What is the required lux intensity in wash areas ( dispensing/sampling/granulation) and which guidelines need to be followed

Engineering
1

what is the required lux intensity in wash areas ( dispensing/sampling/granulation) and which guidelines need to be followed

2

The lux level is to be determined based on the area and criticality of operation. Please refer the GMP guideline for advise on minimum Lux level ( again pl. note that these are guidelines only and not regulatory requirement). You need to decide on appropriate level of Lux required for the size of the area and criticality of operation.

3

I need to know the minimum lux acceptable in wash areas of sampling, dispensing and granulation. now again I ask, is there is guideline stating the min lux required for a particular size of the room or any formula for calculation. I need this as a justification in preparing a SOP for lux level measurement

4

Dear
There is no GMP guidelines (US FDA or EU) which will specifically mention what is the required Lux level. The GMP guidelines only mention general requirements for premises. As a company you need to decide the appropriate lux level for the area.

In the EU-GMP guide you can find general requirements on the ligthing or the light fittings in items 3.3, 3.10 or 3.16.

Normal industrial practice is 200- 250 LUX in normal working areas.

500 to 600 Lux in Inspection area

650 to 700 LUX in documentation areas.

The chapter referred to above is here:
http://ec.europa.eu/health/files/eudralex/vol-4/chapter_3.pdf

Regards
Jay K