Clinicians have had concerns about particulate matter contamination of injectable drug
products since the development of the earliest intravenous therapeutics. All parenteral …

Maxime Perez is a hospital and university pharmacist at the Pharmacy Institute of the
University Hospital of Lille since November 2015 with special interest in clinical pharmacy …

Sterile injectable products are used extensively in health care. Patients, caregivers,
manufacturers, and regulators have an inherent expectation for safe and effective injectable …

Visible particulates (VP) are one subclass of defects seen during the final visual inspection
of parenteral products and are currently one of the top ten reasons for recalls 1, 2. The risk …

The pharmaceutical applications of powder technology have long been recognized. Yet
while many books focus on aspects of powder formation and behavior, there has been no …

Particulate matter in parenteral products is a complex subject. This article contains a
discussion of several aspects of this topic including the use and limitations of the inspection …

Particulate contamination in small volume parenteral medications has been studied and
compared with that found in a selection of large volume infusions. Particle counts in 39 …

Regulatory monographs in Europe and the United States require drug products for
parenteral administration to be “practically free” or “essentially free” of visible particles …

The analysis of particulates has been a longstanding challenge in biopharmaceutical drug
product development and quality control because the active constituents themselves may …

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