21st July 2015  Content supplied by: Parenteral Drug Association (PDA)

Bioburden and Biofilm Management in Pharma Operations - PDA Technical Report

Manufacturers of sterile drug  products devote significant resources on programs to control microbial  contamination in their products/processes. Bioburden and biofilm management is a  significant aspect of microbial control strategies. Persistent bioburden and biofilm problems have been directly linked to several recalls and plant shutdowns.

With current scientific knowledge of microbial growth and adaptation and understanding of the causes and control of bioburden, PDA Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Operations has been written and organized to provide pharmaceutical professionals with all the information  necessary to implement an effective and comprehensive program of bioburden and  biofilm management. Highlights

  • Provides an overview of the science of bioburden and  biofilms
  • Outlines design, control and prevention considerations
  • Details all steps necessary for bioburden and biofilm  detection and characterization
  • Closes the loop with a chapter on bioburden investigation  and remediation

PDA Technical Report No. 69 also includes five instructive,  real-life case studies.

Download/purchase the full report: https://store.pda.org/ProductCatalog/Product.aspx?ID=2789

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Date Published: 21st July 2015

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