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What is sterility testing? Sterility testing is intended to demonstrate the presence or absence of extraneous practical contaminating microorganisms in biological parenterals made for human use.Sterility testing should be carried out on last container content or other acceptable content as defined during the accepted biologics license application o
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Planning a sturdy water method that continuously produces significant-excellent merchandise water is crucial for pharmaceutical production processes.It carries a less stringent specification for bacterial endotoxins than Sterile Water for Injection, and for that reason, will not be appropriate for parenteral programs. Nonmonographed Manufacturing W