What causes fibre and hair contamination in pharmaceutical vials?

Fibre and hair contamination comes from the manufacturing environment, operators, and packaging materials. The common types are black fibres, white fibres, lint fibres, and human hair.

Fibres are classed as extrinsic contamination --- foreign to the product and process --- and are among the most frequently observed visible defects in parenteral manufacturing. Human hair originates from operators despite gowning; lint and cloth fibres from wipes, garments, and cleaning materials; black and white fibres from packaging, cartons, and environmental sources. Because fibres are long and thin (typically 500--2000 µm), they are detected differently from compact particles, which is why a well-designed challenge set includes fibres at several lengths.

FTI's challenge sets include black fibre, white fibre, and human hair units sized from 300 µm upward, so inspection qualification reflects the fibre contamination a facility realistically faces. Controlled gowning, environmental monitoring, and inspector training against fibre standards are the main controls.