Requirement of Light & Sound intensity in Pharma Industry

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Required Light intensity in Pharma Industry

As comfort to work following are level for light Intensity that should provide to areas:

As per requirement 200 lux light or more than it,  is sufficient for production area, and for visual inspection it should be between 300 to 600 based on activity and for documentation point of view it should be between 650 to 700 lux., more than it generate heat in areas and environmental temperature will increase.

To measure the intensity of light lux is a unit The lux (symbol: lx) is the SI unit of illuminance and luminous emittance measuring luminous power per area. It is used in photometry as a measure of the intensity, as perceived by the human eye, of light that hits or passes through a surface.

In English, “lux” is used in both singular and plural.

As per Regulatory requirement

  • As per EU-GMP guide on general information has mentioned followings:

“Lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the medicinal products during their manufacture and storage, or the accurate functioning of equipment.”

  • As per USFDA 21 CFR guide, section 211.44 Lighting, Following is mentioned:

Adequate lighting shall be provided in all areas

 

  • As per Schedule M, Following is mentioned:

The production and dispensing areas shall be well lighted

Required Sound level in Pharma Industry

As per pollution control board guideline:

Noise is measured in decibels. Experts believe that continuous noise levels in excess of 90 decibels can cause loss of hearing and irreversible changes in nervous systems. The World Health Organization [WHO] has fixed 45 decibels as the safe noise level for general, and for plant usually register an average more than 90 decibels.

As per pollution control board guideline followings are limit:

Zone                 Limit in dB(A) Leq*                Day Time                                   Night Time

A                         Industrial Area                          75                                                70

B                        Commercial Area                      65                                                  5

C                        Residential Area                       55                                                45

D                        Silence Zone                             50                                                40

 

 

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