In the design, control, and regulation of the manufacturing and supply of microbiologically
controlled devices (including sterile devices) and drug products (including cleaning, …

… James Agalloco, James Akers, Hal Baseman, Richard Boeh, Russell Madsen, Steven
Ostrove and Anthony Pavell …

Aseptic processing involves the prevention of microbioloigal contamination of sterilized
product and product contact surfaces. Sterile combination products where one or more …

United States. The Food and Drug Administration (FDA) differentiates medical device
products based on their existing approval process. Premarket approval (PMA) submissions …

Interventions performed by personnel during an aseptic process can be a key source of
microbiological contamination of sterile biopharmaceutical products, irrespective of the type of …

The chapter provides insight into the background, intent, and content of the current 2011
guidance, based in part on responses to the 2008 draft guidance, Parenteral Drug Association (…

21 Commentary on the US Food and Drug Administration drug. substances),. collectively.
referred. to. in. this. guidance. as. drugs. or. products.. This. guidance. incorporates. principles. …

… heard disparaging a defensively feeble first baseman by observing he was “no Hal Chase”),
his … To be sustained for as long as it has, the legend of Hal Chase has required more than …

… PDA Pre Use/Post-Sterilization Integrity Test Task Force:, Karen Bartel, Hal Baseman,
Gabriele Gori, Richard Levy, Hemisha Ly, Maik Jornitz, Russell Madsen, Michiel Rook and …