This
document provides firms
considering elimination of
product sterility
testing associated with lot
release of moist heat
sterilized parenterals information and areas for consideration. A parametric release program uses a specific set of engineering and microbiological data generated through sterilization validation studies, biological validation studies, sterilizer control and routine monitoring programs to determine that a desired sterility assurance level is provided and maintained without the need of finished product sterility testing..
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