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<p>This document specifies (i) characterization parameters and methods used to qualify a bronchial air-liquid interface (ALI) microphysiological system (MPS) for a declared context of use (CoU), and (ii) minimum verification/quality control checks (e.g., lot/batch verification) to confirm that manufactured MPS components continue to meet the qualified performance. It does not establish a full quality management system (QMS) or manufacturing process validation requirements; sampling plans and test frequencies are to be defined by the manufacturer/user and reported. This document covers verification of the bronchial MPS platform. It does not standardize specific experimental test methods. This document provides performance-based guidance for bronchial airway MPS/Organ-on-chip (OoC) with microfluidic control using ALI, where dynamic microenvironmental parameters (e.g., flow/shear, cyclic strain) and multi-compartment architectures with integrated sensing introduce additional sources of variability. Conventional static ALI cultures conducted in standard multi-well plates without a microengineered platform are outside the scope of this document.</p>
Reģistrācijas numurs (WIID)
90217
Darbības sfēra
<p>This document specifies (i) characterization parameters and methods used to qualify a bronchial air-liquid interface (ALI) microphysiological system (MPS) for a declared context of use (CoU), and (ii) minimum verification/quality control checks (e.g., lot/batch verification) to confirm that manufactured MPS components continue to meet the qualified performance. It does not establish a full quality management system (QMS) or manufacturing process validation requirements; sampling plans and test frequencies are to be defined by the manufacturer/user and reported. This document covers verification of the bronchial MPS platform. It does not standardize specific experimental test methods. This document provides performance-based guidance for bronchial airway MPS/Organ-on-chip (OoC) with microfluidic control using ALI, where dynamic microenvironmental parameters (e.g., flow/shear, cyclic strain) and multi-compartment architectures with integrated sensing introduce additional sources of variability. Conventional static ALI cultures conducted in standard multi-well plates without a microengineered platform are outside the scope of this document.</p>
