PDA TR 69

Technical Report No. 69 (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations

Parenteral Drug Association , 06/01/2015

Publisher: PDA

File Format: PDF

$162.00$325.00


PDA Technical Report No. 69, (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations presents the current scientific understanding of the causes of and control strategies for bioburden in pharmaceutical production systems, with a special emphasis on biofilms in fluid-handling systems. It encompasses pharmaceutical and biopharmaceutical manufacturing processes, but does not include the final aseptic and terminal sterilization fill-finish operations.

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