Adequate Lux or Light intensity in the pharmaceutical industry is necessary to carry out their work accordingly and correctly. If the work area has too little vision, it may cause problems like eye strain and fatigue particularly when detailed work is to be performed. Too much lighting is also not necessary as it can cause galare and dazzle.
Factor affecting Lux or Light intensity in the area:
The following factors may cause low vision in the working area:
- Position of the source of light.
- Selection of tube lights or bulbs.
Guideline on the intensity of light in pharmaceuticals:
The recommended intensity of light in pharmaceuticals is 500 Lux for the visual inspection of parenteral preparation in an adjustable lamp holder fitted with a diffuser (such as 13 W fluorescent tubes, it is about 52.5 CM in length, the intensity of illumination is kept at 2000 to 3750 Lux or higher for plastic, and colored glass container is specified.
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What are the means of Candle or Lux?
The unit of intensity of illumination that is produced by a standard candle on the inside white surface of a sphere of the unit radius when placed at its center. If the radius of the sphere is one meter, then the intensity of illumination is one lumen per square meter and is known as a meter candle or Lux.
How to measure illumination intensity?
Lux Metre is used to measure the illumination of light, and an intensity meter is used to measure the intensity of UV radiation.
Criteria for measurement of light intensity:
Lux meter shall be used above one-meter height from ground level. For its measurement, select a minimum of five locations inside the room and calculate the average of readings taken to determine the intensity of room light. The light intensity is not to be less than 500 Lux for the production area and 300 for Dispensing and sampling area.
CFR-211.44 states “Adequate lighting shall be provided in all areas”.
Frequency
The frequency of monitoring light intensity shall be once a year.
There is a very imported and use full information.
Is there any specific required by FDA on lux level in stability chambers.
This is very wide topic for discussion, but The stick answer is: at least 1.2 million lux-hours of visible light and 200 Watt Hr/m2 of UVA (near UV) light is required for exposure.