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PDA Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Operations

For Immediate Release:
06/10/2015
Media Inquiries:
Walt Morris
/ morris@pda.org /
301-656-5900, x. 148

Bethesda, Md., June 10, 2015 – 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