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Sterilizing filtration—Principles and practice for successful scale-up to manufacturing

Authors:	P Rajniak SC Tsinontides D Pham WA HunkeSD Reynolds RT Chern

Institution:	Global Pharmaceutical Commercialization, Merck & Co., Inc., Sumneytown Pike WP78-110, West Point, PA 19486-0004, United States

Abstract:

Keywords:	&ldquo 1 + 1&rdquo configuration of redundant filtration containing a single 25 cm filter cartridge in series with a single (redundant) 25 cm filter cartridge &ldquo 3 + 1&rdquo configuration of redundant filtration having three parallel 25 cm filter cartridges in series with a single redundant filter cartridge CB complete blocking CF cake filtration FDA Food and Drug Administration IB intermediate blocking PDA Parenteral Drug Association GCB generalized complete blocking GMP good manufacturing procedures GSB generalized standard blocking GSCB generalized standard and complete blocking QbD quality by design SB standard blocking SCB standard and complete blocking
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