Pharmaceutical Manufacturing Solutions: Microbial Detection in Water

Guidelines for an online water bioburden analyzer may soon lead to a more reliable and sophisticated method of water quality assessment.

Risk reduction and process control in the pharmaceutical industry are in desperate need of modern technologies. This couldn’t be truer when it comes to water quality assessment. The traditional method leaves a lot to be desired. Thanks to an industry workgroup, a solution may be on the way.

The currently accepted practice for microbial detection in water is collecting samples at points-of-use (POU) and assessment via culture-based methods. The idea of POU testing is to reflect the quality of the entire water system. However, this provides limited sampling frequency and retrospective analysis (culture-based methods). Additionally, it is possible that a sample is contaminated during collection. Growth-based methods used here do provide the ability to identify organisms, however, many still go undetected.

The potential solution to this problem may surface thanks to a workgroup of representatives from seven major pharmaceutical companies: Online Water Bioburden Analyzer (OWBA) Workgroup.  They outlined user requirements and a testing protocol to guide the development of an OWBA system. They believe, “an online water bioburden analyzer has the potential to eliminate sampling and testing errors via reduced manipulations while providing increased product safety and process control through the availability of statistically significant data.”

The purpose of an OWBA system isn’t to replace compendial water testing, but to reduce risk. Some potential benefits include:

  • Energy savings via reduced sanitization cycles and the operating temperature of the hot water system
  • Labor reduction through online monitoring and water system optimization, decreasing the frequency of sampling and lab-based testing.
  • Faster remediation response
  • Fewer investigations
  • Real-time monitoring that results in better process understanding and product safety


To learn about a laser-induced fluorescence method that may satisfy the OBWA requirements, visit For questions about cleanroom validation or certification, contact Gerbig Cleanrooms. Call us at 888-628-0056 or email us.