James P Agalloco

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This article reviews current industry practices and regulatory expectations for the aseptic processing of sterile drugs. It provides comparisons and outlines points of tension between curent manufacturing technology and capabilities with regulatory “requirements” for this important activity. n 1988, the Parenteral Drug Association (PDA) published a position(More)
The use of isolator systems for sterility testing is on the increase. Prior to installation and validation careful consideration must be given to the type of barrier to be used, and the design of the facility which will house the barrier system. The validation of these systems requires development and testing of the sterilization cycle. Vapor phase hydrogen(More)
www.pharmtech.com art I of this article, published in the October 2001 issue of Pharmaceutical Technology, discussed the several causes of imprecisions in bubble-point determinations (1). The authors stated that a more accurate fix on the bubble point could be attained by implementing it with diffusive-airflow data. Such measurements, in conjunction with(More)