Intrinsic Particulate Matter

Intrinsic particles are defined as those that arise from sources related to the formulation, packaging, or processes. Examples of intrinsic particle materials include glass, stainless steel, rubber from stoppers, and gasket material. Know more about Intrinsic Particulate Matter at FTI Incorporation.

What is risk associated with visible particles?

There is no published guidance on the potential risk of small numbers of visible particles to patients.

Although there is published literature available describing exposure to large numbers of particles, none of these reports reflect the potential hazards of more typical particle administration via large‐ or small‐volume parenteral pharmaceuticals.

PDA paper published in Jan 2015 describes four pathophysiological symptoms indicating potential possible harm to patients.

1. Particles may act as a substrate to carry microorganism or endotoxins which may cause Infection and inflammation

2. Leachates from particles may cause inflammatory response or tissue injury.

3. Particles might also stimulate allergic reactions or anaphylaxis.

4. Tissue damage can arise from the occlusion of the affected blood vessel

Assessment of the risk to the patient can be decided based on severity of harm or clinically significant impact the patient will experience due to administration of drug products from the affected lot.

Severity can range from temporary discomfort like allergic reaction or symptoms of fever, etc to all the way patient death due to blockage of blood veins.