PDA Technical Reports
PDA Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations
TR-69 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. Both large and small molecule production are covered.
Updates 2003 edition with revisions based on the impact of knowledge gained in the industry as determined by a task force of subject matter experts. The revision provides positions on current topics, best practices, and areas of clarification that are important to the manufacturing of quality sterile products.