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Aseptic filling definition

The bulk production of sterile drug products such as antibiotics, corticosteroids, insulin, and certain biotechnology products requires that a number of processes be carried out under aseptic conditions. These processes can be evaluated in a manner adapted from those employed for aseptic filling processes. A joint PDA/PhRMA task force has developed the definitive guidance document on this subject. ... [Pg.130]

The most recent industry survey on aseptic processing was published by PDA in 1997. It attempted to address the statistical nature of the limits as actually practiced, however the response to questions in that area are inconclusive. It did include evidence that several firms had adopted acceptance criteria tighter than 0.1%, suggesting that another round of acceptance criterion definition might be in the offing. The most recent commentary on acceptance criteria is that provided by USP in draft chapter, 1116. The USP expanded upon PDA s 1996 position, and established ever tighter requirements, The goal is zero contamination. In an individual run not more than one positive unit in 5000 filled units. In a series of three media fills, two of the three media fills should have no contamination present. ... [Pg.136]


See other pages where Aseptic filling definition is mentioned: [Pg.130]    [Pg.137]    [Pg.19]    [Pg.135]    [Pg.702]   
See also in sourсe #XX -- [ Pg.179 ]




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