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Tuesday, August 11, 2009

Clean Room Classification with respect to particle caounts and Microbial load count




Clean room Classification with respect to particle caounts
Clean Aira ----Iso ------> 0.5 um Particles --Microbiological ------Microbiological*
Clasification--Designation--Per Cubic------Ative Air Action leve- Stteling plate *
100------ ----5----------3520------------1-----------------1


1000----- ----6---------35200-----------7-----------------3


10000--- -----7---------352000---------10----------------5


100000---- --8----------3520000-------100--------------50


Action Lvel CFU per 4 HRS*
Also see Pharmaceutical process validation
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Guidelines for Standard operating procedure SOP for microbiology and aseptic techniques for manufacturing of sterile pharmaceuticals , cgmp guidelines for pharmaceuticals, pharmaceutical validations
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