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There are no specific guidelines for pharmaceutical industries to define the required level of light intensity on every working floor.
CFR 211.44 only states that’ adequate levels of light should be available in all working areas.
For some critical areas like visual inspection of injections, guidelines are available which are discussed below.
In a clear day, the outdoor light level is 100,000 lux and a place near the window of a home or office, the lux level is 1000 lux. And in the centre of home lux level may be 25-50 lux and in this area, extra lights are used for proper working.
Lux level of different places is as follow,
- Direct sunlight           100,000 lux
- Daylight in rainy day      100 lux
- Clear night with full moon 1 lux
- Home theaters          150 lux
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For the office, a reasonable lux level is 300-500 lux. Light intensity should be 400 lux in production areas and above 300 lux in the sampling area and dispensing booths.
It should be greater in inspection areas to see things in more details. In the inspection room, lux level should be above 500 lux.
USP Chapter 790 says that all products intended for parenteral use should be free from particulate matter. Particulate material includes fibres, glass, metal and precipitates.
Inspection of parenteral products is conducted without using any magnification against light and dark background and light intensity at the level of inspection for clear glass containers should not be less than 2000-3750 lux. (Ref USP 790). The unit planned for inspection should be swirled for 5 seconds against light backgrounds and 5 seconds for dark background.
For amber glass container, 8000 to 10,000 lux level is recommended. (Ref USP 1790)
For translucent plastic container 8000 to 10,000 lux level is recommended.
(Ref USP 1790)
Also Read:
INSPECTOR FATIGUE
Inspection for long period may develop inspector fatigue. So Persons performing the visual inspection should give rest after every hour, for 5 min to give rest to their eyes and mind or they should be rotated for non-optical checking operation.
lux in all areas should be checked every year.
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