Classified area in microbiology lab

Microbiology
1

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

2

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.

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3

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 ?
regards

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4

Dear Mr. Ankur,

Is AHU of cool zone of microbiology lab & MLT lab can be kept same.

5

AHU could be same but pressure differential must be maintained.

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6

Thanks for prompt reply.