Lighting in Pharmaceutical Areas

Light intensity plays important role for better work at work place. Light intensity levels effect on the systolic and diastolic blood pressure, blood oxygen saturation, heart pulse rate and tympanic temperature of the employees’ health.
Poor lighting can affect the health of the people working in pharmaceutical industry causing headache, eye strain and migraine.
CFR-211.44 gives only one guideline and states that “Adequate lighting shall be provided in all areas”.
Regulatory guideline do not make any comment on the intensity of light required in various operational areas. But there are certain industry norms for specific critical areas in the plant, they are as follows:
Visual inspection areas for ampoules/ Vials or similar sterile products 100 foot candles
Visual inspection areas for liquid oral bottles or similar non-sterile products 50-80 foot candles
Packing line in the packaging department 50 foot candle
Visual inspection of tablets capsules on automatic / semiautomatic inspection belts. 50-80 foot candles
Other Operational areas in the Plant.   50-80 foot candles
Light intensity should be checked at the operational height in the department.
Document Required
Specification and records of light intensity at critical work areas as identified above.
UK Government had published a document on Lighting at work in 1987.

lux-meterIt is better to have sufficient light at work place. Standard unit of Light intensity is Lux. I lux is equal to the light intensity of the surface one meter away from a signal candle. Light intensity is measured by using an instrument called lux meter. Light intensity should be checked at the operational height in the department about one meter from ground. To determine final light intensity, record light intensity of minimum five location minimum and an average of all readings.

Light intensity Level
Clear night with full moon 1 lux
Clear day sun rise and sun set 400 lux
Direct sunlight 100000 lux
Moonless clear night 0.002 lux
Day light in rainy day 100 lux
Living rooms 50 lux
Daylight 2500 lux
Office light 300-500 lux
Production area above 300 lux
Light intensity should be higher than normal in inspection areas to see the thing better.
Monitoring of light intensity in all areas including manufacturing, stores and laboratory should be done yearly.