"Cleanliness is next to Godliness". This sentence is treated as a top priority in the Pharma Industry Domain.
USFDA is very strict when it comes to laws of sterility. It accesses data that specifies the contamination level (presence of micro organism) of the room where the production practise takes place.
Contamination can be caused due to many factors. Like Presence of Moisture, Presence of bacteria and Presence of Different Viruses.
Pharma Companies have to expose the media plate (Petri Dish) to the atmosphere in which production takes place for 4 Hours. They have to be placed in
Area of critical activity
Places where continuous presence of Human beings is there.
The particles are allowed to settle down on the plates.
After 4 Hours These Plates are covered up and then placed in Incubators for Microorganisms to Incubate.
Incubators have different temperature ranges.
Bacterial Growth takes place at a temperature range of 20 - 25 Deg Cel.
Fungal Growth Takes place at a Temperature range of 30-35 Deg Cel.
For this, the best type of Incubator that can be used is the B.O.D Incubator. Hence The temperature range of B.O.D Incubator is from 5-60Deg C. It comes with a refrigeration system as well.
For Virus Growths, The Temperature required is between 50-55 deg cel.
For this the Laboratory Incubator is used. Its Temperature range is from 5 deg cel to 60 deg celcius.
If the growth is beyond permissible levels, The USFDA Audit cell and the Production Team gets the power to suspend production.
Incubators create the environment within the chamber to help in incubation of the bacteria or Fungal growth.
Newtronic Incubators are designed as per the requirements of USFDA and is one of the most trusted Brands.
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