The subvisible and visible particles present in a solution are often classified based on size,
and are quantified by the actual number of particles present rather than by weight or molar …

Formation of aggregates and particulates in biopharmaceutical formulation continues to be
one of the major quality concerns in biotherapeutics development. The presence of large …

A host of diverse stress techniques was applied to a monoclonal antibody (IgG 2) to yield
protein particles with varying attributes and morphologies. Aggregated solutions were …

Vibrational and X-ray spectroscopic techniques are based on the interaction between
radiation and matter. This interaction produces various signals that can be detected and that …

Objective: To develop training and validation kits for staff in a hospital pharmacy who are
involved with inspecting parenteral drugs prepared in the department; to assess the …

The United States (US) Food and Drug Administration's (FDA) draft guidance on visual
inspection (1) states that visible particulate control should be developed and implemented in …

Particulate contamination in parenteral products, in particular protein pharmaceuticals, is an
important issue for the pharmaceutical industry. Significant research has been performed …

Evaluation that the visible particle incidence rate is within USP (1) acceptance limits for
human or veterinary use is an essential part of the injectable batch release procedure (2-4) …

QUALITY AND ECONOMIC EFFICIENCY OF INSPECTION- METHODS Page 1 QUALITY AND
ECONOMIC EFFICIENCY OF INSPECTIONMETHODS M. Kardel¹, G. Kutz¹, R. Rosito², H. von …

Résumé L'inspection visuelle des médicaments injectables ou mirage, est un essai prescrit
par la Pharmacopée Européenne, qui permet de contrôler la présence de particules visibles …