During the processes involved in pharmaceutical manufacturing, particulate matter may be
introduced into a product from a variety of sources and at different points in the …

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

Pharmacopeias recognize particulate matter as a common phenomenon. The current
regulatory requirements relating to particulate matter in parenterals state that solutions for …

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 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 …

Biopharmaceutical companies are required to control subvisible and visible particles in their
products to ensure a consistent manufacturing process, assess product quality, as well as …

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

Contamination with foreign particulate matter continues to be a leading cause of parenteral
drug recalls, despite extensive control and inspection during manufacturing. Glass is a …

The United States (US) Food and Drug Administration's (FDA) draft guidance on visual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 …

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