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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
Regulatory affairs in pharmaceutical industry

Following are some of articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing

Pharmaceutical Validation

Clean Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

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Pharmaceutical companies

Regulatory Affairs in Pharmaceutical Industry

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