Light plays an important role in routine work of a pharmaceutical industry. As a large number of workers are working there for the manufacturing of drugs, the sufficient amount of light is necessary for better output. Poor lighting in working area can result in various ways.


As per ‘21 CFR 211.44 – Lighting’

Adequate lighting shall be provided in all areas.


As per FDA draft guidance on ‘Inspection of Injectable Products for Visible Particulates’

Manufacturers should conduct 100% inspection during the stage at which there is the greatest likelihood that visible particulates will be detected in the final container (e.g., before labeling to maximize container clarity).


As per USP <790> ‘Visible Particulates in Injections’

For injectable products clear containers to be inspected without magnification over a backlight intensity of between 2000–3750 lux.


Lux level of different places is as follow –

  • Office lighting: 320–500 lux
  • Sunrise or sunset on a clear day: 400 lux
  • Very dark overcast day: 100 lux
  • Full daylight (not direct sun):10,000–25,000 lux
  • Direct sunlight: 32,000–100,000 lux


So a reasonable lux level is 300-500 lux for pharmaceutical industry, where should be 400 lux in production areas and above 300 lux in the sampling area and dispensing booths.


As per USP <1790> ‘VISUAL INSPECTION OF INJECTIONS’

  • For amber container, 8000 to 10,000 lux level may require. 
  • For translucent plastic container 8000 to 10,000 lux level is recommended.
  • Recommended light levels NLT 2,000–3,750 lux at the point of inspection for routine inspection of clear glass containers.


What is Lux Level and how to determine lux levels?

Lux is simply the unit of illumination in the International System of Units (SI), used to describe the number of lumens falling on a square meter of a surface.One lux is equal to 0.0929 foot-candle.



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