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This blog mainly talks about QMS,cGMP,Regulatory Filings & Guidelines,Validation & Qualifications,Drug Stability,FDA 483s &Media Fill.
Hope this blog will cater the needs of both fresher’s and experienced professionals.
grade filter is one that will produce a sterile effluent after being challenged
by microorganisms at a challenge level of greater than or equal to 1x107/cm2 of effective filtration
the late 1960’s, 0.45 μm-rated membranes were considered “sterilizing grade”
filters, and were used successfully in the sterilizing filtration of
parenterals. In the mid-1960’s Dr. Frances Bowman observed a 0.45 μm
“sterile-filtered” culture medium to be contaminated with a micro-organism,
subsequently shown to penetrate 0.45 μm-rated membranes repeatedly in small
Brevundimonas diminuta is a standard organism for
validation of sterilizing-grade membrane filters.
diminuta (formerly known as Pseudomonas diminuta)is a gram negative 0.5x1.0 -4.0 μm,motile rod with one