Historical
PDA TR 69-2015
Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations
A comprehensive program of bioburden management includes strategies for preventing and controlling biofilms and is based on current scientific knowledge of microbial growth and adaptation. This technical report 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. The scope of the report encompasses pharmaceutical and biopharmaceutical manufacturing processes but does not include final aseptic and terminal sterilization fill-finish operations. It is important to educate engineers, scientists and managers about the science of bioburden and biofilms because of the broad and complex challenge of bioburden management.
Parenteral Drug Association [pda]