Customer Service:
Mon - Fri: 8:30 am - 6 pm EST


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.

Content Provider
Parenteral Drug Association [pda]

Others Also Bought

ISO 11135, ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11607-1 and ISO 11607-2
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Document History
We have no document history for this standard.
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.