Detecting Low Levels of Microbial Contamination in Pharmaceutical Water Systems

Millipore's innovative disposable manufacturing, filtration, chromatography, process monitoring and water purification solutions will be showcased at Booth #2221 during Interphex 2006, March 21-23, 2006, at the Jacob K. Javits Convention Center in New York City.

On Wednesday March 22, Wayne_Miller@millipore.com Russo, Technology Manager, Process Monitoring Tools will be presenting a study of the detection of low level contamination in pharmaceutical process water, the abstract of which is presented here.

Most bacteria in pharmaceutical water systems are likely to exist as biofilm attached to internal surfaces of the system. As such, the contaminants are not likely to be uniformly distributed throughout the system. Consequently, a quality control (QC) sample taken at any given time may not be representative of the real level of contamination in the system.

One of the most important parameters of pharmaceutical water quality is low to no bioburden. Developing QC processes to ensure low to no bioburden is key to a company's manufacturing success. This study demonstrates the importance of increasing sample volume using an on-line filtration sampler for the detection of low level microbial contamination and/or random biofilm detachment events in a water system. This study also discusses how employing an ATP-bioluminescence based rapid microbial enumeration technology can be beneficial in faster detection of microbial contamination in water samples.

Millipore's MicropreSure on-line filtration samplers are an innovative and convenient tool that allow large volumes of water samples to be aseptically processed at the collection site. The sampler uses the pressure in tanks or pressurized lines to process and collect samples through a microporous membrane within an enclosed chamber. The single-use samplers are securely locked together, so sampling pressurized water will not create water leaks. The samplers are closed throughout the entire test so there is no risk of adventitious contamination while sampling. Organisms are captured on the membrane right at the collection site, ensuring a representative sample and reliable test results. The MicropreSure on-line filtration samplers are shipped sterilized and ready to use.

Millipore's Milliflex Rapid Microbiology Detection System is an automated solution for the rapid detection, response, and resolution of microbial contamination in filterable samples. The system improves process control, product yield and the timely release of products. Based on Adenosine Triphosphate (ATP) bioluminescence technology, the Milliflex Rapid system delivers faster test results than traditional microbial contamination detection methods, such as membrane filtration and pour plates. The Milliflex Sample Prep method also ensures consistent, reliable results. The Milliflex Rapid system can clearly distinguish between mixed microbial growth of slow growing and fast growing microorganisms, as well as variances in their size and ATP content in water samples.

For more information on Millipore products for detection low level contamination in process water please contact your local Millipore representative or Wayne_Miller@millipore.com Russo, contact details are at the top of this page.