TABLE I

Types and Sources of Injectable Particulate Matter

SourceParticulate MaterialIntrinsic/Extrinsic
Environment (including personnel)Dust
Fibers
Biologics—insect parts, microorganisms, pollens
Fibers of anthropogenic origin
Hair
Skin
Paint/coating chips
Rust
Metal (non-product contact types)
Minerals
Polymers (unknown source)
Glass (e.g., carry over from components)
Extraneous Material (e.g., carry over from rubber stopper components)
Extrinsic
Packaging materialRubber
Glass
Polymers
Silicone
Intrinsic
Solution and formulation componentsPrecipitates
Oligomers
Degradants
Agglomerates
Undissolved material
Intrinsic
Product–package interactionsGlass lamellae
Silica
Rubber
Plastic
Intrinsic
Process-generated particulate matterMetal (e.g., stainless steel from processing equipment)
Filter and Consumables fibers
Glass (from breakage events)
Intrinsic