The reduction of visible particles in injectable products is an important element in the
consistent delivery of high-quality parenteral products. An important part of this effort is the …

Visible particles are a critical quality attribute for parenteral products and must be monitored.
A carefully designed, executed, and controlled drug product manufacturing process …

Particulate matter (PM) associated with pharmaceutical systems is in large part unwanted
contamination in sterile products for which there are compendial guideline methods and …

The requirement for visual inspection of pharmaceuticals has been a compendial
expectation for over a century, with some advancement of visible particle control strategies …

Visible particulate matter in injectables presents one important question for
consideration:“What are the potential implications to the patient?” The risks of visible …

The efficient mass production of pharmaceuticals requires scientifically replicable
measurements. The measurements, in turn, must be capable of description in words and …

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

Visible particles must be monitored as part of the control strategy for pharmaceutical
products. Extraneous (foreign) particles are not acceptable in parenteral drug products. In …

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

Particulate matter, visible or subvisible, in sterile parenteral products is regarded as a critical
quality attribute, impacting safety of the product. Particles can arise from many sources …