The major compendia require sterile injectable and ophthalmic drugs, to be prepared in a
manner that is designed to exclude particulate matter. This requirement is satisfied by testing …

The major compendia require sterile injectable and ophthalmic drugs, to be prepared in a
manner that is designed to exclude particulate matter. This requirement is satisfied by testing …

… , protein aggregation, and product attributes that affect patient safety," says Dan Berdovich,
manager of quality assurance and regulatory affairs at Micro Measurement Laboratories. …

Particle analysis tools for the subvisible (< 100 μm) size range, such as light obscuration,
flow imaging (FI), and electrical sensing zone (ESZ), often produce results that do not agree …

Micro-flow imaging (MFItm) has been shown to be more sensitive than light obscuration (LO)
methods for measuring subvisible proteinaceous particles in protein formulations. Given the …

Numerous presentations and articles on manual inspection of pharmaceutical drug products
have been released, since the pioneering articles on inspection by Knapp and associates …

The purpose of this study was to examine the role of the leader in preparing a school climate
for disruptive change. Disruptive change, according to Carter & White (2017), is presenting …

The detectability size threshold of visible particles (“visibility” size) in the context of visual
inspection of parenteral drug products has been an elusive target for several decades. The …

… The guiding theoretical framework for this study was Daniel Goleman’s Emotional Intelligence
Theory. This study used a constructivist worldview approach to gather data through semi-…

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