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.

CONTENT PROVIDER
Parenteral Drug Association [pda]

Others Also Bought
Fundamentals of an Environmental Monitoring Program
Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics
Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities
Included in Packages
This standard is not included in any packages.
Document History
We have no document history for this standard.
Amendments & Corrections
We have no amendments or corrections for this standard.