Source | Particulate Material | Intrinsic/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 material | Rubber Glass Polymers Silicone | Intrinsic |
Solution and formulation components | Precipitates Oligomers Degradants Agglomerates Undissolved material | Intrinsic |
Product–package interactions | Glass lamellae Silica Rubber Plastic | Intrinsic |
Process-generated particulate matter | Metal (e.g., stainless steel from processing equipment) Filter and Consumables fibers Glass (from breakage events) | Intrinsic |