As per Pharmaceuticals Guidelines , What Area classification (Grade C or Grade D ) is required in Microbiology area mainly Media Testing and Culture testing area (under RLAF/LAF) if the bulk/semi finished/finished product is not sterile category. ? can you suggest please
There is no difference in testing area for sample of different pharmaceutical manufacturing stages. Analysis should be done in under LAF or RLAF and LAF must be place in a class 1000 room. To maintain the room you have to maintain the room surroundings class 10000 and 100000.
Dear Mr. Ankur ,
Thanks for your immediately reply , i would like to ask, Back ground of LAF/RLAF Should be class 10,000 or can we maintain it class 1,00,000 if product are not sterile and its not directly exposed in environment . its sealed product in Aluminium can.Can you suggest the exact requirement class C or Class D ?
Dear Mr. Ankur,
Is AHU of cool zone of microbiology lab & MLT lab can be kept same.
AHU could be same but pressure differential must be maintained.
Thanks for prompt reply.