Particulate Matter

Particulate matter has, for parenteral products, been defined as "mobile undissolved substances which are unintentionally present." It is divided into subvisible and visible particles with the limit at 50 ^m. Intravenously administered pharmaceutical products enter the circulatory system and pass through the lungs, where the largest particles are filtered out before the product is pumped on through the arterial circulation.

The potential for patient risk from nonviable particles was first reported in the 1950s, gathering impetus when it was demonstrated in the 1960s, that foreign body granulomas could be produced in the lungs of rabbits following administration of commercially available parenteral infusion solutions.

Thrombosis and phlebitis are clinical complications for which there is sound documentary evidence of both conditions being caused by nonviable particulate contamination (Akers, 1987) of parenterally administered pharmaceutical products.

The sources of nonviable particulate contamination of parenteral products is divided into intrinsic and extrinsic origins (Backhouse et al., 1987). Intrinsic contamination comes from the areas of manufacture, packaging, transit, and storage. Extrinsic particulate contamination is introduced at the time of drug reconstitution and usage.

Most intrinsic nonviable particulate contamination of parenteral products is thought to originate in

• Product-contact packaging materials

• Leaching and dissolution of the surfaces of glass containers (flaking)

The manufacturing environment may, unless controlled carefully, be another important source:

• The use of aluminium for transport containers or for wall finishes

• Machinery used in parenteral manufacture, a well-known intrinsic source of nonviable particulate contamination

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