great detail. Data evaluation considers out-of-specification results. Documentation covers protocols and protocol amendments, deviation reports, out-of-specification reports, test results and raw data, and stability reports. [Pg.19]

MIL-STD-1233 - Procedure for Determining Particle Size Distribution and Packing Den-siry of Powdered Material MIL-STD-1235 — Single and Multilevel Continuous Sampling Procedures and Tests for Inspection by Attributes 2.2 Other Publications See Spec, pp 1 2 3. REQUIREMENTS... [Pg.804]

Process validation starts with the identification of product quality attributes and justification of acceptance criteria, followed by a review of the risk analysis, execution of process development runs, and compilation of clinical material manufacturing data to set specifications considering process variability [11]. There is a greater focus on process validation for downstream steps rather than for upstream steps because downstream steps are associated with virus removal. Process validation is just one approach used to control virus contamination, however others include cell bank characterization, in-process testing, inactivation procedures, control of raw materials, containment, and postmarket surveillance [6]. [Pg.332]

The information and examples presented above demonstrate how compendial procedures and general chapters may be applied for determining the strength, identity, quality, and purity of products on stability. It is up to the users to understand which product attributes are critical for stability and then couple the appropriate compendial test to measure those attributes. [Pg.197]

Selection and evaluation of samples themselves for acceptance of ordnance materials that can be tested by measurable properties is made according to M1L-STD-105D (1963) Sampling Procedures and Tables for Inspection by Attributes. [Pg.215]

Changes in the coal s particles size, which are either intended (e.g., grinding) or are attributed to intrinsic processes in the gasifer (e.g., fragmentation), need to be quantified for reliable technical adaptation. Last but not least, the interaction of the coal bulk with the applied machinery will result in wear, which should be assessed before plant construction. The most relevant calculation procedures and coal tests regarding these granulometric properties will be presented in the following sections. [Pg.91]

Displacement measurements at the beam-column interface indicated a vertical translation of the beam axis with respect to its initial position of about 4 mm. This translation took place gradually during the testing procedure and is attributed to a gradual loss of friction between the beam and the column interface. Shear tabs could be welded on the column flange and bolted on the beam web using slotted holes to... [Pg.3400]

Going back to Table 5, AlSPPO-18.5 appears to be the most permeable to gases among all HMW SPPOs. It should be pointed out however, that all AISPPO films were defective and they could be tested only after lamination with a silicone rubber membrane [19,23]. The defects were attributed to the fact that due to insolubility of AISPPO in any solvent, the films from this polymer could not be prepared directly from the polymer solution unlike the other polymers [19,23]. Considering possible errors due to the difference in preparation procedure and lamination with a silicone rubber membrane, permeabilities of AISPPO are not included in the further discussion. [Pg.96]


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